By Karen Pihl-Carey
Apligraf will reach up to 800,000 new patients now that Organogenesis Inc. has received FDA approval to market it for a second indication - diabetic foot ulcers.
The skin replacement product was approved in February 1998 to treat venous leg ulcers caused by circulatory problems, a condition that afflicts up to 1 million Americans each year. (See BioWorld Today, Feb. 2, 1998, p. 1.)
The Canton, Mass.-based company announced the approval Tuesday shortly before the market closed.
"It really helps establish our position in the field of tissue engineering in that we are not only the first company to have achieved a product of living human skin cells for venous ulcers, but we are also the first to establish such a product for diabetic ulcers," said Carol Hausner, senior director of corporate communications at Organogenesis. "It's another large market. About 800,000 people have diabetic ulcers in the U.S., and it's conservatively estimated that over $1 billion is spent by the U.S. healthcare system for diabetic foot ulcers annually."
Organogenesis' stock (AMEX:ORG) closed Tuesday at $11.64, up 57.81 cents.
Novartis Pharma AG, of Basel, Switzerland, holds worldwide marketing rights for Apligraf in all indications. Organogenesis brought in $646,000, primarily from sales of Apligraf to Novartis, in the first quarter of 2000. For 1999, the company brought in $1.8 million in product sales.
Apligraf is supplied as a living, bi-layered skin substitute and is the only product containing living human skin cells to have proven efficacy and gained FDA approval, the company said. It is an all-natural product engineered from discarded foreskins of human infants and is made by culturing the cells in a three-dimensional culture system that yields the two layers of skin. Unlike human skin, Apligraf does not contain blood vessels, hair follicles or sweat glands. In May, an FDA panel endorsed the use of the product for diabetic foot ulcers under certain labeling conditions. (See BioWorld Today, May 9, 2000, p. 1.)
Hausner said Apligraf, specifically, is indicated for diabetic foot ulcers of greater than three weeks' duration that have not adequately responded to conventional therapy. Conventional therapy involves cleaning the wound and the dressing it with bandages. Some patients do not respond quickly to that kind of therapy, putting them at higher risk for amputations or infections.
"Up until the approval of Apligraf, there really wasn't a lot of choice for physicians," Hausner told BioWorld Today. "Sadly, there are over 50,000 amputations per year among diabetics, so this really gives physicians another option for treating diabetic foot ulcers."
In a pivotal trial, the use of Apligraf with standard care healed 56 percent of diabetic ulcers within 12 weeks, compared with 39 percent for standard care alone. Apligraf also healed the ulcers significantly faster. Average time to closure was 65 days among wounds treated with Apligraf, compared to 90 days for wounds treated using standard care alone.
The most recent approval is "essentially doubling the number of patients" and will treat a condition - the diabetic foot ulcer - that is associated with a more urgent concern than that of the venous leg ulcer, Hausner said. "Because of the risk in diabetic foot ulcers of amputation and infection, it tends to be a higher-profile type of wound," she said.
Organogenesis also plans to submit a PMA supplement within 15 to 18 months for a third use of Apligraf in reducing scarring after skin cancer surgery. A pivotal trial now is under way.
Aside from Apligraf, the company expects to begin pivotal trials with its second living product, the Vitrix dermal replacement, later this year.