Abbvie Inc., of Chicago, has filed a new drug submission (NDS) to Health Canada seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with cirrhosis. The submission is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date, with six phase III studies that included more than 2,300 patients in more than 25 countries. At the beginning of May, Health Canada approved Abbvie's request for priority evaluation for its investigational direct-acting antiviral regimen with and without ribavirin for HCV genotype 1. The designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.

Actavis plc, of Dublin, said that, subject to the close of its pending acquisition of New York-based Forest Laboratories Inc., it is offering to guarantee certain of their outstanding debt securities in exchange for the elimination of the existing registration rights obligations in connection to those outstanding debt securities. Forest is soliciting consents from holders of the securities to eliminate existing contractual registration rights obligations. In exchange for the elimination of such registration rights, and subject to certain conditions and the closing of the acquisition, Actavis is offering to issue an unconditional and irrevocable guarantee for each series of these notes.

Acura Pharmaceuticals Inc., of Patine, Ill., said it entered an agreement with Sandoz Inc. to settle its patent infringement action pending against Sandoz in the U.S. District Court for the District of Delaware. In the suit, Acura alleges that a generic of Acura's Aversion oxycodone product, previously marketed by New York-based Pfizer Inc. under its brand name Oxecta, for which Sandoz is seeking U.S. FDA approval to market with an abbreviated new drug application infringes a U.S. patent owned by Acura. Under the Sandoz settlement agreement, the company may launch its generic to the Aversion oxycodone product in the U.S., through the grant of a non-exclusive license from Acura to Sandoz that would trigger 180 days following the first sale of a generic by an entity that is entitled to the 180 day first-filer exclusivity. In certain circumstances, Acura's license to Sandoz would become effective prior to such time. Sandoz is not obligated to pay Acura a royalty if its current formulation of its generic to the Aversion oxycodone product is approved by the FDA.