BioSante Pharmaceuticals, Inc. (AMEX:BPA) today announced that BioSante has been awarded a subcontract valued at $250,000 for the development of recombinant Factor IX (FIX) formulations for delivery via alternative routes of administration. The subcontract was awarded to BioSante by the University of Nebraska-Lincoln as part of their five year $10M grant entitled "cGMP Recombinant FIX for IV and Oral Hemophilia B Therapy" from the National Institutes of Health (NIH). This subcontract leverages BioSante's expertise in alternative routes of drug administration, specifically oral, buccal, and pulmonary administration using its proprietary CaP BioOral(TM) and BioAir(TM) technologies. The University of Nebraska-Lincoln has received approval for a five year grant totaling $10M. The current subcontract with BioSante is for the first year of the grant, and if warranted, BioSante can apply to renew the subcontract in subsequent years with a total possible value to BioSante of $1.25M over five years. "This subcontract is further validation for our CaP program, and allows us another avenue to use CaP to develop alternative treatment options for a life-threatening disease" said Stephen M. Simes president and chief executive officer of BioSante. Hemophilia B (Christmas disease) is a rare, potentially life threatening, congenital bleeding disorder resulting from a defect or deficiency in blood coagulation factor IX. Currently the only way to administer FIX is through intravenous injection. "We are looking forward to working with the University of Nebraska-Lincoln to find a more convenient and accessible therapy for people with this disease, and hope to continue with the University for years to come" said Mr. Simes. About BioSante Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante's lead products include Bio-E-Gel(TM) (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(TM) (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma Inc. BioSante also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at: www.biosantepharma.com. About the University of Nebraska Founded in 1869, the University of Nebraska-Lincoln is the state's land-grant university and the only comprehensive university in Nebraska. Through its three primary missions of learning, discovery and engagement, UNL is Nebraska's intellectual center. UNL is one of a select group of research universities that holds membership in the Association of American Universities - a distinction granted in 1909. Nebraska was the first university west of the Mississippi to establish a graduate college; today, UNL is one of the top 50 American universities in the number of doctoral degrees granted annually. UNL's project team is led by chemical engineer William Velander, and includes scientists from three universities and two private entities. Velander is a professor and chairman of the department of chemical engineering at UNL and holds the Donald R. Voelte Jr. and Nancy A. Keegan Endowed Chair in Engineering. He has been working on safer and more abundant sources of plasma-derived medicines since 1987, when disease contamination of blood supply medicines by HIV and Hepatitis B and C reached a worldwide epidemic. Velander's work on using this technology to promote hemophilia treatment in developing countries in Latin America has been embraced by the World Federation of Hemophilia, an international nonprofit organization. His work with transgenic animals has earned worldwide acclaim. This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this press release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed on pages 22 to 34 of BioSante's most recent Form 10-Q, which discussion also is incorporated herein by reference. All forward-looking statements 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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