EXTON, Pa., Nov. 2 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (Amex: AIS - News) today announced that at the 3rd annual meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH), on October 29, 2005, Dr. Daniel Shames, Director of The Division of Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA), updated the Agency’s guidelines for the development of testosterone products for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD).
Dr. Shames reported the FDA is pursuing what he himself calls a policy of “feasibility” that is, a level of study that can be accomplished affordably and in a timely manner. Importantly Dr. Shames stated that he agrees that testosterone is effective for HSDD and that the FDA is “not arguing about efficacy” of testosterone. Efficacy and some safety data will be required pre-marketing. Dr. Shames further stated that the FDA is willing to look at additional safety data provided “post marketing.” Dr. Shames indicated that he realizes that it is not economically feasible to complete a full safety database of information before marketing. In addition, he indicated that the FDA will consider supportive epidemiological data and surrogate endpoint information.
Dr. Shames also added that the guidance provided was a “special case” for testosterone use for FSD and that this condition and therapeutic approach has unique challenges that have to be tailored to find a correct “risk-benefit” ratio. Following his presentation, Dr. Shames expressed his concern about the amount of off-label use of male hypogonadism testosterone products in women. Further he feels that there needs to be a marketed and regulated option for FSD.
One of the later speakers during the testosterone symposium was Dr. Glenn Braunstein, Chair of the Department of Medicine at Cedars-Sinai Medical Center and Vice Chair of the Department of Medicine at the David Geffen School of Medicine at UCLA where he serves as Professor of Medicine and lead investigator for P&G in their Intrinsa(TM) testosterone patch studies. His presentation provided an overview of the safety data to date on testosterone use in women and noted that safety data indicated little or no safety concerns in all major areas including that for breast carcinoma there not only was no evidence of any increase but, in fact, testosterone use may be protective.
Jack E. Stover, President and CEO of Antares Pharma commented further, “We are extremely encouraged by the new guidelines provided by the FDA. With this information we believe that we can now proceed with confidence with our low dose testosterone Advanced Transdermal Gel (ATD(TM)), including our licensee’s LibiGel(TM) product. Additionally, we have also recently announced a licensee’s completion of a Phase III clinical study with our estradiol ATD(TM) gel, that is called Bio-E-Gel(TM) for hot flashes and vasomotor symptoms and filing of an NDA which is expected to take place during this quarter.”
About Antares Pharma
Antares Pharma is a specialized pharma product development company with patented drug delivery systems and injectable device engineering capabilities. Antares’ current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM) / Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, its product pipeline will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience.
Antares has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy. Its needle-free injector system is distributed in more than 30 countries for the administration of insulin and is marketed for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that it expects will form the basis of its specialized pharma program.
Antares Pharma has corporate headquarters in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially and which are identified from time to time in the Company’s reports filed with the U.S. Securities and Exchange Commission. Antares Pharma claims the protection of the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
For more information, please contact: Steve Chizzik / Ira Weingarten, Equity Communications; 973.912.0980 Jack E. Stover, President and CEO; 610.458.6200 Lawrence M. Christian, CFO and Vice President - Finance; 610.458.6200
Additional information is available online at http://www.antarespharma.com and http://www.mediject.com. Information included on the Company’s websites is not incorporated herein by reference or otherwise.
Source: Antares Pharma, Inc.