knoqout schreef:
FDA approves the first recombinant human thrombin
(not to be confused with antithrombin)
The plasma-derived thrombin products will now begin their slow descent into inconsequence.
FDA Approves ZymoGenetics' RECOTHROM(TM) Thrombin, topical (Recombinant)
Thursday January 17, 1:45 pm ET
- First recombinant plasma-free thrombin for use in surgical hemostasis -
- $40 million milestone payment from Bayer -
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today announced that the United States Food and Drug Administration (FDA) has approved RECOTHROMTM Thrombin, topical (Recombinant) for sale. RECOTHROM, previously referred to as recombinant thrombin (rThrombin), is the first and only recombinant, plasma-free thrombin approved for use as a topical hemostat. 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. A Phase 3 pivotal clinical trial showed that RECOTHROM had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product.
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“The FDA approval of RECOTHROM recombinant thrombin is important news for patients, surgeons and hospitals,” said Bruce L.A. Carter, Chief Executive Officer. “We believe that RECOTHROM has important features and benefits. We’re well prepared for launch and expect to ship product in the near future.”
Under a global collaboration, Bayer HealthCare Pharmaceuticals will support the launch of RECOTHROM in the US for three years. Both ZymoGenetics and Bayer field representatives, medical science liaisons and sales personnel have been thoroughly trained. The FDA approval triggers a $40 million milestone payment from Bayer HealthCare to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to $20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.
In June 2007 Bayer HealthCare acquired the rights to RECOTHROM in all markets outside the US. Bayer will commercialize RECOTHROM leveraging the company’s strong commercial presence in global markets. Bayer will be responsible for conducting any required clinical trials, securing regulatory approvals and commercializing the product in all countries outside the US.
“The first regulatory approval of RECOTHROM is a significant signal of the product’s strong clinical data,” said Hans Bishop, head of Bayer’s global hematology/cardiology business unit. “RECOTHROM is an attractive addition to our specialty pharmaceutical portfolio. Our partnership with ZymoGenetics demonstrates Bayer’s continued focus on working collaboratively with innovative biotechnology companies to develop and commercialize novel protein therapeutics.”
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