Amgen Beats Sanofi to Market with EU Hurdle for Anti-Cholesterol Drug

Amgen Beats Sanofi to Market with EU Hurdle for Anti-Cholesterol Drug
May 22, 2015
By Alex Keown, BioSpace.com Breaking News Staff

THOUSAND OAKS, Calif. -- Amgen will be the first to market a new anti-cholesterol drug in Europe, beating out rival drugmaker Sanofi , which is seeking approval for its own anti-cholesterol drug.

Amgen announced this morning the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) offered a favorable opinion for the marketing authorization of Repatha (evolocumab), recommending approval for use in certain patients with high cholesterol. The European regulatory agency recommended granting Repatha marketing authorization for the “treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin.”

Additionally the drug was authorized for the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies, the agency said. The opinion will be reviewed by the European Commission for final marketing approval. If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU.

“We are pleased to receive a positive opinion from the CHMP for Repatha as it is an important step in providing a new treatment option for patients with high cholesterol, who are unable to reach their LDL cholesterol goals with current therapies in the European Union," Sean E. Harper , executive vice president of Research and Development at Amgen said in a statement. “Uncontrolled high cholesterol is a burden on the health system and we look forward to continuing to work with regulatory authorities to bring Repatha to patients across Europe.”

Amgen’s stock did not receive an early morning positive bump from the news, trading at a morning low of $162.82, down from the opening of $163.25.

While Amgen appears to be the first to market in Europe, Sanofi is likely to beat the California-based Amgen to market in the U.S. The U.S. Food and Drug Administration (FDA) is expected to rule on Repatha in late August and Sanofi’s Praluent will be ruled on by regulatory authorities in July.

In March, Amgen applied to market Repatha in Japan.

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. 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.

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.” Pfizer is also expecting a ruling sometime later this year on its own PCSK9 inhibitor.

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.



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