Analysts Cheer As Amgen Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor
April 16, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Amgen , the world’s largest biotech, has been granted approval by the U.S. Food and Drug Administration (FDA) to use its drug Corlanor (ivabradine) to treat patients with chronic heart failure, and that’s going to be a significant boost for its cardiovascular franchise, said an analyst with Piper Jaffray on Wednesday.
Chronic heart failure is considered a common disease, which causes millions of worldwide to lose the ability to pump and adequate supply of blood throughout the body. “There are close to 2 million NYHA class II/III HFrEF patients in the U.S., 86 percent of which are currently on beta blockers,” wrote Joshua Schimmer, a biotech analyst, in a note to investors.
“For the patients who are on beta blockers, there are likely 20 to 30 percent who still have HR > 70. In total (including patients intolerant of beta blockers), the addressable patient population for Corlanor in the U.S. is approximately 500,000 to 600,000, we believe,” he said. “We expect AMGN to ramp up its KOL-targeting efforts with this approval in hand and take advantage of its lead-time over NVS' LCZ696 which has a PDUFA date in August.”
RBC Capital Markets analyst Michael Yee has estimated that Corlanor might eventually bring in around $500 million annually for Amgen.
Amgen nabbed the rights to Corlanor from French drugmaker Servier, who has retained its European rights. In clinical trials the drug greatly reduce the risk of re-hospitalization for patients being treated, though the FDA’s nod this week came after a request for additonal data from Amgen.
Corlanor will carry an additional advisory packet warning of its occasional side effects of temporary vision disturbance, atrial fibrillation excessive slowing of the heart rate and high blood pressure.
"We see in the realm of a million patients in the U.S. who would be in this class and might have a heart rate in the range," Amgen's research chief, Sean Harper, told Reuters Wednesday.
Amgen acquired U.S. commercial rights to Corlanor from French drugmaker Servier, which sells the medicine in Europe.
Schimmer said that the benefits to Amgen’s cardiovascular franchise will be measurable, though it has some major milestones to look forward to in coming quarters.
“The PDUFA date for evolocumab (PCSK9 antibody) for elevated LDL is Aug 27, 2015. AMGN has also filed a lawsuit against REGN/SNY for infringement of its PCSK9 targeting patent estate,” he wrote.
“We are also focused on the ongoing Phase II study of an oral formulation of omecamtiv mecarbil (partnered with Cytokinetics, Inc. for chronic twice daily (BID) dosing in patients with chronic heart failure,” said Schimmer. “Omecamtiv mecarbil is reviewed in our deep dive, and represents a differentiated inotropic agent that appears to improve systolic function while reducing heart rate, fitting into our view of ‘cardio-energetics’ and ways to improve energy consumption efficiency in the heart. The data for the Phase II trial is expected later this year.
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After last week's news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?