ZymoGenetics Earns Milestone Payment for RECOTHROM European Filing
SEATTLE--(BUSINESS WIRE)--Sep 2, 2008 - ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that it will receive a $5 million milestone payment from Bayer HealthCare, which was triggered by the submission of the Marketing Authorization Application to the European Medicines Agency (EMEA) for approval to market RECOTHROM(R) Thrombin, topical (Recombinant). Bayer filed with the EMEA for authorization to market RECOTHROM as a topical aid to control surgical bleeding. RECOTHROM received United States Food and Drug Administration approval in January 2008.
"Bayer's filing for approval in Europe demonstrates their commitment to RECOTHROM," said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. "Bayer has been a valued partner in selling RECOTHROM, the first and only plasma-free thrombin, in the US and in driving the ex-US program forward."
RECOTHROM is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the rights to RECOTHROM in all markets outside the US and will commercialize RECOTHROM, leveraging the company's strong commercial presence in global markets. Currently, stand-alone thrombin products are not widely available in the European Union (EU). However, in five of the largest member states of the EU there are in excess of 4 million surgical procedures performed annually where a hemostatic product is generally used. ZymoGenetics retains US market rights and Bayer provides its trained surgical sales force to support the first three years of the US market launch.
About RECOTHROM(R) Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled up to meet market demand.
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
IMPORTANT SAFETY INFORMATION
RECOTHROM is for topical use only and should not be injected directly into the circulatory system. There is a potential risk of thrombosis if the product is absorbed systemically. RECOTHROM should not be used for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
No specific adverse events have been established as adverse reactions causally related to RECOTHROM administration. In a clinical study comparing RECOTHROM to bovine thrombin, adverse events were reported with similar frequency in both treatment groups. The most common event was incision site complication. Limited data (n = 6) are available on repeat exposure to RECOTHROM.
Please see full prescribing information at: http://www.zymogenetics.com/products/recothrom.html.
For additional information, please visit: http://www.recothrom.com.
About ZymoGenetics
ZymoGenetics discovers and develops novel protein therapeutics that are based on the Company's research and biological insights into key disease pathways. The Company developed and markets RECOTHROM(R) Thrombin, topical (Recombinant), which is the first recombinant, plasma-free thrombin. Other product candidates span a wide array of clinical opportunities that include cancer, autoimmune and viral diseases. ZymoGenetics intends to commercialize product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.
About Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future actions or performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual performance and the timing and outcome of actions may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven product sales and marketing abilities, discovery strategy, preclinical and clinical development, strategic partnering, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2007. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
Contact
ZymoGenetics, Inc.
Susan W. Specht, MBA, 206-442-6592
Director, Corporate Communications
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