Syneos Health Consulting
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1 Syneos Health Consulting BioPharma BD Newsletter 2019 has been a year of high value low volume exits and partnerships. Deal activity may be continuing a decline, as H2 faced a decrease in both deal value and volume when compared to H1. The IPO window also seemed to be slightly wavering as the second half of 2019 observed a decrease in volume and value of public exits. A 50% decrease in global collaboration in H2 compared to H1 may signal that companies are favoring full ownership vs partnering their capabilities. On the regulatory side, a spike in FDA approvals through the second half of 2019 lead to 35 novel products and 33 generics launches. Newsletter Content H2 Deal Summary H2 Global & US Deals H2 Ex-US Deals 2019 Deal Summary H2 US IPOs H2 FDA Approvals Q1 ‘20 PDUFA Dates H2 Deal Summary 1 2019 | Full Year & H2 Analysis Note: M&As deals used the buyers HQ country. Partnerships deals listed through the licensing territory. Asset Purchases deals used either the HQ country or the licensing territory. HIGHLIGHTS Novartis agreed to a $9.7 billion deal to buy The Medicines Company for access to their next-generation heart drug inclisiran. The takeover represents a big bet on the cholesterol drug to outperform competitor products sold by Amgen and Regeneron. Galapagos and Gilead have agreed a ten-year multi-billion dollar collaboration to create a ‘global R&D leader’ based in EU and engaged in developing and commercializing breakthrough therapies. Analysts bill this tie-up as one of the largest biotech deals ever in the EU with an upfront payment of $3.95 billion. Amgen buys rights to the psoriasis drug Otezla from Celgene for $13.4 billion, allowing BMS to move forward with its Celgene merger. H2 2019 Summary # of Deals disclosed finances of total Tot. Deal Value ($M) Avg. Deal Value ($M) No. of Deals With upfront payments Avg. Upfront Payments ($M) YoY Growth % H2 2019 v. H2 2018 Tot. Deal Value Mergers & Acquisitions 13 of 27 26,311 2,024 12 1,814 40% Partnerships 37 of 164 20,847 563 29 140 48% Asset Purchases 10 of 21 19,687 1,969 7 2,561 264% Deals by Geography (H2 2019) NA 4 | 2 | 4 EU 7 | 1 | 2 APAC 2 | 8 | 2 WW -- | 26 | 2 Legend: Asset Purchases Partnerships M&A
Transcript of Syneos Health Consulting
1
Syneos Health ConsultingBioPharma BD Newsletter
2019 has been a year of high value low volume exits and partnerships. Deal activity may be
continuing a decline, as H2 faced a decrease in both deal value and volume when compared
to H1. The IPO window also seemed to be slightly wavering as the second half of 2019
observed a decrease in volume and value of public exits. A 50% decrease in global
collaboration in H2 compared to H1 may signal that companies are favoring full ownership
vs partnering their capabilities. On the regulatory side, a spike in FDA approvals through
the second half of 2019 lead to 35 novel products and 33 generics launches.
Newsletter Content H2 Deal Summary
H2 Global & US Deals
H2 Ex-US Deals
2019 Deal Summary
H2 US IPOs
H2 FDA Approvals
Q1 ‘20 PDUFA Dates
H2 Deal Summary1
2019 | Full Year & H2 Analysis
Note: M&As deals used the buyers HQ country. Partnerships deals listed through the licensing territory. Asset Purchases deals used either the HQ country
or the licensing territory.
HIGHLIGHTS
Novartis agreed to a $9.7 billion deal to buy The Medicines Company for access to their next-generation heart drug inclisiran. The takeover represents a big bet on the cholesterol drug to outperform competitor products sold by Amgen and Regeneron.
Galapagos and Gilead have agreed a ten-year multi-billion dollar collaboration to create a ‘global R&D leader’ based in EU and engaged in developing and commercializing breakthrough therapies. Analysts bill this tie-up as one of the largest biotech deals ever in the EU with an upfront payment of $3.95 billion.
Amgen buys rights to the psoriasis drug Otezla from Celgene for $13.4 billion, allowing BMS to move forward with its Celgene merger.
H2 2019
Summary
# of Deals
disclosed
finances of
total
Tot. Deal
Value ($M)
Avg. Deal Value
($M)
No. of Deals
With upfront
payments
Avg. Upfront
Payments
($M)
YoY Growth %
H2 2019 v.
H2 2018
Tot. Deal Value
Mergers &
Acquisitions13 of 27 26,311 2,024 12 1,814 40%
Partnerships 37 of 164 20,847 563 29 140 48%
Asset Purchases 10 of 21 19,687 1,969 7 2,561 264%
Deals by Geography (H2 2019)
NA
4 | 2 | 4EU
7 | 1 | 2
APAC
2 | 8 | 2
WW
-- | 26 | 2
Legend:Asset PurchasesPartnershipsM&A
2
H2 2019 Deal Summary1
Note: Therapeutic count was determined by the largest drug in the pipeline or the focus drug of the deal. The graph only includes deals with disclosed
financing. The development phase was determined by the development phase at the time deal sign of the biopharma products only.
Value & No. of Deals by QuarterQ3 2018 – Q4 2019
0
10
20
30
40
50
60
70
80
80,000
90,000
100,000
110,000
120,000
40,000
0
10,000
20,000
30,000
Value of Deals ($M)
29 Deals
$96,351M
75 Deals
$26,821M
Q4 ‘18 Q3 ‘19
31 Deals
$29,758M
No. of Deals
Q3 ‘18 Q1 ‘19 Q4 ‘19
56 Deals
$37,559M
46 Deals
$112,393M
29 Deals
$37,086M
Q2 ‘19
0
2
4
6
8
10
12
14
16
18
20
22
0
5,000
10,000
15,000
20,000
Cardio
Value of Deals ($M)
Auto
No. of Deals
NeuroOnc Endo/Meta
1 Deal$720M
2 Deals$9,789M
Muscu Pulmonary Gastro
4 Deals$715M
Infectious Hepatic Hema Derma Resp Ophth Otologic Genito
22 Deals$19,917M
3 Deals$16,695M
4 Deal$4,439M 2 Deals
$3,535M8 Deal
$3,048M 3 Deal$1,840M
2 Deal$1,502M
2 Deals$1,386M
2 Deals$963M
2 Deals$850M
1 Deal$750M
1 Deal$625M
1 Deal$73M
Value & No. of Deals by Therapeutic AreaH2 2019
0
2
4
6
8
10
12
14
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
11 Deals
$7,215M
No. of Deals
Preclinical
Value of Deals ($M)
Phase IIMarketed
10 Deals
5,612
UndisclosedPhase IRegistration
13 Deals
$6,591M
Phase III Research
10 Deals
$32,209M
1 Deal
$20M
4 Deals
$4,436M
6 Deals
$6,832M 5 Deals
3,932
Value & No. of Deals by Development PhaseH2 2019
Legend:Asset PurchasesPartnershipsM&A Deal Count
3
Buyer SellerTot. Deal
Value ($M)
Upfront
Payment ($M)Summary
9,700 9,700Novartis acquired The Medicines Company, adding inclisiran
to their portfolio, a cholesterol-lowering therapy
3,000 3,000Astellas Pharma acquired Audentes to broaden its genetic
medicine and gene therapy business
2,800 2,800Exact Sciences completed its acquisition of Genomic Health,
creating a leading global cancer diagnostics company
2,700 2,700Merck acquired ArQule to further diversify its oncology
pipeline with expansion into hematological malignancies
2,500 2,500Sanofi acquired Synthorx bolstering its immuno-oncology
pipeline
H2 2019 Global & US Deals1
Top 5 Mergers & Acquisitions
Top 5 Partnerships
DEAL HIGHLIGHT3
Gilead and Galapagos enter into transformative research and development collaboration
Gilead gains access to Galapagos’ differentiated drug discovery platform and current and future pipeline outside of Europe
The investment enables Galapagos to expand and accelerate research and clinical programs
Galapagos gains broader commercialization role for Filgotinib in Europe and agrees to share equally in future development costs
DEAL HIGHLIGHT2
Novartis successfully completes acquisition of the Medicines Company, adding a potentially first-in-class, investigational cholesterol-lowering therapy inclisiran
The Medicines Company submitted the New Drug Application for inclisiran to the FDA in December 2019; comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with an excellent safety profile
Inlcisiran leverages significant synergies with Novartis’ existing global cardiovascular commercial capabilities
Buyer SellerTot. Deal
Value ($M)
Upfront
Payment ($M)TA Phase Leading Asset
5,100 3,950 Inflammation Phase III Filgotinib
2,099 20Endocrine /
MetabolicPreclinical SLN500
1,550 250Endocrine/
MetabolicPhase II
AKCEA-
ANGPTL3-LRx
1,251 51 Pulmonary Phase I BBT-877
1,226 26 Gastrointestinal Research Undisclosed
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H2 2019 Global & US Deals1
Buyer SellerTot. Deal
Value ($M)
Upfront
Payment ($M)Phase Asset
13,400 13,400 MarketedOtezla: treatment for certain types of psoriasis
and psoriatic arthritis
750 750 Phase IIBermekimab: treatment of atopic dermatitis and
hidradenitis suppurativa
128 3 PreclinicalFX301: potential first-in-class therapy aimed to
provide post operative pain relief
93 -- PreclinicalALT-801: novel therapy to treat the underlying
metabolic dysfunction that leads to NASH
H2 2019 Ex-US Deals1
Buyer SellerTot. Deal
Value ($M)Deal Summary Geography
Me
rge
rs &
Acq
uis
itio
n
557
Zambon is acquiring Sofinnova Partners portfolio
(parent company Breath Therapeutics) which
specializes in respiratory diseases
EU
367
Boehringer Ingelheim acquires AMAL Therapeutics,
significantly enriching its cancer immunology portfolio
with novel cancer products
EU
Pa
rtn
ers
hip 3,950
Amgen enters into strategic collaboration with
BeiGene to expand oncology presence in ChinaAPAC
625
Astellas enters into a partnership with Frequency to
develop Frequency’s lead candidate – sensorineural
hearing loss regenerative therapeutics
APAC / EU
Ass
et
Pu
rch
as
es 3,000
Roivant agreed to sell ownership of five of its Vant
companies (Myovant, Urovant, Enzvant, Altavant, and
Spirovant) to Sumitomo Dainippon
APAC / EU
1,066
Bavarian Nordic buys vaccines against rabies
(Rabipur) and tick-borne encephalitis (Encepur) from
GlaxoSmithKline
EU
Highlighted Deals
DEAL HIGHLIGHT4
Amgen to acquire Otezla for $13.4 B in cash, or approximately $11.2 B net of anticipated future cash tax benefits
The acquisition of Otezla offers a unique opportunity for Amgen to provide patients an innovative oral therapy for psoriasis and psoriatic arthritis that fits squarely within their portfolio and complements their Anbrel and Amgevita brands
Celgene planned a strategic agreement to allow Amgen to purchase its blockbuster psoriasis product, Otezla, to sweeten Celgene’s case to antitrust officials as it seeks approval for the merger with BMS; as BMS has a competing psoriasis drug in development, BMS-986165, a TYK2 inhibitor
Asset Purchases
5
Full Year 2019 Deal Summary
Top Dealmakers of 2019
CompanyNo. of
Deals
Tot. Deal
Value ($M)
6 353,687
11 88,910
6 74,000
10 63,510
21 17,866
The biopharmaceutical sector has experienced
continued volatility as a combination of economic and
regulatory factors drive change across the landscape.
Despite uncertainty around the global economy, 2019
was a banner year in terms of total deal value for the
biopharmaceutical landscape. M&As led the way with
several deals surpassing the billion-dollar threshold,
however robust activity was seen across all deal types.
We expect the 2020 deal landscape to increase in deal
volume and decrease in value, driven mainly by smaller
biotech companies.
51Disclosed Deal $
211,140Tot. Deal Value $M
3,984Avg. Deal Value $M
180Disclosed Deal $
461,688Tot. Deal Value $M
2,496Avg. Deal Value $M
Mergers & Acquisitions Partnerships & Asset Purchases
Bristol-Myers Squibb acquired Celgene to create a premier innovative biopharma company10
Highly complementary portfolios with leading franchise in Oncology, Immunology and Inflammation, and Cardiovascular disease
Significantly expands BMS Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential
Registrational trial opportunities and early-stage pipeline position combined company for sustained leadership underpinned by cutting-edge technologies and discovery platforms
Deal completed after Celgene sold Otezla to Amgen, addressing US Federal Trade Commission concerns
AstraZeneca and Daiichi Sankyo entered into a collaboration for novel HER2-targeting antibody-drug conjugate11
Companies to accelerate and expand development of trastuzumab deruxtecan across breast and other cancers, with the potential to redefine standard of care
The collaboration is aligned with AstraZeneca’s science-led strategy in Oncology, which is based on four key scientific platforms: tumor drivers & resistance, DNA damage response, ImmunoOncology, and ADCs
Funding via an equity placement of approximately $3.5 billion
Novartis acquired Xiidra, expanding front-of-eye portfolio and strengthening leadership in eye care12
Xiidra 5% fits strategically within industry-leading $4.6 billion Novartis ophthalmic pharmaceutical portfolio, laying groundwork for front-of-the-eye pipeline products currently in development
Xiidra is the first and only prescription treatment approved for both signs and symptoms of dry eye disease with a mechanism of action that targets inflammation
Deal terms include a $3.4 billion upfront payment with potential milestone payments of up to $1.9 billion
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H2 2019 US IPOs1
CompanyTicker
(NASDAQ)
Amount
Raised ($M)Therapeutic Area
Lead Product
Status
Date
Complete
Mirum Pharmaceuticals Inc. MIRM 75 Hepatic Phase II Jul 17
Fulcrum Therapeutics Inc. FULC 72 Neurology Preclinical Jul 17
Satsuma Pharmaceuticals Inc. STSA 91 Neurology Phase III Sep 12
SpringWorks Therapeutics Inc. SWTX 186 Oncology Phase III Sep 12
IGM Biosciences Inc. IGMS 201 Oncology Preclinical Sep 17
Frequency Therapeutics Inc. FREQ 89 Otology Phase II Oct 02
Viela Bio Inc. VIE 173 Inflammation Phase III Oct 02
Vir Biotechnology Inc. VIR 143 Infectious Phase II Oct 10
TFF Pharmaceuticals Inc. TFFP 24 Cardiovascular Preclinical Oct 24
Phathom Pharmaceuticals Inc. PHAT 209 Gastrointestinal Phase III Oct 24
Cabaletta Bio Inc. CABA 80 Autoimmune IND Oct 25
RAPT Therapeutics Inc. RAPT 41 Oncology Phase II Oct 30
Oyster Point Pharma Inc. OYST 92 Ophthalmic Phase III Oct 30
Galera Therapeutics Inc. GRTX 65 Oncology Phase III Nov 06
89bio Inc. ETNB 98 Hepatic Phase I Nov 12
CNS Pharmaceuticals Inc. CNSP 10 Oncology Preclinical Nov 13
Monopar Therapeutics Inc. MNPR 10 Oncology Phase II Dec 18
Legend:Amount Raised No. Financing Data
Value & No. of IPOs by QuarterQ3 2018 – Q4 2019
1,767
0
5
10
15
20
0
500
1,000
1,500
2,000
2,500
Q4 ’18Q3 ’18 Q1 ’19
Value of IPOS ($M) No. of IPOs
Q3 ’19Q2 ’19 Q4 ’19
5 IPOs
$625M
19 IPOs
$1,767M
11 IPOs
$1,855M
11 IPOs
$1,065M
12 IPOS
$1,033M
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H2 2019 FDA Approvals
Novel Drugs6 Generic Name, Company, and IndicationApproval
Date
selinexor | Karyopharm
Relapsed or refractory multiple myelomaJul 03
imipenem, cilastatin, and relebactam | Merck & Co.
Complicated urinary tract and complicated intra-abdominal infectionsJul 16
ferric maltol | Shield Therapeutics
Iron deficiency anemiaJul 25
darolutamide | Bayer and Orion Corp.
Non-metastatic castration resistant prostate cancerJul 30
pexidartinib | Daiichi Sankyo
Symptomatic tenosynovial giant cell tumorAug 02
pitolisant | Bioproject
Excessive daytime sleepiness in adult patients with narcolepsyAug 14
entrectinib | Genentech Inc.
Metastatic non-small cell lung cancerAug 15
fedratinib | Impact Biomedicines Inc.
Intermediate-2 or high-risk primary or secondary myelofibrosisAug 16
upadacitinib | Abbvie Inc.
Moderately to severely active rheumatoid arthritisAug 16
lefamulin | Nabriva Therapeutics Inc.
Community-acquired bacterial pneumoniaAug 19
istradefylline | Kyowa Kirin
Parkinson’s disease experiencing “off” episodesAug 27
tenapanor | Ardelyx Inc.
Irritable bowel syndrome with constipationSep 12
trifarotene | Galderma
Topical treatment of acne vulgaris in patients 9 and olderSep 04
brolucizumab-dbll | Novartis
Wet age-related macular degenerationSep 07
lasmiditan | Eli Lilly & Co.
Acute treatment of migraine with or without auraOct 11
elexacaftor/ivacaftor/tezacaftor | Vertex Pharmaceuticals
Common gene mutation that causes cystic fibrosisOct 21
air polymer-type A | ExEm Foam Inc.
Diagnostic agent used to assess fallopian tube patency in women with infertilityNov 07
luspatercept-aamt | Bristol-Myers Squibb and Acceleron
Anemia in adult patients with beta thalassemia who require red blood cell transfusionsNov 08
zanubrutinib | BeiGene
Mantle cell lymphomaNov 14
cefiderocol | Shionogi Inc.
Complicated urinary tract infections who have limited to no alternative treatment optionsNov 14
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H2 2019 FDA Approvals
Novel Drugs6 Generic Name, Company, and IndicationApproval
Date
crizanlizumab-tmca | Novartis
Painful complication of sickle cell diseaseNov 15
givosiran | Alnylam Pharmaceuticals
Acute hepatic porphyriaNov 20
cenobamate | SK Life Science
Treat partial onset seizuresNov 21
voxelotor | Global Blood Therapeutics
Sickle cell diseaseNov 25
golodirsen | Sarepta Therapeutics
Duchenne muscular dystrophyDec 12
enfortumab vedotin-ejfv | Agensys and Seattle Genetics
Refractory bladder cancerDec 18
brilliant blue G Ophthalmic solution | Dutch Ophthalmic Research Center
Dye used in eye surgeryDec 20
lumateperone tasylate | Intra-Cellular Therapies
SchizophreniaDec 20
lemborexant | Eisai
InsomniaDec 20
fam-trastuzumab-deruxtecan-nxki | Daiichi Sankyo
Metastatic breast cancerDec 20
ubrogepant | Allergan plc
Acute treatment of migraine with or without auraDec 23
Biosimilar7 Generic Name, Company, and IndicationApproval
Date
rituximab-pvvr | Pfizer
Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with
polyangiitis
Jul 23
adalimumab-bwwd | Samsung Bioepis
Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,
crohn’s disease, ulcerative colitis, and plaque psoriasis
Jul 23
pegfilgrastim-bmez | Sandoz
Decrease the incidence of infection in patients with non-myeloid malignanciesNov 05
adalimumab-afzb | Pfizer
Psoriatic arthritisNov 18
infliximab-axxq | Amgen
Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritisDec 06
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H2 2019 FDA Approvals
First Generic8 Company and Indication Brand ProductApproval
Date
febuxostatTablet
Mylan, Alembic, Sun
Chronic management of hyperuricemiaJul 01
phenylephrine /
ketorolacIntraocular solution
Lupin Limited
Preventing intraoperative miosis and reducing postoperative painJul 01
carboprost tromethamineInjection
Dr. Reddy’s Laboratories Limited
Aborting pregnancy between the 13th and 20th weekJul 02
technetium tc99mKit
Pharmalucene Inc.
diagnosis of renal failure, urinary tract obstruction, and calculiJul 12
daptomycinInjection
Accord Healthcare Inc.
Complicated skin and skin structure infectionsJul 12
icatibantInjection
Teva Pharmaceuticals
Acute attacks of hereditary angioedemaJul 15
pregabalinCapsule
Teva, Alembic, Alkem, Sciegen, MSN, Dr. Reddy’s, Amneal, Rising,
InvaGen
Management of neuropathic pain
Jul 19
morphine sulfateTablet
Upsher-Smith Laboratories
Management of acute and chronic painJul 22
halcinonideCream
Mylan Pharmaceuticals
Releif of inflammatory dermatosesAug 12
tafluprost ophthalmicSolution
Micro Labs Limited
Reducing elevated intraocular pressureAug 12
triamtereneCapsule
Agnitio Inc
Edema associated with congestive heart failureAug 19
sapropterinPowder
Par Pharmaceuticals
Reduction of blood phenylalanine levelsAug 20
posaconazoleTablet
Sinotherapeutics Inc.
Prophylaxis of invasive aspergillus and candida infectionsAug 21
nitisinoneCapsule
Notivium Pharma
Hereditary tyrosinemia type 1Aug 26
nabumetoneTablet
Nexgen Pharma
Relief of signs and symptoms of osteoarthritis and rheumatoid arthritisAug 30
fosaprepitantInjection
Mylan Pharmaceuticals
Prevention of acute and delayed nausea and vomitingSep 05
carfilzomibInjection
Dr. Reddy’s Laboratories
Relapsed or refractory multiple myelomaSep 09
ivermectinCream
Teva Pharmaceuticals
Inflammatory lesions of rosaceaSep 13
vilazodoneTablet
Teva Pharma
Major depressive disorderSep 30
digoxinOral
Novitium Pharma
Atrial fibrillation and heart failureOct 04
gadoterate meglumineInjection
GE Healthcare
Magnetic resonance imaging to detect areas with disruption of the
blood
Nov 01
10
H2 2019 FDA Approvals
First Generic8 Company and Indication Brand ProductApproval
Date
mesalamineCapsule
Mylan Pharmaceuticals
Maintenance of remission of ulcerative colitisNov 01
deferasiroxTablets
MSN Pharma, Alembic Pharma, Zydus Pharma, Teva Pharma, Actavis
Chronic iron overload due to blood transfusionsNov 20
sucralfateOral
Amneal Pharma
Short-term treatment of active duodenal ulcerDec 02
fingolimodCapsule
HEC Pharm Co, Biocon Limited, Sun Pharma
Relapsing forms of multiple sclerosisDec 04
everolimusTablet
Par Pharmaceutical, Teva Pharma
Advanced hormone receptor-positive, HER2-negative breast cancer in
postmenopausal women; advanced renal cell carcinoma; renal
angiomyolipoma and tuberous sclerosis complex; progressive
neuroendocrine tumors of pancreatic origin
Dec 09
etonogestrel and ethinyl
estradiolVaginal ring
Amneal Pharmaceutical
Prevent pregnancyDec 11
alvimopanCapsule
Watson Laboratories
Accelerate time to upper and lower gastrointestinal recovery following
partial large or small bowel resection surgery with primary anastomosis
Dec 19
diazoxideSuspension
e5 Pharma
Management of hypoglycemia due to hyperinsulinism associated with
certain conditionsProglycem Dec 20
apixabanTablet
Micro Labs Limited, Mylan
Reduce the risk of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation; for the prophylaxis of deep vein
thrombosis
Dec 23
penicillamineTablet
Par Pharmaceutical
Wilson’s disease, cystinuria, and in patients with severe active
rheumatoid arthritisDepen Dec 23
ziprasidone mesylateInjection
Gland Pharma Limited
Acute treatment of agitation in schizophrenic patientsDec 26
mirabegronTablet
Sawai USA
Overactive bladder with symptoms of urge urinary incontinence,
urgency, and urinary frequency
Dec 27
Legend:First GenericBiosimilarNovel
No. of Drug Approvals by Quarter
0
10
20
30
40
50
60
70
Q1 ’19
No. of Approvals
5%
45%
17 Novel
3 Biosimilar
14 Generic
7 Novel
3 Biosimilar
20 Generic
Q3 ’18 Q2 ’19Q4 ’18
18 Novel
4 Biosimilar
23 Generic
50%
7 Novel
2 Biosimilar
12 Generic
Q3 ’19
40%
9%
51%
Q4 ’19
21 Novel
1 Biosimilar
25 Generic 14 Novel
2 Biosimilar
19 Generic
11
Q1 2020 FDA PDUFA Dates9
Company Name Drug Name IndicationEstimated
Date
PDUFA
Review
Aimmune Therapeutics AR101 Peanut Allergy Jan 31
Agile Therapeutics Twirla Contraceptive patch Feb 16
Merck & Co. Keytruda 6-week dosing for melanoma Feb 18
Baudax Bio IV melaxicam Acute pain following bunionectomy surgery Feb 20
Esperion Therapeutics Bempedoic acidHyperlipidemia whose LDL-C is not adequately
controlled with low-and moderate-dose statinsFeb 21
Esperion TherapeuticsBempedoic acid /
ezetimibeHypercholesterolemia Feb 26
Bristol-Myers Squibb Opdivo & Yervoy Previously treated hepatocellular carcinoma Mar 10 Priority
Eton Pharma EM-105 Lennox-Gastaut syndrome, epilepsy Mar 17
Bristol-Myers SquibbOzanimod –
RADIANCERelapsing multiple sclerosis Mar 25
Zogenix Fintepla Dravet syndrome Mar 25 Priority
Heron Therapeutics HTX-011 Post operative pain Mar 26
Intelgenx TechsRIZAPORT (RHB-
103)Migraine Mar 26
Rockwell Medical IV Triferic Anemia Mar 28
AstraZenecaImfinzi +
tremelimumabSmall cell lung cancer Mar 29 Priority
12
1. https://bciq.biocentury.com/deal/all-deals/insights
2. https://www.novartis.com/news/media-releases/novartis-successfully-completes-acquisition-medicines-company-adding-potentially-
first-class-investigational-cholesterol-lowering-therapy-inclisiran
3. https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-and-galapagos-enter-into-transformative-research-
and-development-collaboration
4. https://www.amgen.com/media/news-releases/2019/08/amgen-to-acquire-otezla-for-134-billion-in-cash-or-approximately-112-billion-
net-of-anticipated-future-cash-tax-benefits/
5. https://www.genengnews.com/news/astellas-frequency-therapeutics-partner-to-develop-hearing-loss-drug/
6. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm629491.htm
7. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologic
applications/biosimilars/ucm580432.htm
8. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/andage
nericdrugapprovals/default.htm
9. https://www.biopharmcatalyst.com/calendars/fda-calendar
10. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-acquire-celgene-create-premier-innovative
11. https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-and-daiichi-sankyo-enter-collaboration-for-novel-her-2-
targeting-antibody-drug-conjugate.html
12. https://www.novartis.com/news/media-releases/novartis-acquire-xiidra-expanding-front-eye-portfolio-and-strengthening-leadership-eye-
care
Authors
Syneos Health makes no guarantee, warranty, or assurances concerning the information in this document. Data is based on latest information as of 10/11/2019.
Neel Patel
Senior Managing Director
Katya Magonova
Senior Engagement Manager
Nick Milazzo
Associate Consultant
David Tannin
Senior Consultant
Sources
Note: Mergers & Acquisition deals include: Full Acquisition, Majority Acquisition, Acquisition Option, Merger.
Mergers & Acquisition asset types include: Company, Pharmaceutical Product, Facility.
Partnership deals include: Development and Commercialization License, Collaborative Research and Product License Option, Equity Stake and License Option,
Product License Option, Partnership with Company Acquisition Option, Joint Venture / Consortium, Sales Marketing and Co-Promotion, Cross License.
Partnerships assets include: Company, Pharmaceutical Product, Facility.
Asset Purchases deals include: Business Unit or Division Purchase, Product Pipeline or Platform Purchase.
Asset Purchases assets include: Business Unit or Division Purchase, Company, Pharmaceutical Product
Deal Values have been rounded to the nearest million
Andrew Okimura
Associate Consultant
13
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delivered
Only
end-to-end
outsourced
integrated
solutions
company
of FDA-approved Novel New
Drugs developed or
commercialized by Syneos
Health (2015–2019)
92%of EMA-approved products
developed or commercialized by
Syneos Health (2015–2019)94%
Risk & Program Management
The Risk and Program Management Advisory Group helps pharma consortiums facilitate the
myriad legal, financial, and operational challenges of initiating and implementing complex
single, shared REMS programs
Commercial Advisory Group
The Commercial Advisory Group helps clients maximize the commercial value of their
assets, portfolio, and organization through our four areas of expertise – Portfolio Strategy &
Transactions, Value Access & HEOR, Product & Franchise Strategy, and Customer & Digital
Engagement
Scientific & Medical Affairs Advisory
The Scientific & Medical Affairs Advisory Group helps clients accelerate drug development
and adoption through our four areas of expertise – Regulatory Strategy & Submission,
Medical Affairs Asset & Organizational Strategy, Quality & Compliance Program
Development, and Clinical Development Strategy
R&D Advisory GroupThe R&D Advisory Group (previously Kinapse) encompasses a suite of services to help
customers anticipate, shape, and respond to global trends that are transforming Life
Sciences R&D.
