Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that on August 25, 2010, the United States District Court for the District of Columbia denied sanofi-aventis U.S. LLC's request for a preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application (ANDA) filed by the Company's collaboration partner, Sandoz, for enoxaparin sodium injection USP, a generic version of Lovenox(R). The decision is subject to appeal. "We continue to believe that the FDA engaged in a thorough review of the science supporting the Sandoz enoxaparin sodium injection ANDA, and are pleased that the Court re-affirmed the validity of the FDA's decision," stated Craig Wheeler, President and Chief Executive Officer of Momenta. "Sandoz commenced shipping of enoxaparin sodium injection following the FDA's marketing approval of Sandoz's ANDA on July 23, 2010." Momenta Pharmaceuticals surged as much as 6% in pre-market trading.
Dell (NASDAQ: DELL) announced today that 3PAR has accepted its increased offer to acquire the storage leader for $24.30 per share in cash, or approximately $1.6 billion, net of 3PAR's cash. 3PAR (NYSE: PAR) is a leading global provider of storage solutions with advanced data management features for multi-tenant cloud-computing environments. Dell had previously signed an agreement to acquire 3PAR for $18 per share, with a provision for matching competing bids. Dell and 3PAR have signed an amendment to the agreement reflecting the new offer price. Dell shares of the company soared as much as 1% in pre-market trading.
Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. (NASDAQ: CYPB) . The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, mimicking the nicotine effects of smoking without the harmful side effects associated with cigarettes. According to the terms of the agreement, Cypress will pay Alexza an upfront payment of $5 million to acquire the worldwide license for the Staccato nicotine technology. In addition, following the completion of certain preclinical and clinical milestones relating to the Staccato nicotine technology, Cypress will be obligated to pay to Alexza an additional technology transfer payment of $1 million. Alexza will have a carried interest of 10% (subject to adjustment in certain circumstances) in the net proceeds of any sale or license by Cypress of the Staccato nicotine assets and the carried interest will be subject to put and call rights in certain circumstances. Under the agreement, Cypress has responsibility for preclinical, clinical and regulatory aspects of the development of Staccato nicotine, along with the commercialization of the product. Alexza will execute a defined development plan for Cypress, culminating with the delivery of clinical trial materials for a Phase 1 study with Staccato nicotine. Shares of Alexza Pharmaceuticals jumped as much as 5% in pre-market trading.
Full Disclosure: None.
