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DECEMBER 21, 2009
Fibrocell Science, Inc.
Receives FDA Complete Response Letter Regarding azficel-T
for Wrinkles
EXTON, Pa., Dec. 21 -- Fibrocell Science, Inc. (OTC Bulletin
Board: FCSC) announced today that it has received a Complete
Response letter from the U.S. Food and Drug Administration
(FDA) related to the Biologics License Application (BLA) for
azficel-T, an autologous cell therapy for the treatment of
moderate to severe nasolabial fold wrinkles in adults. A
Complete Response letter is issued by the FDA's Center for
Biologics Evaluation and Research (CBER) when the review of
a file is completed and additional data are needed prior to
approval. The Complete Response letter requested that
Fibrocell Science provide data from a histopathological
study on biopsied tissue samples from patients following
injection of azficel-T. The letter also requested finalized
Chemistry, Manufacturing and Controls (CMC) information
regarding the manufacture of azficel-T as follow-up to
discussions that occurred during the BLA review period, as
well as revised policies and procedures regarding shipping
practices, and proposed labeling.
"We are pleased with the review and will
work closely with the FDA to complete the histopathology
study and provide all of the requested data as quickly as
possible," said Declan Daly, Fibrocell Science, Inc. interim
chief executive officer.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTC Bulletin Board:
FCSC) is a biotechnology company focused on the development
of regenerative cell therapy 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.
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 ability of the Company to complete
the histopathology study and provide to the FDA the
requested data on a timely basis. 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.
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