ZymoGenetics is regaining global promotion rights, except Canada, for Recothrom Thrombin, topical from Bayer Schering Pharma and Bayer HealthCare. Under the restructured U.S. co-promotion and ex-U.S. license and collaboration agreements, active co-promotion by Bayer in the U.S. will end on December 31.
Beginning in 2010, Bayer will receive a reduced commission through December 31, 2011, which was previously capped at $25 million per year and will now be subject to an aggregate maximum of $12 million. ZymoGenetics will no longer be required to pay Bayer U.S. sales bonuses totaling $20 million, which were anticipated to have been payable in 2010 and 2011 or upon termination of the co-promotion agreement. The commission and bonuses were paid to Bayer in exchange for its U.S. sales efforts.
Recothrom is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin and is not derived from animal or human blood. It received FDA approval in January 2008 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 sales for the first three quarters of this year has surpassed sales made during all of 2008. The drug brought in $9 million in the first three quarters of 2009 compared to $8.8 million in full-year sales for 2008. The product continues to gain market share, according to the company. As of September 30, Recothrom had an estimated 15% share of the U.S. topical thrombin market.
“The U.S. marketing and sales operation should achieve greater efficiency with one sales organization,” according to Douglas E. Williams, Ph.D., CEO of ZymoGenetics. “We plan to increase the size of our field force to compensate for Bayer’s exit. However, despite this increase, we expect the change to lower our selling costs and improve our bottom line while enabling us to continue to gain market share.”
Outside the U.S. ZymoGenetics will regain all rights to Recothrom except for Canada, where Bayer will sell the product and pay royalties on net sales to ZymoGenetics. Bayer will no longer be required to pay ZymoGenetics up to $16 million in milestone payments for ex-U.S. regulatory approvals.
ZymoGenetics will assume responsibility for all active regulatory files in countries besides Canada. In September 2008, Bayer filed for the approval of Recothrom in the EU and paid ZymoGenetics a $5 million milestone payment.
“We continue to believe there is substantial potential value to be gained from the commercialization of Recothrom outside the United States,” Dr. Williams adds. “We intend to seek new licensees to pursue the development of these markets.”