Fibrocell has FDA action date in June
That’s a question Fibrocell Science (OTCBB:FCSC) hopes to answer later this year. The FDA has set June 22 as the action date to decide on the company’s application for approval of its laViv treatment of moderate to severe nasolabial folds and wrinkles.
“Those are the classic folds that you see as we age,” Chairman and CEO David Pernock says in an exclusive interview with BioTuesdays.com, referring to the folds that appear from the tip of the nose down to the corner of the mouth and from the corner of the mouth down to the chin. “If approved, laViv will be the first and only personalized cell-based aesthetic treatment,” he adds.
Fibrocell’s scientific approach involves taking a small sample of cells from behind the ear of a patient and sending the sample to the company’s lab, where a proprietary manufacturing process expands the fibroblast cells from the sample into tens of millions of new purified cells in 90 days. Fibroblasts are the cells responsible for releasing collagen, elastin and hyaluronic acid, which add strength and elasticity to the skin.
A portion of the cells are returned to the physician, and the remainder is frozen for use in later treatments. Physicians reinject the cells into patients in three sessions over a 12-week period, and results are visible by the time of the third procedure. The company holds nine U.S. and 28 foreign patents on its IP.
“Our product is biologic, so we attack the problem biologically. This means that more of patients’ own fibroblast cells can be added to the skin for improved wrinkle appearance for a long-lasting affect,” Mr. Pernock says. “What we will do is to help activate skin fibroblasts and extracellular matrix synthesis.”
If the FDA clears laViv at the end of June, Fibrocell will be entering and expanding the $1 billion annual market in injectable aesthetics.
“We think we’re going to compete effectively in the marketplace,” he says. “We will be the first and only personalized product available in the market and the first and only cellular-based product approved in the U.S. for aesthetics.”
Fibrocell hopes to reach women and men looking to improve their appearance through less invasive and more natural procedures.
It has segmented the consumer market into three categories. What it calls “fighters” are people showing signs of aging that may have a regular routine with their dermatologist or plastic surgeon. A second category is “time-freezers” or younger people who want to preserve their look as long as they can. And finally, there are “refreshers”, who occasionally see their physician to have something extra done for their appearance.
Mr. Pernock figures laViv would appeal to “fighters” to complement what they are currently doing, while “time-freezers” may want to use laViv sooner rather than later because of the natural look it produces. “We think this is going to be a good segment for us.”
Fibrocell is also developing a personalized skincare cream. At the end of the manufacturing process to generate new fibroblast cells for reinjection, the company retrieves each patient’s growth media from the fibroblasts that contain the naturally derived components, such as collagen and growth factors, to be added to a luxurious skin cream.
The company plans to register, what it is calling, “U Personalized Skincare Cream” as a cosmetic with the FDA, targeting the second half of this year for its launch. The cream will be available only through physicians.
Last November, Fibrocell teamed up with China’s Hefei Meifu Bio-Tech in a joint venture to market its fibroblast therapies in Asia, excluding Japan. “The health and beauty segment in China is a rapidly growing segment of the economy,” Mr. Pernock points out. “The fact that this is a natural product has a lot of appeal in the eastern part of the world.”
Fibrocell is contributing the IP and the manufacturing know-how to the joint venture. Plant construction is scheduled to start in April and take six to eight months to complete. The company hopes to launch in China in 2012.
“I think Brazil is another market similar to China, with a booming economy and a high acceptance of aesthetic and natural products,” Mr. Pernock says, adding that the number of injectables procedures done in Brazil rivals those done in the U.S. “Our plan is to pursue partnerships in Brazil.”
Mr. Pernock says FDA approval of laViv would set the stage for a development program in aesthetics, including other areas of the face and the décolletage of the upper chest area. The company is also planning to advance its technology beyond facial wrinkles to treat acne, vocal cord and burn scarring. Another opportunity is periodontal disease, in which the company is hoping to do a partnership to enable the development program.
In 2007, the company evaluated 109 individuals with acne scars at seven U.S. clinical sites in a Phase 2/3 study, reporting statistically significant efficacy and safety in treating moderate to severe acne scars. Mr. Pernock says the company plans to meet with the FDA for direction in what would be needed for regulatory approval.