Amgen, Inc. AMGN and its partner UCB announced that its osteoporosis candidate, Evenity (romosozumab) has gained marketing approval in Japan, the first regulatory approval for the pipeline product. Evenity has been approved In Japan to reduce the risk of fractures and increase bone mineral density in men and postmenopausal women with osteoporosis at high risk of fracture.
Evenity is also under review in United States and Europe. In the United States, Amgen re-submitted the biologics license application (“BLA”) in July last year. The first BLA seeking approval of Evenity for the same indication in the United States was issued a complete response letter (“CRL”) by the FDA in July 2017. The CRL was issued due to a cardiovascular side effect observed in the ARCH study. The first BLA included data only from FRAME study. The FDA requested a resubmission of the application with additional data from the ARCH and the BRIDGE studies. The second BLA includes data from the ARCH and BRIDGE studies.
In November, Amgen had informed that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review the BLA for Evenity on Jan 16, 2019.
In Japan, the development of Evenity is being led by Astellas BioPharma, a joint venture between Amgen and Japanese drug company, Astellas Pharma.
In the past year, Amgen’s stock has risen 9.7% against 21.2% decrease of its industry.
Separately, Amgen announced that all device options of its PCSK9 inhibitor, Repatha including pre-filled syringe and the Pushtronex system are now available in the United States at a discount of 60%. The products are now available at a reduced list price of $5,850 per year.
Amgen announced its decision to cut the U.S. list price of Repatha by 60% in October last year to improve access and affordability of Repatha. Please note that Repatha SureClick autoinjector, the most popular device option of Repatha, has been available at a discounted price since Oct 24 last year.
Sales of the drug have suffered since launch due to payer restrictions. At the third quarter conference call held in October, Amgen had said that despite its efforts to improve access to Repatha, patients still face significant hurdles due to high co-pay expenses. Though lower price may impact Repatha sales in the near term, management is optimistic about better volumes.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the biotech sector are Aeterna Zentaris Inc. AEZS, Vanda Pharmaceuticals Inc. VNDA and Inovio Pharmaceuticals, Inc. INO, all sporting a Zacks Rank #1.
Estimates for Aeterna Zentaris have been revised from a loss of 37 cents to earnings of 2 cents for 2019 over the past 60 days. The stock has soared 48.9% in the past year.
Vanda’s earnings estimates have moved 11.1% north for 2019 over the past 90 days. The stock has surged 106.5% in a year.
Inovio’s loss estimates have remained unchanged in the past 60 days. The stock has risen 9.2% in a year.
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