Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
March 09 2009 - 9:00AM
PR Newswire (US)
EXTON, Pa., March 9 /PRNewswire-FirstCall/ -- Isolagen, Inc.
(AMEX:ILE) today announced that the Company has submitted a
Biologics License Application (BLA) for Isolagen Therapy(TM), a
novel, first-in-class cellular therapy for the treatment of
wrinkles/nasolabial folds, to the U.S. Food and Drug Administration
(FDA). The Company's wrinkles/nasolabial folds Phase III trials
were conducted under an FDA Special Protocol Assessment. "This BLA
submission is a significant regulatory milestone for Isolagen,"
said Declan Daly, Chief Executive Officer and President of
Isolagen. "We believe that the Isolagen Therapy(TM), if approved,
would represent a new class of treatment in the facial aesthetic
arena whereby patients will receive their own cells to repair the
skin. We look forward to working with the FDA as it reviews our
application. I am extremely proud of our employees and their
efforts in accomplishing this significant goal for the Company.
Further, I would like to recognize and extend my appreciation to
our investigators and our regulatory and clinical advisors for all
of their dedicated efforts." Mr. Daly continued, "In addition to
submitting our first BLA to the FDA, the Company has recently
completed its Phase II/III trial for the treatment of acne scars
with statistically significant efficacy results. I believe Isolagen
represents a platform technology with an extensive pipeline of
potential indications, such as the treatment of wrinkles, acne
scars, burn scars and stretch marks. The Company is actively
pursuing financing and/or strategic partnerships." Update Regarding
the Company's Cash Position Isolagen currently estimates that its
unrestricted, available cash resources will allow the Company to
continue in operation for approximately three weeks. The Company
continues to pursue potential financing alternatives and potential
strategic partnership discussions. However, there can be no
assurance that any such potential financing alternative will be
completed on terms acceptable to the Company, or successfully
completed at all. Further, there can be no assurance that any
potential strategic partnership discussions will be completed on
terms acceptable to the Company, or completed at all. If the
Company does not obtain additional funding, or anticipate
additional funding in the very near future, the Company may enter
into bankruptcy, and possibly cease operations. In addition, as
previously disclosed, the Company currently has a debt liability of
approximately $89.7 million related to its 3.5% subordinated notes,
which could be called due, at the option of the note holders, as
early as November 2009. Interest on the notes is due semiannually
on May 1 and November 1. Further, the Company is pursuing the
potential sale of its 57% ownership interest in Agera Laboratories,
Inc. There can be no assurance that a sale of this ownership
interest will be completed on terms acceptable to the Company, or
successfully completed at all. About Isolagen, Inc. Isolagen(TM),
Inc. (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 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. Such statements
include, without limitation, the Company's ability to complete any
financings or enter into any strategic partnership or sell its
ownership interest in Agera Laboratories, Inc. 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, 2007, as
updated in "Item 1A. Risk Factors" in the Company's Quarterly
Reports on Form 10-Q. 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, 2007, as well as other public filings with the SEC since such
date. DATASOURCE: Isolagen, Inc. CONTACT: Mike Beyer, Sam Brown
Inc., +1-773-463-4211, Web Site: http://www.isolagen.com/
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