The stock of Amarin soars after the discovery of its fish oil capsule that significantly reduces cardiovascular risks

The biopharmaceutical company Amarin is doing the history of heart medicine Monday with its patented formulation of fish oil, called Vascepa.

In a breathtaking clinical trial result that challenges years of skepticism about the long-term cardiac benefit of products containing omega-3 fatty acids, Amarin's Vascepa has significantly reduced the risk of death, heart attacks, strokes and other serious cardiovascular events.

Amarin has designed his study on cardiovascular outcomes, known as REDUCE-IT, in the hope of showing that Vascepa could reach the primary endpoint with a 15% risk reduction.

The result announced Monday: a risk reduction of 25% – highly statistically significant.

"This is absolutely the most important study in the field of cardiovascular risk reduction since the introduction of statins," said Dr. Matthew Budoff, a UCLA cardiologist and researcher. at the Vascepa study.

Statins have become commercial blockbusters generating billions of dollars in sales, as large clinical trials have shown a positive link between cholesterol reduction and the prevention of heart attacks and fatal strokes. The new class of cholesterol-lowering injectable drugs called PCSK9 inhibitors from Amgen, Regeneron Pharma and Sanofi reduces cardiovascular risk by 15%.

With a 25% greater risk of reduction in patients, Vascepa could be the next standard treatment against cardiovascular disease, potentially prescribed to millions of Americans.

The Amarin action closed Friday at $ 2.99. When dawn broke Monday, Amarin's stock price soared to $ 10, an increase of more than 200 percent during the pre-market trading session.

Vascepa was approved by the Food and Drug Administration in 2012 to treat people with high triglycerides, a type of fat found in the blood. But commercial production of the product has been modest so far – sales last year reached $ 181 million – as there was no scientific evidence linking the decrease in triglycerides and the 39, improved cardiovascular outcomes.

All previous results studies of different formulations of omega-3-containing products have failed, resulting in strong skepticism within the cardiology community about the medicinal value of these supplements. Last August, a study of 15,000 patients with another prescribed quality fish oil, called Lovaza, found no improvement in cardiac benefits.

"I thought Vascepa's study would be negative, colored by all the studies that were missed before, so I'm surprised, I'm ready to eat my shoe, it could be very beneficial for people," said Dr. Ethan Weiss, a cardiologist at the University of California, San Francisco Medical Center. Weiss did not participate in the Amarin study.

"I need to see the [detailed] data, but if these are the results, then that can change the deal, "said Dr. Martha Gulati, chief of cardiology at the University of Arizona College of Medicine .Gulati did not been involved in the Amarin study.

Amarin used a press release Monday morning to unveil the results of the Vascepa REDUCE-IT study. More detailed data is presented at the annual meeting of the American Heart Association on November 10th.

Amarin has long emphasized that the special characteristics of Vascepa would be superior to other fish oil formulations. Vascepa contains only highly purified EPA, the most beneficial omega-3 fatty acid. Other fish oil pills, including Lovaza, contain a mixture of EPA and DHA, the latter being known to increase bad cholesterol levels. Vascepa is administered at a daily dose higher than 4 grams compared to competitors.

The company has designed the REDUCE-IT study to maximize the benefits of Vascepa. The 8,179 patients entered the study with cholesterol levels controlled by statin therapy, but they also had other heart conditions, including persistent high triglyceride levels or diabetes, which made them exposed to increased risk.

Patients were randomized to treatment with Vascepa or a placebo pill and were followed for a median of almost five years. The results:

According to Mr. Amarin, Vascepa presented a relative risk reduction of about 25% of the primary endpoint, which measured the first occurrence of cardiovascular death, non-fatal heart attack, nonfatal stroke, coronary revascularization or unstable angina.

In regards to safety, Vascepa was well tolerated with a side-effect profile consistent with the current approval label of the drug, the company said.

"We are delighted with these first-rate study results," said Amarin CEO John Thero in a statement. "Given that Vascepa is affordable, orally administered, and has a favorable safety profile, the REDUCE-IT results could lead to a new treatment paradigm to further reduce the significant cardiovascular risk that persists in millions of people. patients as studied in REDUCE-IT. "

The 25% risk reduction figure is significant, but Weiss, the UCSF cardiologist, said he looked forward to the most important result until the data from the studies are released publicly in November. He has questions: What factors, exactly, have led to risk reduction? How much lowering of triglycerides has been observed? How close was the enrolled patient population?

But if the data is maintained, Vascepa could become a very big drug. At an annual price of about $ 2,400, Vascepa is already largely covered by insurance companies. Although Amarin is increasing the price of the drug to reflect REDUCE-IT results, it will likely remain a relative bargain compared to other heart medications. PCSK9 inhibitors cost about $ 14,000 a year and insurers have tried to limit their use.

Amarin has previously been involved in litigation against generic drug companies seeking to market cheaper versions of Vascepa. The company's patents on the drug expire in 2030, although the results of the REDUCE-IT study, reinforced by additional approvals from the FDA, could offer more intellectual property protections.

Amarin also believes that the cardiovascular benefit observed in REDUCE-IT is due to the purity and dose of Vascepa and can not be replicated by other quality fish oil products prescribed or available for sale free. Whether this is true or not will depend on the results of concurrent clinical trials. AstraZeneca is currently conducting a study on the results of its quality fish oil product, called Epanova, also using a higher dose, such as Vascepa. A reading of this study, called STRENGTH, could take place next year.

"I went in this study not convinced that Vascepa would make a difference, but these results will certainly change my practice and the way I treat patients," said Dr. Norman Lepor, a cardiologist at Cedars-Sinai Medical Center in Los Angeles . Lepor has recruited patients in the Vascepa study.