In a little more than a week from now, on June 22, to be more precise, aesthetic and therapeutic company Fibrocell Science Inc. (FCSC.OB) will know whether or not its investigational therapy to cure wrinkles - Azficel-T, will get the green signal from the US regulatory agency.
Azficel-T, Fibrocell's lead product candidate, is a fibroblast cell suspension prepared from the patient's own skin, for the proposed treatment of moderate to severe nasolabial fold wrinkles in patients older than 18 years of age. Fibroblast is a kind of cell that is capable of producing collagen. The loss of collagen causes skin to sag and droop.
For readers who are new to Fibrocell Science, here's a brief overview...
The Exton, Pennsylvania-based company emerged from bankruptcy in September 2009 and continues to operate as a going concern. The company's patented fibrocell therapy involves extraction of a patient's own natural fibroblasts, which are multiplied, purified, cryopreserved and re-injected.
Fibrocell's Biologics License Application for Azficel-T, which was accepted for filing by the regulatory agency in May 2009, faced the FDA Cellular, Tissue and Gene Therapies Advisory Committee in October of that year. The Committee voted 11 to 3 in favor of the drug's efficacy and 6 to 8 against its safety for the proposed indication of treatment of nasolabial folds/wrinkles.
When the D-day - on which the FDA was to announce its final decision on Azficel-T , came it was a disappointment for Fibrocell. On December 21, 2009, Fibrocell Science was issued a Complete Response letter for Azficel-T.
In its Complete Response letter, the FDA requested Fibrocell to provide data from a histopathological study on biopsied tissue samples from patients following injection of Azficel-T. The company was also required to provide finalized Chemistry, Manufacturing and Controls information regarding the manufacture of Azficel-T.
A year later, on December 20, 2010, Fibrocell submitted its complete response to the FDA related to the Azficel-T application.
On January 22, 2011, the FDA accepted for review the resubmitted BLA and assigned a decision date of June 22.
If approved, Azficel-T, with the proposed brand name LaViv, will be the first and only personalized cell-based aesthetic treatment, according to the company.
The aging of the "baby boomer" population, the desire of many individuals to improve their appearance and the broadening base of the practitioners performing cosmetic procedures beyond dermatologists and plastic surgeons to non-traditional providers are some of the factors driving the aesthetic procedure market. Americans reportedly spent nearly $10.7 billion on cosmetic procedures in 2010.
According to the American Society for Aesthetic Plastic Surgery, or ASAPS for short, there were almost 10 million surgical and nonsurgical cosmetic procedures performed in the United States in 2010, a decline of 6.3% from 2009. Surgical procedures accounted for 17 percent of the total while nonsurgical procedures accounted for a major chunk of 83 percent.
Upon approval, Azficel-T faces direct competition from silicone injections, laser procedures, facial surgical procedures, such as facelifts and eyelid surgeries, fat injections, dermabrasion, collagen, allogenic cell therapies, hyaluronic acid injections and Botulinum toxin injections, and other dermal fillers. Indirect competition comes from facial care treatment products like facial scrubs, anti-aging treatments, tonics, astringents and skin-restoration formulas.
In addition to wrinkle correction, Fibrocell therapy is also evaluated in treating acne scars and burn scars. The company obtained statistically significant results in a phase II/III acne scar clinical trial in 2009 and a phase II open label full face rejuvenation study in 2008. Fibrocell also has results in early burn scars and periodontal disease studies.
A quick look at the company's beleaguered balance sheet...
As of May 9, 2011, Fibrocell had cash and cash equivalents of about $2.0 million and current liabilities of approximately $1.1 million. The company's current monthly cash run-rate is roughly $1.0 million, according to a recent SEC filing. The Annual Meeting of Stockholders is slated to be held on June 15.
Will Azficel-T pass the FDA muster? What will be the next step taken by Fibrocell, which has a going concern problem, in the event of the wrinkle therapy getting either approved or rejected? Stay tuned...
FCSC.OB has thus far hit a 52-week low of $0.39 and a 52-week high of $1.42. The stock closed Friday's trading at $1.07, down 1.83% on a volume of 519 thousand shares.
Updated on June 22, 2011
The FDA approved Fibrocell Science Inc.'s (FCSC.OB) laVív, on June 22, for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. laVív becomes the first and only personalized aesthetic cell therapy to be approved by the FDA.
The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person's own skin cells (fibroblasts) to create laVív, which is then injected into the patient to improve the appearance of smile lines.
In order to further evaluate the safety of the autologous cell therapy and as part of a post marketing requirement, Fibrocell will establish a registry of about 2,700 patients. laVív is expected to be available soon through trained clinical investigators in select metropolitan areas.
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