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Amgen Gets Positive CHMP Opinion for Mimpara Label Expansion
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Amgen Inc. (AMGN - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval of a pediatric formulation (granules in capsule for opening) of Mimpara for the treatment of secondary hyperparathyroidism (HPT). Upon approval, the drug’s label will be expanded to include use for children aged three years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy where standard of care therapy cannot adequately control secondary HPT.
We note that the European Commission generally follows the recommendation of the CHMP but is not bound to do so. An approval will grant marketing authorization with unified labeling for Mimpara in 28 EU countries.
Amgen’s shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry so far this year. The stock gained 18.8% compared with the industry’s increase of 11.5% during the period.
The positive opinion is based on data from studies assessing the use of Mimpara in pediatric secondary HPT patients that have been conducted by Amgen since 2007.
Mimpara is already approved and marketed in EU as an oral therapy for secondary HPT patients and for the reduction of hypercalcemia in adult patients with parathyroid carcinoma.
Per the data from the press release, of the two million people receiving dialysis worlwide, the majority are affected by secondary HPT. The disease also occurs in patients with chronic kidney disease on hemodialysis.
Mimpara generated sales of $84 million in the first quarter of 2017, down 6% year over year, and $342 million in full year 2016, down 1% year-over-year in Europe. The label expansion, if approved, is expected to boost sales of the drug, which are currently witnessing a downside.
We remind investors that Mimpara is set to face generic competition soon in the U.S. Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. are looking to bring generic version of Sensipar (Mimpara) in the U.S. Amgen has filed a patent litigation lawsuit against both the companies seeking restraint on approval of any generic version of Mimpara by the FDA before the expiration of the drug’s patent.
Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters, with an average beat of 0.45%. Its share price is up 40.6% so far this year.
Sanofi’s earnings estimates moved up from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018, over the last 30 days. The company delivered positive earnings surprises in two of the last four quarters, with an average beat of 5.10%. The stock is up 22.8% so far this year.
Enzo Biochem’s loss estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company came up with positive earnings surprises each of the last four quarters, with an average beat of 55.83%. Its shares are up 65% so far this year.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These are sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.
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Amgen Gets Positive CHMP Opinion for Mimpara Label Expansion
Amgen Inc. (AMGN - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval of a pediatric formulation (granules in capsule for opening) of Mimpara for the treatment of secondary hyperparathyroidism (HPT). Upon approval, the drug’s label will be expanded to include use for children aged three years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy where standard of care therapy cannot adequately control secondary HPT.
We note that the European Commission generally follows the recommendation of the CHMP but is not bound to do so. An approval will grant marketing authorization with unified labeling for Mimpara in 28 EU countries.
Amgen’s shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry so far this year. The stock gained 18.8% compared with the industry’s increase of 11.5% during the period.
The positive opinion is based on data from studies assessing the use of Mimpara in pediatric secondary HPT patients that have been conducted by Amgen since 2007.
Mimpara is already approved and marketed in EU as an oral therapy for secondary HPT patients and for the reduction of hypercalcemia in adult patients with parathyroid carcinoma.
Per the data from the press release, of the two million people receiving dialysis worlwide, the majority are affected by secondary HPT. The disease also occurs in patients with chronic kidney disease on hemodialysis.
Mimpara generated sales of $84 million in the first quarter of 2017, down 6% year over year, and $342 million in full year 2016, down 1% year-over-year in Europe. The label expansion, if approved, is expected to boost sales of the drug, which are currently witnessing a downside.
We remind investors that Mimpara is set to face generic competition soon in the U.S. Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. are looking to bring generic version of Sensipar (Mimpara) in the U.S. Amgen has filed a patent litigation lawsuit against both the companies seeking restraint on approval of any generic version of Mimpara by the FDA before the expiration of the drug’s patent.
Amgen Inc. Price and Consensus
Amgen Inc. Price and Consensus | Amgen Inc. Quote
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Sanofi (SNY - Free Report) and Enzo Biochem, Inc. (ENZ - Free Report) . Regeneron sports a Zacks Rank #1 (Strong Buy) while Sanofi and Enzo Biochem carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters, with an average beat of 0.45%. Its share price is up 40.6% so far this year.
Sanofi’s earnings estimates moved up from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018, over the last 30 days. The company delivered positive earnings surprises in two of the last four quarters, with an average beat of 5.10%. The stock is up 22.8% so far this year.
Enzo Biochem’s loss estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company came up with positive earnings surprises each of the last four quarters, with an average beat of 55.83%. Its shares are up 65% so far this year.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These are sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.
See today's Zacks "Strong Sells" absolutely free >>.