ZGEN wins round one in court battle with King, but suffers major blow to EU Recothrom plans.
>>10-Dec-2009
Other Events
Item 8.01. Other Events.
In a Memorandum Opinion and Order issued today, December 10, 2009, the United States District Court for the Eastern District of Tennessee denied all motions for preliminary injunction filed by King Pharmaceuticals in its lawsuit against us. As previously disclosed, King Pharmaceuticals, Inc. and affiliated entities or, collectively, King, filed suit against us on November 2, 2009, in the United States District Court for the Eastern District of Tennessee, naming as defendants ZymoGenetics, Inc. and fifty unnamed individuals. King alleges that we have engaged in unfair competition, false advertising, trademark infringement, and related claims under federal law and Tennessee state law. King seeks various forms of relief, including damages and injunctive relief precluding us from making certain representations regarding King's products and our RECOTHROM product. King sought preliminary injunctions with respect to certain comparative advertising claims, use of King trademarks as Google ad words, and certain alleged statements regarding the existence of lawsuits against King; the court denied all three motions for preliminary injunction in their entirety. We dispute the allegations of wrongdoing in King's complaint and will continue to vigorously defend ourselves in this matter. We filed an answer to King's complaint and counterclaims with the court on December 7, 2009.
We currently believe that this litigation will not have a material adverse effect on our financial condition, our results of operation, or our cash flows. However, litigation is subject to inherent uncertainties and the actual cost and the distraction from the conduct of our business, as well as the ultimate outcome, will depend upon many unknown factors and our view of these may change in the future.<<
>>14-Dec-2009
Other Events
Item 8.01 Other Events.
On December 11, 2009, Bayer notified the European Medicines Evaluation Agency (EMEA) of Bayer's decision to voluntarily withdraw the Marketing Authorization Application (MAA) for RECOTHROM?, recombinant human thrombin, in Europe, in response to indications from the regulatory authorities that approval would not be forthcoming without additional clinical trial data. ZymoGenetics, Inc. licensed all rights to RECOTHROM outside the United States to Bayer in 2007.
It is the view of the Committee for Medicinal Products for Human Use (CHMP) that the data provided were not sufficient for approval because Bayer's submission did not meet CHMP's fibrin sealant guideline. The MAA was filed by Bayer in August 2008 based on data from ZymoGenetics' Phase 3 clinical trial, which was conducted in the United States prior to the Bayer license transaction and which used a comparator, bovine thrombin, that is not available in Europe. Bayer proceeded with the approval application based on data from the United States trial after consulting with regulatory authorities in certain key member countries. Although RECOTHROM is not a fibrin sealant, it now appears that an additional clinical trial complying with the CHMP fibrin sealant guideline will be required to support approval in Europe.<<
What Bayer does here will be interesting. Do they believe in Recothrom enough to do the trials, or do they walk away? Head to head against plasma derived thrombin might be interesting, but it would cost a lot of time to show the real difference in immunogenicity. Regardless, it puts a damper on ex-US income for a good two or three years, at least. Tough call by EMEA. ZGEN isn't down as much as I would have thought on this news, so perhaps analysts had already figured it could run into trouble on this basis? All the vig is in other programs, and no one cares about Recothrom anymore?
Cheers, Tuck |
