...10 years ago. Since then has gone through phase III and not pursued for FDA approval or licensing to big pharma. If the only hurdle to move this forward was to renegotiate the deal with former Biosyn/Cellegy shareholders, why wasn't this done?
FDA Grants Fast-Track Designation for 1.0% C31G Vaginal Gel for the Reduction of HIV Transmission
November 17, 2003
HUNTINGDON VALLEY, Pa. -- Biosyn, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted fast-track designation for the development program of 1.0 percent C31G vaginal gel for the reduction of HIV transmission. In granting the fast-track designation, the FDA recognized that HIV infection is a serious and life-threatening condition, there is an unmet need for a female controlled method to reduce the sexual transmission of HIV and 1.0 percent C31G has the potential to address this unmet medical need.
"We have worked closely with the FDA on the clinical path for this candidate since it is an important product for the prevention of sexual transmission of HIV," said Anne-Marie Corner, President & CEO of Biosyn. "The fast track designation will help accelerate our development of C31G vaginal gel."
Fast-track programs are designed to facilitate the development and expedite the review of new drug candidates that are intended to prevent or treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Biosyn's lead product candidate, 1.0 percent C31G vaginal gel is entering Phase III clinical trials. Planned studies include prevention of transmission of HIV, prevention of transmission of chlamydia and contraception.
Why was it not seeked ? Also out of memory ,Wyatt ,u might also remember ,the rich family that owned majority of the company stock and sat on the board elected to do just what happened to Celegy. They owned about 16 million shares.
NOW you see some of all our frustration with this company. AMAZING opportunity just sitting on a dusty shelf for YEARS marking time!!! With all my conversations with the past management (and new) and many face to face, I know of no big agreement to keep this from becoming a profitable viable product. I was told it would cost about $10 million to launch alone, but there could be many partnerships created to spread the risk and make a better impact with the product. WHO wouldn't want a birth control with ZERO SIDE EFFECTS, LAST up to 6 hours, AND protects you from most STD'S and all for peanuts in cost???? What a shame to see this sit marking time in a world that needs this type of product yesterday! Social Media could spread the word about this product all around the world in ONE WEEK with internet sales to eliminate the middleman and get the product to the people at a remarkable value to everyone. THIS IS A WIN-WIN product.
wyatt, there is a past agreement that seems to be the problem. from their last 10K filing...
"Before considering any actions to seek regulatory approval for a C31G product, further meetings with the FDA would likely be required to discuss the regulatory pathways for submitting an NDA for marketing approval, including whether any additional trials will be required before an NDA is submitted. In considering commercialization alternatives, we will likely seek to enter into an out-licensing or similar transaction with organizations that have a focus or business unit in the area of contraception. The C31G product candidate is held by our Biosyn, Inc. subsidiary and was acquired in 2004 with Cellegy’s acquisition of Biosyn. Provisions in the acquisition agreement between Biosyn and Cellegy, and in certain of the funding agreements and other agreements relating to the C31G product, provide for payments to the former Biosyn shareholders upon marketing approval by the FDA (or, in certain circumstances, certain foreign regulatory authorities) of C31G for one or more indications and payments to certain other third parties in the event of sales or other revenues relating to C31G or certain other events. In addition, sale or out-licensing of the C31G product candidate may require the consent of one or more such third parties. As a result, commercialization of the product may require renegotiation of the provisions relating to the former Biosyn shareholders and such third parties. Accordingly, there can be no assurances that we will be able to successfully conclude a transaction involving C31G or concerning the amounts that we might receive from any such transaction, or that any C31G product will be submitted for regulatory approval or will be approved or marketed."