Puget Sound Business Journal (Seattle) -- Officials at ZymoGenetics Inc. said Tuesday that the Food and Drug Administration will take at least three more months to review the biotech’s rThrombin bleeding-control drug.
In after-hours trading Wednesday, shares of Seattle-based ZymoGenetics (NASDAQ: ZGEN) fell more than 15 percent, dropping $2.03 to $11.25.
In an 8-K filing with the Securities and Exchange Commission, ZymoGenetics said that additional manufacturing information it submitted was determined by the FDA to be a major amendment to rThrombin’s license application, and the goal date for completion of the FDA review of the drug has been extended three months to Jan. 17, 2008.
In June, ZymoGenetics signed a deal with Bayer HealthCare, which would see Bayer paying a $40 million milestone payment when rThrombin was approved by the FDA. Because of the delay, ZymoGenetics said it won’t receive that money until the first quarter of 2008; the revenue from the deal with Bayer will be reduced from between $5 million and $8 million down to $3 million because of the delay; and ZymoGenetics won’t receive any revenues from rThrombin until 2008.
