CEO Interview: Winston Pharmaceuticals, Inc. - Dr. Joel E. Bernstein

• On 3:48 pm EST, Monday November 2, 2009

67 WALL STREET, New York - November 2, 2009 - The Wall Street Transcript has just published its Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This 76-page feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Small-Cap Specialty Pharma - Patent Expiration - Pending Health Care Reform - Cultivating And Expanding R&D Pipelines - Chinese Drug Manufacturers - Brisk M&A Activity - Indian Pharma VS. U.S. Pharma - Competition From Generics - FDA Approval Process - Clinical Research Outsourcing Market - Stem Cell-Based Technology - Cancer Radiation Therapy - Expansion Into Asian Markets - Traditional Chinese Medicine VS. Western Medicine In Chinese Pharma

Companies include: Aeolus Pharmaceuticals (AOLS.OB); Nutra Pharma (NPHC.OB); Quick-Med Technologies (QMDT.OB); Abbott Labs (ABT); Alexza Pharmaceuticals (ALXA); AmexDrug Corporation (AXRX.OB); Aurobindo Pharma (AUROBINDOP.BO); BioClinica (BIOC); BioPharm Asia (BFAR.OB); Biocon (BIOCON.BO); Cephalon (CEPH); China Sky One Medical, Inc. (CSKI); Claris Lifesciences (CLARICH.BO); Cortex Pharmaceuticals (COR); Daiichi Sankyo (DSKYF.PK); Dr.Reddy's (RDY); Elan (Elan); Eli Lilly (LLY); Forest (FRX); GeoPharma (GORX); Glaxo (GSK); Glenmark (GLENMARK.BO); Johnson & Johnson (JNJ); Lupin (LUPINSL.BO); Mannatech (MTEX); Matrix Laboratories (ATRIXLAB.BO); Medical Nutrition (MDNU); Merck KGaA (MKGAY.PK); Mylan (MYL); NeoStem (NBS); Novartis (NVS); Pfizer (PFE); Piramal Healthcare (PIRAMALHE.BO); Provectus Pharmaceuticals (PVCT.OB); Ranbaxy (RANBAXY.BO); Salix Pharmaceuticals (SLXP); Shire (SHPGY); Telik (TELK); Winston Pharmaceuticals (WPHM.OB).

In the following brief excerpt from the 76-page report, Dr. Joel E. Bernstein, CEO of Winston Pharmaceuticals, Inc., discusses the outlook for the sector and for investors.

DR. JOEL E. BERNSTEIN, M.D., is the Founder, Chief Executive Officer and a Director of Winston Pharmaceuticals. Before starting Winston, Dr. Bernstein was the Founder, Chairman and Chief Executive Officer of GenDerm Corporation, a pharmaceutical company that was acquired by Medicis Pharmaceutical Corporation in 1997. Previously Dr. Bernstein was head of dermatopharmacology at Northwestern University Medical School and the University of Chicago Pritzker School of Medicine. Dr. Bernstein has also held senior scientific positions at Abbott Laboratories and Schering-Plough Corporation. He has authored more than 125 scientific publications and holds over 150 patents. Dr. Bernstein received a B.A. from Carleton College and an M.D. from the University of Chicago Pritzker School of Medicine, where he received the Roche Award for ranking first in his class. He completed specialty-training programs in both dermatology and clinical pharmacology at the University of Chicago. Dr. Bernstein is a past President of the University of Chicago Medical and Biological Alumni Association. In 1988 he was chosen as Illinois high-tech entrepreneur of the year. Dr. Bernstein was also the Founder and Non-Executive Chairman of Sirius Laboratories, Inc., a dermatologic products company acquired by DUSA Pharmaceuticals in 2006.

TWST: Tell us about Winston Pharmaceuticals.

Dr. Bernstein: Winston is a specialty pharma which is focused on developing new products for pain control. Right now the products that we have in development range from products for niche, unserved medical needs, such as the prophylaxis and treatment of episodic cluster headache, to products for the treatment of post-herpetic neuralgia, breakthrough cancer pain, post-surgical pain, and osteoarthritis and rheumatoid arthritis.

TWST: What's on the agenda? When you look out over the short term, 12 to 24 months, what's going to make that time frame a success for Winston?

Dr. Bernstein: We have a number of important milestones that we expect to reach over the next 12 to 24 months. We've just completed a Phase II study with our civamide patch for post-herpetic neuralgia, with which we intend to initiate Phase III pivotals by the end of the first quarter of 2010. The patch has a number of advantages over the Lidoderm patch for the treatment of post-herpetic neuralgia. We have a new oral product to treat Crohn's disease in a very novel fashion. It works by eliminating the neuropeptide inflammatory mediators, which accumulate in the neuronal plexuses in the bowel. We've completed the Phase I study on this product, and we'll soon be starting a Phase II proof-of-concept study. We also have a metered nasal spray for the prophylaxis and treatment of episodic cluster headache with an approved Special Protocol Assessment for the final pivotal trial. We're also awaiting approval of our topical civamide cream for treatment of osteoarthritis in several markets outside of the United States, including Canada, and so we expect to hear something on that. There is, as I say, quite a bit coming up ahead in the next 12 to 24 months.

TWST: What is distinctive about your technologies? Are there other companies working along similar lines and, if so, what might make you different or superior?

Dr. Bernstein: Our flagship is the chemical civamide, which is a TRPV-1 (transient receptor potential vanilloid-1) receptor modulator. There are other companies that have such compounds, Pfizer for example. Lilly licensed a different class of TRPV-1 modulator from Glenmark in India about two years ago. A significant difference between our compound and theirs is that we have a lot more extensive human data on our compound. They have a product that will give eight hours of effective analgesia. Our product in the same models gives over seven days' effective analgesia. It potentially could revolutionize pain control. To have that sort of very prolonged pain control, there is no precedent for it and no other compound that I know of that has that kind of effect that's in late-stage development.

TWST: What is your cash and capital situation?

Dr. Bernstein: This is an expensive business to be in. Drug development is not an inexpensive process, and we are right now initiating some additional fundraising. We do have some agreements that call for some milestones, which we hope and expect to get, which will help. But it's a business where I don't think anyone would complain about having too much cash.

The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This 76-page special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online .

The Wall Street Transcript does not endorse the views of any interviewees nor does it make stock recommendations.

For Information on subscribing to The Wall Street Transcript, please call 800/246-7673

Buzz up!