Genzyme Completes Transaction with Bayer HealthCare
Assumes Primary Responsibility for Alemtuzumab in Multiple Sclerosis; Expands Hematologic Oncology Portfolio
In addition, Genzyme has acquired the worldwide marketing and distribution rights to Fludara® (fludarabine phosphate) and Leukine® (sargramostim), which significantly expands Genzyme's global oncology commercial presence. Genzyme now has full responsibility for developing, marketing and selling the acquired oncology products and will record sales revenue in the United States and more than 90 other countries where they are sold. During a transition period following the closing, Genzyme and Bayer HealthCare will continue to work together to ensure no interruption in product supply to patients or support services to providers.
“With our broad portfolio of new and existing innovative therapies, combined with a large array of genetic testing services, Genzyme is positioned to offer patients and physicians a comprehensive set of treatment options across the continuum of care for hematologic malignancies,” said Mark Enyedy, president of Genzyme Oncology and Multiple Sclerosis. “In addition, alemtuzumab for multiple sclerosis is a potential significant therapeutic advance for patients, and we are pleased to be leading this program that we expect will provide an important catalyst for the company's long-term growth.”
Under the terms of the transaction, Genzyme will make no upfront payment to Bayer. In exchange for the rights to alemtuzumab, Genzyme will make payments to Bayer following product approval under an earn-out arrangement that is based on product revenue. Similarly, in exchange for the rights to Campath, Fludara and Leukine, Genzyme will make future payments based upon revenue. In addition, Genzyme will acquire a new Leukine manufacturing facility upon FDA approval of the plant, which is expected in 2010. The revenue and earnings impact of this transaction is included in Genzyme's 2009 guidance.
Genzyme is now leading the development program for alemtuzumab in MS, and following approval, will have primary responsibility for its commercialization.
Alemtuzumab in MS is in two phase 3 trials. 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 this year, 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.
Bayer, which has been co-developing alemtuzumab in MS with Genzyme, will continue to fund development at current levels until the investigational compound is approved for this indication.
The transaction also leverages Genzyme's international commercial infrastructure within the areas of transplantation and hematologic malignancies. Genzyme's hematologic oncology sales force, which will expand in the United States and globally with the addition of Campath, Fludara and Leukine, will support a comprehensive portfolio of products covering acute and chronic leukemia, bone-marrow transplant and managing post-transplant complications.
Campath/MabCampath and Leukine are expected to see continued growth through the company's specialized sales force and further clinical development. Campath and Fludara, marketed broadly worldwide, are recognized therapeutic options for patients with B-cell chronic leukemia. Leukine, marketed in the United States, reduces the incidence of severe and life-threatening infections in older adult patients with AML following chemotherapy and is also used to mobilize stem cells.
This new and significant global market presence can also accelerate the adoption of Clolar®/Evoltra® (clofarabine injection) and Mozobil® (plerixafor injection). Genzyme is introducing these drugs throughout the world and continues to invest in their development. Peak sales for these products are expected to generate approximately $1 billion in revenue.
Clolar, marketed in the United States and Europe (where it is known under the trade name Evoltra), has become the standard of care for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients. Genzyme's supplemental New Drug Application for Clolar to treat older adults with newly diagnosed acute myeloid leukemia (AML) will be reviewed in September by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee.
Mozobil, launched in the United States earlier this year, mobilizes hematopoietic stem cells in patients with non-Hodgkin's lymphoma and multiple myeloma for subsequent autologous stem-cell transplants. The launch of Mozobil in the United States is proceeding well due to the clinical benefits it offers patients and the potential economic benefits to transplant centers. European Union approval of Mozobil is expected in the second half of 2009, and the company plans to submit additional applications in up to 60 countries.
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. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements, including the statements regarding: the timing and potential benefits of the completed acquisition; the extent to which the acquisition ultimately advances Genzyme's hematologic oncology business, including revenue projections for Leukine, Fludara, Clolar and Mozobil; expectations regarding receipt of regulatory approvals for Mozobil and Clolar in adult AML. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, Genzyme's ability to successfully integrate the acquired products; the actual design, results and timing of clinical studies for Mozobil and Clolar in adult AML; enrollment rates for on-going and planned clinical trials; the extent to which the safety and efficacy the product candidates is demonstrated; the actual timing and content of submissions to and decisions made by regulatory authorities; the ability to manufacture sufficient quantities of product and to do so in a timely and cost-efficient manner; the availability and extent of reimbursement from third party payers; the scope, validity and enforceability of Genzyme's and third party patents; the accuracy of Genzyme's information concerning product market potential, including growth projections; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended March 31, 2009. We caution investors not to place undue reliance on the forward-looking statements contained in this document. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements.
Genzyme®, Campath®, MabCampath®, Mozobil®, Clolar®, and Evoltra® are registered trademarks and Leukine® and Fludara® are licensed trademarks, of Genzyme Corporation or its subsidiaries. All rights reserved.
Posted: June 2009