BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the receipt of two US patents directed to its 2A/Furin technology for expressing proteins. The first issued US patent, US Pat. No., 7,632,059, covers methods for manufacturing recombinant antibodies. By incorporating our 2A/Furin technology into antibody-expression in viral vectors it is possible to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of commercial antibody production. The second issued US patent, US Pat. No. 7,662,623 covers antibody expressing constructs containing the 2A/furin technology and builds on already issued patents covering vectors and methods for producing antibodies in vivo and in vitro. The two new patents expire in 2023. “We are pleased to receive these two new patents. These patents are the third and fourth issued patents in our patent estate covering our 2A/Furin technology and add patent protection for an additional manufacturing technology for quickly generating antibody producing cell lines. Additional patent applications are pending in the United States and outside the United States,” said Stephen M. Simes, president & CEO of BioSante. “Our objective with this technology is to maximize its value to our stockholders in the shortest time possible. We are in discussion with interested parties who may seek a license to or acquisition of this exciting technology. The market for antibody products in 2008 was approximately $31 billion and growing.” 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, 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 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 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. 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. 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 “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 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.