BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced BioSante's receipt of Orphan Drug designation from the FDA's Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.
"The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October"
"The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante's president & CEO. "It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing better cancer therapy to patients in need. Currently, GVAX Pancreas Vaccine clinical trials are ongoing at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. In addition, clinical trials of GVAX vaccines against many different cancer types are being conducted, including leukemia and breast cancer. We value our collaborative relationship with the researchers at the Cancer Center and intend to work with them to advance the development of these potentially life-saving therapies."
Patients with pancreatic cancer have one of the poorest 5-year survival rates for any form of cancer. Median survival after diagnosis is around 3 to 6 months. Pancreatic cancer is sometimes called a "silent killer" because generally it does not cause symptoms, and when symptoms do arise, they are usually non-specific and varied. Consequently, pancreatic cancer often is not diagnosed until the disease is advanced. In view of this poor patient prognosis, the need for new, effective pancreatic cancer treatment regimens is urgent.
The ongoing GVAX Pancreas Vaccine trials are designed to determine the safety, overall survival and response to GVAX Pancreas Vaccine combined with various anti-cancer agents, as compared to those agents on their own or in combination with other agents.
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for a tax credit and seven years of marketing exclusivity of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition. The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and ElestrinTM (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-GelTM, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ: TEVA) and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLookTM), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery. In addition, BioSante will seek opportunities for its GVAX cancer immunotherapies, 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may" or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the possibility that early clinical results will not be repeated in larger scale clinical trials; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; BioSante's need for and ability to obtain additional financing; the effect of general business and economic conditions; and risks arising from BioSante's merger with Cell Genesys. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its registration statement on Form S-4 filed in connection with the merger with Cell Genesys and BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. The information set forth in this news release speaks only as of the date hereof, and BioSante undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.