Partners & Licensees
|A subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is the licensee for Bio-T-Gel™ (testosterone gel) for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel™ was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel™ regulatory and marketing activities.
An NDA for Bio-T-Gel™ is pending with the FDA and has a PDUFA date of February 14, 2012. BioSante received $1.5 million upfront on signing the license agreement and will receive royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion
|Azur Pharma International II Limited is marketing Elestrin in the U.S. using its women's health sales force that targets estrogen prescribing physicians in the U.S. comprised mostly of gynecologists. In December 2009, we entered into an amendment to our original licensing agreement with Azur which permanently reduced the royalty percentage due to us related to Azur's sales of Elestrin, for this Azur has paid us $3.16 million. We maintain the right to receive up to $140 million in sales-based milestone payments from Azur if Elestrin reaches certain predefined sales per calendar year.|
|In July 2011, BioSante signed an exclusive worldwide license to its Melanoma Vaccine with The John P. Hussman Foundation.
The Hussman Foundation has committed up to approximately $11M to fund melanoma clinical trials at Johns Hopkins University, the first of which is planned to begin in the second half of 2011. BioSante received an upfront payment of $100,000 and is eligible for up to $39M in milestones plus a royalty on commercial sales. BioSante also will receive between 15 and 33 percent of any sublicense payments made to the Foundation depending on the timing of a sublicense to a corporate partner.
The Hussman Foundation is a charitable foundation seeking 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.
A BioSante melanoma vaccine clinical trial was initiated in the third quarter of 2011.
|BioSante’s Pancreas Cancer Vaccine and Prostate Cancer Vaccine have been licensed to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes (Lm).
BioSante will receive milestone and royalty payments after commercialization of combination cancer vaccines using BioSante's cancer vaccine technology. Aduro also has an option to additional BioSante Cancer Vaccine indications, all for use in combination with Aduro's proprietary vaccine platform.
Aduro initiated a Phase II trial in the third quarter of 2011 which will enroll 90 late-stage pancreatic cancer patients, using a novel sequential vaccine regimen of BioSante's Pancrease Cancer Vaccine and CRS-207.
|In November 2010, BioSante sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology. The technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer. In exchange for the technology, BioSante received a 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments.
Cold Genesys, Inc is a specialty pharmaceutical company that focuses on fulfilling unmet medical needs in cancer treatment with a present emphasis on bladder cancer. Based in Newport Beach, California, Cold Genesys is a privately funded, early-stage company anticipating global development of its technology.
|In May 2007, BioSante signed an exclusive agreement with Pantarhei Bioscience B.V. for the development and marketing of an oral contraceptive, The Pill-Plus™ in the United States. BioSante will co-fund the early development of The Pill-Plus, up to $1.0 million while Pantarhei will be responsible for all other expenses to develop and market the product. In addition to receiving $1.0 million upfront, BioSante will be eligible to receive certain development and regulatory milestone payments, along with royalty payments on the sales of The Pill-Plus in the U.S. Further, if the product is sublicensed by Pantarhei to another company, BioSante will receive a percentage of any and all payments received by Pantarhei from a third party.|