OT: I would like to say that Aschoff is a scumbag, but then Dew would write me up for a TOS. See 1 and 2 below.
1)
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.
ADVERTISEMENT
“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.”
ZymoGenetics Down on 'Sell' Initiation
Wednesday January 16, 7:15 pm ET
ZymoGenetics Falls As Analyst Starts Coverage at 'Sell' on Possible Product Delays
NEW YORK (AP) -- Shares of biotechnology company ZymoGenetics Inc. fell Wednesday after a Brean Murray, Carret & Co. analyst started coverage with a "Sell" rating, saying the company's lead experimental product could face further approval delays.
ADVERTISEMENT
Seattle-based ZymoGenetics is seeking approval for blood-clotting product Recothrom, or rThrombin, to be used when standard techniques cannot control bleeding in patients.
2) Aschoff's call yesterday:
In a note to investors, analyst Jonathan Aschoff questioned the likelihood Recothrom will receive outright approval from the Food and Drug Administration, based on its safety profile.
He noted that the development and regulatory pathways for Recothrom have been mired with problems. In August, ZymoGenetics cut its revenue guidance after the FDA postponed a decision date on rThrombin upon receiving additional manufacturing-related information from the company.
"We question the product's outright approvability based on the clinical safety data generated to date, ZymoGenetics' manufacturing capabilities, and the company's claims to superior safety in regards to live-sourced thrombin," said Aschoff.
The analyst predicted the FDA will issue ZymoGenetics a "complete response letter" on Thursday, the date when the FDA is expected to release a decision on the drug's application. Such letters often request additional data and information on a drug candidate before the review is completed.
Aschoff said he expects late-stage trial results for Recothrom in the third quarter, and believes the FDA will wait for those results before approving the product, saying the market for this type of treatment is already well-served.
Even if the drug is approved, Aschoff sees it facing tough competition from similar products by Johnson & Johnson and King Pharmaceuticals Inc.
"We believe that further regulatory delay for Recothrom will also force ZymoGenetics to raise substantial capital at an unfavorable valuation, as we project a cash raise before the Phase 3b results are released," he added.
On the upside, Aschoff believes the company's pipeline is promising in the longer term in the auto-immune and cancer areas.
He put a $7 price target on ZymoGenetics shares.
AI
