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.
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