Aralez Announces FDA Acceptance of New Drug Application for YOSPRALA™

MILTON, Ontario, March 28, 2016  Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ - News) (TSX:ARZ.TO -News) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.
"The acceptance of our NDA for YOSPRALA marks an important and exciting step toward approval of this product," said Adrian Adams, Chief Executive Officer of Aralez. "We look forward to working with the FDA during the review process in order to bring YOSPRALA to market as quickly as possible."
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Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine 

Alder Also Reports Positive Phase 1 Data Supporting Quarterly Single Injection Dosing Strategy for ALD403
Alder to Host Conference Call at 8:30 a.m. Eastern Time Today
 
BOTHELL, Wash., March 28, 2016  -- Alder BioPharmaceuticals, Inc. (ALDR), today announced positive top-line data from two clinical trials evaluating ALD403, Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP). Positive top-line data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12 week study period, meeting both primary and secondary efficacy endpoints.  Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.
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Cerulean Announces Publication Showing CRLX101 Localizes Selectively in Human Tumors, Sparing Adjacent Healthy Tissue

Phase 1 Data Published in Proceedings of the National Academy of Sciences (PNAS)
 
WALTHAM, Mass.-- Cerulean Pharma Inc. (CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced the publication of clinical data for its lead compound, CRLX101, in the journal Proceedings of the National Academy of Sciences (PNAS). The publication highlights results from an investigator-sponsored clinical trial, in which pre- and post- treatment tumor biopsies from patients with gastric cancer treated with CRLX101 show the presence of CRLX101 and its payload, camptothecin, in tumors, and their absence in surrounding normal tissue. Importantly, inhibition of the molecular targets of CRLX101 was demonstrated in post-treatment biopsies. The article was published online. Initial results from the trial were presented at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 7, 2015.
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Celator® Pharmaceuticals Announces Pricing Of A $38.0 Million Public Offering Of Common Stock

EWING, N.J., March 23, 2016  -- Celator Pharmaceuticals, Inc. (CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced the pricing of an underwritten public offering of 4,000,000 shares of common stock. The shares of common stock are being offered at a price of $9.50 per share.  The gross proceeds to Celator from this offering are expected to be approximately $38.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Celator. The Company has granted the underwriters a 30-day option to purchase an additional 600,000 shares of common stock to cover over-allotments.  The offering is expected to close on or about March 29, 2016, subject to customary closing conditions.
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Theratechnologies and TaiMed Biologics Sign Exclusive Marketing and Distribution Agreement for Ibalizumab

MONTREAL, QUEBEC--(Mar 18, 2016) - Theratechnologies inc. (TH.TO) and TaiMed Biologics, Inc. today announced a 12-year collaboration agreement to market and distribute ibalizumab in the United States and in Canada. Ibalizumab is a novel CD4-directed HIV entry-inhibitor and is the first humanized monoclonal antibody in clinical trials for the treatment of HIV.
 
Ibalizumab is currently in a late-stage Phase III clinical trial, the last step before submitting the product for regulatory approval to the Food and Drug Administration in the United States ("FDA"). Over two-thirds of patients required for the open-label, 24-week trial have been enrolled. Patient screening for this study is anticipated to close later this month. The objective of this study is to reduce viral replication in patients with multi-drug resistant HIV infection. The primary endpoint of the Phase III trial is the proportion of patients achieving a 0.5 log10 decrease in viral load 7 days after initiating treatment.
 
Once the Phase III trial is completed, ibalizumab will be evaluated under the FDA's priority review process which is expected to be completed within six months of the application or during the first half of 2017.
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