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Amgen (AMGN) Reports Positive Data on Prolia and Repatha

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Amgen, Inc. (AMGN - Free Report) announced positive top-line results from a phase III study on Prolia for use in patients with glucocorticoid-induced osteoporosis.

The study evaluated the efficacy and safety of Prolia 60 mg administered subcutaneously every six months, compared with Actonel 5 mg daily in patients receiving glucocorticoid treatment.

Data from the study showed that treatment with Prolia for 12 months led to higher gains in bone mineral density (BMD) at the lumbar spine and total hip, in both patients receiving continuing glucocorticoid therapy and patients starting with glucocorticoid therapy compared to Actonel.

We remind investors that Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture as well as to increase bone mass in men with osteoporosis at high risk for fracture. Prolia is also approved in the EU for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures among others.

Concurrently, Amgen announced encouraging results on Repatha from three 12-week phase III studies at the at the European Society of Cardiology (ESC) Congress 2016. Data showed that Repatha consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia. We note that Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.

We note that Amgen’s growth products – Prolia, Xgeva, Vectibix, Nplate, Sensipar and Enbrel – are all performing well. These products totaled $3 billion in revenues in the second quarter of 2016 or more than half of second quarter product sales, growing 13% year over year. Contribution from new products such as Repatha should also be meaningful this year, thereby boosting sales and countering sluggish sales of mature products. Last week, however, the company received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Actelion Ltd. . While both Anika and ANI Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).

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