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Amgen Announces Acceptance of MAA for Evenity in Europe


Amgen AMGN and its partner UCB announced that the marketing authorization application (“MAA”) seeking approval of Evenity for treating osteoporosis has been accepted by the European Medicine Agency (“EMA”). Amgen is looking to get Evenity approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture in Europe.

Shares of the company have increased 13.7% in the past year, outperforming the industry’s decline of 3.4% in that period.

The MAA included data from three pivotal phase III studies – FRAME, ARCH and BRIDGE – in postmenopausal women with osteoporosis, postmenopausal women with osteoporosisat high risk for fracture and men who have osteoporosis.

Evenity treats osteoporosis by increasing bone formation and reducing bone resorption simultaneously, which increases bone mineral density (“BMD”) and reduces the risk of fracture.

In the ARCH study, Evenity showed statistically significant superior fracture risk reduction in postmenopausal women compared to current standard of care for osteoporosis, Merck & Co., Inc.’s MRK Fosamax.

The EMA will review the potential of Evenity in increasing BMR as well as reducing risk of fracture and also cardiovascular safety signal from ARCH study.

We remind investors that the biologics license application (“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 BLA included data only from FRAME study and the FDA has requested a resubmission of the application with additional data from ARCH and BRIDGE study.

In a separate press release, Amgen reported that Mechelen, Belgium-based Biocartis Group has signed a development agreement with Amgen for developing the former’s Idylla(TM) CDx biomarker tests for analyzing novel oncology compound, which can be used for the treatment of certain solid tumors.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma sector include Celldex Therapeutics, Inc. CLDX and Catabasis Pharmaceuticals, Inc. CATB. Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celldex’s loss estimates remained stable at 93 cents for 2017 and at 90 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.36%.

Catabasis’s loss estimates narrowed from $1.39 to $1.37 for 2017 and from $1.09 to 89 cents for 2018 over the last 30 days. The company delivered a positive earnings surprise in the trailing four quarters with an average beat of 9.94%.

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