Amgen, Sanofi in Race to Get European Green light for Anti-Cholesterol Drugs
May 20, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – Amgen ’s cholesterol drug Repatha could be recommended for approval in Europe later this week, which would give the California-based Amgen a leg up over rival drugmaker Sanofi , which is seeking European approval for its own anti-cholesterol drug.
Repatha is on the four-day meeting agenda of the European Medicines Agency, which is expected to conclude Friday, the company confirmed this morning. The U.S. Food and Drug Administration (FDA) is expected to rule on Repatha in late August, although Sanofi’s Praluent will be ruled on by regulatory authorities in July.
Following news of the EMA’s discussion of the drug, Amgen’s stock was trading as high as $164.39 this morning over Tuesday’s closing price of $163.66. Sanofi’s stock was slightly down this morning, trading at $50.82 per share, 14 cents lower than its closing price of $50.96 per share.
Repatha is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. 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.
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.
Analysts have said that Repatha and Praluent, both PSCK9 inihbitors, 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.”
In March Amgen applied to market Repatha in Japan.
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.
Last week Amgen reported the company’s experimental anti-migraine drug AMG 334 cleared its Phase II trial endpoints, showing 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.
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