Arecentreportcontainedthefollowing:“Anidealhypno5c...

Zolpimist®

Confidential Information

1 Zolpimist®


A recent report contained the following: “An ideal hypno5c that promotes rapid onset of sleep, maintains sleep and its structure, does not have neurocogni5ve consequences and has a low side effect profile does not yet exist.“

It does now

Zolpimist®


2

The Opportunity: Zolpimist® Zolpimist® (zolpidem oral spray)

•  Approved by FDA December 2008; currently being sold by Hi-‐Tech Pharmacal (“HITK” Nasdaq), licensed from NovaDel Pharma.

•  Zolpidem, the ac5ve ingredient in both Ambien® (Sanofi-‐Aven5s) and Zolpimist®, is the leading sleep aid on the market with an approximate market share of 70%.

•  Zolpimist® is a patented product developed and designed to provide pa5ents with faster onset of sleep as demonstrated in various clinical studies.

•  Two dosages have been approved

•  5 mg – one spray

•  10 mg – two sprays

Zolpimist®


3

Amherst Pharmaceu5cals Strategy •  Over the past several years the insomnia market has become largely genericized with

li\le product differen5a5on and having no consumer focus. •  The introduc5on of a product that can be differen5ated based on a patented delivery

technology and offering the consumer clear advantages, will be accepted and adopted.

•  Given the above, the key strategic objecBves of Amherst PharmaceuBcals are:

•  Posi5on Zolpimist® as the treatment of choice for insomnia; Zolpimist® will be seen as an important lifestyle product for insomniacs, with any degree of insomnia, including transient or chronic insomnia

•  Ini5ally sell Zolpimist® into key markets, such as the interna5onal travelers, where its benefits can be fully exploited and developed;

•  Posi5on Zolpimist® as the alterna5ve to zolpidem tablets in those pa5ents where the tablets do not work (step therapy) thereby making managed care (and reimbursement restric5ons) a partnering opportunity and;

•  Manage the company as virtual as possible thereby maximizing earnings.

Zolpimist®


4

Execu5ve Summary •  Zolpimist® (zolpidem tartrate) is a patented, FDA approved bioequivalent version of

the market leading sleep aid, Ambien® in an oral spray formula5on. •  Zolpidem is the most commonly prescribed agent for the treatment of insomnia

with a market share of approximately 70%, with over 1.2 billion zolpidem tablets prescribed in 2010 in the US.

•  Zolpimist® is engineered to outperform the oral tablets

•  Using a proprietary and patented technology we deliver the drug as a fine mist into the mucosal membranes lining the cheeks in the mouth (buccal delivery). This mode of delivery offers some very clear advantages as compared to other delivery methods:

!  Faster onset of ac5on; !  No food effect that mi5gates the efficacy of other zolpidem products

Zolpimist®


5

Execu5ve Summary

•  The benefits to consumers will include:

•  Rapid bioavailability should be a key requirement for a sleep aid. Zolpimist® is formulated as a buccal spray to facilitate more rapid absorp5on as compared to zolpidem oral tablets

•  Zolpimist® induces sleep three 5mes faster than oral tablets – 10 minutes as compared to 30 – 40 minutes for oral tablets.

•  Due to the fine mist technology, Zolpimist® is absorbed directly into the blood stream through the oral mucosa; food does interfere with the absorp5on of zolpidem. More ac5ve drug to sleep faster with no increase in adverse events or next day residual effects.

Zolpimist®


6

Amherst Pharmaceu5cals, LLC Formed Through Asset Acquisi5on Hi-‐Tech Pharmacal, Inc. (ECR PharmaceuBcals) •  Acquired North American commercial

rights except for psychiatry, sleep centers and oncology

•  ECR will pay a transfer price of $14 per unit

•  Amherst receives a 7.5% royalty on net sales

NovaDel Pharma, Inc. •  Zolpimist® NDA and regulatory files •  Global rights •  Patents and other IP •  Clinical data •  No royalty obliga5ons •  Amherst assumes FDA PDUFA

obliga5on

Amherst PharmaceuBcals

Zolpimist®


7

Execu5ve Biographies Ira Weisberg – President and Chief Execu7ve Officer

Mr. Weisberg is an accomplished pharmaceu5cals and biotech execu5ve with extensive experience in business and corporate development, strategic marke5ng, and opera5ons with large and specialty pharmaceu5cal and biotech companies. Working in both large Pharma (American Home Products, Aven5s Behring, Cooper Laboratories) as well as emerging Pharma and biotech companies (Interferon Sciences, LifeCycle Pharma), Mr. Weisberg has amassed more than 35 years experience and knowledge in managing companies, fund raising, product development, sales and distribu5on channels, compliance, regulatory, managed care, reimbursement systems, licensing, and other corporate and business development transac5ons in both the U.S. and interna5onal markets. He has led or been involved with corporate partnering, mergers and acquisi5ons, new venture forma5on and financing within a number of therapeu5c areas such as cancer and cardiovascular medicine. Mr. Weisberg was President and CEO of AlphaVax, an emerging cancer vaccine development company. He has also led product launches in the pharmaceu5cal, biopharmaceu5cal and biotechnology sectors, including managing the Cri5cal Care business for Aven5s Behring.

Some of the key transac5ons included:

•  Ini5ated and closed on a $105 million transac5on with Cowen Healthcare Royalty in which we mone5zed the royalty stream of a key product

•  Led the capital raise of $4 million in a Series G financing for a cancer immunotherapy development stage company

•  Raised ini5al funding for the development of a new company involved in an innova5ve cardiovascular therapeu5c.

•  Led acquisi5on of a business from Baxter Healthcare enabling company to be first entrant into $400 million US market.

•  Generated proceeds of $30 million in IPO providing capital for growth and product development.

•  Out-‐licensed an oncology/immune-‐enhancement biologic to a mid-‐sized pharmaceu5cal company – Deal Value: $200 million

•  Divested the viral tes5ng business of Aven5s Behring to Na5onal Gene5cs Ins5tute, subsidiary of LabCorp

Zolpimist®


8

Execu5ve Biographies Michael Romano, CPA (Fesnak and Associates) – Outsourced Chief Financial Officer Michael Romano is a Partner with Fesnak and Associates, LLP, a regional accoun5ng firm based in Blue Bell, PA and oversees “Outsourced” CFO Services for the company. Mr. Romano is responsible for Fesnak’s Life Sciences Industry Prac5ce and func5ons as the CFO for Amherst Pharmaceu5cals. Mike brings over fimeen years of diverse experience in the life sciences industry and an addi5onal eight plus years serving in various capaci5es such as audit with Ernst & Young at the start of his career and more recently in an audit, tax and business advisory capacity with his own firm, prior to joining Fesnak in December 2012.

Michael is experienced in general management, financial management, M&A, global opera5ons, and Big Four audi5ng. He has orchestrated successful financial and opera5onal turnarounds, restructured and reorganized businesses, and executed growth strategies.

For the past three years Michael ran his own firm, Preston, Romano & Shea where he was recognized for his passion for serving clients and helping them grow their businesses.

While in the private industry sector, Michael gained in-‐depth experience in the pharmaceu5cal services market where he was Vice President and General Manager of a global medical publisher offering health informa5on products and services to the pharmaceu5cal, biotech, and medical device markets. He also spent four years with a privately held, specialty medical educa5on company and four years with a clinical research organiza5on. Both roles served him well working for small to medium sized business in a rapid growth, entrepreneurial environment. Michael began his career in the audi5ng prac5ce of Ernst & Young in Philadelphia.

Michael holds a Bachelor of Science degree in Accoun5ng with a dual major in finance from Drexel University in Philadelphia, PA. He is a Cer5fied Public Accountant, and a member of the AICPA, PICPA and the Greater Philadelphia Senior Execu5ve Group.

Zolpimist®


9

Execu5ve Biographies Joshua Weisberg – Vice President, Sales and Marke7ng Mr. Weisberg is a successful Brand Strategist and Marke5ng Director with experience in both marke5ng and adver5sing. Mr. Weisberg has developed a niche in pharmaceu5cal sales and marke5ng through his experience on varying prescrip5on and over the counter drug campaigns such as Enbrel, Xifaxan, Taclonex, Betaseron, Percocet, Viadur and Salagen for companies diverse as Dudnyk Healthcare, Interlink Healthcare, Gillespie (MRM Worldwide), and Concentric Pharma .

Mr. Weisberg graduated from the Art Ins5tute of Philadelphia with a degree in Visual Communica5ons.

Zolpimist®


10

Partners

•  Fesnak and Associates – CFO and Financial Services

•  Publicis Touchpoint Solu5ons – Contract Sales

•  Sudler & Hennessey NY – Communica5ons and Adver5sing •  Beckloff Associates – Regulatory Affairs

•  Rechon Life Sciences – Manufacturing

•  Cardinal Health Specialty Solu5ons – Sales Opera5ons and Third Party Logis5cs

Zolpimist®


11

Zolpimist® -‐ Be\er by Design

Higher Cmax with Zolpimist® = faster onset of ac5on

Data Source: Zolpimist and Ambien Package Inserts

The most common side effects of zolpidem or Zolpimist® are:

•  drowsiness •  dizziness •  diarrhea •  grogginess or feeling as if you have been drugged

Zolpidem is a hypno5c agent which interacts with a GABA-‐BZ receptor complex.

Zolpimist®


12


•  Both Zolpimist® and Ambien have essen5ally the same half lives.

•  These data suggest an improved sleep quality and dura5on. The higher blood levels following Zolpimist® dosing should improve the dura5on of sleep, reduce middle of the night awakening

•  Zolpimist also conforms to the FDA suggested 50 ng level well before someone is likely drive

Data Source: Zolpimist and Ambien Package Inserts

Zolpimist®


13

Clinical Conclusions •  The results of FDA submi\ed clinical studies indicate that similar plasma

concentra5ons of zolpidem are achieved with over-‐the-‐tongue applica5on of Zolpimist® when compared with 10 mg Ambien, with total exposure to zolpidem not exceeding that observed with Ambien.

•  Higher plasma concentra5ons are transiently achieved earlier with Zolpimist® than with Ambien, but not at later 5mes. Most subjects having detectable plasma levels within 5 minutes amer administra5on.

•  The results of this study demonstrated a linear rela5onship to dose for mean Cmax and AUC0–∞ over the range of Zolpimist® doses studied and indicated that values for the 10 mg Zolpimist® dose did not exceed those for 10 mg Ambien.

•  These studies further demonstrated that in terms of bioavailability (AUC0–∞), 5 and 10 mg Zolpimist® was bioequivalent to 10 mg Ambien

•  Overall, these data suggest that detectable drug concentraBons as well as zolpidem plasma concentraBons associated with sedaBon may be achieved more rapidly with Zolpimist® than with Ambien

Zolpimist®


14

The Insomnia Market •  According to IMS Health, the number of prescrip5ons filled in the United States to treat insomnia grew

to approximately 79 million for the twelve months ending September 30, 2011.

•  The insomnia market is large and con5nues to grow. •  Zolpidem con5nues to be the market leader (~70%) with li\le change over 10 years. •  Zolpidem is widely accepted and known within both the health care provider and consumer markets. •  There are only a handful of prescribed drugs approved for the treatment of insomnia.

•  These include Sanofi-‐Aven5s’s Ambien, Ambien CR and Sepracor ’s Lunesta, Takeda’s Rozerem and King’s Sonata

Zolpimist®


15

The Insomnia Market •  The number of people in the United States with insomnia is between 70-‐90

million or approximately 20% of the popula5on. This es5mate is based on the number of people experiencing one or more of the following sleep related issues: •  Difficulty ini5a5ng sleep •  Difficulty maintaining sleep •  Waking up too early •  Non-‐restora5ve sleep

•  The insomnia market has significant untapped poten5al – only 20% of people considered to have insomnia are prescrip5on users. This leaves a large gap of about 56 million undertreated insomniacs These include people: •  Who are pill phobics •  With gastric absorp5on problems •  Who are unable to swallow (Alzheimer’s, Mul5ple Sclerosis, Parkinson’s) •  Who did not respond to oral tablets

Zolpimist®


16

The Interna5onal Traveler Market •  The ini5al objec5ve of Amherst Pharmaceu5cals is to launch Zolpimist® into the

largely ignored interna5onal travelers market. •  The interna5onal business travelers market represents a fairly well defined

popula5on of individuals that share some common characteris5cs: •  Well-‐educated, management/professional level; financially stable •  Males and females •  A large percentage of people will be over 30 and under 60 •  As a group, they are less sensi5ve to co-‐pay limita5ons •  Poten5ally take more than one medica5on at any one 5me •  Know what they want and will buy a brand they believe to be more effec5ve

Zolpimist®


17

The Interna5onal Traveler Market •  These travelers also share some common concerns – inability to sleep and jet lag*

•  Business travelers are affected by insomnia away from home •  23% of business travelers said they have fallen asleep in a mee5ng •  18% said a presenta5on went badly •  14% missed a mee5ng or flight due to their transient insomnia

•  More than 90% of primary care physicians, recognizing these needs, feel comfortable prescribing a sleep aid for transient insomnia due to jet lag

•  It is into the New York, New Jersey and Philadelphia markets where Amherst will first launch Zolpimist.

•  According to airline and US government data (US Department of Commerce, Office of Travel and Tourism, 2009 Report), there are approximately 30 million people in the US traveling interna5onally with approximately 35% flowing through JFK, Newark and Philadelphia airports.

•  Amer establishing the market in these areas, the intent would be to expand into other interna5onal hubs such as Chicago, Los Angeles, San Francisco and other key metropolitan airports.

*Bri5sh Airways (07/05)

Zolpimist®


18

Business Traveler Objec5ves

•  Direct the frequent interna5onal business travelers to their physicians; create physician awareness

•  Create the awareness and build the demand for Zolpimist® among these frequent business travelers

•  Zolpimist® as a Lifestyle Product •  Lifestyle has changed from being an indicator of the overall well being of an

individual to a condi5on requiring medical treatment •  Define insomnia as a lifestyle condi5on for which the differen5ated benefits of

Zolpimist® are the best treatment op5on •  This Brand Defini5on will be carried into all insomnia markets

Zolpimist®


19

Market Research •  Amherst retained Sudler & Hennessey to conduct a primary research study on how

Zolpimist would be viewed and prescribed by primary care physicians •  Between December 16 – 20, 2013 they surveyed 126 PCPs and learned the following:

•  The Zolpimist product profile was viewed as “overwhelmingly posi5ve” – well above norm for new products in mul5ple categories

•  It was concluded that Zolpimist will readily take market share from all currently available sleep medica5ons – most prominently Ambien, Ambien CR, and generic zolpidem

•  Physicians indicate that Zolpimist is an appropriate treatment for a wide range of pa5ents – including the leisure and business traveler

•  There was strong agreement to honor pa5ent requests for product – this readiness to prescribe increases when pa5ent indicates willingness to pay

•  The overall conclusion that Sudler offered was;

•  Zolpimist shows significant opportunity for rapid adop5on and growth

Complete report is available

Zolpimist®


20

Research Results

Zolpimist®


21

Launch Strategies

Zolpimist® Launch plan •  Wave 1 – Physician (Brand) Awareness Campaign ini5ated 4 months prior

to DTC launch

CSO Media

•  Target high zolpidem prescribers

•  Cycle 5mes – 3 weeks •  Leave behinds

•  Key Message – Bioequivalence to zolpidem, confidence, reduc5on in anxiety, improved QOL

•  Non-‐personal selling •  e-‐marke5ng •  Magazines / Journal Ads •  Social networking •  Segment travelers; high value consumers

Zolpimist®


22

Crea5ng Physician Awareness Key strategic imperaBve •  Tele-‐detailing is an efficient and cost effec5ve mode of communica5on for crea5ng

and delivering cost effec5ve outbound sales-‐genera5on messaging designed to reach target HCPs and influen5al office staff.

•  Tac5cal elements to include: •  Detailed message delivery to high zolpidem prescribers •  Reminder messaging (less than 2 minutes) •  Performance repor5ng and analy5cs •  Seamless mul5-‐channel integra5ons (digital programs, direct mail, etc.) •  Development/Distribu5on of insomnia educa5on outreach programs to

include an insomnia newsle\er •  No Rx subs5tu5on

•  Compliance management

Zolpimist®


23

Launch Strategies Zolpimist® Launch plan •  Wave 1.5 – Interna5onal Traveler (Brand) Campaign ini5ated 2 months amer

physician introduc5on •  Engage pharmacies •  Communicate the Rest Assured / Rest Confidant message to Business Travelers –

“Coming Soon” type approach

CSO Media

•  Target high prescribers and local pharmacies

•  Key Message – Faster onset of ac5on; ideal for long distance traveler; build on previous message

•  “Coming Soon” – new genera5on zolpidem

•  Target traveling public •  Websites/Banner Ads •  e-‐marke5ng •  Magazines / Journal Ads •  Social networking

Zolpimist®


24

Launch Strategies Launch plan •  Wave 2 – Interna5onal Traveler Launch (DTC) •  Our tac5cal sales and marke5ng plan is based on our ability to have mul5ple

conversa5ons and touch points with the travelers in their homes, offices, on their way to the airport and at the airport

CSO Media

•  Target high prescribers and local pharmacies – contact wholesalers

•  Key Message – Launch ini5ated, expect inquiries; faster onset of ac5on; ideal for long distance traveler; build on previous message

•  New genera5on zolpidem " improved QOL, enhanced control

•  Target traveling public; geo-‐targe5ng •  Websites •  Banner Ads •  e-‐marke5ng •  Magazines / Journal Ads •  Social networking •  Segment travelers; high value consumers

Zolpimist®


25

Mul5ple Touch Points Create Awareness and Demand

✔

✔

✔

✔

✔

✔

✔

Book Tickets & Hotel

Arrange TransportaBon

Arrive at Airport & Check-‐in

Buy Reading Materials

Depart on Flight UA 54 from EWR

Relax in Club Lounge

Arrive Refreshed in Paris

TO DO:

Touch Points •  Physician’s Office •  Online travel sites •  Travel publicaBons •  Taxi Entertainment Network •  Subway Wraps •  Limousine Business Cards •  Geo-‐TargeBng at Airports •  In-‐Airport Messaging/Ads •  Ticket Jackets •  Boarding Pass Receipt Ads •  Wireless Hotspots with AutomaBc Homepage

•  Refreshed Awakenings Pack

Zolpimist®


26

Sleep for a Be\er Life •  Interven5onal prac5ces have evolved from purely procedural to clinical, they have

become more aggressive about being involved in public and professional educa5on.

•  Insomnia – whether non-‐clinical (travelers), transient or chronic – is recognized as an important index of health

•  Insomnia can be either a stand-‐alone ailment or a co-‐morbid condi5on associated with a wide range of disorders

•  Sleep for a Be\er Life is an outreach mechanism for primary care physicians who treat insomnia. It will consist of various tac5cal elements: •  Newsle\ers

•  Pa5ent Informa5on

•  Websites

•  Social Media

•  A key strategic goal is to posi5on Zolpimist® as a quality of life product

Zolpimist®


27

Zolpimist® Launch Plan

Zolpimist®


28

Pro Forma Financials

Zolpimist®


29

Use of Proceeds

Zolpimist®


30

Company Info

Amherst Pharmaceu5cals

15 Benedict Crescent Basking Ridge, NJ 07920

Phone: 732 773 4332

Ira Weisberg President and CEO

Zolpimist®


31

Back-‐up Slides

Zolpimist®


32


Zolpimist® is bioequivalent to Ambien

Sleep response is more rapid with Zolpimist®

Zolpimist®


33

Recent News From FDA On January 10, 2013 FDA Announced:

–  FDA recommends that the bed5me dose be lowered because new data show that blood levels in some pa5ents may be high enough the morning amer use to impair ac5vi5es that require alertness, including driving. This announcement focuses on zolpidem products approved for bed5me use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

–  Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-‐release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-‐release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-‐release products and 6.25 mg for extended-‐release products (see Dosing Recommenda5ons).

Zolpimist®


34

What Are the Implica5ons of the FDA Required Change in Dosing for Zolpimist®

•  Unique PK profile will favor the lower dose recommenda5on

•  Lack of food effect will favor lower dose recommenda5ons

•  Buccal (oral) adsorp5on will favor the lower dose recommenda5on

Zolpimist®


35

… and the Benefit of Zolpimist® is?

•  Poorer onset of acBon for oral tablets

•  PotenBal for reduced efficacy for oral tablets

•  Increased likelihood for consumers taking oral zolpidem tablets to experience Middle of the Night Awakening

OpportuniBes favorable to Zolpimist® that will be exploited by Amherst

Zolpimist®


36

Product Comparisons

Zolpimist®


37

Zolpimist® Core Strategy

CURRENT SITUATION

Zolpidem tablets lead the market; Zolpimist® is a new delivery technology of zolpidem

Sources of business:

BRAND VISION – SLEEP FOR A BETTER LIFE

Sleep when you want to sleep

Zolpimist rescues paBents from unpredictable insomnia

1. Generics

2. Ambien CR

3. CompeBBve brands

Rapid onset is a measure of efficacy

4. InternaBonal Travelers

Zolpimist®


38

Market Expansion AddiBonal Market OpportuniBes – following the introduc5on into the interna5onal travelers market, Zolpimist® will be launched into the following markets:

Chronic Insomniacs Pill Phobics

Trouble Swallowing Gastric Absorp5on Problems

Shim Work Disorders Insomnia Co-‐Morbidity

Arecentreportcontainedthefollowing:“Anidealhypno5c...

Documents

Transcript of Arecentreportcontainedthefollowing:“Anidealhypno5c...