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Amarin $ AMRN has claimed the next big hit in the cardio space, announcing an obvious statistical victory over the main criterion for its 7-year clinical research aimed at proving that its Vascepa industrial purified fish oil can significantly reduce major cardio threats for a wide band of patients.
A preliminary overview of the first-line data deployed Monday morning revealed a 25% decrease in the risk of major cardiovascular events, such as death, stroke and hospitalizations due to angina. chest. achieve a highly statistic p = <0.001 for patients in the REDUCE-IT study conducted over several years. And the researchers also fought for a clean security profile in the same title data to make the statement.
The data supported "robust" evidence of its effect on several secondary endpoints, according to the company. We will not see the details until later, but the company is about to apply for approval early in 2019.
Jefferies analysts said a success here could turn Vascepa into a $ 2 billion drug. And this figure resonated this morning, while Amarin's share price has risen by 288%. This amazing breakthrough follows Jefferies' new remarks on the relative value that Amarin pointed out this morning compared to other drugs that have tried – and failed – to make a good impression.
The magnitude of MACE reduction is up to now the largest among all therapies above statins, far exceeding clinically relevant CV benefit expectations. Remember, two inhibitors of PCSK9 (Repatha and Praluent) and Ilaris all reduced the risk of MACE by 15% in newly completed CVOTs (FOURIER, ODYSSEY and CANTOS). The FDA has expanded the Repatha label to include a CV risk reduction and is currently reviewing the Praluent sLAB in the MACE reduction (PDUFA 28/04/19). Our doc study suggested that the 10-15% + risk reduction in MACE is considered clinically significant.
"We are pleased with these results of the study," said John Thero, President and CEO of Amarin, in a statement. "Because Vascepa is affordable, orally administered, and has a favorable safety profile, the REDUCE-IT results could lead to a new treatment paradigm aimed at further reducing the significant cardiovascular risk that persists in millions of people. of patients as studied in REDUCE-IT. "
However, none of this is going to make it easy for society, with a crowd of short-run investors likely to try everything needed to provoke a reaction against data from the last big catalyst of the third quarter . Complicating their success, AstraZeneca has its own results study for rival Epanova ready to be read next year, while GSK's Lovaza became generic several years ago.
But as the morning progressed, it became clear that Amarin kept his big winnings and the fans fainted.
Patients enrolled in the REDUCE-IT program had an LDL-C level of 41-100 mg / dL (initial C-LDL-C 75 mg / dL) controlled by statin therapy with a list of cardiovascular risk factors . 499 mg / dL (median initial value 216 mg / dL) and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor.
It's a big market.
This phase III was constantly debated at the approach of reading. The Amarin Vascepa – approved more than 4 years ago for hypertriglyceridemia – has demonstrated its ability to significantly reduce triglycerides in these patients while influencing biomarkers of inflammation. But as we know from previous cardiovascular studies, this does not necessarily translate into definite and demonstrable health benefits, so payers are ready to cover much larger populations of at-risk members.
REDUCE-IT has attempted to answer this question, with researchers recruiting more than 8,000 patients to compare them to statin supplementation to reduce the number of major cardiovascular events (MACE) compared to statin-treated patients and placebo.
The recent ASCEND study has already taught us that popular fish oil products sold in all pharmacies do not present any obvious health benefits and that the Amarin rests on the premise that its omega-3 fatty acid. The company's leaders said the weakness of the fish oil would simply facilitate the demonstration of the value of Vascepa once the outcome data would be available.
Is it sufficient?
Even positive cardio data does not always translate into a business opportunity, and analysts will now see if Amarin has found data good enough to qualify as a practice change event that the company's funders have insisted on. now be at your fingertips.
The difference is equivalent to a market with millions of potential patients.
Jefferies analysts who helped boost the drug's success recently noted:
REDUCE-IT positive will be a scalable practice as it will provide the POC that the use of a highly purified Omega-3 drug (vascepa) in MD patients under stable and relatively well-controlled statins (<100 mg / dL ) contributes to a CV profit. While LDL-C has declined over the decades, TGs continue to grow. The market needs this type of medicine.
But for each defender, you can count two other players who are betting against the drug and any rise in the course of action. The players will not back down without a fight, but their number has definitely decreased on Monday.
Picture: John Thero. Amarin
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