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HEALTHCARE CONFERENCE: DAY 3

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Healthcare Conference: Day 3

JP Morgan Healthcare Conference: Day 3

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SUMMARY The 34th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 11-14, 2016. A list of events and catalysts that were announced or updated at the conference today is included in this report. Additionally, below are some key points from today’s company presentations.

ABOUT THE AUTHORS BioMedTracker is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clients from the pharmaceutical, biotech, and investment industries rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication. Over the last several years, BioMedTracker has become the leader in providing objective information alongside evidence based clinical assessments and investment research on pipeline drugs worldwide. For more information on getting direct access to BioMedTracker, please email [email protected]. MedDeviceTracker is an all new medtech intelligence platform that provides clients with real-time data and analysis on medical devices and diagnostics. From the people behind BioMedTracker, comes an event-driven research service for the medical device and diagnostic marketplace. For access to MedDeviceTracker please contact your sales representative or email [email protected].

DISCLAIMER Copyright © 2016 Sagient Research This report is published by Sagient Research (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made to publish accurate information, you assume sole responsibility for the selection, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the information or advice contained herein. The Publisher wishes to make it clear that any views or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher.


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KEY POINTS – DAY 3

PTC Therapeutics (PTCT) expects approval of Translarna in Duchenne muscular dystrophy in mid-2016. Just before the start of the conference, they had announced completion of the rolling NDA submission.

Enanta (ENTA) announced nomination of FXR agonist EDP-305 as their developmental candidate for NASH (nonalcoholic steatohepatitis) and PBC (primary biliary cirrhosis). The Company is currently on track to initiate clinical trials in 2016. In preclinical data presented, EDP-305 was more potent than obeticholic acid (OCA, the active ingredient of INT-747) on FXR activation, and in the STAM mouse model, there were suggestions it may have an advantage on hepatocyte ballooning and the NAFLD activity score at a similar dose.

Esperion (ESPR) reiterated the FDA has never told them they will need a CV outcomes trial completed before approval of ETC-1002—just that it must be well underway—but said they will only be able to disclose Phase III plans in Q2 2016, after discussions with the agency. Their focus is on statin intolerant patients, for which no drugs have previously been formally approved.

Clovis (CLVS) gave reassurance that their next-generation EGFR inhibitor, rociletinib, would both gain approval this year and be able to compete with Tagrisso (AZN), which beat it to market late last year. Officials did suggest that an ODAC is a distinct possibility, perhaps in April, but were not sure what questions the FDA would have given the rather straight-forward nature of the single-arm study. They also suggested that both Tagrisso and rociletinib would be viewed relatively comparable on efficacy in the relevant US population, and competition with thus likely come down to the different safety profiles (namely rash vs hyperglycemia).

Earlier this week, Juno (JUNO) announced the acquisition of AbVitro and its single-cell sequencing technology which it is planning to use to refine its development of T-cell therapies. The company had few other major updates but did seem well-focused on a singular goal of developing CAR-T therapies for hematologic cancers. Indeed, officials highlighted the difficulty in addressing solid tumors with CAR-Ts. They similarly suggested an allogeneic therapy would be extremely difficult. Lastly, the company noted that it had developed an in-house mouse model to study neurotoxicity issues.


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Array (ARRY) suggested that binimetinib NEMO data would probably be presented at ASCO, and OS data would be included if mature. Filing for binimetinib should also come in the first half of 2016. Officials also highlighted the potential of selumetinib in neurofibromas.

Infinity (INFI) and AbbVie (ABBV) reiterated that key top-line data from the duvelisib program in lymphoma are expected later this year. Results from the Phase II DYNAMO study in indolent NHL will be reported in early Q3, followed by an interim analysis from the Phase III DUO study in CLL during the second half of 2016. Both companies are also collaborating on a combination therapy of duvelisib and ABBV’s venetoclax which is slated to advance into a clinical study this year.


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CONTENTS Array BioPharma, Inc. (ARRY) ..................................................................................................... 6

ARRY-797 for Congestive Heart Failure (CHF) ......................................................................... 6 Bayer AG (BAYRY) ....................................................................................................................... 6

Finerenone for Congestive Heart Failure (CHF) ....................................................................... 6 BioCryst Pharmaceuticals, Inc. (BCRX) ........................................................................................ 7

BCX7353 for Hereditary Angioedema (HAE) ............................................................................ 7 Avoralstat for Hereditary Angioedema (HAE) ......................................................................... 8

China Biologic Products, Inc. (CBPO) ........................................................................................... 8

Human fibrinogen (CBPO) for Hemostasis............................................................................... 8 Clovis Oncology, Inc. (CLVS) ....................................................................................................... 9

Lucitanib for Breast Cancer ...................................................................................................... 9 Lucitanib for Non-Small Cell Lung Cancer (NSCLC) ................................................................ 10 Lucitanib for Ovarian Cancer .................................................................................................. 10 Lucitanib for Hepatocellular (Liver) Cancer (HCC) (including secondary metastases) ......... 11 Rociletinib for Non-Small Cell Lung Cancer (NSCLC).............................................................. 12 Rociletinib for Non-Small Cell Lung Cancer (NSCLC).............................................................. 12 Rociletinib for Non-Small Cell Lung Cancer (NSCLC).............................................................. 13 Rociletinib for Non-Small Cell Lung Cancer (NSCLC).............................................................. 14 Rucaparib for Prostate Cancer ............................................................................................... 15 Rucaparib for Ovarian Cancer ................................................................................................ 15

Enanta Pharmaceuticals, Inc. (ENTA) ........................................................................................ 17

EDP-305 for Non-alcoholic Steatohepatitis (NASH) .............................................................. 17 EDP-305 for Primary Biliary Cirrhosis (PBC) and Hepatic Fibrosis ........................................ 18 Non-Fusion Inhibitor Program for Respiratory Syncytial Virus (RSV) ................................... 18 Core Inhibitor Program for Hepatitis B (HBV) Treatment (Antiviral).................................... 19

Esperion Therapeutics, Inc. (ESPR) ............................................................................................. 19

ETC-1002 for Dyslipidemia / Hypercholesterolemia ............................................................. 19 Global Blood Therapeutics Inc. (GBT) ........................................................................................ 20

Oral Kallikrein Inhibitor (GBT) for Hereditary Angioedema (HAE) ....................................... 20 Hanmi Pharmaceutical Co., Ltd. ................................................................................................. 21

HCP1302 for Hypertension (Systemic) ................................................................................... 21 HCP1105 for Dyslipidemia / Hypercholesterolemia .............................................................. 22 HCP1405 for Osteoporosis / Osteopenia ............................................................................... 22 HCP1401 for Hypertension (Systemic) ................................................................................... 23 HIP1402 for Benign Prostatic Hyperplasia (BPH) ................................................................... 23 HCP1202 for Chronic Obstructive Pulmonary Disease (COPD) ............................................. 24


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Indivior plc .................................................................................................................................. 24

RBP-6300 for Drug Addiction ................................................................................................. 24 RBP-7000 for Schizophrenia ................................................................................................... 25

Inrexon Corporation (XON)........................................................................................................ 25

Ocular Disease Program (Intrexon/Sun) for Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology) .......................................................................................................... 25 Non-Viral CAR-T Program for Solid Tumors ........................................................................... 26

MannKind Corporation (MNKD) ................................................................................................ 26

Treprostinil (MannKind) for Pulmonary Arterial Hypertension (PAH) ................................. 26 Momenta Pharmaceuticals (MNTA) ........................................................................................... 27

M740 for Undisclosed ............................................................................................................. 27 M615 for Undisclosed ............................................................................................................. 27 M706 for Undisclosed ............................................................................................................. 28 M710 for Undisclosed ............................................................................................................. 28 M730 for Undisclosed ............................................................................................................. 29

Regeneron Pharmaceuticals, Inc. (REGN) .................................................................................. 29

Praluent for Dyslipidemia / Hypercholesterolemia .............................................................. 29 Fasinumab for Chronic Pain ................................................................................................... 30

St. Jude Medical, Inc. (STJ) ......................................................................................................... 30

Portico TAVI System for Cardiac Valve Surgery ..................................................................... 30 Taiwan Liposome Company, Ltd. .............................................................................................. 31

TLC178 for Cutaneous T-Cell Lymphoma (CTCL) - NHL .......................................................... 31 TLC198 for Anesthesia ............................................................................................................ 31 Lipotecan for Hepatocellular (Liver) Cancer (HCC) (including secondary metastases) ........ 32 Lipotecan for Renal Cell Cancer (RCC) .................................................................................... 32 Lipotecan for Prostate Cancer ................................................................................................ 33 Lipotecan for Colorectal Cancer (CRC) ................................................................................... 33

List of New BioMedTracker Catalysts…………………………………………………………………………………….35 List of Updated BioMedTracker Catalyts………………………………………………..……………………………..39 List of MedDeviceTracker Catalysts……………………………………………………………………………………….43


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ARRAY BIOPHARMA, INC. (ARRY) ARRY-797 for Congestive Heart Failure (CHF)

Event Date: 01/13/2016

Event Type: Trial Announcement - Trial Progressing (Clinical Analysis)

Trial Name: Phase II - LMNA-Related Dilated Cardiomyopathy

Market Group: Cardiovascular

Lead Company: Array BioPharma, Inc. (ARRY)

Partner Companies: N/A

Phase: II

Change to Likelihood of Approval: 0%

Likelihood of Approval: 13% (Same As Avg.)

Average Approval: 13%

Analysis: Array announced that the Phase II trial of ARRY-797 for LMNA-related dilated cardiomyopathy is ongoing. Data is expected to be presented in the near future. Array also stated that compared with historical benchmarks in the 6 minute walk test, the study's primary endpoint, the data emerging is "encouraging." ARRY-797 secondary endpoint measures also suggest activity (NT-proBNP, patient reported outcomes).

Source: J.P. Morgan Healthcare Conference 01/13/2016 (ARRY, Slide 30-31, 33)

BAYER AG (BAYRY) Finerenone for Congestive Heart Failure (CHF)


Event Type: Trial Announcement - Initiation (Clinical Analysis)

Trial Name: Phase III - FINESSE-HF


Lead Company: Bayer AG (BAYRY)


Phase: III


Likelihood of Approval: 49% (2% Above Avg.)


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Analysis: Bayer announced that Phase III trials of finerenone for diabetic kidney disease and chronic heart failure have been initiated.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (BAYRY, Slide 21)

BIOCRYST PHARMACEUTICALS, INC. (BCRX) BCX7353 for Hereditary Angioedema (HAE)


Event Type: Trial Announcement (Clinical Analysis)

Trial Name: Phase II - APeX-1

Market Group: Autoimmune/ immunology

Lead Company: BioCryst Pharmaceuticals, Inc. (BCRX)


Phase: I




Analysis: BioCryst announced the study design for a Phase II proof of concept study of BCX7353 for the treatment of hereditary angioedema (HAE). The study is planned to start in the first quarter of 2016 following regulatory review and IRB approvals, with results expected in mid-2016. Phase II APeX-1 Study APeX-1 is a Phase II randomized, placebo-controlled, blinded, oral, once daily, 4-week cohort study of BCX7353 in HAE patients. The study is dose-ranging, with three doses of BCX7353:

Lowest dose not less than 100 mg Highest dose not greater than 350 mg

The primary endpoint of the study is mean acute angioedema attack rate.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (BCRX, Slides 19 and 23)


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Avoralstat for Hereditary Angioedema (HAE)



Trial Name: Phase III - OPuS-4 (Long-Term Safety)


Lead Company: BioCryst Pharmaceuticals, Inc. (BCRX)


Phase: III




Analysis: BioCryst announced the initiation of a long-term safety study of avoralstat for the treatment of hereditary angioedema (HAE) entitled OPuS-4. Results from the study are expected in 2017. Phase III OPuS-4 Study OPuS-4 is a long-term safety study of avoralstat. The goals of the study are to evaluate 6 to 12 month dosing with avoralstat and satisfy filing requirements.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (BCRX, Slide 13)

CHINA BIOLOGIC PRODUCTS, INC. (CBPO) Human fibrinogen (CBPO) for Hemostasis


Event Type: Progress Update (Clinical Analysis)

Trial Name: N/A

Market Group: Hematology

Lead Company: China Biologic Products, Inc. (CBPO)


Phase: Development Outside U.S.



Average Approval: N/A


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Analysis: China Biologic Products currently lists its human fibrinogen program in Phase III development in its pipeline.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (CBPO, Slide 18)

CLOVIS ONCOLOGY, INC. (CLVS) Lucitanib for Breast Cancer


Event Type: Trial Data (Clinical Analysis)

Trial Name: Phase II - Advanced BC (FGFR1-amp; 11q-amp) (Clovis; US)

Market Group: Oncology

Lead Company: Clovis Oncology, Inc. (CLVS)

Partner Companies: Servier Advenchen Laboratories SIMM

Phase: II




Analysis: Clovis announced an overview of lucitanib at the 34th annual JP Morgan Healthcare Conference. Context There is an unclear regulatory path as monotherapy, and future development is focused on combination studies. Enrollment (n=160) completion is expected the first quarter of 2016 for the Phase II trial of lucitanib for breast cancer. Design The Phase II trial of lucitanib for advanced breast cancer, with no limit on previous therapies, randomizes patients to 10mg or 15mg. The 10mg dose was selected as the recommended dose, and this arm is still enrolling. The 15mg arm is closing. Results Positive PFS data is emerging from the ongoing U.S. breast cancer study in patients with median of four prior therapies. There is an unclear regulatory path as monotherapy, and future development is focused on combination studies. The


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emerging profile suggests VEGF inhibition drives risk:benefit. There was no additional benefit in FGFR1-amp patients. Most Common Adverse Events No new safety signals were observed.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (CLVS, Slide 20-21)

Lucitanib for Non-Small Cell Lung Cancer (NSCLC)


Event Type: Trial Announcement - Trial/Enrollment Suspension (Clinical Analysis)

Trial Name: Phase II - FGFR1-amplified Squamous NSCLC




Phase: II

Change to Likelihood of Approval:

0%



Analysis: Clovis announced that they are discontinuing the Phase II lung cancer study for lucitanib as it has been a very difficult study to enroll.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (CLVS, Slide 21)

Lucitanib for Ovarian Cancer



Trial Name: N/A



Partner Companies: Servier


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Advenchen Laboratories SIMM

Phase: Preclinical

Change to Likelihood of Approval: N/A



Analysis: Clovis announced that there is an opportunity for an intra-portfolio lucitanib/rucaparib combination in ovarian cancer. The company stated a Phase Ib study is planned to initiate the second half of 2016.


Lucitanib for Hepatocellular (Liver) Cancer (HCC) (including secondary metastases)



Trial Name: N/A




Phase: Preclinical




Analysis: Clovis announced that there was synergy with lucitanib and mTOR inhibitors in pre-clinical models in hepatocellular cancer. The company stated a Phase Ib study is planned to initiate the second half of 2016.



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Rociletinib for Non-Small Cell Lung Cancer (NSCLC)


Event Type: Regulatory - Progress Update (Clinical Analysis)

Trial Name: N/A



Partner Companies: Celgene (CELG)

Phase: NDA/BLA




Analysis: Clovis announced that an Oncologic Drugs Advisory Committee (ODAC) meeting remains a possibility ahead of the June 28, 2016, PDUFA date for rociletinib for the treatment of advanced, EGFR-mutant, T790M-positive non-small cell lung cancer. A potential time when the ODAC currently has no meeting agenda may be from April 11-13, 2016. Any discussion may be related to the FDA requesting additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib.

Source: www.fda.gov (2016 Advisory Committee Tentative Meetings) J.P. Morgan Healthcare Conference 01/13/2016 (CLVS, Slide 4)



Event Type: Trial Data - Updated Results (Clinical Analysis)

Trial Name: Phase I/II - TIGER-X (US)




Phase: NDA/BLA





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Treatment Treatment Treatment Treatment Description Rociletinib 500mg

T790M-Positive Rociletinib 625mg T790M-Positive

Rociletinib 625mg T790M-Negative

Number of Patients 79 170 24 Confirmed Overall Response Rate (ORR) (Endpoint=Primary)

28.000 % 34.000 % 29.000 %

Analysis: Clovis Oncology gave an overview of clinical data for rociletinib for the treatment of non-small cell lung cancer (NSCLC) at the 34th annual JP Morgan Healthcare Conference. Results from this study were last seen in September 2015. Context The 625mg BID dose is the likely go-forward dose. Results The T790M-positive patients had a confirmed ORR of 34% at the 625mg BID dose (n=170) and a confirmed ORR of 28% at the 500mg BID dose (n=79). Median duration of response was ~9 months for both doses. The T790M-negative patients had a confirmed ORR of 29% at the 625mg BID dose (n=24). Median duration of response was ~7 months. The magnitude of benefit compares with SoC chemotherapy. Most Common Adverse Events Notable AEs include hyperglycemia and QTc prolongation. QTc was readily managed and few arrhythmic events were observed. Safety profiles were similar between doses.




Event Type: Progress Update - Development Review (Clinical Analysis)

Trial Name: Phase II/III - TIGER-1 (vs. Erlotinib) , Phase III - TIGER-3




Phase: NDA/BLA



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Analysis: Clovis announced its rociletinib clinical priorities in mEGFR NSCLC. They plan to complete the TIGER-3 monotherapy confirmatory study vs. chemotherapy in both T790M-positive and -negative cohorts. In addition, the focus now will be the on best combination therapies in first and later line patients with immuno-oncology agents, including inhibitors of PD1 and PDL-1, bevacizumab, and cetuximab. Clovis is also deprioritizing certain monotherapy programs:

Discontinuing TIGER-1 monotherapy study in treatment-naïve patients Front line treatment paradigm evolving to combination therapies

o Tarceva/Avastin combination with 13.8 month PFS (Stahel, ECC, Sept 2015)

Evaluating best front-line combination Delaying TIGER-J2 Phase II study in Japanese patients; enrolling Asian

patients in other ongoing studies





Trial Name: Phase Ib/II - w/Atezolizumab




Phase: NDA/BLA




Analysis: Clovis announced that the Phase Ib/II study of the safety and efficacy of rociletinib (CO-1686) administered in combination with atezolizumab in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic non-small cell lung cancer (NSCLC) has begun clinical activities this week, starting with the first clinical site.



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Rucaparib for Prostate Cancer



Trial Name: N/A



Partner Companies: Pfizer (PFE)

Phase: Preclinical




Analysis: Clovis announced that they are expanding Rucaparib into prostate cancer, with a registration study to initiate in the third quarter of 2016. Two trials total are planned to initiate in the second half of 2016:

Clovis-sponsored Phase III trial in metastatic castrate-resistant BRCA mutant (inclusive of germline and somatic) prostate cancer patients

STRAT-STAMPEDE study in newly-diagnosed castrate-sensitive de novo metastatic tBRCAmut and BRCA-like prostate cancer patients

The proposed design for the CRPC registration trial includes metastatic prostate adenocarcinoma, castration resistant, Germline or Somatic BRCA mutant, progressive disease patients with prior Enzalutamide or Abiraterone treatment. They will receive Rucaparib 600 mg po BID or a control. Key study endpoints will be rPFS, OS, ORR, PSA kinetics, and patient reports outcomes.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (CLVS, Slide 10, 16-17)

Rucaparib for Ovarian Cancer


Event Type: Trial Data - Updated Results (Clinical Analysis)

Trial Name: Phase II - ARIEL2



Partner Companies: Pfizer (PFE)

Phase: III


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Treatment Treatment Treatment Treatment Description Rucaparib

tBRCAmut Rucaparib

BRCAwt (tBRCA-like)

Rucaparib BRCAwt

(Biomarker Negative)

Number of Patients 40 77 68 Confirmed Overall Response Rate (ORR) (Endpoint=Primary)

75.000 % 30.000 % 10.000 %

Complete Response 15.000 % N/A N/A Median Duration of Response (Endpoint=Secondary)

9.500 Months

9.500 Months

5.500 Months

Median PFS (Endpoint=Secondary) 12.800 Months

5.700 Months

5.300 Months

Analysis: Clovis Oncology gave an update of clinical data for rucaparib for the treatment of ovarian cancer at the 34th annual JP Morgan Healthcare Conference. Results from this study were last seen in September 2015. Context The initial NDA for tBRCAmut patients with advanced disease plans to start by a rolling submission to initiate in the first quarter of 2016 and to complete by the second quarter of 2016. A supplemental NDA for maintenance indication in tBRCAmut and BRCA-like populations is to follow, based on ARIEL 3, for which enrollment is expected to complete in the first quarter of 2016 with data approximately 12 months later. Clovis plans on initiating the ARIEL4 confirmatory study in mid 2016, which includes tBRCAmut and BRCA-like patients, as well as initiating multiple combination studies in ovarian cancer during 2016. Results Part 1 of the ARIEL 2 study showed tumor tissue BRCAmut confirmed ORR was 75%. 6 patients achieved a CR (15%). Median duration of response was 9.5 months. Median number of prior therapies was 2. Other results are represented in the table above. Overall confirmed response and duration of response in patients with tBRCAmut advanced ovarian cancer who received 3 or more prior lines of chemotherapy was


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61% and 12.9 months, respectively. Complete response was 13% and partial response was 48%. Rucaparib data was from 23 patients from ARIEL2 part 1 and study 010; data cutoff dates are consistent with ECC ESMO presentations in September 2015. All responses are confirmed responses per RECIST 1.1 tumor response criteria. Most Common Adverse Events Grade 3/4 treatment-related AEs observed in >15% of patients:

In ARIEL2, anemia/decreased hemoglobin (19%) In Study 10, fatigue/asthenia (21%) and anemia (26%) Readily managed with dose modifications

Source: J.P. Morgan Healthcare Conference 01/13/2016 (CLVS, Slide 11-15)

ENANTA PHARMACEUTICALS, INC. (ENTA)

EDP-305 for Non-alcoholic Steatohepatitis (NASH)



Trial Name: N/A

Market Group: Endocrine

Lead Company: Enanta Pharmaceuticals, Inc. (ENTA)


Phase: Preclinical




Analysis: Enanta announced the nomination of EDP-305 as the developmental candidate for the study of NASH and PBC. The Company is currently on tract to initiate clinical trials in 2016.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (ENTA, Slide 28)


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EDP-305 for Primary Biliary Cirrhosis (PBC) and Hepatic Fibrosis



Trial Name: N/A




Phase: Preclinical




Analysis: Enanta announced the nomination of EDP-305 as the developmental candidate for the study of NASH and PBC. The Company is currently on tract to initiate clinical trials in 2016.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (ENTA, Slide 28)

Non-Fusion Inhibitor Program for Respiratory Syncytial Virus (RSV)



Trial Name: N/A

Market Group: Infectious disease



Phase: Preclinical




Analysis: Enatna announced that the Company is currently studying a core inhibitor for the treatment of hepatitis B virus, and a non-fusion inhibitor for the treatment of RSV. Both compounds are in preclinical development, and the Company expects to advance one of the two product candidates to Phase I clinical studies in 2017.

Source: Press Release 01/11/2016 J.P. Morgan Healthcare Conference 01/13/2016 (ENTA, Slide 5 and 32)


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Core Inhibitor Program for Hepatitis B (HBV) Treatment (Antiviral)



Trial Name: N/A

Market Group: Infectious disease



Phase: Preclinical




Analysis: Enatna announced that the Company is currently studying a core inhibitor for the treatment of hepatitis B virus, and a non-fusion inhibitor for the treatment of RSV. Both compounds are in preclinical development, and the Company expects to advance one of the two product candidates to Phase I clinical studies in 2017.

Source: Press Release 01/11/2016 J.P. Morgan Healthcare Conference 01/13/2016 (ENTA, Slide 5 and 32)

ESPERION THERAPEUTICS, INC. (ESPR)

ETC-1002 for Dyslipidemia / Hypercholesterolemia



Trial Name: Phase III - ETC-1002-040


Lead Company: Esperion Therapeutics, Inc. (ESPR)


Phase: III





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Analysis: Esperion Therapeutics announced the start of a global Phase III long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017. This study marks the launch of the Phase III clinical program — known as Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen (CLEAR) — which will be focused on the development of bempedoic acid for statin intolerant patients with uncontrolled LDL-C levels. The Company will provide details of the full Phase III global development strategy in the second quarter of 2016. Separately, the Company anticipates formalizing and communicating the design of the planned cardiovascular outcomes trial in the second quarter of 2016. Phase III ETC-1002-040 Study ETC-1002-040 is a Phase III randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 900 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study will enroll patients at approximately 125 sites in the U.S., Canada and the European Union. The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on other lipid and cardiometabolic risk markers, including LDL-C and high-sensitivity C-reactive protein.

Source: Press Release 01/13/2016 J.P. Morgan Healthcare Conference 01/13/2016 (ESPR)

GLOBAL BLOOD THERAPEUTICS INC. (GBT) Oral Kallikrein Inhibitor (GBT) for Hereditary Angioedema (HAE)



Trial Name: N/A


Lead Company: Global Blood Therapeutics Inc. (GBT)


Phase: Preclinical


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Analysis: Global Blood Therapeutics (GBT) is currently conducting preclinical research to identify and develop an oral therapy for hereditary angioedema (HAE). The oral therapeutic could potently and selectively inhibit plasma kallikrein for the treatment of HAE. GBT intends to initiate a Phase I clinical trial of the HAE candidate in the second half of 2016.

Source: Company Website (GBT) J.P. Morgan Healthcare Conference 01/13/2016 (GBT)

HANMI PHARMACEUTICAL CO., LTD.

HCP1302 for Hypertension (Systemic)



Trial Name: N/A


Lead Company: Hanmi Pharmaceutical Co., Ltd. (128940:KS)






Analysis: Hanmi lists HCP1302 under Phase III development for hypertension/erectile dysfunction.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (Hanmi, Slide 9)


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HCP1105 for Dyslipidemia / Hypercholesterolemia



Trial Name: N/A








Analysis: Hanmi lists HCP1105 under Phase III development for the treatment of complex dyslipidemia.


HCP1405 for Osteoporosis / Osteopenia



Trial Name: N/A

Market Group: Endocrine







Analysis: Hanmi lists HCP1405 under Phase I development for osteoporosis.



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HCP1401 for Hypertension (Systemic)



Trial Name: N/A








Analysis: Hanmi lists HCP1401 under Phase III development for hypertension.


HIP1402 for Benign Prostatic Hyperplasia (BPH)



Trial Name: N/A

Market Group: Urology







Analysis: Hanmi lists HIP1402 under Phase III development for the treatment of prostatism.



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HCP1202 for Chronic Obstructive Pulmonary Disease (COPD)



Trial Name: N/A

Market Group: Respiratory







Analysis: Hanmi lists HCP1202 under Phase I development for the treatment of COPD.


INDIVIOR PLC

RBP-6300 for Drug Addiction



Trial Name: Phase I - RB-EU-14-0001

Market Group: Neurology

Lead Company: Indivior plc (INDV:LN)


Phase: II




Analysis: Indivior announced that they enrolled and dosed the first patients in a PK study (RB-EU-14-0001) of RBP-6300 in September 2015.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (INDV, Slide 15)


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RBP-7000 for Schizophrenia


Event Type: Trial Announcement - Trial/Enrollment Reinitiated (Clinical Analysis)

Trial Name: Phase III - RB-US-13-0005 (Long-Term Safety)

Market Group: Psychiatry

Lead Company: Indivior plc (INDV:LN)


Phase: III


0%



Analysis: Indivior announced that enrollment is currently on-going in a Phase III long-term safety study of RBP-7000 for the treatment of schizophrenia.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (INDV, Slide 16)

INREXON CORPORATION (XON) Ocular Disease Program (Intrexon/Sun) for Wet Age-Related Macular Degeneration (Wet

AMD) (Ophthalmology)



Trial Name: N/A

Market Group: Ophthalmology

Lead Company: Intrexon Corporation (XON)

Partner Companies: Sun Pharma (SUNP:IN)

Phase: Preclinical




Analysis: Intrexon lists their ocular disease program with Sun Pharma for the treatment of age-related macular degeneration in preclinical development. An IND filing is anticipated


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in the second half of 2016.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (XON, Slides 16 and 28)

Non-Viral CAR-T Program for Solid Tumors



Trial Name: N/A


Lead Company: Intrexon Corporation (XON)

Partner Companies: Merck KGaA (MKGAY) ZIOPHARM (ZIOP) MD Anderson Cancer Center

Phase: Preclinical




Analysis: Intrexon announced that they will test next-generation CAR-T cells for efficacy in solid tumors in 2017.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (XON, Slide 11)

MANNKIND CORPORATION (MNKD) Treprostinil (MannKind) for Pulmonary Arterial Hypertension (PAH)



Trial Name: N/A


Lead Company: MannKind Corporation (MNKD)


Phase: Preclinical





August 2016 / 28



27


Analysis: MannKind announced that they are pursuing development of an inhaled version of Treprostinil using their proprietary Technosphere technology. They have currently tested three formulations and anticipate conducting IND enabling studies throughout 2016, with the aim of submitting an IND in the fourth quarter of 2016.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (MNKD, Slide 10-11)

MOMENTA PHARMACEUTICALS (MNTA) M740 for Undisclosed



Trial Name: N/A

Market Group: Not Specified

Lead Company: Mylan Inc. (MYL)

Partner Companies: Momenta Pharmaceuticals (MNTA)

Phase: Preclinical




Analysis: Momenta reported that the M740 program is undergoing process development.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (MNTA, Slide 10)

M615 for Undisclosed



Trial Name: N/A




Phase: Preclinical




August 2016 / 29



28








Trial Name: N/A




Phase: Preclinical









Trial Name: N/A




Phase: Preclinical







August 2016 / 30



29





Trial Name: N/A




Phase: Preclinical






REGENERON PHARMACEUTICALS, INC. (REGN) Praluent for Dyslipidemia / Hypercholesterolemia


Event Type: Progress Update - Product Launch (Europe) (Clinical Analysis)

Trial Name: N/A


Lead Company: Regeneron Pharmaceuticals, Inc. (REGN)

Partner Companies: Sanofi (SNY)

Phase: Approved


0%



Analysis: Regeneron announced that Praluent has been made available in Germany, UK, and the Nordic countries.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (REGN, Slide 10)


August 2016 / 31



30


Fasinumab for Chronic Pain


Event Type: Regulatory - Meeting with FDA (Clinical Analysis)

Trial Name: N/A


Lead Company: Regeneron Pharmaceuticals, Inc. (REGN)

Partner Companies: Sanofi (SNY) Mitsubishi Tanabe (4508:JP)

Phase: III


Likelihood of Approval: 45% (7% Below Avg.)


Analysis: Regeneron announced that the partial hold on Fasinumab has been lifted. Based on discussions with the FDA, Phase III trials (>16 weeks) are expected to begin in the first half of 2016.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (REGN, Slide 24)

ST. JUDE MEDICAL, INC. (STJ)

Portico TAVI System for Cardiac Valve Surgery


Event Type: Progress Update - Product Launch (Europe) (Clinical Analysis)

Trial Name: N/A


Lead Company: St. Jude Medical, Inc. (STJ)


Phase: IDE


0%




August 2016 / 32



31


Analysis: St. Jude announced that it has now launched all 4 sizes of Portico (23, 25, 27, and 29 mm) in Europe.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (STJ)

TAIWAN LIPOSOME COMPANY, LTD. TLC178 for Cutaneous T-Cell Lymphoma (CTCL) - NHL



Trial Name: N/A


Lead Company: Taiwan Liposome Company, Ltd. (4152:TWO)


Phase: Preclinical




Analysis: Taiwan Liposome currently lists TLC178 in preclinical development for CTCL.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slides 8, 11)

TLC198 for Anesthesia



Trial Name: N/A




Phase: Preclinical





August 2016 / 33



32


Analysis: Taiwan Liposome currently lists TLC198 in preclinical development as a local anesthetic.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slide 11)

Lipotecan for Hepatocellular (Liver) Cancer (HCC) (including secondary metastases)



Trial Name: N/A





Change to Likelihood of Approval: -6%



Analysis: Taiwan Liposome outlined its development plan for TLC388. The Company intends to pursue TLC388 for rectal cancer, HCC and other indications in Taiwan and China. Given that US development was not included, we are moving the phase to Development Outside US.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slide 22)

Lipotecan for Renal Cell Cancer (RCC)


Event Type: Progress Update - Suspension (Clinical Analysis)

Trial Name: N/A




Phase: Suspended



August 2016 / 34



33




Analysis: Taiwan Liposome currently lists TLC388 in Phase II development for hepatocellular carcinoma and rectal cancer in Taiwan and China. Given that renal cancer is not in the pipeline, we are suspending this drug in this indication.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slide 11, 22)

Lipotecan for Prostate Cancer


Event Type: Progress Update - Suspension (Clinical Analysis)

Trial Name: N/A




Phase: Suspended




Analysis: Taiwan Liposome currently lists TLC388 in Phase II development for hepatocellular carcinoma and rectal cancer in Taiwan and China. Given that prostate cancer is not in the pipeline, we are suspending this drug in this indication.

Source: Sagient Analysis J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slide 11, 22)

Lipotecan for Colorectal Cancer (CRC)



Trial Name: N/A






August 2016 / 35



34





Analysis: Taiwan Liposome outlined its development plan for TLC388. The Company intends to pursue TLC388 for rectal cancer, HCC and other indications in Taiwan and China. TLC388 is currently listed in Phase II development for rectal cancer.

Source: J.P. Morgan Healthcare Conference 01/13/2016 (Taiwan Liposome, Slide 11, 22)


August 2016 / 36


Expected Date Range Company Symbol Drug Indication Phase Expected Catalyst Catalyst Title Analysis Link

01/13/2016-12/31/2016 AbbVie Inc. ABBV ABT-122 Psoriatic Arthritis (PA) IITrial Data - Top-Line Results

Phase II - Top-Line ResultsAbbvie announced that mid-stage results from their Phase II trial of ABT-122 for the treatment of psoriatic arthritis (PsA) will be available in 2016.

118306

01/13/2016-06/30/2016 AbbVie Inc. ABBV ABT-414Brain Cancer (malignant glioma; AA and GBM)

IITrial Data - Top-Line Results

Phase II - Top-Line Results

Abbvie expects data from the expansion arm of the second-line GBM study of ABT-414 to be available in 2016. If the data is positive the Company will then target a regulatory submission in the second half of 2016. As such we await top-line results in the first half of 2016.

118300

07/01/2016-12/31/2016 AbbVie Inc. ABBV ABT-414Brain Cancer (malignant glioma; AA and GBM)

IIRegulatory - NDA/BLA Filing

NDA Filing - 2nd Line GBM

Abbvie expects data from the expansion arm of the second-line GBM study of ABT-414 to be available in 2016. If the data is positive the Company will then target a regulatory submission in the second half of 2016.

118301

07/01/2016-12/31/2016 AbbVie Inc. ABBV ABT-493 Hepatitis C (HCV) (Antiviral) IIITrial Data - Top-Line Results

Phase III - Top-Line ResultsAbbvie announced that beginning in the second half of 2016 data from the Phase III trials for their next-gen HCV portfolio will become available.

118308

07/01/2016-12/31/2016 AbbVie Inc. ABBV ABT-530 Hepatitis C (HCV) (Antiviral) IIITrial Data - Top-Line Results

Phase III - Top-Line ResultsAbbvie announced that beginning in the second half of 2016 data from the Phase III trials for their next-gen HCV portfolio will become available.

118310

01/13/2016-12/31/2016 AbbVie Inc. ABBV VenetoclaxDiffuse Large B-Cell Lymphoma (DLBCL) - NHL

I/IITrial Data - Top-Line Results

Phase II - Top-Line ResultsAbbvie expects data from the Phase II study of Venetoclax in DLBCL to be available in 2016.

118298

01/13/2016-12/31/2016 AbbVie Inc. ABBV VenetoclaxIndolent Non-Hodgkin's Lymphoma - NHL


Phase II - Top-Line ResultsAbbvie expects data from the Phase II study of Venetoclax in iNHL to be available in 2016.

118297

01/13/2016-12/31/2016AMAG Pharmaceuticals, Inc.

AMAG Digoxin Immune Fab Eclampsia/Pre-Eclampsia II/IIITrial Announcement - Initiation

Severe Pre-Eclampsia - Clinical Program to Start

AMAG announced that Velo plans to complete preclinical work and initiate a clinical program of Digoxin Immune Fab for the treatment of severe pre-eclampsia in 2016.

118324


AMAG Makena Preterm Labor ApprovedProgress Update - Product Launch (U.S.)

Product Launch (US) - Single-Dose Vial

AMAG announced that they expect to launch the single-dose vial of Makena for the treatment of preterm labor within 3 or 4 weeks of FDA approval. As we expect an approval decision by March 23 2016 we await an update between March 23 2016 and the end of April 2016.

118333


AMAG Makena Preterm Labor ApprovedTrial Announcement - Initiation

PK Study - Trial to StartAMAG announced that they plan to initiate a Makena PK study for the treatment of preterm labor in 2016.

118323


AMAG Makena Preterm Labor ApprovedRegulatory - sNDA/sBLA Filing

sNDA Filing - Auto-InjectorAMAG announced that they plan to file a sNDA for a Makena subcutaneous auto-injector in the first quarter of 2017.

118321

01/13/2016-03/31/2016 Apple Tree Partners Probuphine Drug Addiction NDAProgress Update - Product Launch

Product Launch - U.S.Braeburn announced that the Company anticipates to launch Probuphine 6 months buprenorphine implant in the first quarter of 2016.

118381

01/13/2016-12/31/2016 Array BioPharma, Inc. ARRY Binimetinib Colorectal Cancer (CRC) ITrial Announcement - Initiation

Registration Study to StartArray BioPharma expects to initiate a Phase III global registration trial for binimetinib in BRAF-mutant metastatic colorectal cancer in 2016.

118425

02/01/2016-02/29/2016 Array BioPharma, Inc. ARRY Binimetinib Melanoma IIITrial Announcement - Initiation

Phase II SECOMBIT Trial to Start

A three arms prospective randomized Phase II study to evaluate the best sequential approach with combo immunotherapy (Ipilimumab/Nivolumab) and combo target therapy (LGX818/MEK162) in patients with metastatic melanoma and BRAF mutation is expected to start in February 2016.

118427

01/13/2016-12/31/2016 Array BioPharma, Inc. ARRY Binimetinib Ovarian Cancer IIITrial Announcement - Patient Enrollment Completed

Phase III Study - Patient Enrollment Complete

Array BioPharma announced that the Phase III MILO study of binimetinib on ovarian cancer is expected to complete enrollment in 2016.

118419

01/01/2017-12/31/2017 aTyr Pharma LIFEiMod.Fc Discovery Program

Pulmonary Fibrosis PreclinicalTrial Announcement - Initiation

Phase Ib/II - Trial to Start

aTyr plans to initiate a clinical program in rare pulmonary diseases with an immune component (RPIC) in patients with interstitial lung disease (ILD). In 2017 the Company expects to initiate a Phase Ib/II study with iMod.Fc.

118326

04/01/2016-09/30/2016BioCryst Pharmaceuticals, Inc.

BCRX Avoralstat Hereditary Angioedema (HAE) IIITrial Data - Updated Results

Phase I Healthy Volunteers (PK) - Updated Results

BioCryst announced that data from a solid-dose PK study of avoralstat for the treatment of hereditary angioedema (HAE) are expected in mid-2016.

118307


BCRX Avoralstat Hereditary Angioedema (HAE) IIIRegulatory - Meeting with FDA

End of Phase II Meeting w/FDA

BioCryst announced that they plan to conduct an end-of-Phase II meeting with the FDA regarding avoralstat for the treatment of hereditary angioedema (HAE) in mid-2016.

118313


BCRX Avoralstat Hereditary Angioedema (HAE) IIITrial Announcement - Initiation

Phase III OPuS-3 - Trial to StartBioCryst announced that they plan to initiate a study entitled OPuS-3 of avoralstat for the treatment of hereditary angioedema (HAE) at the end of 2016.

118309


BCRX Avoralstat Hereditary Angioedema (HAE) IIITrial Data - Top-Line Results

Phase III OPuS-4 - Top-Line Results

BioCryst announced the initiation of a long-term safety study of avoralstat for the treatment of hereditary angioedema (HAE) entitled OPuS-4. Results from the study are expected in 2017.

118311


BCRX BCX7353 Hereditary Angioedema (HAE) ITrial Announcement - Trial Completion

Phase II APeX-1 - Trial to Complete

BioCryst announced that the Phase II dose-ranging study of BCX7353 for the treatment of hereditary angioedema (HAE) is expected to complete in mid-2016.

118315


BCRX BCX7353 Hereditary Angioedema (HAE) ITrial Data - Top-Line Results

Phase II APeX-1 - Top-Line Results

BioCryst announced that results from the Phase II dose-ranging study of BCX7353 for the treatment of hereditary angioedema (HAE) are expected in mid-2016.

118299


BCRX BCX7353 Hereditary Angioedema (HAE) ITrial Announcement - Initiation

Phase III Confirmatory Japan Trial to Start

BioCryst announced that a pivotal trial for Japanese filing of BCX7353 for the treatment of hereditary angioedema (HAE) is expected to start at the end of 2016. This study will proceed under the sakigake process.

118304


BCRX BCX7353 Hereditary Angioedema (HAE) ITrial Data - Top-Line Results

Phase III Confirmatory Japan Trial - Top-Line Results

BioCryst announced that data from a pivotal trial for Japanese filing of BCX7353 for the treatment of hereditary angioedema (HAE) are expected in mid-2017.

118305

01/13/2016-06/30/2016Bristol-Myers Squibb Company

BMY FPA008Pigmented Villonodular Synovitis (PVNS)

I/IITrial Announcement - Initiation

Phase I/II Study 002 - Phase II Portion to Start

Five Prime announced that they expect to expand FPA008 into a Phase II portion for the treatment of pigmented villonodular synovitis (PVNS) in the first half of 2016.

118291


BMY FPA008 Solid Tumors ITrial Announcement - Other

Phase Ia/b Study 003 - Phase Ia Dose Escalation Complete

Five Prime announced that they expect to complete Phase Ia dose escalation testing FPA008 in 8 tumor settings in mid-2016.

118295


BMY FPA008 Solid Tumors ITrial Announcement - Initiation

Phase Ia/b Study 003 - Phase Ib Portion to Start

Five Prime announced that they expect to complete Phase Ia dose escalation testing FPA008 in 8 tumor settings and expand to Phase Ib in mid-2016.

118293

01/13/2016-06/30/2016 BTG plc BTC:LN Vistogard Drug Toxicity ApprovedProgress Update - Product Launch (U.S.)

Product Launch (U.S.)BTG announced that they plan to launch Vistogard for the treatment of drug toxicity in the United States in the first half of 2016.

118345

10/01/2016-12/31/2016 Cempra, Inc. CEMP SolithromycinChronic Obstructive Pulmonary Disease (COPD)

IITrial Announcement - Trial Completion

Phase II - Trial CompletedCempra announced the Company expects to complete the Phase II study of Solithromycin for the treatment of COPD by the end of 2016.

118418

BioMedTracker JPM New Catalysts - Day 3


August 2016 / 37




01/13/2016-03/31/2016 Clovis Oncology, Inc. CLVS Lucitanib Breast Cancer IITrial Announcement - Patient Enrollment Completed

Phase II Study - Patient Enrollment Complete

Clovis announced an overview of lucitanib at the 34th annual JP Morgan Healthcare Conference. There is an unclear regulatory path as monotherapy and future development is focused on combination studies. Enrollment (n=160) completion is expected the first quarter of 2016 for the Phase II trial of lucitanib for breast cancer.

118405

07/01/2016-12/31/2016 Clovis Oncology, Inc. CLVS LucitanibHepatocellular (Liver) Cancer (HCC) (including secondary metastases)

PreclinicalTrial Announcement - Initiation

Phase Ib Study to Start

Clovis announced that there was synergy with lucitanib and mTOR inhibitors in pre-clinical models in hepatocellular cancer. The company stated a Phase Ib study is planned to initiate the second half of 2016.

118407

07/01/2016-12/31/2016 Clovis Oncology, Inc. CLVS Lucitanib Ovarian Cancer PreclinicalTrial Announcement - Initiation

Phase Ib Study to Start

Clovis announced that there is an opportunity for an intra-portfolio lucitanib/rucaparib combination in ovarian cancer. The company stated a Phase Ib study is planned to initiate the second half of 2016.

118406

01/13/2016-06/30/2016 Clovis Oncology, Inc. CLVS RociletinibNon-Small Cell Lung Cancer (NSCLC)

NDATrial Announcement - Initiation

Phase Ib/II w/Pembrolizumab Trials to Start

Clovis announced that two additional anti-PD(L)-1 pembrolizumab trials will be initiating in the first half of 2016 one Phase Ib/II in the U.S. in EGFRm NSCLC 2nd line + T790M+ and - and the other a Phase II in Asia in EGFRm NSCLC 2ndline + T790M+ and -.

118367

Now-12/31/2016 Clovis Oncology, Inc. CLVS Rucaparib Breast Cancer IITrial Announcement - Initiation

RIO Study to StartClovis plans to initiate the RIO trial in triple-negative or gBRCA breast cancer patients with rucaparib in 2016.

118399

06/03/2016-06/07/2016 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIITrial Data - Updated Results

Phase II ARIEL2 Part 2 - Results at ASCO

Clovis announced that results from Part 2 of the Phase II ARIEL2 study of rucaparib will be presented at the 2016 ASCO meeting.

118396

04/01/2016-06/30/2016 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIIRegulatory - Rolling NDA/BLA Completion

Rolling NDA Completion

Clovis is planning a U.S. NDA submission in the advanced tumor tissue BRCA mutant (germline and somatic mutations) ovarian cancer population. The NDA will include platinum sensitive and platinum resistant patients. The initial NDA for tBRCAmut patients with advanced disease plans to start by a rolling submission to initiate in the first quarter of 2016 and to complete by the second quarter of 2016.

118389

07/01/2016-09/30/2016 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIIRegulatory - MAA Submission (Europe)

MAA FilingClovis is planning a MAA submission for rucaparib in ovarian cancer in the third quarter of 2016.

118369

04/01/2016-09/30/2016 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIITrial Announcement - Initiation

ARIEL4 Confirmatory Study to Start

Clovis plans on initiating the ARIEL4 confirmatory study in mid 2016 which includes tBRCAmut and BRCA-like patients as well as initiating multiple combination studies in ovarian cancer during 2016.

118391

04/01/2017-09/30/2017 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIIRegulatory - sNDA/sBLA Filing

sNDA Filing - tBRCAmut and BRCA-like

Clovis announced that a supplemental NDA for the rucaparib maintenance indication in tBRCAmut and BRCA-like populations is to follow based on ARIEL 3 in mid-2017.

118390

07/01/2016-09/30/2016 Clovis Oncology, Inc. CLVS Rucaparib Prostate Cancer PreclinicalTrial Announcement - Initiation

Registration Study to StartClovis announced that they are expanding Rucaparib into prostate cancer with a registration study to initiate in the third quarter of 2016.

118371

01/01/2017-12/31/2017Enanta Pharmaceuticals, Inc.

ENTA Core Inhibitor ProgramHepatitis B (HBV) Treatment (Antiviral)


Clinical Trials to Start

Enatna announced that the Company is currently studying a core inhibitor for the treatment of hepatitis B virus and a non-fusion inhibitor for the treatment of RSV. Both compounds are in preclinical development and the Company expects to advance one of the two product candidates to Phase I clinical studies in 2017.

118356


ENTA EDP-305Primary Biliary Cirrhosis (PBC) and Hepatic Fibrosis


Clinical Trials to StartEnanta announced plans to initiate clinical studies for EDP-305 for the treatment of primary biliary cirrhosis and hepatic fibrosis in 2016.

118353


ENTANon-Fusion Inhibitor Program

Respiratory Syncytial Virus (RSV)


Clinical Trials to Start

Enatna announced that the Company is currently studying a core inhibitor for the treatment of hepatitis B virus and a non-fusion inhibitor for the treatment of RSV. Both compounds are in preclinical development and the Company expects to advance one of the two product candidates to Phase I clinical studies in 2017.

118359

04/01/2016-06/30/2016Esperion Therapeutics, Inc.

ESPR ETC-1002Dyslipidemia / Hypercholesterolemia

IIIProgress Update - Development Review

Progress Update - Cardiovascular Outcomes Trial Update

Esperion Therapeutics anticipates formalizing and communicating the design of the planned cardiovascular outcomes trial in the second quarter of 2016.

118282

07/01/2016-12/31/2016Global Blood Therapeutics Inc.

GBTOral Kallikrein Inhibitor (GBT)

Hereditary Angioedema (HAE) PreclinicalTrial Announcement - Initiation

Phase I to StartGlobal Blood Therapeutics intends to initiate a Phase I clinical trial of the HAE candidate in the second half of 2016.

118423

04/01/2016-09/30/2016 Horizon Pharma plc HZNP Actimmune Friedreich's Ataxia IIITrial Announcement - Patient Enrollment Completed

Phase III STEADFAST - Patient Enrollment Completion

Horizon reports that the Phase III STEADFAST trial of Actimmune for Friedreich's Ataxia is set to complete enrollment by mid-year 2016.

118374

12/01/2016-12/31/2016 Horizon Pharma plc HZNP Actimmune Friedreich's Ataxia IIITrial Data - Top-Line Results

Phase III STEADFAST - Top-Line Results

Horizon reports that the Phase III STEADFAST trial of Actimmune for Friedreich's Ataxia will have data available in December 2016.

118377

04/01/2016-06/30/2016 Horizon Pharma plc HZNP Ravicti Urea Cycle Disorder (UCD) ApprovedRegulatory - sNDA/sBLA Filing

sNDA Filing - Age 2

Horizon expects to file a supplemental New Drug Application (sNDA) for Ravicti in pediatric patients ages two months to two years with Urea Cycle Disorder by the second quarter of 2016.

118368

01/01/2017-12/31/2017 Horizon Pharma plc HZNP Ravicti Urea Cycle Disorder (UCD) ApprovedProgress Update - Product Launch (Europe)

Product Launch - EuropeHorizon expects a product launch of Ravicti for Urea Cycle Disorder in Europe in 2017.

118366

01/01/2018-03/31/2018 Horizon Pharma plc HZNP Ravicti Urea Cycle Disorder (UCD) ApprovedRegulatory - sNDA/sBLA Filing

sNDA Filing - Birth

Horizon expects to file a supplemental New Drug Application (sNDA) for Ravicti in pediatric patients from the age of birth to two months with Urea Cycle Disorder by the first quarter of 2018.

118370

01/13/2016-12/31/2016Idera Pharmaceuticals, Inc.

IDRA IMO-8400

Waldenstrom Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) - NHL

I/IITrial Data - Updated Results

Phase I/II - Updated ResultsIdera announced that they expect to release updated results from the Phase I/II study of IMO-8400 for Waldenstrom macroglobulinemia in 2016.

118347

2/28/2016 Indivior plc INDV:LN Suboxone Film Drug Addiction ApprovedPatent - Expiration of 30-Month Stay

Expiration of 30-Month Stay

Indivior announced that a decision in the lawsuits against Actavis and Par involving the Orange Book-listed patents for Suboxone Film November and December 2015 is expected soon. As is Actavis’ 30 month stay of FDA approval expires February 28th 2016. Par’s 30 month stay of FDA approval expires on September 25th 2016.

118414

07/01/2016-12/31/2016Infinity Pharmaceuticals, Inc.

INFI DuvelisibIndolent Non-Hodgkin's Lymphoma - NHL

IIITrial Data - Top-Line Results

Phase Ib/II CONTEMPO - Top-Line Results

Infinity expects to report initial data from CONTEMPO a Phase Ib/II study in treatment-naïve patients with follicular lymphoma in 2H16.

118397

Now-12/31/2016 Insmed, Inc. INSM INS-1009Pulmonary Arterial Hypertension (PAH)

PreclinicalTrial Data - Top-Line Results

Phase I - Top-Line Results Insmed expects Phase I data on INS1009 during 2016. 118329

Now-12/31/2016 INSYS Therapeutics, Inc. INSY Buprenorphine Spray Chronic Pain Program HoldTrial Announcement - Initiation

Clinical Trials to StartInsys reported that clinical studies for Buprenorphine in acute and chronic pain are expected to initiate in 2016.

118403

Now-12/31/2016 INSYS Therapeutics, Inc. INSY CannabidiolInfantile Spasms (West Syndrome; Epilepsy)

INDTrial Announcement - Initiation

Clinical Trials to StartInsys reported that clinical studies of Cannabidiol for Infantile Spasms (West Syndrome; Epilepsy) are expected to be initiated in 2016.

118398


August 2016 / 38




Now-12/31/2016 INSYS Therapeutics, Inc. INSY LEP-ETU Breast Cancer IITrial Announcement - Initiation

Phase II - Trial to StartInsys reported that Phase II studies of Liposomal Entrapped Paclitaxel-Easy to Use (LEP-ETU) for metastatic breast cancer are expected to begin in 2016.

118404

01/13/2016-12/31/2016 Intrexon Corporation XON AG013 Mucositis ITrial Announcement - Initiation

Phase II - Trial to StartIntrexon announced that they plan to initiate a Phase II clinical trial for the treatment of oral mucositis with ActoBiotics in 2016.

118337

01/13/2016-12/31/2016 Intrexon Corporation XON Non-Viral CAR-T Program Hematologic Cancer ITrial Announcement - Hold Lifted

Phase I Hematological Tumors - Trial to Start

Intrexon announced that they will assess CAR-T cells targeting hematological tumors in preclinical and clinical studies in 2016.

118392

01/13/2016-12/31/2016 Intrexon Corporation XON Non-Viral CAR-T Program Hematologic Cancer ITrial Announcement - Initiation

Phase I Myeloid Malignancies - Trial to Start

Intrexon announced that a clinical trial for CAR-T targeting myeloid malignancies is planned for 2016.

118395

01/01/2017-12/31/2017 Intrexon Corporation XON Non-Viral CAR-T Program Solid Tumors PreclinicalTrial Announcement - Initiation

Phase I Solid Tumors - Trial to Start

Intrexon announced that they will test next-generation CAR-T cells for efficacy in solid tumors in 2017.

118393

07/01/2016-12/31/2016 Intrexon Corporation XONOcular Disease Program (Intrexon/Sun)

Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology)

Preclinical Regulatory - IND Filing IND Filing

Intrexon announced that they anticipate an IND filing for the next-gen RTS controlled gene therapy for the treatment of wet age-related macular degeneration (Wet AMD) in the second half of 2016.

118402

09/01/2016-12/31/2016Karyopharm Therapeutics

KPTI KPT-8602 Multiple Myeloma (MM) PreclinicalTrial Data - Top-Line Results

Phase I - Top-Line Results

Karyopharm expects to reach the recommended Phase II dose for KPT-8602 by the end of 2016. As such we expect results for the Phase I study of KPT-8602 within this time frame.

118346


KPTI KPT-9274Acute Myelogenous Leukemia (AML)

PreclinicalTrial Data - Top-Line Results

Phase I - Top-Line ResultsKaryopharm expects to reach the recommended Phase II dose for KPT-9274 by mid-2017. As such we expect results for the Phase I study of KPT-9274 within this time frame.

118348


KPTI SelinexorAcute Myelogenous Leukemia (AML)

IIRegulatory - MAA Submission (Europe)

MAA FilingKaryopharm expects to file an MAA for Selinexor in AML in the first half of 2017.

118330


KPTI SelinexorChronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL

II Trial Data - Final Results Phase II SIRRT - Final Results Karyopharm expects final results for the Phase II SIRRT study of Selinexor for Richter's Transformation by the end of 2017.

118349


KPTI SelinexorDiffuse Large B-Cell Lymphoma (DLBCL) - NHL

IIRegulatory - MAA Submission (Europe)

MAA FilingKaryopharm expects to file an MAA for Selinexor in DLBCL in mid-2017.

118331


KPTI SelinexorDiffuse Large B-Cell Lymphoma (DLBCL) - NHL

II Trial Data - Final Results Phase II SADAL - Final ResultsKaryopharm reported that final results for the SADAL study of Selinexor are expected in mid-2017.

118341


KPTI Selinexor Multiple Myeloma (MM) IIbTrial Data - Top-Line Results

Phase II SCORE - Top-Line Results

Karyopharm reported that an interim analysis for the Phase II SCORE study of Selinexor for MM is expected in mid-2017.

118320


KPTI Selinexor Multiple Myeloma (MM) IIbRegulatory - MAA Submission (Europe)

MAA FilingKaryopharm plans to file an MAA/NDA for Selinexor in MM in the second half of 2017 based on results of the STORM study.

118325


KPTI Selinexor Multiple Myeloma (MM) IIb Trial Data - Final ResultsPhase IIb STORM - Final Results

Karyopharm reported that final data for the STORM study of Selinexor is expected in the second half of 2017.

118339


KPTI Selinexor Multiple Myeloma (MM) IIbRegulatory - sNDA/sBLA Filing

sNDA FilingKaryopharm plans to file an MAA/NDA for Selinexor in MM in mid-2018 based on results of the SCORE study.

118327


KPTI Selinexor Multiple Myeloma (MM) IIbRegulatory - Supplemental Filing (Europe)

Supplemental EU FilingKaryopharm plans to file an MAA/NDA for Selinexor in MM in mid-2018 based on results of the SCORE study.

118328


KPTI Selinexor Sarcoma II/IIITrial Data - Top-Line Results

Phase II/III SEAL - Top-Line Results

Karyopharm expects the Phase II/IIII SEAL study of Selinexor to read out in the fourth quarter of 2016.

118332

01/13/2016-12/31/2016 MannKind Corporation MNKD Afrezza Diabetes Mellitus, Type I Approved Partnership - New New PartnershipMannKind has announced that they are currently seeking a new partner for Afrezza. We await an update in the time frame above.

118408

01/13/2016-12/31/2016 MannKind Corporation MNKD Afrezza Diabetes Mellitus, Type II Approved Partnership - New New PartnershipMannKind has announced that they are currently seeking a new partner for Afrezza. We await an update in the time frame above.

118409

10/01/2016-12/31/2016 MannKind Corporation MNKD Treprostinil (MannKind)Pulmonary Arterial Hypertension (PAH)

Preclinical Regulatory - IND Filing IND Filing

MannKind announced that they are pursuing development of an inhaled version of Treprostinil using their proprietary Technosphere technology. They have currently tested three formulations and anticipate conducting IND enabling studies throughout 2016 with the aim of submitting an IND in the fourth quarter of 2016.

118411

07/01/2016-12/31/2016 Novavax, Inc. NVAX RSV F Vaccine (Novavax)Respiratory Syncytial Virus (RSV)


Phase II Eldery Rollover Trial - Top-Line Results

Data from the Phase II rollover trial of the RSV F vaccine in older adults is expected in the second half of 2016.

118426

01/01/2017-06/30/2017 Novavax, Inc. NVAX RSV F Vaccine (Novavax)Respiratory Syncytial Virus (RSV)

IIIRegulatory - NDA/BLA Filing

BLA FilingNovavax intends to submit a Biologics License Application (BLA) for its RSV F vaccine during the first half of 2017.

118424

Now-06/30/2016Regeneron Pharmaceuticals, Inc.

REGN Dupilumab Atopic Dermatitis (Eczema) IIITrial Announcement - Initiation

Phase III Pediatric Study to Start

Regeneron expects to initiate a Phase III study of Dupilumab in pediatric patients with atopic dermatitis in the first half of 2016.

118302


REGN Dupilumab Atopic Dermatitis (Eczema) IIITrial Data - Top-Line Results

Phase IIa Pediatric - Top-Line Results

Regeneron expects to have data from its Phase II pediatric study of dupilumab in patients with atopic dermatitis in the first half of 2016.

118303


REGN EyleaDiabetic Retinopathy (Ophthalmology)

ApprovedTrial Announcement - Initiation

Phase III to StartRegeneron plans to initiate a Phase III study of Eylea in diabetic retinopathy in the first quarter of 2016.

118287


REGN EyleaDiabetic Retinopathy (Ophthalmology)

ApprovedTrial Announcement - Initiation

Protocol-W Trial to Start

Regeneron expects that the Diabetic Retinopathy Clinical Research Network's Protocol-W study of Eylea in patients with diabetic retinopathy is expected to begin in early 2016.

118290


REGN Fasinumab Chronic Pain II/IIITrial Data - Top-Line Results

Phase II/III - Top-Line ResultsRegeneron expects to have data from the 16 week Phase II/III study of Fasinumab in patients with osteoarthritis pain in the first half of 2016.

118314


REGN Fasinumab Chronic Pain II/IIITrial Announcement - Initiation

Phase III Trials to StartBased on discussions with the FDA Regeneron intends to intiaite Phase III trials (>16 weeks) of Fasinumab in patietns with chronic pain in the first half of 2016.

118312


REGN REGN1979 Hematologic Cancer ITrial Data - Top-Line Results

Phase I - Top-Line ResultsRegeneron expects to have initial data from its CD20-CD3 bispecific program in 2016.

118319

10/01/2016-12/31/2016Regeneron Pharmaceuticals, Inc.

REGN REGN2176-3Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology)


Phase II - Top-Line ResultsRegeneron expects to have topline data from its Phase II data of Eylea in combination with PDGFR-beta by year end 2016.

118292


REGN REGN2222Respiratory Syncytial Virus (RSV)

IIITrial Announcement - Patient Enrollment Completed

Phase III NURSERY-Pre-term - Patient Enrollment Completed

Regeneron expects to complete enrollment of its Phase III NURSERY-Pre-term study of REGN2222 in infants with RSV in 2017.

118316


REGN REGN2810 Cancer ITrial Data - Top-Line Results

Phase I - Top-Line ResultsRegeneron expects to have initial data from its PD-1 antibody collaboration with Sanofi in the first half of 2016.

118317


REGN REGN910-3Other Ophthalmological Indications (Ophthalmology)

ITrial Announcement - Initiation

Phase II Studies to StartRegeneron expects to initiate Phase II studies of Eylea in combination with an ANG2 antibody in Wet AMD and Diabetic macular edema in the first half of 2016.

118294

04/20/2016-12/31/2016Valeant Pharmaceuticals International, Inc.

VRX Relistor (Oral)Opioid Induced Constipation (OIC)

NDAProgress Update - Product Launch (U.S.)

Product Launch (US)Valeant plans to launch Relistor Oral for the treatment of opioid induced constipation with chronic non-cancer pain in the US in 2016.

118335


August 2016 / 39




07/22/2016-12/31/2016Valeant Pharmaceuticals International, Inc.

VRX VesneoGlaucoma / Ocular Hypertension (Ophthalmology)

NDAProgress Update - Product Launch (U.S.)

Product Launch (US)

Valeant expects to launch Latanoprostene Bunod for the reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension in 2016 sometime after the PDUFA decision on July 21 2016.

118336

Now-06/30/2016 Vectura Group VEC:LN VR942 Respiratory Disease ITrial Data - Top-Line Results

Phase I - Top-Line ResultsVectura reported that top-line data for the Phase I study of VR942 for asthma will be available in the first half of 2016.

118416

Now-06/30/2016 Vectura Group VEC:LN VR942 Respiratory Disease ITrial Announcement - Other

Phase II - Trial AnnouncementVectura reported that the selection of the final Phase II clinical study design is anticipated to be released in the first half of 2016.

118417

05/04/2016-05/07/2016ZIOPHARM Oncology, Inc.

ZIOP Ad-RTS IL-12Brain Cancer (malignant glioma; AA and GBM)

I Trial Data - Other Preclinical Data at ASGCTZIOPHARM Oncology announced that an abstract has been submitted to be presented at the 2016 ASGCT meeting in May for Ad-RTS IL-12.

118410


August 2016 / 40


Expected Date Range Company Symbol Drug Indication Phase Expected Catalyst Catalyst Title Analysis Updated Analysis Link

Now-03/31/2016 Array BioPharma, Inc. ARRY ARRY-797Congestive Heart Failure (CHF)


Phase II - Top-line ResultsTopline results from the Phase II study of ARRY-797 in patients with LMNA-related dilated cardiomyopathy (DCM) are expected in late 2014.

Date Range Delayed (11/12/2014) - Array plans to provide an update on the LMNA_related DCM program of ARRY-797 early next year. We look for a potential data update in the same timeframe.Date Range Delayed (01/14/2015) - Array expects to release results for the Phase II study of ARRY-797 for the treatment of dilated cardiomyopathy (DCM) in 2015.Date Range Delayed (12/15/2015) - Array continues to progress select other wholly-owned programs including two Phase II trials of filanesib in multiple myeloma and a Phase II trial of ARRY-797 in a rare cardiovascular disease. We continue to await an update.New Information (01/13/2016) - Array announced that the Phase II trial of ARRY-797 for LMNA-related dilated cardiomyopathy is ongoing. Data is expected to be presented in the near future.

98415

04/01/2016-09/30/2016 Array BioPharma, Inc. ARRY Binimetinib Melanoma IIITrial Data - Updated Results

Phase III NEMO - Updated Results

Results from the NEMO trial including progression free survival overall survival objective response rate safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical meeting in 2016.

Date Range Refined (01/13/2016) - Array BioPharma announced that the updated results from the Phase III NEMO study of binimetinib will be presented in mid-2016.

117374

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Binimetinib Melanoma IIIRegulatory - sNDA/sBLA Filing

Supplemental NDA Filing (BRAF)

Array expects to submit regulatory filings for MEK162 based on the 900-patient COLUMBUS study in BRAF-mutant melanoma patients in 2016.

Date Range Refined (01/13/2016) - Array BioPharma expects to submit regulatory filings for binimetinib and encorafenib based on the 900-patient COLUMBUS study in BRAF-mutant melanoma patients in the second half of 2016.

92663

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Binimetinib Melanoma IIIRegulatory - Supplemental Filing (Japan)

Supplemental JNDA Filing (BRAF)



92664

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Binimetinib Melanoma IIIRegulatory - Supplemental Filing (Europe)

Supplemental MAA Filing (BRAF)



92665

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Encorafenib Melanoma IIIRegulatory - MAA Submission (Europe)

MAA Filing (BRAF)Novartis plans on filing MEK162 + LGX818 for approval for BRAF mutant melanoma in 2016.


98255

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Encorafenib Melanoma IIIRegulatory - J-NDA Filing (Japan)

J-NDA Filing (BRAF)Novartis plans on filing MEK162 + LGX818 for approval for BRAF mutant melanoma in 2016.


98254

07/01/2016-12/31/2016 Array BioPharma, Inc. ARRY Encorafenib Melanoma IIIRegulatory - NDA/BLA Filing

NDA Filing (BRAF)Novartis plans on filing MEK162 + LGX818 for approval for BRAF mutant melanoma in 2016.


98253

04/01/2016-09/30/2016 AstraZeneca PLC AZN SelumetinibNon-Small Cell Lung Cancer (NSCLC)


Phase III SELECT-1 - Top-Line Results

Array expects primary data from the 634-patient KRAS-mutant NSCLC study of Selumetinib (SELECT-1) to be available in July 2016.

Date Range Delayed (02/13/2014) - AstraZeneca expects an external representation of results for the Phase III SELECT-1 study for selumetinib in patients with non-small cell lung cancer in the second quarter of 2017. Date Range Expedited (05/02/2014) - Array expects primary data from the SELECT-1 study of Selumetinib in July 2016.Date Range Delayed (08/24/2015) - Array expects data from the SELECT-1 study in the second half of 2016.Date Range Refined (01/13/2016) - Array expects data from the Phase III SELECT-1 study of selumetinib in patients with non-small cell lung cancer in mid-2016.

92661

Now-03/31/2016 aTyr Pharma LIFE Resolaris Muscular Dystrophy I/IITrial Data - Top-Line Results

Phase Ib/II - Top-Line Results

aTyr Pharma expect to report initial results from its Phase Ib/II clinical trial of Resolaris in adult patients with FSHD in the fourth quarter of 2015 or early 2016.

Date Range Refined (09/10/2015) - aTyr Pharma announced that data from the Phase Ib/II study of resolaris for the treatment of FSHD are expected in the fourth quarter of 2015 or first quarter of 2016. Date Range Refined (01/13/2016) - aTyr Pharma announced that it has completed patient dosing for its Phase Ib/II trial for Resolaris in adult FSHD patients and is in the process of database curation and analysis. The Company expects to report data at approximately the end of the first quarter of 2016.

110096

Now-12/31/2016 aTyr Pharma LIFE Resolaris Muscular Dystrophy I/IITrial Announcement - Initiation

Phase Ib/II RPIC - Trial to Start

aTyr expects to initiate a Phase Ib/II study of Resolaris for RPIC in the first half of 2016.

Date Range Delayed (01/13/2016) - aTyr plans to initiate a clinical program in rare pulmonary diseases with an immune component (RPIC) in patients with interstitial lung disease (ILD). By the end of 2016 the Company will make a determination as to whether to move forward with an exploratory Phase Ib/II trial for Resolaris.

110100

Now-03/31/2016 Bayer AG BAYRY FinerenoneCongestive Heart Failure (CHF)

IIITrial Announcement - Initiation

Phase III FINESSE-HF to Start

Bayer HealthCare announced the expansion of the clinical development programme for finerenone with three Phase III studies. The studies will investigate the efficacy and safety of finerenone in patients with chronic heart failure (CHF) and patients with diabetic kidney disease (DKD) with the first patients expected to be enrolled by the year-end.

Date Range Delayed (12/31/2015) - We await an update in the first quarter of 2016.Catalyst Occurred (01/13/2016) - Bayer announced that Phase III trials of finerenone for diabetic kidney disease and chronic heart failure have been initiated.

114548


BCRX BCX7353Hereditary Angioedema (HAE)

ITrial Announcement - Initiation

Phase II APeX-1 - Trial to Start

BioCryst expects to initiate a Phase II proof of concept study of its second generation HAE compound (BCX7353) by year end 2015.

Date Range Delayed (10/08/2015) - BioCryst Pharmaceuticals announced that the randomized placebo-controlled Phase I clinical trial of orally-administered BCX7353 in healthy volunteers successfully met all of its objectives. A Phase II four week dose ranging trial to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of BCX7353 as a preventative treatment to reduce the frequency of attacks in HAE patients is expected to begin by late 2015 or early 2016.New Information (01/13/2016) - BioCryst announced that the Phase II dose-ranging study of BCX7353 for the treatment of hereditary angioedema (HAE) is expected to start in the first quarter of 2016 following regulatory review and IRB approvals.

106360

Now-03/31/2016 Cempra, Inc. CEMP TakstaBone and Joint Infections (Antibacterial)

IITrial Announcement - Initiation

Phase III - Trial to StartCempra expects to initiate Phase III development of Taksta in refractory bone and joint infections in 2015.

Date Range Refined (10/05/2015) - A Phase II/III open-label non-randomized single-arm multi-center study to evaluate oral sodium fusidate (CEM-102) for the treatment of staphylococcal bone or joint infections in subjects for whom chronic antibiotic suppressive therapy is indicated has been announced but is not yet open for participant recruitment. The study is expected to begin in October 2015. Date Range Delayed (10/28/2015) - The Phase II/III study of CEM-102 for the treatment of bone or joint infections is not yet open for participant recruitment. We await an update in the time frame above.Date Range Delayed (11/16/2015) - The Phase II/III study of CEM-102 for the treatment of bone or joint infections is not yet open for participant recruitment. We await an update in the time frame above.Date Range Delayed (12/08/2015) - Cempra plans to initiate an exploratory trial for Taksta early next year in patients with refractory bone or joint infections. Date Range Refined (01/13/2016) - Cempra announced plans to initiate a Phase III study of Taksta for the treatment of bone or joint infections in the first quarter of 2016.

109330

BioMedTracker JPM Updated Catalysts - Day 3


August 2016 / 41




01/13/2016-03/31/2016 Clovis Oncology, Inc. CLVS Lucitanib Breast Cancer IITrial Data - Top-Line Results

Phase II (Clovis) - Top-Line Results

Clovis expects preliminary data from its Phase II breast cancer study of lucitinib by year-end 2015 presumably at the San Antonio Breast Cancer Symposium (SABCS) to be held December 8-12 2015.

Date Range Delayed (12/14/2015) - Results from the Clovis sponsored U.S. Phase II study of lucitanib was not presented at the 2015 San Antonio Breast Cancer Symposium. As such we await an update in the time frame above. Date Range Delayed (01/13/2016) - Clovis announced an overview of lucitanib at the 34th annual JP Morgan Healthcare Conference. There is an unclear regulatory path as monotherapy and future development is focused on combination studies. Enrollment (n=160) completion is expected the first quarter of 2016 for the Phase II trial of lucitanib for breast cancer. We await an update on the initial data in the same time frame.

106057

01/13/2016-09/30/2016 Clovis Oncology, Inc. CLVS RociletinibNon-Small Cell Lung Cancer (NSCLC)


Phase II (TIGER-J2) to Start

Clovis announced that a Phase II study of rociletinib in Japanese patients agreed upon with Japanese regulatory authorities is expected to initiate in the second half of 2015.

Date Range Delayed (12/28/2015) - We await an update.Date Range Delayed (01/13/2016) - Clovis announced that they are delaying the TIGER-J2 Phase II study in Japanese patients and enrolling Asian patients in other ongoing studies. We await an update on the start of this trial.

111246

Now-01/31/2016 Clovis Oncology, Inc. CLVS RociletinibNon-Small Cell Lung Cancer (NSCLC)


Phase Ib/II w/Atezolizumab - Trial to Start

Clovis Oncology announced that they have entered into a clinical trial collaboration with Genentech a member of the Roche Group to evaluate a novel combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) and rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC). The Phase Ib/II trial of rociletinib in combination with atezolizumab is planned to begin enrolling patients before the end of 2015.

Date Range Delayed (12/28/2015) - A Phase Ib/II study of the safety and efficacy of rociletinib (CO-1686) administered in combination with MPDL3280A in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic non-small cell lung cancer (NSCLC) is not yet open for participant recruitment. We await an update.Catalyst Occurred (01/13/2016) - Clovis announced that the Phase Ib/II study of the safety and efficacy of rociletinib (CO-1686) administered in combination with atezolizumab in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic non-small cell lung cancer (NSCLC) has begun clinical activities this week starting with the first clinical site.

114046

01/13/2016-04/30/2016 Clovis Oncology, Inc. CLVS Rucaparib Breast Cancer IITrial Announcement - Initiation

Phase II RUBY (Unicancer) Study to Start

Clovis plans to initiate a Phase II trial called the RUBY Study during the second quarter of 2015.

Date Range Delayed (06/29/2015) - We await an update in the third quarter of 2015.Date Range Delayed (09/30/2015) - This study is not yet open for participant recruitment. We await an update.Date Range Delayed (11/18/2015) - This study is not yet open for participant recruitment. We continue to await an update.Date Range Delayed (01/13/2016) - Clovis plans to initiate the Phase II RUBY trial in non-known gBRCA and BRCA-like HER2-negative ER/PR-positive breast cancer patients with rucaparib in 2016. We await an update.

106062

Now-03/31/2016 Clovis Oncology, Inc. CLVS Rucaparib Ovarian Cancer IIIRegulatory - Rolling NDA/BLA Initiation

Rolling NDA InitiationClovis is planning an NDA submission for rucaparib in ovarian cancer in 2016.

New Information (04/06/2015) - Clovis Oncology announced that the ARIEL2 trial was recently expanded into a registration study (the ARIEL2 extension) which will include an additional approximately 300 women with recurrent disease after at least three prior lines of chemotherapy. Data from this study are planned to serve as the basis of a New Drug Application (NDA) filing for the treatment of ovarian cancer in 2016.Date Range Refined (01/13/2016) - Clovis is planning a U.S. NDA submission in the advanced tumor tissue BRCA mutant (germline and somatic mutations) ovarian cancer population. The NDA will include platinum sensitive and platinum resistant patients. The initial NDA for tBRCAmut patients with advanced disease plans to start by a rolling submission to initiate in the first quarter of 2016 and to complete by the second quarter of 2016.

106054

Now-12/31/2016Enanta Pharmaceuticals, Inc.

ENTA EDP-305Non-alcoholic Steatohepatitis (NASH)


Clinical Trials to StartEnanta announced that in their NASH program the Company expects to select the candidate by the end of 2015 and initiate clinical studies in 2016.

New Information (01/13/2016) - Enanta announced the nomination of EDP-305 as the developmental candidate for the study of NASH and PBC. The Company is currently on tract to initiate clinical trials in 2016.

111422

Now-12/31/2016Enanta Pharmaceuticals, Inc.

ENTA EDP-305Non-alcoholic Steatohepatitis (NASH)

PreclinicalProgress Update - Development Review

Candidate SelectionEnanta expects to select a candidate for its FXR agonist program for NASH in 2015.

Date Range Delayed (12/14/2015) - Enanta announced that they are working on several compounds that selectively bind to and activate the farnesoid X receptor. Enanta plans to develop these compounds for use in the treatment of non-alcoholic steatohepatitis or NASH and possibly primary biliary cholangitis or PBC. Clinical trials of an FXR agonist candidate are expected to initiate in 2016. We await an update.Catalyst Occurred (01/13/2016) - Enanta announced the selection of EDP-305 as the product candidate to enter clinical trials for the treatment of NASH and PBC.

108480



IIIProgress Update - Development Review

Progress Update - Phase III Program Update

Esperion reported that specifics of the Phase III development program for ETC-1002 for the treatment of patients with hypercholesterolemia are anticipated to be finalized by the first half of 2016.

Date Range Refined (01/13/2016) - Esperion Therapeutics will provide details of the full Phase III global development strategy in the second quarter of 2016.

115253




Phase III Long-Term Safety Study - Top-Line Results

Esperion expects to start a Phase III long-term safety study of ETC-1002 in Q4 2015 with a potential for results in the first half of 2017.

Date Range Delayed (01/13/2016) - Esperion Therapeutics announced the start of a global Phase III long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid and top-line results are expected in the fourth quarter of 2017.

115277

10/01/2016-12/31/2016 Insmed, Inc. INSM ArikayceRespiratory Tract Infections (Excluding Pneumonia) (Antibacterial)

IIITrial Announcement - Patient Enrollment Completed

Phase III MAC-NTM - Patient Enrollment Complete

Insmed anticipates that the Arikayce Phase III global study for NTM will be fully enrolled in 2015. We expect full enrollment in the second half of 2015.

Date Range Delayed (05/07/2015) - Insmed announced that they expect to complete enrollment in the Phase III 212 study of Arikayce for the treatment of NTM lung infections in approximately twelve months from the initiation of the trial. Since the study initiated in January 2015 we await an update on patient enrollment completion in the first quarter of 2016. Date Range Delayed (01/13/2016) - Insmed expects the Phase III CONVERT trial of Arikayce to be fully enrolled by the end of 2016.

106299

Now-12/31/2016 INSYS Therapeutics, Inc. INSY Cannabidiol Dravet Syndrome PreclinicalTrial Announcement - Initiation

Phase III - Pivotal Trial to Start

Insys Therapeutics intends to initiate a pivotal Phase III trial of their pharmaceutical cannabidiol (CBD) candidate to treat Dravet Syndrome in 2015.

Date Range Refined (12/22/2014) - According to clinicaltrials.gov the Phase III study of Cannabidiol in Dravet Syndrome is planned to initiate in April 2015.Date Range Delayed (03/20/2015) - Insys projects to file an IND for the use of cannabidiol for patients with epilepsy in 2015 and also plans to initiate a Phase III study later this year. We now await an update on this Phase III study to start during the second half of 2015.Date Range Delayed (12/10/2015) - The Phase III study is not yet open for participant recruitment. We await an update. Date Range Delayed (01/13/2016) - Insys reported that clinical studies of Cannabidiol for Dravet Syndrome are expected to be initiated in 2016.

105345

Now-12/31/2016 INSYS Therapeutics, Inc. INSY CannabidiolLennox-Gastaut Syndrome (LGS; Epilepsy)


Phase III - Pivotal Trial to Start

Insys Therapeutics intends to initiate a pivotal Phase III trial of their pharmaceutical cannabidiol (CBD) candidate to treat Lennox-Gastaut Syndrome in 2015.

Date Range Refined (12/22/2014) - According to clinicaltrials.gov the Phase III study of Cannabidiol in LGS is planned to initiate in April 2015. Date Range Delayed (03/20/2015) - Insys projects to file an IND for the use of cannabidiol for patients with epilepsy in 2015 and also plans to initiate a Phase III study later this year. We now await an update on this Phase III study to start during the second half of 2015.Date Range Delayed (12/10/2015) - The Phase II study is not yet open for participant recruitment. We await an update. Date Range Delayed (01/13/2016) - Insys reported that clinical studies of Cannabidiol for Lennox-Gastaut Syndrome (LGS; Epilepsy) are expected to be initiated in 2016.

105346


August 2016 / 42




Now-06/30/2016Intra-Cellular Therapies, Inc.

ITCI ITI-007 Alzheimer's Disease (AD) I/IITrial Announcement - Initiation

Phase II - Trial to Start

Intra-Cellular Therapies intends to initiate a Phase II clinical trial in 2015 evaluating ITI-007 in patients with behavioral disturbances associated with dementia including Alzheimer's disease.

Date Range Refined (05/04/2015) - Intra-Cellular plans to initiate a clinical trial evaluating ITI-007 for the treatment of behavioral disturbances in patients with dementia including Alzheimer's disease in the second half of 2015.Date Range Delayed (12/02/2015) - The Company plans to commence its late phase clinical program evaluating ITI-007 for the treatment of behavioral disturbances in patients with dementia including Alzheimer's disease in late 2015 or during the first half of 2016.Date Range Refined (01/13/2016) - Intra-Cellular plans to initiate a clinical trial evaluating ITI-007 for the treatment of behavioral disturbances in patients with dementia in the first half of 2016.

103831

01/13/2016-12/31/2016Intra-Cellular Therapies, Inc.

ITCI ITI-214 Schizophrenia IProgress Update - Development Review

ITI-214 Development Review

Upon termination of the agreement with Takeda all rights granted under the Takeda License Agreement were returned to Intra-Cellular. Intra-Cellular expects to finalize their strategy for the PDE1 inhibitor program by the end of 2015.

New Information (09/21/2015) - Intra-Cellular Therapies is currently evaluating ITI-214 for several indications including cognition in patients with Parkinson's disease dementia schizophrenia and other CNS and non-CNS disorders.Date Range Delayed (12/09/2015) - We await an update. Date Range Delayed (01/13/2016) - Intra-Cellular Therapies announced that the Company is currently evaluating ITI-214 in several indications and expect to continue clinical development in 2016. As such we continue to await an update regarding a finalized strategy in the time frame above.

111117

04/01/2016-09/30/2016 Karyopharm Therapeutics KPTI KPT-9274Acute Myelogenous Leukemia (AML)


Phase I - Trial to StartKaryopharm plans to initiate clinical development in patients with heavily pretreated solid tumors or lymphoma in the first half of 2016.

Date Range Delayed (01/13/2016) - Karyopharm reported that the first in human trial of KPT-9274 is anticipated in patients with solid tumors or NHL in mid-2016.

117247

04/01/2017-09/30/2017 Karyopharm Therapeutics KPTI SelinexorDiffuse Large B-Cell Lymphoma (DLBCL) - NHL

IIRegulatory - NDA/BLA Filing

NDA FilingKaryopharm expects to file an NDA for Selinexor in DLBCL Richter's and AML in the first half of 2017.

Date Range Delayed (01/13/2016) - Karyopharm expects to file an NDA for Selinexor in DLBCL in mid-2017.

106252

07/01/2017-12/31/2017 Karyopharm Therapeutics KPTI Selinexor Multiple Myeloma (MM) IIbRegulatory - NDA/BLA Filing

NDA FilingKaryopharm plans to file an NDA for Selinexor in MM in the first half of 2018.

Date Range Expedited (01/13/2016) - Karyopharm plans to file an MAA/NDA for Selinexor in MM in the second half of 2017 based on results of the STORM study.

106258

Now-04/30/2016 Karyopharm Therapeutics KPTI Selinexor Multiple Myeloma (MM) IIbTrial Announcement - Initiation

Phase III SCORE - Trial to Start

Karyopharm is preparing to launch Phase III studies. As they did not provide a time frame we expect the initiation sometime in 2016.

Date Range Expedited (12/07/2015) - Karyopharm plans to initiate a Phase II/III clinical study (SCORE) in early 2016 to evaluate the combination of selinexor carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma who were previously treated with a proteasome inhibitor and an immunomodulatory drug.Catalyst Occurred (01/13/2016) - The Phase II study of selinexor plus carfilzomib (Kyprolis) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma is currently recruiting participants.

106263

Now-01/31/2016 Karyopharm Therapeutics KPTI Selinexor Sarcoma II/IIITrial Announcement - Initiation

Phase II/III SEAL - Trial to Start

Karyopharm plans to initiate a registration-directed clinical trial of selinexor to treat liposarcoma in the second half of 2015.

Date Range Refined (10/19/2015) - Karyopharm plans to initiate a randomized placebo-controlled Phase II/III trial of selinexor to treat liposarcoma during the fourth quarter of 2015. New Information (12/08/2015) - In solid tumors Karyopharm plans to initiate a randomized placebo-controlled Phase II/III trial of selinexor to treat liposarcoma during the fourth quarter of 2015. Date Range Delayed (12/31/2015) - This study is not yet open for participant recruitment. We await an update.New Information (01/13/2016) - Karyopharm expects to initiate its Phase II/III SEAL study of Selinexor for liposarcoma shortly. We expect an update in the time frame above.

112659

07/01/2016-12/31/2016 Novavax, Inc. NVAXRSV F / Seasonal Influenza Vaccine

Respiratory Syncytial Virus (RSV)


Phase I Trial to Start

Novavax announced during the 2015 J.P. Morgan Healthcare Conference that a Phase I study testing RSV F+ seasonal influenza VLP as a pentavalent respiratory vaccine candidate is planned to begin in the second quarter of 2015.

Date Range Delayed (06/30/2015) - We await an update through the third quarter of 2015.Exact Date (09/17/2015) - Novavax will provide an update on its planned Phase I study of its RSV/Flu vaccine combination during its Analyst & Investor Day on September 29 2015.Date Range Delayed (09/29/2015) - We await an update.Date Range Delayed (12/29/2015) - �We await an update. Date Range Delayed (01/13/2016) - The Phase I combination respiratory (RSV + Flu) trial is expected to start in the second half of 2016.

106347

07/01/2016-12/31/2016 Novavax, Inc. NVAXRSV F / Seasonal Influenza Vaccine

Seasonal Influenza Vaccines PreclinicalTrial Announcement - Initiation

Phase I Trial to Start

Novavax announced during the 2015 J.P. Morgan Healthcare Conference that a Phase I study testing RSV F+ seasonal influenza VLP as a pentavalent respiratory vaccine candidate is planned to begin in the second quarter of 2015.

Date Range Delayed (06/30/2015) - We await an update through the third quarter of 2015.Date Range Delayed (09/29/2015) - We await an update.Date Range Delayed (12/29/2015) - �We await an update. Date Range Delayed (01/13/2016) - The Phase I combination respiratory (RSV + Flu) trial is expected to start in the second half of 2016.

106369

01/01/2017-04/30/2017 PTC Therapeutics, Inc. PTCT Translarna Cystic Fibrosis (CF) IIITrial Data - Top-Line Results

Phase III ACT CF - Top-line Results

PTC expect to complete the Phase III CF confirmatory trial of ataluren and have initial top-line data available in 2016.

Date Range Refined (09/16/2014) - PTC expects to complete enrollment in the ACT CF study in the second half of 2015 with data expected a year later. As such we look for top-line results in H2 2016.Date Range Delayed (01/13/2016) - PTC reported that the Phase III study of Translarna in cystic fibrosis is ongoing with data expected in early 2017.

88612

9/8/2016 PTC Therapeutics, Inc. PTCT Translarna Muscular Dystrophy NDARegulatory - PDUFA/Approval Decision (US)

PDUFA for NDA - First Review

PTC Therapeutics announced the completion of its rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Based on a standard 12-month review timeline the PDUFA decision should occur on January 8 2017. As this date falls on a weekend we expected the PDUFA decision on the Friday before.

Date Range Expedited (01/13/2016) - PTC Therapeutics expects a US approval decision for Translarna in Duchenne muscular dystrophy in mid-2016. As such assuming the FDA grants an 8-month priority review we expect a PDUFA decision on September 8 2016.

117686


REGN Dupilumab Atopic Dermatitis (Eczema) IIITrial Data - Top-Line Results

Phase III SOLO Studies - Top-Line Results

Sanofi expects top-line Phase III results for dupilumab in atopic dermatitis during the first quarter of 2016.

Date Range Delayed (10/08/2015) - Regeneron Pharmaceuticals and Sanofi announced that results from Phase III studies of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis that is not adequately controlled with topical atopic dermatitis medications are expected in the first half of 2016. Date Range Refined (10/30/2015) - Sanofi continues to expect Phase III top-line results for dupilumab in atopic dermatitis during Q1 2016. Date Range Delayed (01/13/2016) - Regeneron expects to have data from the Phase III SOLO studies of dupilumab in patients with atopic dermatitis in the first half of 2016.

113794


REGN Fasinumab Chronic Pain II/IIITrial Announcement - Hold Lifted

FDA Response to Partial Hold

Regeneron announced that the Company expects to hear from the FDA in the second half of 2015 about the partial clinical hold which if lifted will allow the Company to conduct studies that are longer than 16 weeks in duration.

Date Range Delayed (12/22/2015) - Regeneron reported that fasinumab is still under partial clinical hold by the FDA. We await an update.Catalyst Occurred (01/13/2016) - Regeneron announced that the partial hold on Fasinumab has been lifted. Based on discussions with the FDA Phase III trials (>16 weeks) are expected to begin in the first half of 2016.

114336


REGNRegeneron BARDA Program

Ebola PreclinicalTrial Announcement - Initiation

Clinical Trials to StartRegeneron Pharmaceuticals announced that the Company plans to initiate a Phase I study of the Regeneron BARDA Program in January 2016.

Date Range Delayed (01/13/2016) - Regeneron plans to initiate a Phase I study of its Ebola program in healthy volunteers in the first half of 2016.

115100


REGN Sarilumab Rheumatoid Arthritis (RA) BLATrial Data - Top-Line Results

Phase III MONARCH - Top-Line Results

Sanofi expects the MONARCH Phase III results in rheumatoid arthritis during Q3 2016.

Date Range Delayed (01/13/2016) - Regeneron expects to have Phase III MONARCH study data of Sarilumab vs. adalimumab in the second half of 2016.

116169


August 2016 / 43




07/01/2016-12/31/2016 Seres Health, Inc. MCRB SER-109

Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI)


Phase III - Trial to Start

Seres announced that they plan to meet with the FDA to present Phase II safety and efficacy results and a proposed protocol for the Phase III clinical trial following analysis of Phase II study data. The Company expects to initiate a Phase III clinical trial of SER-109 for the treatment of clostridium difficile-associated diarrhea/infection (CDAD/CDI) in 2016. Since data read-out is expected in mid 2016 we await an update on the initiation of a Phase III study in the second half of 2016.

New Information (01/13/2016) - Seres Therapeutics announced that they anticipate initiating a Phase III trial of SER-109 for C. difficile by the end of 2016.

112174

04/01/2016-06/30/2016Teva Pharmaceutical Industries Ltd.

TEVA NeoFuseCongestive Heart Failure (CHF)


Phase III - Top-Line DataInterim analysis results for Revascor expected in early 2016 will follow the initial cohort completing six months of follow-up.

Date Range Delayed (01/13/2016) - Mesoblast reported that the Phase III trial of NeoFuse for Congestive Heart Failure is recruiting across North America. A first interim analysis will be performed during the first quarter of 2016 while the results will be available during the second quarter of 2016.

108680

Now-01/31/2016 ThromboGenics NV THR:BB JetreaDiabetic Retinopathy (Ophthalmology)


Phase II CIRCLE - Trial to Start

ThromboGenics expects the first patient in the Jetrea US Phase IIa trial in proliferative diabetic retinopathy to be enrolled in the second half of 2015.

Date Range Refined (11/12/2015) - ThromboGenics announced that the FDA has accepted its Investigational New Drug (IND) Application for its CIRCLE study a Phase II randomized double-masked sham-controlled multi-center study that will evaluate the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in subjects with non-proliferative diabetic retinopathy (NPDR). ThromboGenics remains on track to recruit the first patient in the United States around year-end 2015. Date Range Delayed (12/23/2015) - We await an update.Catalyst Occurred (01/13/2016) - ThromboGenics announced that the first patient has been enrolled in its Phase II CIRCLE study evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).

106473

Now-03/31/2016 UCB SA UCB:BB UCB5857 Sjogren's Syndrome IITrial Announcement - Initiation

Phase II - Study to StartUCB announced that Phase II studies for UCB5857 are expected to begin in early 2015.

Date Range Delayed (04/02/2015) - UCB announced that Phase II studies for UCB5857 are expected to begin in the second half of 2015.Date Range Delayed (12/30/2015) - We await an update.Catalyst Occurred (01/13/2016) - The Phase II study of UCB5857 in patients with primary Sjogren's syndrome is currently recruiting participants.

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August 2016 / 44


Expected Start Date Company Symbol Device Indication Phase Expected Catalyst Analysis Updated Analysis Catalyst ID

Now-05/31/2016 AngioDynamics, Inc. ANGO Celerity System Surgical Tools (General) ApprovedCelerity with Navigation - Product Launch (US)

AngioDynamics announced that it expects to launch a second-generation Celerity Navigation product in the second half of FY2016.

Date Range Refined (10/19/2015) - AngioDynamics said in its Q2 FY2015 earnings call that it plans to file an application with the FDA for Celerity with Navigation within a month or two and expects to launch the product by the end of the fiscal year.

113351

Now-12/31/2016 NovoCure Limited NVCR OptuneBrain Cancer (secondary; metastases)

Development Outside U.S. Phase III to Start

Novocure plans to open a Phase III trial the METIS trial for the treatment of brain metastases originating from non-small cell lung cancer (NSCLC) in 2016 subject to FDA approval of the final protocol.

117070

Now-12/31/2016 NovoCure Limited NVCR Optune Ovarian Cancer Development Outside U.S. INNOVATE Enrollment Completion

Novocure said it expects to enroll the last patient in the INNOVATE trial in 2016.

117363

Now-12/31/2016 NovoCure Limited NVCR OptuneNon-Small Cell Lung Cancer (NSCLC)

DevelopmentPhase III LUNAR Study to Start

Novocure said it expects to begin the first patient in the Phase III LUNAR trial in 2016.

117381

1/19/2016 NovoCure Limited NVCR Optune Pancreatic Cancer Development Outside U.S. PANOVA - 1st Cohort Top-Line Data at ASCO GI

Novocure said it expects to present results from the 1st cohort of the PANOVA trial in 2016.

Date Range Expedited (01/13/2016) - Novocure announced that 1st cohort data from the PANOVA trial is expected to be presented at the ASCO GI meeting in January 2016. The company noted that the data will be available on January 19 once the embargo is lifted.

117364

01/13/2016-06/30/2016 BTG plc BTC:LN LC BeadHepatocellular (Liver) Cancer (HCC) (including secondary metastases)

Approved CE Mark DecisionBTG announced that they expect EU approval of DC Bead LUMI in the first half of 2016.

118350

01/13/2016-06/30/2016 BTG plc BTC:LN LC BeadHepatocellular (Liver) Cancer (HCC) (including secondary metastases)

ApprovedBioresorbable Bead - Studies to Start

BTG announced that they plan to commence studies for a bioresorbable bead product in the first half of 2016.

118351

01/13/2016-06/30/2016 BTG plc BTC:LN PneumRx Coil System Emphysema IDE PMA Filing to U.S. FDABTG said it is progressing its regulatory application in the US which it anticipates submitting around mid-2016.

Date Range Refined (01/13/2016) - BTG announced that they intend to submit a U.S. PMA for PneumRx in the first half of 2016.

117328

01/13/2016-06/30/2016 St. Jude Medical, Inc. STJ EnSite SystemHemodynamic/Vital Sign Monitoring

ApprovedEnSite Precision Cardiac Mapping System - Product Launch (US)

St. Jude Medical announced that it expects a H1 2016 launch for the EnSite Precision Cardiac Mapping System.

118322

01/13/2016-09/30/2016 Abiomed, Inc. ABMD Impella 2.5Congestive Heart Failure (CHF)

Approved

Impella 2.5, Impella 5.0, and Impella CP Supplemental PMA Approval - Cardiogenic Shock

Abiomed announced that it has submitted U.S Food & Drug Administration (FDA) pre-market approval (PMA) supplemental submissions requesting to expand Impella 2.5 PMA approval to all of the Impella family of devices (Impella 2.5 Impella CP and Impella 5.0/LD). Under the FDA’s Medical Device User Fee Amendment of 2012 (MDUFA III) an approval decision on this PMA application is expected to be made within 180 days of filing.

Date Range Delayed (01/13/2016) - Abiomed announced that it hopes to have approval for the cardiogenic chock indication by summer 2016.

114227


Approved


Abiomed plans to submit supplemental PMAs for Impella 5.0 and Impella CP indicated for emergency use in Q2 FY2016 and expects to receive approval in Summer 2016.

Date Range Refined (08/17/2015) - Abiomed announced that it has submitted U.S Food & Drug Administration (FDA) pre-market approval (PMA) supplemental submissions requesting to expand Impella 2.5 PMA approval to all of the Impella family of devices (Impella 2.5 Impella CP and Impella 5.0/LD). We expect U.S. Food and Drug Administration Approval to occur during this time-range. User Fee Amendment of 2012 (MDUFA III) an approval decision on this PMA application is expected to be made within 180 days of filing.Date Range Delayed (01/13/2016) - Abiomed announced that it hopes to have approval for the cardiogenic chock indication by summer 2016.

114064

01/13/2016-09/30/2016 Abiomed, Inc. ABMD Impella CPCongestive Heart Failure (CHF)

Approved


Abiomed plans to submit supplemental PMAs for Impella 5.0 and Impella CP indicated for emergency use in Q2 FY2016 and expects to receive approval in Summer 2016.

Date Range Refined (08/17/2015) - Abiomed announced that it has submitted U.S Food & Drug Administration (FDA) pre-market approval (PMA) supplemental submissions requesting to expand Impella 2.5 PMA approval to all of the Impella family of devices (Impella 2.5 Impella CP and Impella 5.0/LD). We expect U.S. Food and Drug Administration Approval to occur during this time-range.User Fee Amendment of 2012 (MDUFA III) an approval decision on this PMA application is expected to be made within 180 days of filing.Date Range Delayed (01/13/2016) - Abiomed announced that it hopes to have approval for the cardiogenic chock indication by summer 2016.

114071

01/13/2016-12/31/2016 Cepheid CPHD Xpert Bladder Cancer Bladder Cancer Development Outside U.S. Product Launch (EU)Cepheid announced that it has has targeted commercial release outside the US in late 2015 or early 2016.

Date Range Delayed (01/13/2016) - Cepheid said it plans to launch the Bladder test in Europe in 2016.

111345

01/13/2016-12/31/2016 Cepheid CPHD Xpert Carba-R Antibacterial - General Approved in Europe 510(k) ClearanceIn a Q1 2015 pipeline update Cepheid said it expects commercial release of the Xpert CARBA-R test to occur in the second half of 2015.

Date Range Delayed (12/15/2015) - Cepheid said that Xpert Carba-R was submitted to the FDA in the middle of September. We await an update on the approval and launch in the time frame above.Date Range Delayed (01/13/2016) - Cepheid announced it plans to launch Xpert Carba-R in the U.S. in 2016. We await an update on the approval in the time frame above.

101490

01/13/2016-12/31/2016 Cepheid CPHD Xpert MTB/RIF Tuberculosis Approved Product Launch (EU) Cepheid announced that it expects to launch the Xpert MTB/RIF Ultra assay in Europe in 2016.

118342

01/13/2016-12/31/2016 Cepheid CPHD Xpert TrichomonasUrinary Tract and Reproductive Tract Infections (Antibacterial)

ApprovedTrichomonas Male Indication Launch

Cepheid announced it plans to launch a version of Xpert Trichomonas for men in 2016.

118334

01/13/2016-12/31/2016 Spectranetics Corp. SPNCAngioSculptX Drug-Coated PTCA Scoring Balloon Catheter

Coronary Artery Disease Development Outside U.S. CE Mark ApprovalSpectranetics announced that it is developing a coronary drug-coated angiosculpt balloon and expects to receive CE Mark approval in 2016.

New Information (06/24/2015) - Spectranetics announced it submitted a CE mark application for its AngioSculpt product and is targeting a mid-2016 European launch.Date Range Delayed (01/13/2016) - Spectranetics expects CE mark approval for the AngioSculptX drug-coated PTCA scoring balloon catheter in 2016.

106406

04/26/2016-04/29/2016 Spectranetics Corp. SPNC Stellarex DCBPeripheral Arterial Disease (PAD)

IDEILLUMENATE GLOBAL - Top-Line Results at Charing Cross

Spectranetics will present 12 month interim data from the ILLUMENATE Global study in April at the Charing Cross International Symposium.

118379


ApprovedImpella 2.5 Japanese Approval

Abiomed estimates launching the Impella 2.5 in Japan around mid calendar year 2016.

Date Range Refined (01/13/2016) - Abiomed announced that the PMA in Japan is pending and the company expects to receive approval during the summer of 2016.

114076

06/01/2016-09/30/2016Integra LifeSciences Holdings Corporation

IARTIntegra Dermal Regeneration Template

Diabetic Foot Ulcers Approved U.S. Product Launch Integra plans to launch the Omnigraft in summer 2016. 118394

07/01/2016-12/31/2016 BTG plc BTC:LNEkoSonic Endovascular System

Pulmonary Arterial Hypertension (PAH)

ApprovedImproved Control Unit Launch

BTG will roll-out an improved version of the control unit for the EKOS System in H2 2016.

118400

07/01/2016-12/31/2016 BTG plc BTC:LN PneumRx Coil System Emphysema IDE Reimbursement (France)BTG announced that they expect to secure full reimbursement in France for PneumRx in the second half of 2016.

118288


IDEILLUMENATE EU RCT - Top-Line Results at VIVA

Spectranetics will present 12 month data from the ILLUMENATE EU RCT study at the VIVA conference in September.

118380

10/01/2016-12/31/2016 BTG plc BTC:LNEkoSonic Endovascular System

Pulmonary Arterial Hypertension (PAH)

ApprovedOPTALYSE PE - Patient Enrollment Complete

BTG announced that they plan to complete patient enrollment in the OPTALYSE PE study of EKOS at the end of 2016.

118343

MedDeviceTracker JPM Catalysts - Day 3


August 2016 / 45


10/01/2016-12/31/2016 BTG plc BTC:LN PneumRx Coil System Emphysema IDEPMA Approval Decision U.S.

BTG said it is progressing its regulatory application in the US which it anticipates submitting around mid-2016. Given this timeline for filing we expect an update on the approval in the time frame above.

Date Range Refined (01/13/2016) - BTG announced that they expect a U.S. PMA decision for PneumRx at the end of 2016.

117327


IDEPhase II ILLUMENATE Pivotal Study (US) - Top-Line Results at TCT

Spectranetics will present 12 month data from the ILLUMENATE US pivotal study at the TCT meeting in October.

118362


IDEILLUMENATE Global Registry - Top-Line Results at LINC

Spectranetics will present 12 month data from the ILLUMENATE Global Registry study at the LINC meeting in January 2017.

118382

01/01/2017-12/31/2017 NovoCure Limited NVCR Optune Mesothelioma Development Outside U.S. Phase II STELLAR - Enrollment Completion

Novocure said it expects to enroll the last patient in the STELLAR trial in 2017.

117365

01/01/2017-12/31/2018 Cepheid CPHD Xpert Bladder Cancer Bladder Cancer Development Outside U.S. Product Launch (US)Cepheid said it plans to launch the Bladder test in the U.S. in the 2017-2018 time frame.

118340

01/01/2017-12/31/2018 Cepheid CPHD Xpert HBVHepatitis B (HBV) Treatment (Antiviral)

Development Outside U.S. Product Launch (EU)Cepheid announced that Xpert HBV has moved into active development with targeted CE IVD release in the 2016-2017 timeframe.

Date Range Delayed (01/13/2016) - Cepheid announced it expects to launch the Xpert HBV Viral Load assay in Europe during the 2017-2018 time frame.

111344

01/01/2017-12/31/2018 Cepheid CPHD Xpert HBVHepatitis B (HBV) Treatment (Antiviral)

Development Outside U.S. Product Launch (US)Cepheid announced it expects to launch the Xpert HBV Viral Load assay in the U.S. during the 2017-2018 time frame.

118338

01/01/2017-12/31/2018 Cepheid CPHD Xpert HCV Viral LoadHepatitis C (HCV) (Antiviral)

Development Outside U.S. Product Launch (U.S.)

Cepheid announced that the Xpert HCV Viral Load test is in clinical trials and is expected to be released in the U.S. in the 2016-2017 time frame. The company said it will narrow that window as it gets closer to the FDA submission.

Date Range Delayed (01/13/2016) - Cepheid announced it expects to launch the Xpert HCV Viral Load assay in the U.S. during the 2017-2018 time frame.

111340

01/01/2017-12/31/2018 Cepheid CPHD Xpert HIV-1 Viral Load HIV / AIDS Approved in Europe Product Launch (U.S.)

Cepheid announced that the Xpert HIV Viral Load test is in clinical trials and is expected to be released in the U.S. in the 2016-2017 time frame. The company said it will narrow that window as it gets closer to the FDA submission.

Date Range Delayed (01/13/2016) - Cepheid announced it expects to launch the Xpert HIV-1 Viral Load assay in the U.S. during the 2017-2018 time frame.

111341

06/01/2017-05/30/2018 AngioDynamics, Inc. ANGO NanoKnife System Solid Tumors ApprovedNext Generation NanoKnife System - Product Launch

AngioDynamics expects to launch a next-generation NanoKnife System during FY2018.

118401

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