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 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.
SOURCE Isolagen, Inc.
CONTACT:
Mike Beyer
+1-773-463-4211
beyer@sambrown.com
