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Penwest Pharmaceuticals

Penwest Pharmaceuticals
Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients.

The company in detail

Summary

Penwest Pharmaceuticals was incorporated under the name Edward Mendell in the State of Washington in February 1991 as a wholly-owned subsidiary of Penford (formerly known as PENWEST). The company later changed its name to Penwest Pharmaceuticals and was divested from Penford after the IPO in 1998. Penwest's product strategy focuses on the development of drugs that enhance therapeutic value because of the application of their oral drug delivery technologies. Penwest is constantly seeking to expand in new directions with the development of novel pharmaceutical drug products.

R&D

Penwest's pharmaceutical portfolio includes four marketed products [Procardia XL (Hypertension, Angina); Stofedipine XL (Hypertension, Angina); Cronodipin (Hypertension); Cystrin CR (Urinary incontinence)]. These products were all developed using the company's proprietary controlled release drug delivery technology, TIMERx®. The products which were developed with collaborators such as Mylan Pharmaceuticals, Sanofi, Merck and Leiras have been approved in various countries.

TIMERx® is the company's proprietary oral controlled-release technology. It is adaptable to soluble and insoluble drugs, flexible to a variety of release profiles, and provides easy scale-up and technology transfer to more rapidly formulate and advance products into clinical trials. From the TIMERx platform, Penwest has developed two additional and distinct oral drug delivery systems: Geminex(TM) and SyncroDose(TM).

Geminex is a dual drug delivery system which provides independent release of combined drug actives and SyncroDose(TM) is a chronotherapeutic drug delivery system which releases the drug at the desired site and time in the body. In addition, Penwest has several products in its pipeline that are in various stages of development, including the pain product oxymorphone ER, which the Company is jointly developing with Endo Pharmaceuticals.

Partnerships

Endo Alliance: In 1998, Penwest established a strategic alliance with Endo to develop oxymorphone ER. This alliance demonstrates the value of leveraging complementary expertise, sharing drug development risk and sharing in success of the product if successfully introduced into the market place. Endo brought an understanding of the molecule as well as an expertise in clinical development and marketing of pain management products. Penwest contributed its proprietary TIMERx® technology and drug formulation expertise. Oxymorphone ER, being developed for twice-a-day dosing, would represent the first oral extended-release version of oxymorphone and would compete in the severe analgesic market with products such as OxyContin®, MS Contin®, and Duragesic, which had aggregate sales in the U.S. in 2002 of approximately $3.0 billion.

Arakis Pain Alliance: In 2001, Penwest entered into a three-year strategic alliance with Arakis to develop up to six orally-delivered enhanced medicines for pain management. These medications will be jointly developed by combining our drug delivery capabilities with Arakis' ability to use new biological information to enhance pharmacological agents. The alliance has identified two product candidates which are in the early stage of development.

In January 2002, Penwest and Finzelberg signed a collaboration.

In February, 2002, Penwest And Ranbaxy signed Nifedipine License and Supply Agreement; Will Also Collaborate On Developing Other Controlled Release Products

Other collaborative partners include Sanofi-Synthelabo, IVAX Pharmaceuticals, Ranbaxy Laboratories, E. Merck and Leiras OY (Schering).

Senior management

Jennifer L. Good (President, Chief Operating Officer and Director)
Ms. Good has served as Penwest's Chief Financial Officer since March, 1997. Prior to joining the Company, Ms. Good served as Corporate Controller and Corporate Director of Finance of Penford, Penwest's former parent company, from 1993 to 1997. From 1987 to 1993, Ms. Good was employed by Ernst & Young in a number of positions, the most recent being audit manager where she focused primarily on high-tech and biotech clients. Ms. Good holds a Bachelor of Business Administration degree from Pacific Lutheran University.

Benjamin Palleiko, M.B.A. (Senior Vice President, Corporate Development and Chief Financial Officer)
Mr. Palleiko is the founder of Intrepid Merchant Partners, LLC, a healthcare strategic advisory and investments firm. In 2003, he founded SunTrust Robinson Humphrey's Life Sciences Investment Banking practice, focused on biotechnology and specialty pharmaceuticals, which he built and led until 2006. Before that, Mr. Palleiko was a Vice President in Investment Banking at Robertson Stephens, Inc., specializing in life sciences, and at Volpe Brown Whelan & Co. He is a veteran of the U.S. Navy, with fourteen years of active duty and reserve service as a Naval Aviator. Mr. Palleiko earned a BA in Quantitative Economics from Tufts University in 1987, and both an MBA and MA in International Relations from the University of Chicago in 1996.

Mehrdad Abedin (Vice President, Information Technology and Chief Information Officer)
Mr. Abedin is the Vice President of Information Technology and Chief Information Officer at Penwest Pharmaceuticals. He has over twenty years of experience in design, development, operation, and management of distributed computing systems with a proven record of recognizing business needs, developing strategy, and implementing initiatives to meet the requirements. Mr. Abedin came to Penwest in October 2000 from Hoffmann-La Roche in Nutley, New Jersey where he served as the Director, Infrastructure Services with responsibility for the engineering, support, and operation of U.S. Information Technology Infrastructure. Prior to joining Hoffmann-La Roche, he headed the planning and support functions of the America's Infrastructure at BASF. Mr. Abedin has also held various technical, consulting, and managerial positions in the information technology areas of organizations from diverse industries. He holds Degrees in Mathematics and Computer Science from Moorhead State University and has completed graduate studies in Computer Science at North Dakota State University.

Anand R. Baichwal, Ph.D. (Senior Vice President of Research and New Technology Development and Chief Scientific Officer)
Dr. Baichwal is the Chief Scientific Officer and Senior Vice President of Research and New Technology Development for Penwest. Dr. Baichwal started his business career in 1986 with the Mendell, which was acquired by Penford in 1991. He has been with the Company and its predecessors for sixteen years in various technical positions. Dr. Baichwal is the co-inventor of the company's flagship oral drug delivery technology, TIMERx®. He is listed as an inventor on a number of patents on this system and has presented and published extensively on drug delivery. His research interests include excipients, formulation technology, and drug delivery. Dr. Baichwal received a Bachelor of Pharmacy degree and master's degree in pharmacy from Bombay University, India in 1977 and 1979, respectively. He continued his education in the United States with a master's in industrial pharmacy from St. John's University in New York in 1981, then received a Ph.D. in industrial pharmacy from the University of Maryland in 1985.

Paul Hayes, M.B.A. (Vice President, Strategic Marketing)
Mr. Hayes joined Penwest in October 2005 as Vice President of Strategic Marketing with over 17 years of pharmaceutical experience including nine launch and pre-launch products in the CNS, anti-infective, diabetes and cardiovascular therapeutic categories. Prior to joining Penwest, he was Senior Director of Marketing at Oscient Pharmaceuticals where he played a key role in transforming the company from an Research and Development - focused to a commercially-focused organization with the launch of their first product. Prior to that he spent 10 years at Bayer Pharmaceuticals in a number of Marketing and Project Management roles. He started his pharmaceutical career with the Parke-Davis division of Warner-Lambert company. Mr. Hayes holds an MBA degree in Management from George Washington University, an MS degree in Environmental Science from Florida State University and a BA degree in Biological Science from the University of Delaware.

Thomas R. Sciascia, M.D. (Senior Vice President and Chief Medical Officer)
Dr. Sciascia has served as Vice President of Clinical Operations and Medical Affairs as well as Chief Medical Officer at Penwest since March 2001. Dr. Sciascia served as Medical Director at Quintiles between 1997 and 2000. From 1983-1997 he was on the faculty of Boston University. Dr. Sciascia received his medical degree from Columbia University College of Physicians and Surgeons in 1979 and a B.S. degree from the Massachusetts Institute of Technology in 1975.

Amale Hawi, Ph.D. (Senior Vice President, Pharmaceutical Development)
Dr. Hawi, 53, joins Penwest with over 17 years of pharmaceutical development experience in the areas of drug discovery support, product development and regulatory affairs. Before joining Penwest, Dr. Hawi served as President of A. Hawi Consulting, Ltd, a firm she founded in 2002, which focused on biopharmaceutical concepts, strategies, and the development of new chemical entities for numerous pharmaceutical and biotechnology companies. Prior to that, Dr. Hawi served in various roles of increasing responsibility at Boehringer Ingelheim Pharmaceuticals from 1990, culminating in her appointment to Director of Drug Metabolism and Pharmacokinetics, a position she assumed in 1998. Dr. Hawi has a Ph.D. in Organic Chemistry from the University of London, Queen Elizabeth College, and both an M.S. and a B.S. in Chemistry from the American University of Beirut, Lebanon. Dr. Hawi is a member of the American Association of Pharmaceutical Scientists (AAPS) and has published over 40 articles in academic journals and research publications.

Board of directors

Paul E. Freiman (Director)
Mr. Freiman is President and Chief Executive Officer of Neurobiological Technologies. He is the former Chairman and Chief Executive Officer of Syntex, where he had a long and successful career and was instrumental in the sale of Syntex to Roche Holdings for $5.3 billion. He is credited with much of the marketing success of Syntex's lead product, Naprosyn, and was responsible for moving the product to over-the-counter status, marketed by Proctor & Gamble as Aleve. Mr. Freiman currently serves as chairman of the boards of Digital Gene Technologies, a private genomics company, and SciGen. Mr. Freiman currently serves on the boards of Calypte Biomedical, Alexza Molecular Delivery, PHYTOS and Otsuka America Pharmaceuticals. He has been chairman of the Pharmaceutical Manufacturers of America Association (PhRMA) and has also chaired a number of key PhRMA committees. Mr. Freiman holds a B.S. degree from Fordham University and an honorary doctorate from the Arnold & Marie Schwartz College of Pharmacy.

Peter F. Drake, Ph.D. (Director)
Dr. Drake is Managing General Partner of Mayflower Partners, a healthcare sector-focused investment fund. From 1999 to 2002 he served as Managing Director at Prudential Securities and was the co-founder of Vector Securities International, an investment banking firm, Vector Fund Management, a $230 million healthcare venture fund, and Deerfield Management, a $2 billion healthcare hedge fund. Dr. Drake joined the investment banking firm of Kidder, Peabody and Co., as a Biotechnology Analyst in 1983, becoming a partner in 1986. He holds a B.A. in Biology from Bowdoin College and a Ph.D. in Biochemistry and Neurobiology from Bryn Mawr College. Dr. Drake also serves on the Boards of Directors of Trustmark Insurance, a healthcare insurance provider, the Alliance for Aging, a non-profit organization dedicated to improving the health and quality of life for the elderly, TLContact, a private medical information services company, Ocularis Pharma, a private specialty pharmaceutical company servicing the ophthalmic market, and Cortex Pharmaceuticals, a publicly traded neuroscience company.

Jennifer L. Good (President, Chief Operating Officer and Director)
Ms. Good has served as Penwest's Chief Financial Officer since March, 1997. Prior to joining the Company, Ms. Good served as Corporate Controller and Corporate Director of Finance of Penford, Penwest's former parent company, from 1993 to 1997. From 1987 to 1993, Ms. Good was employed by Ernst & Young in a number of positions, the most recent being audit manager where she focused primarily on high-tech and biotech clients. Ms. Good holds a Bachelor of Business Administration degree from Pacific Lutheran University.

Robert J. Hennessey (Director)
Mr. Hennessey is the retired Chairman, President and CEO of Genome Therapeutics Corporation and currently serves on its Board. Additionally, he was previously an independent consultant of Hennessey & Associates. Prior to that, Mr. Hennessey was Senior Vice President of Corporate Development for Sterling Drug and also served in various executive assignments at Merck, SmithKline Beecham, and Abbott Laboratories. Mr. Hennessey is also a director of Repligen. Mr. Hennessey holds an M.A. and an A.B. from the University of Connecticut.

David P. Meeker, M.D. (Director)
During his leadership of the LSD business unit, Dr. Meeker has held development responsibility for its therapeutics portfolio, and global responsibility for three marketed enzyme replacement products which have generated over one billion dollars in revenue. In addition to serving as President of the LSD unit, Dr. Meeker, 52, has served in various roles at Genzyme Corporation since joining in 1994, including Senior Vice President, Therapeutics Europe and Senior Vice President, Medical Affairs. Dr. Meeker has had extensive experience in the development and market launch of orphan drugs while at Genzyme. Prior to joining Genzyme, he served at the Cleveland Clinic Foundation, initially joining in 1988 as Staff Physician for the Department of Pulmonary and Critical Care Medicine and later serving as the Program Director for the Department's fellowship program.

John N. Staniforth, Ph.D. (Director)
Dr. Staniforth is Chief Scientific Officer of Vectura, a UK biosciences company. Dr. Staniforth serves as a scientific advisor to a number of international pharmaceutical companies and has extensive teaching and research experience. He is an Honorary Professor of the University of Bath in England and has past associations with a number of US universities as well as Monash University in Australia. His research in the field of powder technology has been widely published and is the recipient of numerous research awards. Dr. Staniforth is a Churchill Fellow and has been elected Fellow of a number of scientific societies around the world, including the American Association of Pharmaceutical Sciences. Dr. Staniforth has been affiliated with Penwest as a consultant since its inception and is the co-inventor of its flagship technology platform, TIMERx. Dr. Staniforth is also the recipient of the 2003 AstraZeneca Industrial Achievement Award.

Anne M. VanLent (Director)
Ms. VanLent is currently Executive Vice President and Chief Financial Officer for Barrier Therapeutics, a publicly-traded emerging specialty pharmaceutical company in the field of dermatology. Prior to joining Barrier in May 2002, Ms. VanLent was a founder of The Technology Compass Group, a healthcare/technology consulting firm. From mid-1997 through October 2001, Ms. VanLent was with Sarnoff, a privately-held research and development company which creates and commercializes electronic, biomedical, and information technologies, where her last position held was Executive Vice President, Portfolio Management, overseeing creation of spin-off companies and patent and licensing activities. Ms. VanLent served as President of AMV Associates, an emerging growth healthcare consulting firm from March 1994 through August 1997, and as Senior Vice President and Chief Financial Officer of The Liposome Company, a biotechnology company, from 1985 through 1993. She currently serves as a director of a private fuel cell development company. Ms. VanLent received a B.A. in Physics from Mount Holyoke College.

W. James O'Shea (Director)
Mr. O'Shea currently serves as Vice Chairman at Sepracor Inc. From October 1999 through March 2007, Mr. O'Shea served as President and Chief Operating Officer of Sepracor, where he was responsible for building the organization's commercial infrastructure. Prior to joining Sepracor, Mr. O'Shea served in several positions of increasing responsibility in international sales and marketing for Zeneca, Inc., now known as AstraZeneca, culminating in his appointment as Senior Vice President of Sales and Marketing and Medical Affairs for Zeneca Pharmaceuticals, a business unit of Zeneca, Inc. Mr. O'Shea is a graduate of Liverpool Lord Byron University, where he received an Honors Degree in Applied Physics from the Institute of Physics.

Christophe Bianchi, M.D. (Director)
Dr. Bianchi is Executive Vice President, Commercial at Millennium Pharmaceuticals Inc., which markets VELCADE® (bortezomib) for injection, a therapy for blood cancers. Prior to joining Millennium in 2006, Dr. Bianchi served as the head of the U.S. oncology business unit of Sanofi-Aventis, with responsibility for brands such as Eloxatin® and Taxotere®. From 2001 through 2004, Dr. Bianchi served as Vice President of the Internal Medicine and Central Nervous System Business Unit of Sanofi. In 2000, Dr. Bianchi served as President of Europe and Senior Vice President of Global Marketing and Business Development for SangStat Medical Corporation, a biotechnology firm later acquired by Genzyme. Between 1990 and 2000, Dr. Bianchi held several positions of increasing responsibility at Rhone-Poulenc Rorer in the U.S., culminating in his appointment to Vice President and Head of Global Marketing. During that period he led many of the domestic and global commercial efforts for its antithrombotic, Lovenox®. Dr. Bianchi earned an M.D. from the University of Reims-Champagne in France and an M.B.A. from the Wharton School at the University of Pennsylvania. He is also a graduate of Ecole Des Hautes Etudes Commerciales (EDHEC Graduate School of Management) in France.

Clients in focus...

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