Halozyme Partners with Pfizer, Venaxiz Seeks CE Mark for APPY1: Healthcare Business Recap
On Friday, Transcept Pharmaceuticals (NASDAQ:TSPT) reported that initial top-line results from its Phase 2 clinical trial evaluating the efficacy and safety of TO-2061 (ondansetron oral tablets 0.5 mg and 0.75 mg) in patients suffering from obsessive compulsive disorder who had not sufficiently responded to treatment with approved first-line therapies. The data from the trial indicated that TO-2061 did not meet the primary efficacy endpoint to demonstrate an improvement in OCD symptoms compared to a placebo.
Halozyme Therapeutics (NASDAQ:HALO) reached a worldwide Collaboration and License Agreement with Pfizer (NYSE:PFE) for the development and commercialization of products combining proprietary Pfizer biologics with Halozyme’s Enhanze technology, which comprises the firm’s proprietary drug delivery platform and is based on the Company’s patented recombinant human hyaluronidase enzyme (rHuPH20). Through the terms, Halozyme grants Pfizer a global license to develop and commercialize products combining rHuPH20 with Pfizer proprietary biologics directed to as many as six targets. Halozyme will receive an initial payment of $8 million.
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Horizon Pharma (NASDAQ:HZNP) said Friday that the United Kingdom Medicines and Healthcare products Regulatory Agency, based on the favorable recommendation of their Commission on Human Medicines, will award a Marketing Authorization for Duexis (ibuprofen/famotidine) pending a review of updated licensing documents that the firm has supplied to the Agency. The authorization of Duexis is for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to lower the risk of developing upper gastrointestinal ulcers. The drug is both approved and available in the United States.
Venaxis (NASDAQ:APPY) has filed for CE Mark approval in Europe for APPY1, its blood-based appendicitis test. Based upon the standard protocol for submission of its technical file for the test through the firm’s authorized representative, Venaxis hopes to win CE Mark under the European Economic Area by the end of 2012. Commercialization in Europe should in the first quarter in key territories, including the United Kingdom, France, Italy, Germany and the Benelux countries.
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