Biotech major, Amgen, Inc. (AMGN - Free Report) presented detailed results from the phase III cardiovascular outcomes study (FOURIER) on its PCSK9 inhibitor, Repatha, at the 2017 American College of Cardiology conference. Top-line results from the study were announced last month.
Data presented showed that Repatha lowers LDL-C or bad cholesterol to unprecedented low levels, which results in meaningful cardiovascular benefit in patients with clinically evident atherosclerotic cardiovascular disease. The study demonstrated that Repatha treatment led to a 15% reduction in the primary endpoint of risk of major adverse cardiovascular events (MACE), which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.
However, the magnitude of the benefit was probably below market expectations as the shares of Amgen tanked more than 6% on Friday.
However, so far this year, Amgen’s shares rose 14.9%, comparing favorably with an increase of 8% for the Zacks classified Biomed/Genetics industry.
Coming back to the FOURIER study data, Repatha significantly reduced risk of hard MACE (heart attack, stroke or cardiovascular death) by 20% compared with standard treatment with statin therapy. For individual components, with Repatha, risks of heart attack, stroke and coronary revascularization were nominally reduced by 27%, 21% and 22%, respectively. However, Repatha did not show any improvement in the risk of cardiovascular death, which raised investor concern.
Uptake of Repatha, which gained FDA approval in Aug 2015, has not been very encouraging so far due to pricing and re-imbursement issues/payer restrictions. At present, Repatha sells at a discount to the list price. Following the data, Amgen said it will offer innovative contract options to payers willing to remove barriers, including refunds for patients who have a heart attack or stroke. The outcomes data is the key to the commercial success of Repatha as it would broaden the use for the drug. Though data from the study looks good, it is not very clear if payers will be willing to improve access to Repatha based on this data.
Separately, data from the Repatha cognitive function study (EBBINGHAUS), which evaluated the impact on cognitive function in 1,974 patients enrolled in the FOURIER study were also presented at the medical meeting. Data from the study showed that the effect of Repatha on the primary endpoint of executive function was non-inferior to placebo.
In Jan 2017, Amgen announced that the U.S. District Court in Delaware granted it permanent injunction against infringement by Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) for two patents owned by Amgen for Repatha. The decision bans Sanofi and Regeneron from selling Praluent during the term of the two patents, which describe and claim monoclonal antibodies of PCSK9. Regeneron and Sanofi, however, appealed against the ruling in a higher court. The appeals court granted their request to stay (suspend) the permanent injunction, pending the outcome of the appeal.Praluent’s ban could in turn drive sales of Repatha.
Amgen currently carries a Zacks Rank #3 (Hold). A pharma stock worth considering is Summit Therapeutics plc (SMMT - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Summit Therapeutics rose 65.2% in the past one year while loss estimates for the current year ending Jan 2018 have narrowed around 2% in the past 60 days.
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