Irish company takes on pharma giants in hunt for a cure-all
Allison Connolly and Nick Webb look at the multi-billion euro potential of fish oil as a new life-saving medicine
FISH oil has been touted as useful for everything from growing hair to treating clinical depression. Now an Irish pharmaceutical company is jostling with some of the world's biggest drug-makers to step up their promotion of its benefits for treating heart disease.
Along with the likes of AstraZeneca and GlaxoSmithKline, Irish drug firm Amarin is betting the market for prescription fish-oil pills will follow the success of cholesterol-lowering drugs including Lipitor, once the world's best-selling medicine with revenue of $13bn a year.
Nasdaq-listed Amarin has been backed by the likes of billionaire Dermot Desmond, Spurs owner Joe Lewis and the late Tony Ryan, founder of Ryanair. Former Elan executive Tom Lynch chaired the company.
Heart disease remains the world's biggest killer, accounting for 30 per cent of global deaths, even as statins and other treatments have become more widely used. Now that Lipitor and many other statins have cheaper, generic competitors, drug-makers are looking for new ways to tackle the array of conditions that can lead to heart disease, including coupling triglyceride treatments with existing cholesterol-lowering pills for a one-two punch.
"The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes," AstraZeneca chief executive Pascal Soriot said when he bought fish-oil pill-maker Omthera Pharmaceuticals Inc for $443m last month. "There is a clear need for effective and convenient alternatives to the existing treatments."
Unlike capsules that can be bought in health-food stores, the drug-makers' products are only available with a prescription, are highly concentrated and undergo a several-step purification process approved by the US Food and Drug Administration.
There is a hitch, however. While statins have been shown in studies to cut the risk of heart disease, the benefits of fish-oil pills are less certain. Although they target triglycerides – fatty substances in the blood linked to a higher risk of heart attacks – little evidence exists that the pills prevent heart attacks.
"It's very unclear what role fatty acids play for cardiac patients," said Mark Urman, a member of the American College of Cardiology Prevention Committee and practising cardiologist.
Study results have been mixed. Japanese research on almost 19,000 people who took fish oil with a statin had a 19 per cent lower risk of heart attacks, sudden cardiac death and other major coronary events compared with those who took a statin alone.
A late-stage trial of Vascepa sponsored by Amarin found that it cut triglyceride levels by almost 22 per cent at a four-gram dose and 10 per cent at a two-gram dose without raising cholesterol levels in patients taking statins.
Other trials have shown little or no benefit. A study of more than 12,500 patients showed that a one-gram daily dose of omega-3 fatty acids did not prevent death or other cardiovascular events compared with a placebo, according to an article in the New England Journal of Medicine in June 2012. A review of data from 68,000 patients who took fish-oil supplements over 24 years showed no reduction in risk of heart attack, stroke and death.
If cleared by regulators, Astra-Zeneca's Epanova would be the latest prescription pill to enter the market. It would bolster the London-based company's best-selling drug, a statin called Crestor, once it faces generic competition in 2016. While the drug-maker is still formulating its strategy, the Crestor sales team will pitch the product as an added benefit to statins, said William Mongan, AstraZeneca's executive director of US business development.
Amarin won US approval to market Vascepa to people who have triglyceride levels of 500 milligrams per decilitre of blood or greater, a group of about four million people, according to the Dublin-based drug-maker. It is also seeking clearance to sell Vascepa for an additional 40 million people who have triglyceride levels between 200 milligrams and 500 milligrams, a "multi-billion dollar market opportunity."
Vascepa has a long way to go to catch Lovaza. The drug had $4.3m in sales between January and the end of April compared with $424.6m for Lovaza.
Amarin has fallen 60 per cent in the last year and is worth around $854m. Analysts predict Lovaza sales will decline about 1.4 per cent this year.