Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
DUBLIN – Afimmune Ltd. is starting a phase IIb trial of a bioactive lipid, epeleuton, in patients with high triglycerides and type 2 diabetes, in an effort to confirm prospective observations already seen in a phase IIa study.
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) unanimously concluded Thursday that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular (CV) events in adults with elevated triglyceride levels (≥135 mg/dL) and other risk factors for CV disease. The 16-0 vote followed a day's discussion about potential effects of mineral oil, about the proper age population and the value of labeling. EMDAC's conclusion is only an advisory, as the FDA makes the final decision. FDA representatives at the panel discussion noted the study provided convincing data and waived off most concerns about mineral oil's impact on LDL cholesterol levels and blood pressure.
The fish were biting Tuesday at Amarin Corp., as the FDA released its briefing documents for Thursday's advisory committee review of a first-of-its-kind indication for the company's fish oil-based Vascepa.
Amarin Corp. plc's sale of $400 million in American depositary shares (ADSs) ahead of the Sept. 28 PDUFA date for Vascepa (icosapent ethyl) boosted investor confidence while sparking buzz about another player in the space: Acasti Pharma Inc., of Laval, Quebec, which has a krill oil-based product due to report pivotal data soon.
