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Industry Project

Tibusec
by

Michael Pazirandeh

on 7 January 2011

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Transcript of Industry Project

Epidemiology Market Competitive and
Target Strategy SWOT Analysis Promotional, Marketing, and Launch Strategy Operations Life Cycle Management Future Development Financials Questions? Strategic Position
and Risk Analysis Strategic Strenghts Strategic Risks Differentiation Strategy Reimbursement Strategy
Education Strategy
Sales Strategy
Pricing Strategy

Patient Assistance and Rebate Program

DTC: Commercial and magazine ads Existing manufacturing plants in Vietnam and New Jersey

RASATEC (Himotidine) manufacturing plant will be converted to produce TIBUSEC (Lephoprazole)

Work with 3rd party distributors Use of TIBUSEC (lephoprazole) as a once daily dosing in the treatment of H. pylori

Less drug interactions with the use of TIBUSEC

Use of TIBUSEC as adjunct treatment for osteoporosis

Pediatric indication Target Patient Population
moderate-to-severe chronic GERD sufferers
H. pylori peptic ulcer disease

Therapeutic Classes:
Histamine2 Receptor Antagonists (H2RAs)
Proton-Pump Inhibitors (PPIs) PPIs dominate 66% of the world gastrointestinal market. Excluded because of patent expiration (current/imminent):
Lansoprazole, Omeprazole, Pantoprazole

Note: Takeda singularly increased PPI sales. Distribution of top three mainly U.S., European Countries, Australasia
Targets: Canada, Emerging Markets (India, Central and South America), Africa United Nations Global Compact
10 Principle
-2 Human Rights
-Principle 1: Businesses should support and respect the protection of internationally proclaimed human rights.
-4 Labor Standards
-Principle 5: the effective abolition of child labor
-3 Environment
-Principle 8: undertake initiatives to promote greater environmental responsibility.
-1 Anti-Corruption

Takeda (March 2009) and AstraZeneca (January 2010) signed up.
Takeda demonstrated reduced carbon emissions consistent with Principle 8. Takeda’s dexlansoprazole is positioned to replace lansoprazole as an similar drug with improved efficacy. Physician perception represents a strategic opportunity to take market share. Health care reform
increased access to PPIs vs OTC alternatives to previously uninsured expanding market and sales volume

Aciphex ER
Phase III
Claims increased holding time and duration of acid suppression.
Reduced economic climate translates to conservatory spending on healthcare delaying entry of competitor.
Opportunity to position Tibusec as having the same properties but immediately available. Marketing and Launch Plan Executive Management Michael Pazirandeh, M.D., Ph.D., President & CEO

Dr. Pazirandeh has served as President and CEO of Phringe Pharmaceuticals, INS since 2001.

From 1991 to 2000 he was Senior Scientist and Group Leader at GastroProtect, Inc.

Dr. Pazirandeh published several scientifically acclaimed papers describing the various cellular pathways involved in GERD’s disease while working as an academic scientist funded by the National Institute on gastrointestinal and the National GERD Association.

During his tenure as CEO, Dr. Pazirandeh and Phringe Pharmaceuticals have received several awards recognizing the company’s success as an emerging biopharmaceutical company.

Dr. Pazirandeh has published more than 50 scientific papers and holds several patents. Kaywan Joseph Mansubi, Ph.D., Director of Research and Development

Dr. Mansubi has served as our chief research director since May 2004. He has benn an active researcher in the field of molecular imaging of GERD’s diseas progression for the last two decades.

Prior to joining the company, he was Assistant Professor of Molecular Biology at Princeton Medical School.

Dr. Mansubi’s current research efforts focus on imaging techniques to detect subtle changes that occur during the disease process.

Dr. Mansubi recently served as President of the Society of GERD Disease. He received his Ph.D. in Pharmacology from University of Arkansas in 1984 as a NIH Predoctoral Fellow. Zahra Azadbadi, M.S., MBA; Vice President, Regulatory Affairs

Ms. Azadbadi has served as our Vice President, Regulatory Affairs and Quality Assurance since May 2005.

Previously, Ms. Azadbadi held regulatory and compliance positions at Hybridon, Inc., Searle Orthopedicsm and Baxter International.

From 1998 to 2003, Ms. Azadbadi worked at Medronic Inc., where she served as the Executive Director of Regulatory Affairs.

From 2003 to May 2005, she worked at PHRINGE PHARMACEUTICALS, INC, where she served as Chief Regulatory Officer. Ms. Azadbadi received an M.S. in Regulatory Science from University of southern California and an MBA from Stanford University. Kyna Ngo, Pharm.D., MBA; Director of Marketing

Dr. Ngo has over 15 years experience in the pharmaceutical industry.

During her career Dr. Ngo has held positions in sales and marketing in both global and local organizations.

Dr. Ngo started her career in sales at Marakon, Inc. and rapidly rose through the ranks to the position of marketing director.

Her pharmaceutical experience at AstraZeneca Inc. includes extensive experience in reimbursement, formulary and public policy issues.

Dr. Ngo holds a Pharm.D. in Bioscience from the University of Southern California and an MBA from the Wharton Business School of the University of Pennsylvania. Eddie Wong, Pharm.D., MBA, Financial Director

Dr. Wong has served as financial director for Phringe Pharmaceuticals, INC. since January 2005.

Dr. Wong is president of Loftlink Advisors and has provided financial consulting and appraisal services in the health care sector since June 1985.

He served from July 1990 to February 1999 as the chief financial officer, and from February 2000 to January 2001 as senior vice president.

From March 2001 to June 2004 Dr. Wong held the position of chief financial officer of Nascent Pharma Inc., a privately held contract research organization and was actively recruited to Phringe Pharmaceuticals, INC in 2005.

Dr. Wong received his MBA degree from Harvard and also holds a Pharm.D. in from Columbia University. Nexium sales in the first quarter of 2009 were $705 million, down 4 percent compared with first quarter last year.

Nexium sales in other markets were up 12 percent to $487 million.

Sales in Western Europe increased by 8 percent despite the 35 percent decline in Germany. Sales in Emerging Markets were up 19 percent, including good growth in China. Prilosec sales in the US were down 62 percent in the first quarter of 2009 following generic entry of the 40mg dosage.

Other PPIs sales reported were Prevacid $3.9 billion, Protonix $2.7 billion, and Aciphex $1.8 billion. Prilosec and Omeprazole equally share approximately $562 million of the market.  The mean age was 45 years, and 336 (68%) were women. Racial distribution was 43% black, 34% white, and 23% other races. Heartburn occurring at least weekly was reported in 27%, 23%, and 24% of these racial groups, respectively.

The age-adjusted prevalence of heartburn or regurgitation was not significantly different among the groups. Erosive esophagitis was found in 50 of 215 participants (23%). More than 60 million Americans suffer from heartburn at least once a month. More importantly, an estimated 15 million Americans have symptoms every day, indicating they may have GERD.

In fact, more than 35% of Americans are thought to have GERD. Although GERD can affect people of all ages, statistics show that the risk increases as you age and tends to rise dramatically after age 40. GlobalData's analysis suggests that the global GERD market was worth $ 21.5 billion in 2009.

It is forecast to decline at a compound annual growth rate of 9% for the next seven years to reach $11.7 billion by 2016.

The high projected rate of decline is primarily attributable to the patent expiries of all proton pump inhibitors (PPIs) by the end of the forecast period. Payer

Tibusec as a new drug in the market will target the same population as other PPIs. However, Tibusec will target specific patients who have failed other PPIs due to their side effects or non-responsiveness. As a result, third party payers will cover the cost of this medication. clinical skills
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