BioSante Announces FDA Orphan Drug Designation for GVAX Chronic Myeloid Leukemia Cancer Vaccine
LINCOLNSHIRE, Illinois (June 7, 2010) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA's Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.
"The orphan drug designation for the GVAX CML Vaccine resulted from BioSante's third GVAX regulatory submission since acquiring this portfolio of cancer vaccines in October 2009. This is the third orphan drug designation for BioSante; the company also has received orphan drug designations for its vaccines to treat pancreatic cancer and acute myeloid leukemia.
"We continue to develop our vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center," said Stephen M. Simes, president and chief executive officer of BioSante. "Clinical trials of GVAX cancer vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. In addition, we recently announced reinitiation of the GVAX Prostate cancer vaccine program."
As previously reported, in a clinical study, the GVAX CML vaccine was administered to 19 CML patients with measurable cancer cells, despite taking Gleevec® for at least one year (range of 13-53 months). Each patient was given a series of four vaccines administered in three-week intervals while remaining on a stable dose of Gleevec. After a median of 72 months of follow-up, the number of remaining cancer cells declined in 13 patients, eight of whom had increasing disease burden before vaccination. Twelve patients reached their lowest levels of residual cancer cells to date following vaccination. Seven CML patients had complete remission. Patients receiving the GVAX CML vaccine experienced relatively few side effects that included injection site pain and swelling, occasional muscle aches and mild fevers.
The study was conducted by researchers at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, led by Hyam Levitsky, M.D., professor of oncology, medicine and urology at the Cancer Center. The research was funded by the National Institutes of Health.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. 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 Elestrin™ (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 is a portfolio of cancer vaccines (GVAX), two of which have been granted orphan drug designation, currently in several Phase II clinical trials, at minimal cost to BioSante. Other products in development are Bio-T-Gel™, 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 (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates, " "may," other words of similar meaning or the use of future dates. 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 marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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 most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information please contact:
Harris D. McKinney, Inc.
For information about participating in the LibiGel clinical studies call or visit the following:
877- BLOOM81 www.bloomstudy.com