Isolagen TherapyTreatment for Wrinkle Correction
BLA Submitted for Isolagen Therapy
Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
EXTON, Pa., March 09, 2009 /PRNewswire-FirstCall/ -- Isolagen, Inc. today announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy, 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, 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."
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.
Isolagen, Inc. 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.
Posted: March 2009
- Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review - May 12, 2009