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.
Tickers included in this excerpt: WPHM.OB
For more information call (212) 952 7433. The Wall Street Transcript does not endorse any of the comments made by interviewees, and does not make stock recommendations.