By Kim Coghill
Advanced Tissue Sciences Inc. (ATS) plans to launch its device designed to help prevent leg amputations in diabetics, within the next two weeks.
The FDA Monday notified ATS, along with marketing partner Smith & Nephew plc, that its premarket approval application for Dermagraft, a treatment for chronic foot ulcers in diabetic patients, was approved. The approval triggers a $5 million milestone payment from London-based Smith & Nephew.
Calling Dermagraft a significant product for the diabetes market, David Berish, a research analyst with SCO Financial Group Inc. in New York, said the device should generate about $7.5 million in its first year and, by 2006, it should reach $128 million.
¿This is an exciting day for Advanced Tissue Sciences after many years of developing this product,¿ Gail Naughton, president of La Jolla, Calif.-based ATS, told BioWorld Today. ¿It is particularly wonderful to know that Dermagraft is a product that can have an impact on diabetic patients and it will now be available to them. That¿s what we all care about, helping patients.¿
Dermagraft, a bioengineered, cryopreserved tissue, stimulates a foot ulcer to heal. The product consists of viable dermal fibroblasts cultured on a bioabsorbable scaffold that secretes vital matrix proteins, growth factors and glycosaminoglycans (a protein-polysaccharide complex needed for wound healing to occur).
¿What makes this product special is that it can be frozen and you can keep it for six months,¿ Doug Sowell, a podiatrist in Oklahoma City who conducted clinical trials, told BioWorld Today. ¿I don¿t know the company¿s trade secret, but I can tell you from my clinical experience, it heals diabetic wounds. I think it is going to make a big difference in people¿s lives because if we can preserve the limbs of diabetic patients, we can help them maintain a normal lifestyle and they will not be subjected to an above-the-knee or below-the-knee amputation.¿
Sowell said Dermagraft is applied to the ulcer weekly for about eight weeks. Within his clinic, Sowell said all of his 22 patients treated with Dermagraft were healed. ¿I had one patient with an exposed bone in a toe ¿ which is basically considered virtually impossible in the wound care-healing environment ¿ who was successful with Dermagraft. I¿ve been very excited about this product, and I¿ve been anxiously waiting to put it on a wider variety of people. Now that it is available, it is going to be a great asset to the treatment of diabetic foot wounds.¿
According to Sowell¿s figures, there are about 16 million people in the U.S. with diabetes, about 10 million of them who have been diagnosed. ¿About 15 percent [of the 10 million] will develop ulcers in their lifetimes. There are about 86,000 lower leg amputations for diabetic patients each year,¿ he said. ¿Amputation has significant societal and health care costs, and individually it can be devastating to the patient. People who have one leg amputated have the other leg amputated within three to five years.¿
Apligraf, a product of Novartis AG, of Basel, Switzerland, and Organogenesis Inc., of Canton, Mass., currently is used by physicians to treat foot ulcers. Sowell said Apligraf is not frozen and must be used upon receipt.
The journey to get Dermagraft to the market has not been without a bump or two.
It all seemed to start back in January 1998 when ATS, also the maker of TransCyte, a treatment for serious burns, entered a $111 million, 50-50 global joint venture with Smith & Nephew to commercialize Dermagraft. And later that month, in a 7-2 vote, the FDA¿s General and Plastic Surgery Devices Advisory Committee recommended approval of Dermagraft. (See BioWorld Today, Jan. 20, 1998, and Jan. 30, 1998.)
But the FDA issued a non-approvable letter in mid-1998 asking the company to conduct another randomized, multicenter clinical study. The move caused the company¿s stock to dive 44 percent to close at $3.938, down $3.125. (See BioWorld Today, June 15, 1998.)
The stock (NASDAQ:ATIS) gained 58 cents, or 16.3 percent, Monday to close at $4.13.
That final study reached statistical significance in the primary endpoint and was submitted for approval. The primary endpoint was complete wound closure within 12 weeks. Thirty percent of patients treated with Dermagraft healed compared to 18 percent of control patients. (See BioWorld Today, Aug. 28, 2000.)
Despite the earlier setbacks, Naughton said this has been an exciting year because the company has gone from having one product on the market to preparing for four. Aside from TransCyte, which Naughton said was used to treat burn victims of the terrorist attack on the Pentagon Sept. 11, two anti-wrinkle products will enter the market.
ATS and its partner, Inamed Corp., of Santa Barbara, Calif., already are generating revenue from a wrinkle-removing product that is in the FDA review process, and another anti-wrinkle product that contains NouriCel has been ¿soft-launched.¿
Meanwhile, Naughton said Dermagraft is in pivotal studies for people with venous ulcers (leg ulcers), in pilot clinical trials for periodontal disease and in late-stage animal studies for some heart repair applications.