Some setbacks in the pharmaceutical drug development game are worse than others, as Progenics
Back in March, Progenics announced that a phase 2 study of the oral version of the drug was unsuccessful in testing and that it would need to reformulate a new version of the drug and start clinical testing all over again.
After this first successful test of the new oral formulation, Progenics and Wyeth plan on starting a second phase 1 study of the drug before pushing it back into phase 2 testing. If everything goes according to plan, the timeline is for a marketing application for this oral version of the drug to be filed in late 2009 or early 2010 with possible regulatory approval around 2011.
Progenics and Wyeth are already awaiting FDA and European Union responses to their marketing applications for the subcutaneous version of the methylnaltrexone compound. The projected review date with the FDA is January 30 and final word from the EU medical authorities is likely sometime in the first half of next year.
Being the first approved to market an oral compound to treat one of the more painful side effects from opioid use will be a boon to whichever drugmaker can reach this goal. With the competitior Adolor
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