Shares in Irish pharma group Amarin jumped almost 80 per cent today after it announced positive results from the final clinical trial into its prospective cardiovascular therapy.
The company will now file a new drug application with the US regulator for what insiders believe could 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 efficacy targets.
Triglycerides are a type of fat stored from food and released as energy. At elevated levels they are considered to increase the risk of heart disease.
A previous phase three trial, “Marine”, showed Amarin’s AMR101 drug was effective in significantly reducing triglyceride levels in patients with very high readings – above 500 milligrams/decilitre.
The latest trial showed it was also effective in reducing triglyceride levels in patients with less elevated figures – between 200 and 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”.
According to the company the US patient population in the area of triglyceride readings above 500 is around four million, while as many as 40 million suffer from the less elevated readings.
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, who is also a director at Amarin added: “The product is now firmly on track to become a multibillion dollar blockbuster on a scale similar to well known statin-based lipid management drugs.”
Amarin, which has till now been primarily a drug development company, has stated previously that 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 on alternative approaches.
The company said there was no other approved therapy on the market for patients in the less elevated triglyceride sector addressed by the most recent trial.
In a statement, Amarin chairman and chief executive Joseph Zakrzewski said the company was delighted with the results.
