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A subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is the licensee for our testosterone gel for the treatment of male hypogonadism or low testosterone levels. The testosterone gel for men was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all of the testosterone gel for men regulatory and marketing activities.
An NDA for our testosterone gel for men was approved by the FDA on February 14, 2012. BioSante has received $3.75 million in upfront and milestone payments to date and will receive royalties upon commercialization. The current U.S. market for male testosterone products is over $1.6 billion
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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.
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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.
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