Developing new drugs is a complicated process; delays and setbacks are an almost inevitable part of the process of bringing new compounds to market. Earlier in the week, Progenics Pharmaceutics
Progenics is developing its altered version of naltrexone in various dosage forms as a treatment for a variety of gastrointestinal disorders. The largest market opportunity for its methylnaltrexone compound is in treating opioid-induced bowel dysfunction (OBD), which it was running a phase 2 study in.
After this week, though, it's back to the drawing boards, as the oral version of methylnaltrexone failed to "exhibit sufficient clinical activity" in its phase 2 testing. (The drug is also being tested in subcutaneous and intravenous administration.) Now the new timeline for the oral version is for a New Drug Application in late 2009 or early 2010, which pushes possible approval out until 2011.
The biggest winner from the Progenics drug delay is definitely Adolor
The good news for Progenics shareholders is that the company is sticking to the timeline to file marketing applications with the FDA for the subcutaneous and intravenous forms of methylnaltrexone in 2007. If Progenics and Wyeth can't develop a much more convenient oral formulation of the drug, though, its market potential and use will be quite limited.
GlaxoSmithKline is an Income Investor recommendation. Want to get paid to invest? Analyst James Early and his team can show you how to find companies that have good dividends with a 30-day free trial to Motley Fool Income Investor.