Regeneron's anti-cholesterol drug Praluent reduces death risk in trial

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In keeping with ICER's established "in confidence" procedures, Sanofi and Regeneron provided early access to data from the Odyssey Outcomes trial to ICER, an independent organization that evaluates the value of prescription drugs and other health care innovations, to enable a revised assessment of alirocumab value incorporating the Odyssey Outcomes results. "We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need", said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi in a statement.

Baird's Brian Skorney (OUTPERFORM/$408 on REGN): Conclusion from ICER (Institute for Clinical and Economic Review) that Praluent would be cost effective at $2.0K - 3.4K for all patients and $4.5K - 8.0K for high-risk patients with elevated bad cholesterol would be a 43 - 68% discount and may trigger a price war.

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

Data from the ODYSSEY OUTCOMES trial presented at the American College of Cardiology's annual scientific session (ACC) show that high-risk patients who added Praluent (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events (MACE) compared to those on maximally-tolerated statins alone. When researchers looked at causes of death separately, there was no significant difference between the two groups in terms of coronary heart disease and cardiovascular disease deaths.

People who started the study with LDL cholesterol of 100mg/DL or higher had a 24-percent reduction in the risk of heart attack or stroke and a 29-percent lower risk of death.

The results give a clear advantage to Sanofi and Regeneron in the duel with Repatha, which like Praluent, is a PCSK9 inhibitor drug.

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Sanofi and Regeneron will be meeting with US health plans to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients.

The hope is that the new data, coupled with a flexible approach to pricing, will boost sales for Praluent, while also dealing a blow to Amgen, whose quality of life-based cardio data from Repatha has already been used by health economists to question the its high price.

Sanofi also seems to have won over the doctors attending the conference, which will help it in the coming months as the battle with Amgen begins in earnest. "In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk", commented George Yancopoulos, president and chief scientific officer at Regeneron.

Patients were randomized equally to be treated either by Praluent injection or a placebo, with the treatment period lasting an average of 2.8 years. They had LDL cholesterol at 70 mg/dL or above and non-HDL cholesterol 100 mg/dL or above.

Data showed 730 patients stopped receiving Praluent while on the 75mg dose after experiencing two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose.

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