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February 14, 2014
09:43 EDTENZY, ACST, NEPTNeptune, Acasti say patent settlement with Enzymotec not finalized
Neptune Technologies (NEPT) and Acasti Pharma (ACST), a Neptune subsidiary, announce that a settlement agreement has not been finalized with Enzymotec (ENZY) that would resolve the International Trade Commission investigation into infringement of Neptune's composition of matter patents, as well as related federal court actions initiated by Neptune against Enzymotec and its distributors. the Administrative Law Judge presiding over the pending ITC Investigation previously stay the proceedings through February 5 to give the parties more time to finalize a settlement agreement. To date, the parties have reached an impasse on certain fundamental settlement terms, including terms to which Enzymotec had already agreed in the parties' signed term sheet. Consequently, as strongly encouraged by the ITC, Neptune will participate in the ITC's Mediation Program in a final attempt to reach a mutually satisfactory agreement. The mediation process is expected to be completed over the next 45 to 60 days.
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March 2, 2015
07:56 EDTACSTAcasti Pharma receives full data for Phase II TRIFECTA trial
Acasti Pharma announces that it has received full data for its Phase II double blind, placebo controlled TRIFECTA trial. The full set of data further confirms and supports the positive Phase II TRIFECTA results announced in September 2014, on the safety and efficacy of CaPre in the treatment of patients with hypertriglyceridemia. As previously announced, the TRIFECTA trial's primary endpoint was met, with patients on 1 gram or 2 grams of CaPre achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, benefits in other key cholesterol markers were announced, including slight increases in HDL-C, no deleterious effect on LDL-C and no safety concerns. With full data, Acasti is now able to meet with the FDA to discuss next steps in the clinical development of CaPre. The meeting is expected to take place in the Corporation's first quarter, ending May 31. "With the encouraging results announced to date, we are well positioned to move forward with our clinical program, including a pivotal Phase III trial for CaPre in patients with severe hypertriglyceridemia," said Pierre Lemieux, PhD, Acasti's COO. "In anticipation that we will eventually receive approval to conduct a Phase III trial, we are ramping up production of CaPre clinical material, using current Good Manufacturing Practices, to ensure a quality product in sufficient quantities is available. This will allow us to avoid any delays due to inventory shortages."
February 20, 2015
07:34 EDTNEPTNeptune , NeuroBioPharm receive final court approval, completes arrangement
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February 18, 2015
07:35 EDTENZYEnzymotec sees FY15 EPS 21c-34c, consensus 56c
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07:34 EDTENZYEnzymotec reports Q4 EPS 6c, consensus 8c
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