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Medtronic, Genzyme Form Joint Venture to Target Cardiac Repair
MG Biotherapeutics to Develop Treatments that Combine Cell Therapy, Medical Devices
MINNEAPOLIS and CAMBRIDGE, Mass., June 1, 2004 – Medtronic, Inc. (NYSE: MDT) and Genzyme Corporation (NASDAQ: GENZ) announced today that they have formed a joint venture to accelerate the development of new treatments for some of the most intractable forms of cardiovascular disease. The new venture, named MG Biotherapeutics, will work to develop therapies that leverage the complementary strengths of two industry leaders – Medtronic’s experience developing delivery devices for targeted therapy and leadership in treating heart disease, as well as imaging and navigational technologies; and Genzyme’s experience developing biological approaches for cardiac repair and the treatment of heart disease.
Under the agreement, the two companies will collaborate on:
• An ongoing Phase 2 clinical trial investigating the use of cell therapy to repair damaged heart tissue and bring this therapy to market
• A portfolio of advanced delivery devices that will locally deliver therapeutic cells to the heart in a less invasive manner
• Long-term cell therapy research into repairing damaged heart tissue Financial terms of the joint venture agreement were not disclosed.
“We are enthusiastic about collaborating with Genzyme in an effort that we believe has the potential to change the way heart disease will be treated in the coming decades,” said Stephen Oesterle, M.D., Medtronic’s senior vice president of medicine and technology. “This collaboration builds on Medtronic’s Mission in treating chronic disease and its record of applying broad expertise in biomedical engineering to address some of the most pressing health problems. The initial results of cell therapy have been encouraging. This joint venture combines Medtronic with the remarkable talents of Genzyme’s scientific staff and its expertise in biological engineering into a formidable venture focused on ‘combination’ products.”
Duke Collier, executive vice president, Genzyme, said, "Combining our research and clinical program in cell therapy with Medtronic's expertise will greatly enhance our efforts to bring innovative biology to bear on serious heart disease. Together, we will be a leader in developing new therapies for heart disease, and building a global commercial enterprise that will help bring these programs to clinical and commercial success."
Phase 2 Clinical Trial
Among other activities, the companies will co-fund Genzyme’s ongoing Myoblast Autologous Graft in Ischemic Cardiomyopathy (MAGIC) Phase 2 clinical trial of cell therapy to repair damaged heart tissue. This trial, which is believed to be the largest and most advanced of its kind, is designed to determine whether cell therapies can be used to reverse damage done to cardiac muscle following a heart attack, or to safely halt a patient’s further progression of heart failure, a usually incurable condition affecting more than 20 million individuals worldwide.
The Phase 2 clinical trial, which is currently being conducted in Europe with partial funding from Assistance Publique - Hôpitaux de Paris, will enroll up to 300 patients. This trial builds upon the work of Genzyme’s European Principal Investigator, Philippe Menasché, M.D., Ph.D. of Hôpital Bichat, Paris, who was among the first to test whether autologous cell therapy (a treatment that utilizes a patient’s own cells) could be used to stop or reverse the damage done to the heart muscle by a heart attack. The trial has enrolled patients in France, and is currently expanding to sites in Belgium, the United Kingdom, Italy, Germany and Switzerland.
Because the cells involved in growing new heart tissue – cardiomyocytes – have limited regenerative ability in adults, the heart has minimal potential to heal itself after a heart attack occurs. Investigators in the Phase 2 trial harvest a patient’s own skeletal muscle (myoblast) cells prior to bypass surgery through a small biopsy in the leg. These cells are multiplied many-fold in the laboratory over approximately 21 days using proprietary cell-culture techniques. The investigators then inject the cells into a damaged region of the heart during a coronary artery bypass operation. Investigators are examining the safety of this procedure, and are monitoring a range of outcomes designed to provide a meaningful indication of potential efficacy.
While the Phase 2 trial progresses, the companies will work to develop a catheter-based system to deliver cells to the heart using Medtronic¡¦s sophisticated TransAccess® Delivery System. This device has shown potential in pre-clinical studies to effectively deliver autologous cells to damaged areas of the heart. Catheter-based delivery could make cell therapy treatments less invasive, enabling access to the heart through a patient¡¦s vascular system. The companies believe that this may greatly increase the number of patients who could benefit from cardiac cell therapy.
In addition to these efforts, Medtronic and Genzyme will pursue a longer-range joint research program focused on potential next-generation cell therapy approaches, including the use of genetically modified cells, allogeneic cells (cells from a donor or cell bank), and advanced biomaterials designed to enhance cellular engraftment and survival.
The creation of this joint venture brings together two respected industry innovators. Medtronic, the worldwide leader in device therapy for a wide range of chronic conditions, also has a long and successful history of combining chemical compounds or biologics with medical devices to achieve improved therapeutic results. Notable examples are steroid-eluting leads for pacemakers and defibrillators, bioactive coatings for heart valves and heparin-coated components used in open heart surgery. More recent examples include an investigative drug-coated coronary stent, drug infusion systems and INFUSE® Bone Graft, a morphogenic protein used in conjunction with spinal instrumentation. INFUSE Bone Graft was recently approved by the U.S. Food and Drug Administration for the treatment of acute, open fractures of the tibial shaft. Combined with its imaging and navigational technologies, Medtronic¡¦s expanding portfolio of local delivery tools gives physicians access to a wide selection of devices with the potential to deliver biologics to the heart.
Genzyme has more than a decade of experience in manufacturing autologous cell therapy products that have been used to treat thousands of patients, including Carticel® (autologous cultured chondrocytes), a cell therapy for repairing injuries to articular knee cartilage, and Epicel® (cultured epidermal autograft), a cell therapy for treating patients with severe burns. These products represent the first and largest autologous commercial cell therapy products ever brought to market, providing Genzyme with unmatched scientific and commercial expertise in this field.
Medtronic, Inc., headquartered in Minneapolis, is the world¡¦s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com. LT CAGE® + INFUSE®, INTERFIX™and INTERFIX™ RP + INFUSE®, and BRYAN® TCD Instruments incorporate technology developed by Gary K. Michelson, M.D.
Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. The company's broad product portfolio is focused on rare genetic disorders, renal disease, osteoarthritis and immune-mediated diseases, and includes an industry-leading array of diagnostic products and services. Genzyme's commitment to innovation continues today with research into novel approaches to cancer, heart disease, and other areas of unmet medical need. More than 6,300 Genzyme employees in offices around the globe serve patients in over 80 countries.
News Media: An electronic media kit for MG Biotherapeutics is available by visiting: www.medtronic.com/newsroom
Medtronic - Any statements made about the company¡¦s anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as the risks inherent in the development, manufacturing, marketing and sale of medical products, competitive factors, general economic conditions, legal disputes and government actions as more fully described in Medtronic¡¦s Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.
Genzyme - This press release contains forward-looking statements, including the statements regarding the Companies' plans to develop new treatments for cardiovascular disease using catheter-based delivery systems to deliver biologic therapies to the heart and their current plans to enroll 300 patients in the MAGIC Phase 2 clinical trial. 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, the inherent uncertainties associated with conducting clinical trials; the regulatory approval process for new products; competitive product development; the requirement for substantial funding to conduct additional research and development work relating to the local delivery of biologics for the treatment of heart disease; uncertainties inherent in drug development and commercialization, market acceptance of new products; the ability to obtain and maintain patent or other proprietary intellectual property protection and the actual impact of those patents and rights and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending March 31, 2004. Genzyme cautions investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
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