Amgen, Inc. (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved a new cholesterol-lowering medication, Repatha™ (evolocumab) Injection. Repatha is a human 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.1 Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
“We are excited about today’s approval of Repatha in the U.S. as patients and physicians will now have a new treatment option to lower LDL cholesterol,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Data from key clinical studies have shown that Repatha significantly reduces LDL cholesterol in patients who have not been able to lower their LDL cholesterol through diet and statins alone. At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease.”
Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood.2,3 In the U.S., there are approximately 11 million people with ASCVD and/or familial hypercholesterolemia (FH), who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.4,5 Familial hypercholesterolemia is caused by genetic mutations that lead to high levels of LDL-C at an early age.6 It is estimated that one million people in the U.S. have FH (heterozygous and homozygous forms), yet less than one percent are diagnosed.7
“Through PCSK9 inhibition, evolocumab substantially reduces LDL or ‘bad’ cholesterol, a well-validated, modifiable risk factor for cardiovascular disease,” said Marc Sabatine, M.D., M.P.H., chairman of the TIMI Study Group, the Lewis Dexter, MD Distinguished Chair in Cardiovascular Medicine at Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston. “Many patients still require further LDL cholesterol lowering and evolocumab now offers an important new treatment option for them.”
In Phase 3 trials, adding Repatha to background lipid-lowering therapy that included statins resulted in intensive reductions in LDL-C levels with favorable effects on other lipid parameters. In patients with clinical ASCVD or HeFH, Repatha reduced LDL-C by approximately 54 to 77 percent compared with placebo.8 In a pivotal Phase 3 trial, 90 percent of clinical ASCVD patients who received Repatha in addition to maximum doses of statins achieved a LDL-C level less than 70 mg/dL.5 In patients with HoFH, Repatha reduced LDL-C by approximately 30 percent compared with placebo.8
Repatha is generally well-tolerated with an established safety profile. The most common adverse reactions that occurred in greater than 5 percent of the Repatha group, and more frequently than in the placebo group, were nasopharyngitis, upper respiratory tract infection, influenza, back pain and injection site reactions.8
Repatha is available as a single-use 140 mg prefilled SureClick® autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every two weeks or 420 mg once a month. For adults with HoFH, the recommended dose is 420 mg once a month. Amgen will continue discussions with the FDA regarding the 420 mg every two weeks dosing for HoFH patients.
The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually for the every two weeks administration. For the monthly 420 mg administration, Amgen plans to make a single injection monthly dosing option available next year. Until then, Amgen anticipates monthly administration predominately for HoFH patients. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.
“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “We are confident in the ability of Repatha to demonstrate real-world effectiveness and value based on intensive LDL cholesterol reductions, and we will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization. By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy.”
Amgen is committed to providing personalized support services for patients and providers in the U.S. through its RepathaReady™ program. RepathaReady is a comprehensive suite of services to help patients and providers, including one or more months of free Repatha through the Repatha Patient Start Program while insurance coverage is pending; the Repatha $5 co-pay card for eligible commercial patients; insurance coverage support; and injection training.
Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines throughThe Safety Net Foundation for qualifying individuals with no or limited drug coverage.
Repatha is expected to be available in the U.S. next week.
Today’s U.S. approval of Repatha follows the marketing authorization of Repatha in Europe, which was announced on July 21, 2015. (Original Source)
In reaction, shares of Amgen are trading slightly up in after-hours trading. AMGN has a 1-year high of $181.81 and a 1-year low of $127.67. The stock’s 50-day moving average is $163.74 and its 200-day moving average is $159.63.
On the ratings front, Amgen has been the subject of a number of recent research reports. In a report issued on August 17, Deutsche Bank analyst Robyn Karnauskas maintained a Buy rating on AMGN, with a price target of $195, which represents a potential upside of 25.2% from where the stock is currently trading. Separately, on August 12, RBC’s Michael Yee maintained a Buy rating on the stock and has a price target of $190.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Robyn Karnauskas and Michael Yee have a total average return of 11.7% and 6.5% respectively. Karnauskas has a success rate of 63.1% and is ranked #151 out of 3734 analysts, while Yee has a success rate of 58.8% and is ranked #537.
The street is mostly Bullish on AMGN stock. Out of 10 analysts who cover the stock, 6 suggest a Buy rating and 4 recommend to Hold the stock. The 12-month average price target assigned to the stock is $178.90, which implies an upside of 14.9% from current levels.