SHARES IN Irish pharma group Amarin jumped almost 80 per cent yesterday after it announced very strong results from the final clinical trial of its prospective cardiovascular therapy.
The company will now move to file a new drug application with the US regulator for what insiders believe will be a blockbuster drug.
The “Anchor” trial into the effectiveness of the drug – a form of refined Omega-3 fishoil – in reducing levels of triglycerides met its targets in efficacy while also proving very safe, with no serious side-effects for patients.
Triglycerides are a type of fat stored from food intake and released as energy. At elevated levels, they are seen as increasing the risk of heart disease. A previous phase III trial, “Marine”, showed that Amarin’s AMR101 drug was effective in significantly reducing levels in patients with very high triglyceride readings, above 500 milligrams/decilitres.
The latest trial showed it was also effective in cutting levels in patients with less elevated figures – 200-500mg/dl – with reductions of 21.5 per cent and 10.1 per cent on 4mg and 2mg doses respectively. In both cases, it does not increase the level of low density lipoprotein or “bad cholesterol”, a factor which is an issue for the only rival therapy on the market.
The significance of the findings, the company said, was that as many as 40 million patients in the US suffer from the less elevated readings, as opposed to 4 million with readings above 500.
Manus Rogan, managing partner of Fountain Healthcare, which led a $70 million investment in Amarin in October 2009 to fund the current trials, said: “The successful pivotal clinical trial results today clearly position Amarin’s lead drug as a highly differentiated, effective and safe therapy for patients with at-risk lipid profiles.”
Dr Rogan, also a director at Amarin, said: “The product is now firmly on track to become a multibillion-dollar blockbuster”.
Amarin, until now primarily a drug development company, stated previously it believes it has the capacity to build the infrastructure to commercialise the drug itself. However, it is also understood to be in discussions with major pharmaceutical groups.
