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Biotechnology company ImmunoGen Inc. (IMGN) said Roche has reported that updated results from its EMILIA Phase III study show that patients treated with trastuzumab emtansine or T-DM1 had a significant improvement in OS compared to those randomized to standard-of-care therapy. Trastuzumab emtansine utilizes ImmunoGen's TAP technology with the trastuzumab antibody and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
Separately, the marketing application for trastuzumab emtansine has been submitted to the US FDA, and one is to be submitted shortly to the European Medicines Agency or EMA.
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Zalicus Inc. (ZLCS) said FDA has approved the supplemental new drug application or sNDA filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
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Lpath Inc. (LPTN) said the FDA has lifted the clinical hold on iSONEP, Lpath's anti-S1P monoclonal antibody that is being developed as a potential treatment for wet AMD and possibly other ocular disorders.
The hold was placed on iSONEP in late January 2012 after the FDA deemed that the company's fill/finish contractor was not in compliance with the FDA's Good Manufacturing Practice or cGMP requirements for about a three-year period (2008-2010).
Lpath has since manufactured new clinical material, utilizing a different fill/finish supplier. The manufacturing process and new drug supply met all specifications, leading to the FDA's action to allow the Nexus trial to continue. The company's Nexus study is now open for enrollment, with plans to treat the first patient in mid-September.
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