Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles...

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Mon Mar 9, 2009 9:01am EDT

Isolagen, Inc. Submits Biologics License Application for the Treatment of
Wrinkles to the U.S. Food and Drug Administration

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 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.


SOURCE  Isolagen, Inc.

Mike Beyer, Sam Brown Inc., +1-773-463-4211, beyer@sambrown.com
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