BioSante Pharmaceuticals Receives Two New Patents for Manufacture of Proteins, Including Antibodies
Patents Subject to Recent Option Agreement
LINCOLNSHIRE, Illinois (May 17, 2010) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the receipt of two US new patents directed to its 2A/Furin technology for expressing proteins. The first issued US patent, US Pat. No., 7,709,224, 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. 7,714,199 covers additional adeno-associated virus (AAV) vectors containing the 2A/furin technology and methods for expressing antibodies in vivo using these vectors 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 fifth and six 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 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. 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. 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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