Keeping the platform focused on approval

Tight capital in the biotech sector means that companies often end up betting the ranch on one product. But the low odds of success in product development argue for a different strategy geared to spreading risk more broadly. The trick is to match limited funds to multiple product development.

One possible solution to the conundrum is being followed by Advanced Tissue Sciences Inc. ATIS has evolved a strategy that focuses on developing families of products to maximize the chances that one or more can get marketing approval. The strategy "provides built-in contingencies for the investor and a balanced product portfolio," said Arthur Benvenuto, chairman, president and CEO.

Speed to approval

The watchword at the San Diego company is balanced development of groups of similar products for multiple indications, with easier or harder clinical endpoints and different reimbursement profiles, and picking one product within each family for fast-track development.

"More than a worry about product failure, it's a question of not having any control over how fast they get through the regulatory process," said Gail Naughton, executive vice president and COO.

ATIS is developing a variety of living human tissue products for therapeutic applications. First in development is the Dermagraft family of products. There are five Dermagraft products for seven indications: Dermagraft-Burns for severe burns, Dermagraft-Ulcers for venous, diabetic and decubitus ulcers, Dermagraft-TC as a transitional covering for severe burns, Dermagraft-Epidermis for full thickness skin replacement, and Dermagraft-Injectable for cosmetic surgery and scar revision.

In burns, ATIS is fast-tracking Dermagraft-TC and in ulcers it plans to ask the FDA for expedited review in diabetic ulcers.

ATIS plans to roll out one new Dermagraft product every 12-18 months.