laVivTreatment for Wrinkles
FDA Accepts for Review Complete Response Submission for Azficel-T
Fibrocell Science, Inc. Announces FDA Accepts for Review Complete Response Submission for Azficel-T
EXTON, Pa.--(BUSINESS WIRE)--Jan 12, 2011 - Fibrocell Science, Inc., a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's complete response submission for azficel-T, proposed brand name laViv, for the treatment of moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date is June 22, 2011.
"We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process," said David Pernock, Fibrocell Science Chairman and CEO. "If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment."
The Fibrocell Science scientific approach results in a replenishment of the patient's own fibroblasts, the cells that are responsible for releasing collagen, elastin and hyaluronic acid which add strength and elasticity to the skin. The Company is planning to conduct studies on applying its autologous fibroblast technology in additional areas including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease.
About The Fibrocell Science Technology
Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
Fibrocell Science's lead therapy, azficel-T, is an investigational autologous (personalized) cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on the development of autologous (personalized) cell therapies 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. For additional information, please visit www.fibrocellscience.com.
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 include, without limitation, the future approval of azficel-T and the Company ability to conduct studies on applying its autologous fibroblast technology in additional areas, including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease . 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, 2009, 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.
Contact: Fibrocell Science, Inc.
David M. Pernock
President & CEO
Phone: (484) 713-6000
Posted: January 2011
- Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T) - June 22, 2011
- Fibrocell Science, Inc. Submits Complete Response to FDA Regarding Azficel-T - December 20, 2010
- Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles - December 22, 2009
- Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles - October 12, 2009
- Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review - May 12, 2009
- Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration - March 9, 2009