BioSante Pharmaceuticals Announces Novartis’ Successful Use of 2A/Furin Technology in Their Antibody Development Platform
LINCOLNSHIRE, Illinois (May 20, 2010) ) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that results of an evaluation of its 2A/Furin technology by Novartis Pharma AG in its industrial antibody CHO expression system were published in the Journal of Applied Microbiology & Biotechnology. The results demonstrate that the 2A/Furin technology was integrated successfully into a plasmid-based, industrial-scale, CHO antibody cell line development process, with minimal optimization required. Use of 2A/Furin could enhance further the distribution of high- expressing clones, improve the average productivity of clones, while also improving the stability of high producer cell lines generated using this animal-free CHO antibody development platform.
“We are pleased by the results published by Novartis,” said Stephen M. Simes, president & CEO of BioSante. “These results are third party-generated support for the value of our 2A/Furin technology. Our objective with this technology is to maximize its value to our stockholders. To this end, on April 26, 2010, we announced entering 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, and we continue to work toward additional non-exclusive licenses. 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 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: biosantepharma.cdmail.biz.
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.
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