On Friday, drugmaker Progenics Pharmaceuticals (NASDAQ:PGNX) and partner Wyeth (NYSE:WYE) started the FDA regulatory waiting game on an opioid-induced constipation (OIC) compound, methylnaltrexone, after submitting a New Drug Application.
The FDA has 60 days to decide whether to accept the marketing application for methylnaltrexone. Progenics is expecting a 10-month standard review period, which places possible approval in the first quarter of 2008, and a launch soon after.
The version of methylnaltrexone for which Progenics just filed the NDA is in the form of an inconvenient subcutaneous injection. While this will curtail the uptake in sales of the drug, there are currently no marketed products that adequately treat OIC.
Fortunately, Progenics is developing a much more user-friendly oral version of the drug. However, its development was dealt a setback earlier in the year, and an NDA for this oral version isn't expected until the end of 2009 at the earliest. Getting the subcutaneous form of the drug approved will still prime the marketing pump and increase the rate of sales ramp-up if Progenics can work out the formulation issues for this version.
There are a host of other companies working on compounds to treat OIC and other complications from opioid use. Progenics has the first shot at gaining approval in this indication and getting all the advantages that come from being the first mover in this competitive sector. After reporting two strongly positive phase 3 trials for the subcutaneous version of methylnaltrexone, Progenics has a great chance of gaining regulatory approval for the drug. Whether the sales and royalty revenue that methylnaltrexone can bring in will be enough to support its current valuation is still in doubt.
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
