DUBLIN -- Alkermes plc (ALKS) today announced positive topline results from FORWARD-5, the third phase 3 efficacy study to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated. The most common adverse events observed for ALKS 5461 were nausea, dizziness and fatigue. Based on these results, along with the substantial data collected to date on the efficacy and safety of ALKS 5461 for the treatment of MDD, the company plans to request a meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.

XIANYANG, China, Oct. 11, 2016 - Biostar Pharmaceuticals, Inc. (BSPM) ("Biostar"), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that it will launch its new topical health product called "Easy Breathing" designed to treat rhinitis and sinusitis for sales in the PRC in November 2016. Rhinitis is irritation and inflammation of the mucous membrane inside the nose. Sinusitis is an inflammation or swelling of the tissue lining the sinuses.

 

This new product was developed by the Company's R&D team over the past 3 years. Having being developed based upon the principles of the traditional Chinese medicine, the product is designed to have effects of relieving stuffy nose, inhibiting nasal bacteria and viruses, and mitigating effects on the inflammation of nasal mucosa. It will be manufactured, distributed and sold in the PRC.

-On an Adjusted EBITDA Basis, Transaction Expected to be EBITDA Accretive and to Move Profitability Forward to 2017-

-Company to Host Conference Call on October 4, 2016 at 8:30 a.m. ET-

 

MISSISSAUGA, Ontario, Oct. 4, 2016 -- Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ - News) (TSX:ARZ.TO - News), a global specialty pharmaceutical company, today announced it will acquire the U.S. rights to Toprol-XL® (metoprolol succinate) and its Authorized Generic (AG) pursuant to an agreement entered into between AstraZeneca and Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez. Toprol-XL is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long term treatment of angina pectoris and treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins. It was first approved in the U.S. in 1992. AstraZeneca recorded U.S. net revenues from Toprol-XL and its AG of $89 million and $53 millionin 2015 and year-to-date June 2016, respectively. The transaction is expected to be immediately EBITDA accretive and to move profitability forward to 2017, in each case on an adjusted EBITDA basis. The transaction is expected to be completed in the fourth quarter of 2016, subject to customary closing conditions.

Robert L. Rosiello to Remain at Valeant as Executive Vice President, Corporate Development and Strategy

 

LAVAL, Quebec, Aug. 22, 2016  -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that Paul S. Herendeen has been appointed Executive Vice President, Finance and will take over the role of Chief Financial Officer from Robert L. Rosiello effective immediately.  Mr. Rosiello will remain at Valeant as Executive Vice President, Corporate Development and Strategy.

 

Mr. Herendeen has more than 30 years of broad financial experience and leadership, including 16 years as CFO of Warner Chilcott and MedPointe.  He joins Valeant from Zoetis, where he served as Executive Vice President and CFO for the past two years.  As Valeant CFO, he will oversee all of the company's finance functions, including: controllership, tax, and treasury, reporting directly to chief executive officer Joseph C. Papa.