Fibrocell Science, Inc. Reports Outcome Of FDA Advisory Committee Meeting On Azfibrocel-T For Wrinkles

Main Category: Dermatology
Also Included In: Seniors / Aging;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 10 Oct 2009 - 1:00 PDT

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Fibrocell Science, Inc. (OTCBB: FCSC) announced that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication. The FDA is currently evaluating the USAN name, azfibrocel-T, and a proposed brand name, Laviv(TM).

"We will continue to work closely with the FDA following the discussions and recommendations from today's Advisory Committee meeting," said Declan Daly, Fibrocell Science, Inc. interim chief executive officer.

Although it is not binding, the Committee's recommendation will be considered by the FDA as the agency completes its review of the BLA for azfibrocel-T, which was originally filed in March 2009. The FDA is expected to make a decision whether to approve Fibrocell's biologics license application (BLA) for azfibrocel-T by January 4, 2010.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence.

Forward Looking Statements

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, without limitation, the timeliness of the target date for FDA response of January 4, 2010. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.

Source: Fibrocell Science, Inc