Genzyme Corporation has entered into an agreement to acquire the worldwide rights to Campath (alemtuzumab) from Bayer HealthCare, giving Genzyme primary responsibility for the development and commercialization of this potential break-though treatment for multiple sclerosis (MS). Bayer will continue to fund a portion of alemtuzumab's development in 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 leukaemia (CLL), 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 haematologic oncology commercial presence beyond Campath through the addition of Fludara (fludarabine) and Leukine (sargramostim), 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 $100 million and hire the plant's operating personnel following FDA plant approval, which is expected in 2010.
The transaction is accretive and already reflected in Genzyme's 2009 revenue and non-GAAP earnings per share guidance. The deal is structured as an earn-out arrangement. Bayer will receive payments based on revenues (subject to an aggregate cap) and potential milestone payments if cumulative revenue targets are achieved. There are no upfront payments for the rights of these three drugs. The transaction would provide Genzyme approximately $185 million in oncology revenue in 2009 and up to $700 million in revenue over the next three years. Genzyme's Oncology segment revenues in 2008 were $117 million. Today's announcement supports the company's goal of 20 per cent compound average non-GAAP earnings growth from 2006 to 2011.
"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," said Henri A. Termeer, chairman and CEO of Genzyme Corporation. "We will continue to collaborate with Bayer in a more streamlined and focused way."
"Through the acquisition of these hematologic oncology assets, we enhance our commercial presence in the oncology market with a comprehensive product portfolio," said Enyedy. "Genzyme is committed to this important disease area and to deepening our relationship with the specialist providers in this field around the world."
The long-term growth of Genzyme Oncology will be driven by regulatory approvals for Mozobil (plerixafor injection) in new markets and new indications for Clolar (clofarabine injection). The addition of members of Bayer's global commercial team will support the introduction of Mozobil and Clolar for adult AML.
Mozobil, launched in the United States earlier this year, mobilizes haematopoietic stem cells in patients with non-Hodgkin's lymphoma and multiple myeloma for subsequent autologous stem-cell transplants. Because of the clinical benefits Mozobil offers patients, and the potential economic benefits to transplant centers, the US product launch is proceeding well. European Union approval of Mozobil is expected in the second half of 2009, and additional applications in up to 60 countries are planned.
Clolar is in several clinical trials to secure new therapeutic indications. The US FDA will review Genzyme's supplemental NDA for Clolar to treat adult AML at its September Oncologic Drugs Advisory Committee meeting. European authorities have asked Genzyme to include in its submission for Clolar in adult AML data from a randomized clinical trial, several of which are ongoing. Clofarabine is currently approved in the United States and Europe (where it is marketed under the tradename Evoltra) for the treatment of acute lymphoblastic leukaemia in relapsed and refractory paediatric patients, and has become a standard of care in this setting. Additional approvals are expected in Latin America and Canada this year.
Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body's immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL).
Leukine (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991. Leukine is the only growth factor approved in the US for use following induction chemotherapy in older adults with acute myelogenous leukaemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the US for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay.
Unlike alkylating cytotoxic chemotherapies, Fludara, a purine nucleotide analog, inhibits the synthesis of new DNA, thus preventing leukaemia cells from multiplying.
Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood in patients with non-Hodgkin's lymphoma and multiple myeloma.
Clolar is indicated in the US for the treatment of paediatric patients one to 21 years old with relapsed or refractory acute lymphoblastic leukaemia after at least two prior regimens.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases.