New Cholesterol Drugs From Amgen, Sanofi, Regeneron Cut Heart Risks in Half But Questions Remain
March 16, 2015
By Mark Terry and Riley McDermid, BioSpace.com Breaking News Staff
New data concerning two cholesterol medications were published Sunday in the New England Journal of Medicine, with significant, if not definitive, evidence of their effectiveness.
Both medications are PCSK9 inhibitors, evolocumab, under development by Amgen , and alirocumab, being developed by Sanofi and Regeneron Pharmaceuticals, Inc. . Both drugs show significant effects in lowering LDL cholesterol. Side effects and tolerability are less clear.
“Reductions were seen in all classes of adjudicated events,” wrote Geoffrey Porges, a biotech analyst with Sanford Bernstein, in a note to investors Monday. “It is worth noting, however, that the absolute incidence of events in this sample was very low. Only 60 adjudicated cardiovascular events occurred in the OSLER-1 and OSLER-2 sample over the year followed.”
Thousand Oaks, Calif.-based Amgen announced the results yesterday of the Phase II (OSLER-1) and Phase III (OSLER-2) open-label studies of Repatha (evolocumab). The data was also presented at the Late-Breaking Clinical Trial session of the American College of Cardiology ’s 64th Annual Scientific Session.
“Data analysis from the OSLER studies show that evolocumab consistently reduced LDL cholesterol over the one-year period and reduced the rate of cardiovascular events when added to standard of care,” said Marc Sabatine, chair of the TIMI Study Group and a senior physician in the division of cardiovascular medicine at Brigham and Women's Hospital in Boston, in a statement. “We look forward to the results of the ongoing 27,500-patient dedicated outcomes study, FOURIER.”
On the same day, Tarrytown, N.Y.-based Regeneron Pharmaceuticals and Paris-based Sanofi announced the 18-month results of a Phase III trial of Praluent (alirocumab). The compound was studied in 2,341 high-risk patients with high cholesterol.
“These results demonstrated the durable efficacy for Praluent when added to the maximally-tolerated statin therapy and further reinforce its generally consistent safety profile,” said Jennifer Robinson, director of the Prevention Intervention Center and professor in the department of Epidemiology & Medicine at the University of Iowa in a statement. “Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent—we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events.”
The findings are promising, without being definitive. However, the positive results should make it easier for regulators to grant approval based on how well they reduce cholesterol levels. “It helps the companies developing these drugs,” said Steve Nissen, chief of cardiology at the Cleveland Clinic a statement, “to reassure the Food and Drug Administration that early approval, based on cholesterol-lowering benefits, is not a risky proposition.” Nissen was not involved in either study.
It is also expected to make it easier for insurance companies to add the drugs to their payment schedules while still giving them leverage in price negotiations with the companies. The companies have yet to provide data on potential prices. Analysts expect the Regeneron and Sanofi drug to hit the market first when the FDA makes a decision in July. Amgen ’s compound is expecting approval in August. Pfizer also has a similar drug in early stages of development.
“Amgen now consists in our opinion of two very different businesses held together by a common interest in profitable drug revenue and maintaining size and scale. Their legacy products contribute nearly 80 percent of revenue today, and 100 percent of their operating profit. However, these products face an increasing array of branded and generic challengers and are likely to come under increasing price pressure in developed markets around the world,” wrote Porges.
“Amgen also has a handful of growth products, which are based on relatively recent research investments and should soon be bolstered by the approvals for other breakthroughs such as evolocumab for lipid disorders, brodalumab for psoriasis and eventually romosozumab for osteoporosis,” he said. “The near term cost of developing and launching these potential blockbusters will be a brake on earnings growth through 2016, but should offer margin and growth upside after 2016, provided the launches are successful. The major risk and uncertainty facing the company now, is whether the market will be receptive to their new treatments, which could potentially be used by hundreds of thousands, if not millions, of patients.”
BioSpace Temperature Poll
After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? Tell us your thoughts.