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| |  Regranex Approved In Canada For Diabetic Foot Ulcer Treatment TORONTO, ON -- Feb. 11, 1999 -- Janssen-Ortho Inc.’s Regranex(R) becaplermin 0.01%, the first drug to actively stimulate wound healing, has been approved by Health Canada's Therapeutic Products Programme for the treatment of diabetic foot ulcers, the leading cause of amputation among Canadians with diabetes. "Regranex is the first breakthrough drug to offer active wound healing. It is powerful medicine, yet it is a simple, easy-to-use topical treatment,'' said Dr. John Embil, assistant professor of internal medicine and infectious diseases, The University of Manitoba and co-ordinator of the Diabetic Foot and Complication Wound Clinic at the University of Manitoba Health Sciences Centre in Winnipeg. "Before Regranex, patients with diabetic foot ulcers could only rely on wound care products to merely dress the wound while the body healed on its own. But with Regranex, the body is actively stimulated to heal the ulcer." The active ingredient in Regranex is recombinant human platelet-derived growth factor (PDGF) that is produced through genetic engineering, similar to that used in the production of insulin for treating diabetes. This biotechnology-engineered product works the same way naturally-occurring PDGF works in the body by actively stimulating the body's healing process so that the wound fills with new healthy tissue. Clinical trial results demonstrate that a once daily topical application of Regranex, in conjunction with a good wound care program, significantly enhances and speeds the healing of diabetic foot ulcers. It is estimated that 15 per cent of the 1.5 million Canadians with diabetes will develop foot ulcers at some point over the course of their lives. Foot ulcers often go undetected since other ailments associated with diabetes -- such as nerve damage and visual and circulatory problems – make it difficult for patients to feel or see the ulcer as it develops. In Canada, the estimated direct and indirect costs of an amputation are between $35,000 and $50,000 CDN. Diabetic foot ulcers precede approximately 85 percent of all amputations in patients with diabetes and account for more hospital days than all other diabetic complications combined. Additionally, five to six billion dollars is spent annually in Canada for the treatment of diabetes and its complications. Given that diabetes is increasing to epidemic proportions and, with that, diabetes-related complications such as foot ulcers, so too are the associated health care costs likely to skyrocket. "With the advent of an active wound healing drug like Regranex, along with a good wound care program, the majority of diabetic foot ulcers will heal completely and more quickly. And by treating patients early, the chance of an ulcer progressing to the stage where amputation is necessary is lessened," said Dr. Gordon Dow, internist and infectious disease specialist at The Moncton Hospital in New Brunswick. "For these reasons, we can presume that treatment with Regranex will reduce overall costs to the health care system." Regranex is applied directly to the ulcer once a day and can be applied by the patient or caregiver in the comfort of home. "The ease of use of Regranex means that patients can apply it themselves, easily," Dr. Embil said. "This leads to a patient's feeling of empowerment over the state of their health. That is truly a step forward in ulcer care."
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