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Fibrocell Plans Slow Launch of New Wrinkle Drug

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The small-cap company faces capital-raising challenges after FDA approval of smile-line treatment.

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When a drug company gets the green light to market its new product in the US, there's usually a big sales push planned. Fibrocell Science, which just got Food and Drug Administration approval to sell its wrinkle treatment LaViv, has a much slower growth plan.

The reason for the slow pace is the company doesn't have a whole lot of money or a deep-pocketed partner to help ramp up production and sales. Exton, Pennsylvania-based Fibrocell is held back by its own inability to make enough product. And it needs to raise some more money.

"It's a trot -- not a sprint in the first year," says CEO David Pernock, a former GlaxoSmithKline (GSK) executive who joined the company last year.

What the small-cap company has is an interesting science behind its first approved drug. Fibrocell will extract cells from patients to produce a personalized treatment that is injected into the area of the wrinkles. On Wednesday, Fibrocell won FDA approval to sell LaViv as a treatment for smile lines, technically known as nasolabial fold wrinkles. The company also is studying the drug to treat acne and burn scars.

Long term, the company could generate $500 million in sales from LaViv for smile lines and acne scars, Pernock predicts.

That goal, of course, is contingent on winning approval for acne treatment and it assumes LaViv will take off as a product. Fibrocell is going up against established players such as Botox maker Allergan (AGN) and Medicis Pharmaceutical (MRX), which sells Restylane injectable gels.

Pernock is counting on LaViv attracting people who want an alternative to the existing treatments and he calls his product a more natural way to treat wrinkles since the patient's own skin cells are being used. But LaViv isn't a quick trip to the doctor's office for a one-time shot (like Botox). The LaViv treatment takes three months to complete.
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