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Daily Dose: AEZS Soars, SGYP Gets It Right, MYL, PFE, BMY Get FDA Blessings

DailyDose 121812

Shares of Aeterna Zentaris Inc. (AEZS) (AEZ.TO) were up nearly 14% Friday after the company announced that it has been granted special protocol assessment by the FDA for phase III registration trial in endometrial cancer with AEZS-108.

According to the company, the phase III trial will compare AEZS-108 with Doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer, and will involve approximately 500 patients. The primary efficacy endpoint is improvement in median Overall Survival.

Synergy Pharmaceuticals Inc. (SGYP) has successfully completed a phase I single-ascending-dose clinical trial of SP-333 to treat ulcerative colitis and other gastrointestinal diseases.

SP-333 exhibited gastrointestinal pharmacodynamic characteristics in the study, and no serious or unexpected adverse events were observed. The company plans to start a multi-dose, dose-escalation trial in volunteers in January of 2013.

The company is scheduled to release top-line data from a phase IIb/III clinical trial of Plecanatide in chronic idiopathic constipation patients during the first week of January 2013.

Actavis Inc., which was acquired by Watson Pharmaceuticals Inc. (WPI) in October, has been slapped with a lawsuit over an alleged patent infringement of cancer drug Velcade.

Actavis has filed an Abbreviated New Drug Application with the FDA seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Velcade raked in total U.S. sales of about $740 million for the 12 months ended October 31, 2012, according to IMS Health data.

Millennium filed a suit against Actavis on December 21, 2012, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents.

Mylan Inc.'s (MYL) subsidiary Mylan Pharmaceuticals Inc. has received final approval from FDA for its Phenytoin Chewable Tablets USP, 50 mg, the generic version of Pfizer's Dilantin Chewable Tablet.

Dilantin, an antiepileptic, is the indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

Mylan said that the product will be shipped immediately.

Emergent BioSolutions Inc. (EBS) has secured exclusive U.S. commercial rights to a next generation pandemic influenza vaccine candidate from VaxInnate Corp. under a license agreement signed Friday.

The transaction allows Emergent to take a step forward as a Biomedical Advanced Research and Development Authority, or BARDA, Center for Innovation in Advanced Development and Manufacturing.

Just two days after being approved in Japan for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation, Eliquis, an anticoagulant that was jointly developed by Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) won the FDA approval on Friday.

The FDA's decision comes much earlier than the original decision date of March 17, 2013.

Eliquis is already approved in the European Union and Canada for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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