Genzyme acquires rights to multiple sclerosis drug from Bayer

Genzyme, a biotechnology company, has entered into an agreement to acquire the worldwide rights to Campath from Bayer HealthCare, giving Genzyme primary responsibility for the development and commercialization of this potential break-though treatment for multiple sclerosis.

Bayer will continue to fund a portion of alemtuzumab’s development in multiple sclerosis (MS) and will retain an option to co-promote the product in MS upon approval. In addition, Genzyme will assume sole responsibility for worldwide sales and marketing for Campath in B-cell chronic lymphocytic leukemia, where it is indicated for use as a single agent in first-line and previously-treated patients with this disease. Bayer will retain the right to develop and commercialize alemtuzumab in solid organ transplant indications.

The agreement further expands Genzyme’s hematologic oncology commercial presence beyond Campath through the addition of Fludara and Leukine, and provides an opportunity to integrate members of Bayer’s experienced commercial team for all three drugs into Genzyme’s global operations.

Genzyme will acquire a new, Seattle-area Leukine manufacturing facility for $75 to $100m and hire the plant’s operating personnel following the FDA plant approval, which is expected in 2010. Bayer will receive payments based on revenues and potential milestone payments if cumulative revenue targets are achieved. There are no upfront payments for the rights of these three drugs.

Genzyme is now conducting two Phase III studies of alemtuzumab in MS. The first trial, for which enrollment is complete, treats early, active relapsing-remitting patients who have received no prior therapy.

The second study, which is expected to complete enrollment before the end of 2009, is studying relapsing-remitting patients who had active disease while on other MS therapies. Data from the trials are expected to be available in 2011, and approval is anticipated in 2012.

Henri Termeer, chairman and CEO of Genzyme, said: Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis, and an important part of our future. This strategic transaction clarifies the responsibilities of each company and gives Genzyme control over the execution of this program. We will continue to collaborate with Bayer in a more streamlined and focused way.