Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
May 08 2009 - 9:00AM
PR Newswire (US)
EXTON, Pa., May 8 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc.
(NYSE Amex: ILE) today announced that the United States Food and
Drug Administration ("FDA") has completed its initial review of the
Company's Biologics License Application ("BLA") related to its
Nasolabial Fold/Wrinkles product candidate and that the FDA has
accepted (or filed) the BLA for full review. In a communication
received from the FDA on May 7, 2009, the FDA noted that it had
completed its initial review of the Company's BLA to determine its
acceptability for filing and that the FDA has filed the Company's
application. The FDA noted that its review completion target date
is January 4, 2010. The FDA's filing review is only a preliminary
review, and deficiencies may be identified during full review of
the BLA. Also, the acknowledgment of filing by the FDA does not
mean that the FDA has issued a license, nor did the FDA represent
any evaluation of the adequacy of the data submitted. About
Isolagen, Inc. Isolagen(TM), Inc. (NYSE Amex: ILE) is an aesthetic
and therapeutic company committed to developing and commercializing
scientific advances and innovative technologies. The company's
technology platform includes the Isolagen Process(TM), a cell
processing system for skin and tissue rejuvenation which is
currently in clinical development for a broad range of aesthetic
and therapeutic potential applications including wrinkles, acne
scars, burns and periodontal disease. Isolagen also commercializes
a scientifically-advanced line of skincare systems through its
majority-owned subsidiary, Agera(R) Laboratories, Inc. For
additional information, please visit http://www.isolagen.com/.
Isolagen Forward Looking Statements All statements in this news
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
FDA's review completion target date and the Company's ability to
obtain license approval from the FDA with respect to its Nasolabial
Fold/Wrinkles product candidate in the timeframe discussed above,
if at all. 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 our
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. We operate 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. We
disclaim any intention to, and undertake 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 Annual Report on Form 10-K for the year ended December
31, 2008, as well as other public filings with the SEC since such
date. DATASOURCE: Isolagen, Inc. CONTACT: Mike Beyer,
+1-773-463-4211, Web Site: http://www.isolagen.com/
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