Maybe my prediction of delays because of Congress' holdup of the Prescription Drug User Fee Act reauthorization has come true. Or perhaps ZymoGenetics (Nasdaq: ZGEN ) just got unlucky. Either way, the company is going to have to wait just a little bit longer before it can market its recombinant Thrombin product.
Yesterday, ZymoGenetics announced that it had to give the FDA so much additional paperwork to support its Biologics License Application that the FDA considers the update a major amendment. That triggers an automatic three-month delay of the PDUFA date; the FDA now has until Jan. 17 of next year to review the application.
The delay stems from a decision by the FDA not to do a pre-approval on the Italian plant where the product will be put into vials. Instead, the agency requested a ton of supporting paperwork during the mid-cycle review and then informed the company that it wouldn't have time to review it all before the mid-October PDUFA date.
The delay is good news for Omrix Biopharmaceuticals (Nasdaq: OMRI ) , which is waiting to hear about its Thrombin product made from human plasma. If it's approved, Omrix's product, which is marketed by Johnson & Johnson (NYSE: JNJ ) , could have a head start of several months. It's going to need it, too; recombinant proteins are considered safer than those derived from human plasma and have fared better than human-derived proteins in other markets.
In June, ZymoGenetics inked a deal with a Bayer (NYSE: BAY ) subsidiary to market rThrombin. The deal brought the company an up-front payment of $30 million, and an FDA approval will trigger another $40 million payment. Bayer will co-promote the drug in the U.S. with ZymoGenetics for three years, with ZymoGenetics paying Bayer commissions and sales bonuses. The delay won't result in any penalties for ZymoGenetics, but it will increase the amount of money it burns through before the launch.
The company had already started producing commercial lots for sale so that it could launch the product within 10 days of approval. Those vials can be stored at room temperature for two years, so it's unlikely that the delay will result in any wasted product.
It's also hired 38 of the 48 salespeople it expects to use for the launch of the drug. It will have to eat those salaries for up to an additional three months before those employees can get out and talk to doctors.
ZymoGenetics' management clearly believes the product will be approved. Why else would they start producing commercial lots before FDA approval? There's nothing in the announcement to imply that the FDA feels there's a problem with the efficacy or the safety of the drug. With a 9% drop in stock price today, it looks to me like investors are overreacting to the delay.
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