Fresh off the news that Sanofi and Regeneron won a patent suit against Amgen over the companies’ respective cholesterol-lowering drugs, another company announced data that could lead to the introduction of a competitor with the same target but a different mechanism into the market.
Parsippany, New Jersey-based The Medicines Company – partnered with Cambridge, Massachusetts-based Alnylam Pharmaceuticals – announced Monday the presentation of data on patients with cardiovascular disease from its Phase III ORION-11 study of the drug inclisiran, a drug designed to lower cholesterol by blocking production of the protein PCSK9.
The data, presented Monday at the European Society of Cardiology’s annual congress in Paris, demonstrated that the drug showed a statistically significant, placebo-adjusted 54 percent lowering of LDL cholesterol at day 510, with time-averaged, placebo-adjusted reductions of 50 percent from days 90 to 540. The drug and placebo showed similar safety profiles. The company plans to submit the data for publication in a medical journal and to release top-line data from the ORION-9 and ORION-10 studies later in the third quarter of this year. Regulatory submissions are anticipated for the U.S. in the fourth quarter and Europe in the first quarter of next year.
PCSK9 is also the target of Amgen’s Repatha (evolocumab) and Sanofi and Regeneron’s Praluent (alirocumab). However, whereas Repatha and Praluent are monoclonal antibodies, inclisiran is a small interfering RNA, or siRNA, using RNA interference to prevent the protein’s production. The first siRNA drug to win Food and Drug Administration approval was Alnylam’s Onpattro (patisiran), for polyneuropathy in hereditary transthyretin-mediated amyloidosis, in August 2018.
Wall Street greeted the results with enthusiasm, as The Medicine Company’s shares rose 13 percent on the Nasdaq by noon, while Alnylam’s shares were up slightly.
In a note to investors Monday, Oppenheimer analysts Jay Olson and Silvan Tuerkcan wrote that the ORION-11 results de-risk ORION-10, because both studies enrolled patients with similar levels of cholesterol. In addition, a differentiating factor for inclisiran versus Repatha is time-average reduction and dosing schedule of two times per year – compared with every two weeks in most cases for the Amgen drug.
Cowen analyst Ritu Baral wrote pointed out that amid the “impeccably clean” safety profile of the drug, there did not appear to be hints of cardiac, liver or kidney toxicity that have dogged many of Alnylam’s other RNA-interference programs. Similarly to the Oppenheimer analysts, she wrote that the sustained LDL reduction up to 18 months made it likely the ORION-10 and also ORION-9 would show similar results.
B. Riley FBR analyst Mayank Mamtani called the results a “near home run” and also agreed that they de-risk the ORION-10 and ORION-9 studies.
On Friday, a federal judge ruled in favor of Sanofi and Regeneron in a lawsuit that Amgen had filed against them, alleging that Praluent infringed on its patents covering Repatha. The ruling overturned an earlier decision in Amgen’s favor and means that Praluent can stay on the market, though Amgen has said it plans to appeal.
Photo: BrianAJackson, Getty Images
