ZymoGenetics' recent deal with Bayer HealthCare to market its new blood-clotting agent rThrombin has hit a snag. The company says that the FDA is considering its request for more manufacturing information as a major amendment to the application, which will push back final approval for the therapy. The FDA review now won't be completed until mid-January, three months later than anticipated. That marketing pact is worth up to $198 million [1] and none of the $40 million in milestones outlined in the deal can now flow this year.
- read the report [2] from The Street
Related Articles:
ZymoGenetics inks $198M deal. Report [1]
Pivotal Thrombin trial a success for ZymoGenetics. Report [3]
ZymoGenetics builds cash reserves as it advances Thrombin. Report [4]
Links:
[1] http://www.fiercebiotech.com/story/spotlight-zymogenetics-inks-198m-deal/2007-06-19
[2] http://www.thestreet.com/s/zymogenetics-suffers-fda-setback/newsanalysis/biotech/10375879.htmlpuc=googlefi
[3] http://www.fiercebiotech.com/story/pivotal-thrombin-trial-a-success-for-zymogenetics/2006-09-06?utm_medium=rss&utm_source=rss
[4] http://www.fiercebiotech.com/story/zymogenetics-builds-cash-reserves-as-it-advances-thrombin/2005-08-05