Genzyme has entered into an agreement with Bayer HealthCare to acquire worldwide rights to Campath for the development and commercialization for the treatment of multiple sclerosis (MS). Bayer will continue to fund a portion of Campath’s development in MS and will retain an option to co-promote the product if approved. Genzyme will assume sole responsibility for worldwide sales and marketing for Campath in B-cell chronic lymphocytic leukemia (CLL). Bayer will retain the right to develop and commercialize it in solid organ transplant indications.
The agreement also adds to Genzyme’s hematologic oncology presence with the addition of Fludara and Leukine, and an opportunity to integrate members of Bayer’s commercial team for all three drugs into Genzyme’s global operations. Genzyme will acquire a new, Seattle-area Leukine manufacturing facility for $75 to $100 million and hire the plant’s operating personnel following FDA plant approval, which is expected in 2010.
Bayer will receive payments based on revenues (subject to an aggregate cap) and potential milestone payments if certain revenue targets are met. There are no upfront payments for the rights of these three drugs. The transaction would provide Genzyme with approximately $185 million in oncology revenue in 2009 and as much as $700 million in revenue during the next three years.
Genzyme is now conducting two Phase III studies of Campath in MS. Data from the trials are expected to be available in 2011, and approval is anticipated in 2012. Phase II results showed that patients with early, active relapsing-remitting MS experienced significant reductions in the risk of sustained accumulation of disability and annualized relapses after two annual cycles of Campath when compared with the active comparator Rebif (interferon beta-1a).
The transaction is expected to close in the second quarter, pending FTC review and international regulatory clearances. Genzyme and Bayer will work together for the transition of drug sales and distribution.