Price-Point for Amgen's Anti-Cholesterol Drug Repatha Could be a Sticking Point for Investors
August 21, 2015
By Alex Keown, BioSpace.com Breaking News Staff
THOUSAND OAKS, Calif. – The U.S. Food and Drug Administration (FDA) is set to make a final regulatory approval for Amgen ’s new anti-cholesterol drug Repatha, a PSCK9 inhibitor, later this month and some investors have expressed concern over the final price-point of the medication.
This morning Sean Williams, an analyst with the Motley Fool, expressed such a concern, primarily based upon the cost of another recently approved PSCK9 inhibitor, Praluent, which is manufactured by Sanofi . That medication, which also targets the PSCK9 protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood, has a daily price-tag of $40, which amounts to $14,600. Williams noted the high cost of the drug is something that many insurance companies might not be willing to cover. If Amgen’s Repatha has a similar cost to consumers, it might not be a first-resort medication for some physicians to prescribe. Recently some prescribers including Express Scripts Inc. and CVS Health have been pushing for Sanofi and its partner Regeneron Pharmaceuticals, Inc. to offer discounts on Praluent.
“Long story short, if PCKS9 drug developers aren't willing to play a little hardball and lower their wholesale costs, they could find their revolutionary therapies on the outside of the approved formulary list,” Williams said. “Of course, pricing for Repatha is going to depend on two key factors (assuming it's approved by the FDA). First is the potential for a discount war between Amgen's Repatha and Regeneron and Sanofi's Praluent. Both are likely to be willing to give insurers substantial discounts if it means their drug becomes a PBM's or insurer's high cholesterol therapy of choice.”
Analysts at BioPharma Dive said Repatha and Praluent, both PSCK9 inhibitors, have the ability to change the landscape when it comes to treating cardiovascular issues primarily due to clinical trial data that showed the efficacy of both drugs to “lower hypercholesterolemia in the hardest-to-treat patients with refractory or familial hypercholesterolemia.” Other PCSK9 drugs are being developed by rival companies that could impact price competition. Pfizer is expecting a ruling to begin human trials sometime later this year on bococizumab, a PCSK9 inhibitor. Also, Alnylam is developing an RNAi therapeutic targeting PCSK9 in collaboration with The Medicines Company .
Repatha has already cleared regulatory hurdles in Europe. In May the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) authorized Repatha for the treatment of adults with certain high cholesterol issues, as well as for the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
In Phase III trials, Repatha lowered the bad cholesterol by about 60 percent and decreased the rate of cardiovascular events, including heart attack, heart failure leading to hospitalization and death, by approximately 50 percent. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
High cholesterol is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood. There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.
But, one thing to remember, and it’s something that Williams points out in his column, Amgen has had a strong run with new additions to its pipeline clearing regulatory hurdles, so the company is not dependent on one drug. Following its 2013 acquisition of Onyx Pharmaceuticals, Inc. for $10.4 billion, Amgen has been in a stronger position with 10 products either ready for regulatory approval, or in mid- to-late stage clinical development. The company has announced several successes, including with its anti-migraine drug AMG 334, which cleared its Phase II trial endpoints in April. The trial showed the drug, when compared to a placebo, lowered mean migraine days per month in patients – but only when delivered at its highest dose.
In April, the FDA granted approval to Amgen’s drug Corlanor (ivabradine) to treat patients with chronic heart failure – a drug that could bring in approximately $500 million or more in annual revenue some analysts have predicted. Amgen acquired U.S. commercial rights to Corlanor from French drugmaker Servier, which sells the medicine in Europe.
In December, the FDA also approved Blincyto, a drug designed to treat a rare form of acute lymphoblastic leukemia. Analysts predict Blincyto could generate about $400 million in annual sales, investopedia.com reported. However, the expected $178,000 price tag on the drug was worrying to some in the medical community.
Another drug Amgen has in its pipeline is Kyprolis, designed to treat multiple myeloma. Data from Phase III trials in March showed patients taking Kyprolis as part of their drug regimen lived approximately 18.7 months without their multiple myeloma worsening, which is about twice as long as patients taking Velcade, a popular treatment produced by Takeda Pharmaceuticals and Johnson & Johnson . Multiple myeloma is a blood cancer that kills more than 10,000 patients in the U.S. annually. Kyprolis patients showed fewer cases of weakness or numbness in their hands and feet, but had higher rates of cardiac and renal failure than those taking Velcade, Amgen said.
Since last year, Amgen has freed up capital from laying off about 20 percent of its workforce, part of an effort to slash $15 billion in expenses by 2018. The company has eliminated more than 4,000 global jobs from its payroll. The freed capital is expected to be used to drive additional clinical trials in an effort to get more drugs to market.