BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has entered into an Option Agreement with an undisclosed large multi-national pharmaceutical company to obtain a non-exclusive worldwide license for the use of BioSante’s 2A/Furin technology in the expression of antibodies. The technology is covered by four issued U.S. patents incorporating BioSante’s 2A/Furin technology into antibody expression in viral vectors in order to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of antibody production compared to current commercial technologies. Financial terms of the Option Agreement were not disclosed. The option period will last up to six months, at which time the multi-national pharmaceutical company may exercise its option to enter into a non-exclusive license for the use of BioSante’s 2A/Furin technology. “The market for antibody products was approximately $31 billion in 2008 and growing," said Stephen M. Simes, president and chief executive officer of BioSante. “This agreement is very exciting for BioSante, as it acknowledges the pharmaceutical industry’s interest in our 2A/Furin technology for its potential use in manufacturing antibodies. Perhaps as important, it reconfirms our commitment to maximize the value of this technology to our stockholders, through potentially multiple non-exclusive licenses. We continue our discussions with other interested parties who may seek a license or other transaction related to this exciting antibody technology.” The 2A/Furin technology rapidly generates cell lines that express levels of antibodies suitable for commercial production in a matter of weeks, compared to months for current techniques, which gives the potential to dramatically reduce the costs required to generate commercial antibodies. This technology allows for high-level, equimolar expression of two coding sequences using a single promoter that is applicable for generating expression vectors for in vivo gene therapy applications, pre-clinical target validation and lead identification as well as to rapidly generate high producer antibody cell lines that produce, in vitro, high levels of mature antibody without requiring any amplification currently employed in antibody expression systems.
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 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 “may,” “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” 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 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 most recent annual report on Form 10-K . 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.