Last week busy biotech Progenics Pharmaceuticals
In March Progenics submitted a New Drug Application (NDA) for methylnaltrexone in the treatment of opioid-induced constipation. With the acceptance of the NDA, the clock will start ticking on when the FDA will give the compound the thumbs up or down.
The target date for this decision is January 30, 2008, which will give Progenics a large lead on other drugmakers, like Adolor
Progenics received a $5 million milestone payment from Wyeth upon acceptance of the marketing application. Progenics also received $4 million for getting the review process started in the European Union. All of this comes as a welcome cash infusion to help stave off the inevitable dilution for shareholders when Progenics' $140 million in cash and investments begins to run out.
It's important for biotech investors to remember that the acceptance of a New Drug Application is not an indication of a compound's chances for approval. Nonetheless, it's nice to have the clock ticking on the methylnaltrexone approval decision and a formal date for the compound's review.
Hopefully the FDA won't tag Progenics with a call for additional safety data like it did with Adolor. But after reporting strongly positive efficacy results in its two phase 3 studies, the odds are high that the compound will get approved on the first go-round without the need for more clinical studies.
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