MADISON, N.J., and LEIDERDORP, The Netherlands, April 19
/PRNewswire-FirstCall/ -- Wyeth and Astellas BV, today announced that the European Commission has approved InductOs(TM) (rhBMP-2/ACS) [recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge] for the treatment of single level (L4-S1) anterior lumbar spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least six months of nonoperative treatment for this condition. InductOs has been approved by the European authorities since 2002 for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation.
Degenerative disc disease is a leading cause of lower back pain and one of the most prevalent health problems in the world. Nonoperative forms of treatment fail to provide sufficient relief from pain and disability for many patients. For them, fusion of the involved spinal segments, and often anterior lumbar interbody spine fusion using autogenous bone with interbody fusion cages, is considered a viable course of action.
"With InductOs, surgeons can now offer EU patients an alternative to painful autogenous bone harvesting," said Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America. "The potential benefit for the patient is relief from the symptoms of degenerative disc disease without the additional pain and morbidity associated with autograft harvesting."
InductOs contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a naturally occurring human protein that was discovered and developed by Wyeth Pharmaceuticals. The protein is manufactured at a Wyeth biopharmaceutical facility in Andover, Massachusetts.
The EMEA approval was based on data from a randomized multicenter study of 279 patients undergoing an open anterior lumbar fusion procedure. At 24 months postoperation, results in terms of predetermined overall success, pain and disability, and radiologic fusion were comparable between the patient group treated with InductOs and the patient group treated with autologous bone fusion.
Like all medicines, InductOs may have side effects. The undesirable effects observed in anterior lumbar spine fusion patients were generally representative of the morbidity associated with spine fusion using autogenous bone graft taken from the iliac crest. Very common (>10 percent) undesirable effects such as accidental injury, neuralgia, back pain and bone disorder, were similar in both control and InductOs treatment groups. In spinal fusion studies 0.7 percent of patients receiving InductOs developed antibodies to rhBMP-2 vs. 0.8 percent of patients receiving bone grafts; in addition 19 percent of patients receiving InductOs developed antibodies to bovine Type I collagen vs. 13 percent of patients receiving autogenous bone graft.
Wyeth Pharmaceuticals and Astellas BV, a subsidiary of Astellas Pharma Inc., are partners in the development and commercialization of BMP products in Europe. Medtronic Sofamor Danek (MSD), the spinal business of Medtronic , has the exclusive promotion rights for InductOs in Europe for certain indications, including acute tibial fractures and spinal fusion.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
Astellas Pharma Europe BV is a subsidiary of Astellas Pharma Inc., located in Tokyo, a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.