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Press Release - BioSnate Pharmaceuticals, Inc. (BPAX-NASDAQ)
BioSante is a product development company. From the beginning, we have had our eye on women’s sexual health. Right now, we are developing a product, LibiGel®, for the treatment of female sexual dysfunction for which there is no product approved in the United States. We believe this represents a blockbuster opportunity. - Stephen M. Simes (BPAX) (Interview published March 11, 2011)
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BioSante Pharmaceuticals Signs Melanoma Vaccine License
LINCOLNSHIRE, Illinois (July 21, 2011) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced an exclusive worldwide license of its Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities. BioSante received $100,000 on signing the license and is eligible for up to $39 million in milestone payments, plus royalties on sales. Additionally, the Hussman Foundation has committed up to approximately $11 million in Melanoma Vaccine clinical development funding. Also, BioSante will receive between 15 and 33 percent of any sublicense payments received by the Hussman Foundation depending on the timing of any sublicense by the Foundation to a corporate sub-licensee.
BioSante's Melanoma Vaccine is one of a portfolio of BioSante cancer vaccines in development including vaccines for leukemia, breast and pancreatic cancer. BioSante's Melanoma Vaccine was granted Orphan Drug designation by the FDA earlier this year.
"We are excited by the Melanoma Vaccine license with the Hussman Foundation since the Foundation's funding will allow for the first human clinical trial of our Melanoma Vaccine," said Stephen M. Simes, BioSante's president & CEO. "Importantly, the Foundation intends to move rapidly into human clinical trials. Assuming a successful outcome of the first Phase I clinical trial, the Foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence and engaging a corporate sponsor for Phase III clinical trials."
"We at the Hussman Foundation have very personal family reasons for wanting to fund work in melanoma research," said John P. Hussman, PhD, director of the Hussman Foundation. "In our ongoing partnership with leading melanoma and cancer specialists, we are increasingly encouraged that targeting the immune system using BioSante's cancer vaccine may be a viable treatment approach for this most immunogenic of cancers. We chose to license and fund BioSante's Melanoma Vaccine based on its potential to enhance the effective treatment options that are available to melanoma patients in need," Dr. Hussman added.
The first Phase I clinical trial of the Melanoma Vaccine is expected to begin within the next several months. The clinical trial protocol is being finalized at this time and Melanoma Vaccine has been produced for the trial.
About the Hussman Foundation
The mission of the John P. Hussman Foundation is to provide life-changing assistance through medical research, education, and direct aid to vulnerable individuals having urgent needs or significant disabilities. The Hussman Foundation seeks to "tip the balance" in critical areas where research or intervention can significantly alter the course of individual lives, and where resources would otherwise not be available. Additional information is available online at: www.hussmanfoundation.org.
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) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel&, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at:
For more information, please contact:
phone: (312) 506-5220
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Phone: (646) 378-2953
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, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words 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 report 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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