Dallas, Texas 07/07/2015 (Financialstrend) – Amarin Corporation plc (ADR) (NASDAQ:AMRN) the maker of the much talked-about Vascepa drug appears to have its future tied down by its peers. Amarin has had a topsy-turvy growth phase, ever since April 2011 when the data from its trial proved that Vascepa, which is a Omega-3 fatty acid drug, can lower high triglycerides in the blood.
However, in the years since, it has had to contend with already established drugs in this segment, namely Lovaza. It has also had to contend with GlaskoSmithKline (NYSE:GSK) large presence.
FDA decision in October of 2013 to reject Vascepas label expansion to be used for high triglycerides such as 500mg/dL and above had affected share prices. In fact, it has a massive 8000-patient trial in progress to establish that Vascepa can lower triglyceride levels as well as improve clinical outcome. The results of the trial are expected by the end of 2017.
Other smaller biotechnology players too have placed Matinas BioPharma under pressured. This company too has an Omega-3 fatty acid drug called MAT9001. The top-line results of this drug have proved to be superior to Vascepa in terms of Pharmacokinetics as well as pharmaco dynamics studies. However, the design of the trial type for MAT9001 does allow ‘higher statistical power’ over ‘placebo versus active drug arms’ gold standard. The results showed that MAT9001 had 33% reduction in triglycerides from baseline in comparison to 10.5% reduction in Vascepa. The results for the group of patient with 200 to 499 mg/dL group, which Amarin Corporation plc (ADR) (NASDAQ:AMRN) is also targeting.
Currently, the bestselling statin for lowering cholesterol levels with proven clinical outcome is Lipitor. The product was approved because of its outcome for 200-499mg/dL patient group.
The race is now between MAT9001 and Amarin to prove their product worthiness in terms of clinical outcome. Experts believe, Amarin is currently pegged down by Matnias BioPhama’s Phase 2 results, but with Matina’s yet to begin its Phase 3, Amarin’s Phase 3 trial results by 2017, will prove to be crucial.