-Aralez Sales Force Will Be Expanded by 85 to 110 Sales Representatives by Launch-

-YOSPRALA U.S. Commercial Launch Planned for First Week of October-

-Company to Host Conference Call Today at 11:00 a.m. ET-

 

MISSISSAUGA, Ontario, Sept. 15, 2016-- Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ - News) (TSX:ARZ.TO - News), a global specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved once-daily YOSPRALA™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S. YOSPRALA is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The Company is expanding its U.S. sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the U.S. promotional launch of YOSPRALA the first week in October.

IRVINE, Calif.-- Aerie Pharmaceuticals, Inc. (AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today reported the successful 90-day primary efficacy results of its 12-month Phase 3 “Mercury 1” clinical trial for its fixed-dose combination product candidate, RoclatanTM. The study achieved its primary efficacy endpoint demonstrating statistical superiority over each of its components, including Aerie product candidate RhopressaTM (netarsudil ophthalmic solution) 0.02%, and market leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg (millimeters of mercury). The IOP-lowering effect of RoclatanTM was 1 to 3 mmHg greater than monotherapy with either latanoprost or RhopressaTM throughout the duration of the study. Management will host a conference call with accompanying slides to discuss these results at 5:00 p.m. ET today. The accompanying slides are available at Aerie’s web site, aeriepharma.com.

FREMONT, Calif., Sept. 14, 2016 / -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), today presented positive interim efficacy data from the 10 million cell cohort in the Company's ongoing AST-OPC1 SCiSTAR Phase 1/2a multicenter clinical study in complete cervical spinal cord injury patients.  While early in the study, with only 4 of the 5 patients in the cohort having reached 90 days after dosing, all patients have shown at least one motor level of improvement so far and the efficacy target of 2 of 5 patients in the cohort achieving two motor levels of improvement on at least one side of their body has already been achieved.  Patient improvements are being measured by the ISNCSCI neurological classification scale widely used to quantify functional status of patients with spinal cord injuries.  As suggested by existing research, patients with complete cervical spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing. 

LAVAL, QUEBEC--(Marketwired - Sep 14, 2016) - Acasti Pharma (ACST)(TSX VENTURE:APO) today announced that its bridging study for novel drug candidate CaPre® (omega-3 phospholipid) has successfully met its objectives, supporting Acasti's strategy to pursue the U.S. Food and Drug Administration's (FDA) 505(b)(2) regulatory pathway for approval. Acasti is developing CaPre for the treatment of patients with severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. The 505(b)(2) regulatory pathway allows Acasti to streamline the overall development program required to support a New Drug Application (NDA) by relying on the safety data of an approved drug.

 

"We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre," said Jan D'Alvise, president and CEO of Acasti Pharma. "With this momentum, we look forward to working with the FDA to confirm the pathway and optimize the design of our Phase 3 program, which will seek to demonstrate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia."