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Amgen: Phase III Data on Hyperparathyroidism Drug Published
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Amgen Inc. (AMGN - Free Report) announced that data from three phase III studies on its pipeline candidate, Parsabiv (etelcalcetide), were published in the Journal of the American Medical Association (JAMA). The studies evaluated Parsabiv in 1706 adult patients with secondary hyperparathyroidism (sHPT) on hemodialysis.
Amgen’s one-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry. Specifically, the company gained 8.9%, compared with the industry’s return of 4.7%.
The phase III, randomized, placebo-controlled studies were designed to evaluate the safety and efficacy of Parsabiv in the treatment of sHPT in adults on hemodialysis.
Data from the two parallel phase III studies on chronic kidney disease (CKD) patients (n=1023) with sHPT showed that Parsabiv met the primary endpoint and significantly reduced serum parathyroid hormone (PTH) levels — a key marker of sHPT. Moreover, the candidate led to an over 30% reduction in PTH levels in 74.7% of the patients, compared with 8.9% in the placebo arm. In addition, a head-to-head study (n=683) comparing Parsabiv to Amgen’s oral sHPT drug, Sensipar, met the primary endpoint. This head-to-head study demonstrated Parsabiv’s superiority over Sensipar in the proportion of patients achieving 30% or greater serum PTH reduction.
We note that in Nov 2016, the European Commission granted marketing approval to Amgen for Parsabiv. The approval did not come as a surprise given that in September, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had earlier rendered a positive opinion for the candidate in the sHPT indication. Moreover, in Dec 2016, Amgen's partner, Ono Pharmaceuticals (OPHLF - Free Report) , received manufacturing and marketing approval in Japan for Parsabiv for the same indication.
Note that Amgen received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv in this indication. The company has resubmitted the regulatory filing in the U.S. addressing the CRL, with a PDUFA date of Feb 9, 2017.
Per the company’s press release, SHPT is a chronic and serious condition that is estimated to affect two million individuals in the world, who are receiving dialysis. Approximately 88% of dialysis patients and 79% of patients on hemodialysis are expected to develop sHPT. Hence, an approval will provide Parsabiv access to a large population of eligible patients.
We expect investors to focus on further regulatory updates by the company pertaining to Parsabiv.
Amgen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Kite Pharma, Inc. and Enzo Biochem, Inc. (ENZ - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kite Pharma’s loss estimates widened from $5.50 to $5.48 for 2016 and from $7.00 to $6.85 for 2017 over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 7.89%. Its share price increased 8.6% in the past one month.
Enzo Biochem’s loss estimates widened from 17 cents to 16 cents for 2016 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
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Amgen: Phase III Data on Hyperparathyroidism Drug Published
Amgen Inc. (AMGN - Free Report) announced that data from three phase III studies on its pipeline candidate, Parsabiv (etelcalcetide), were published in the Journal of the American Medical Association (JAMA). The studies evaluated Parsabiv in 1706 adult patients with secondary hyperparathyroidism (sHPT) on hemodialysis.
Amgen’s one-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry. Specifically, the company gained 8.9%, compared with the industry’s return of 4.7%.
The phase III, randomized, placebo-controlled studies were designed to evaluate the safety and efficacy of Parsabiv in the treatment of sHPT in adults on hemodialysis.
Data from the two parallel phase III studies on chronic kidney disease (CKD) patients (n=1023) with sHPT showed that Parsabiv met the primary endpoint and significantly reduced serum parathyroid hormone (PTH) levels — a key marker of sHPT. Moreover, the candidate led to an over 30% reduction in PTH levels in 74.7% of the patients, compared with 8.9% in the placebo arm. In addition, a head-to-head study (n=683) comparing Parsabiv to Amgen’s oral sHPT drug, Sensipar, met the primary endpoint. This head-to-head study demonstrated Parsabiv’s superiority over Sensipar in the proportion of patients achieving 30% or greater serum PTH reduction.
We note that in Nov 2016, the European Commission granted marketing approval to Amgen for Parsabiv. The approval did not come as a surprise given that in September, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had earlier rendered a positive opinion for the candidate in the sHPT indication. Moreover, in Dec 2016, Amgen's partner, Ono Pharmaceuticals (OPHLF - Free Report) , received manufacturing and marketing approval in Japan for Parsabiv for the same indication.
Note that Amgen received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv in this indication. The company has resubmitted the regulatory filing in the U.S. addressing the CRL, with a PDUFA date of Feb 9, 2017.
Per the company’s press release, SHPT is a chronic and serious condition that is estimated to affect two million individuals in the world, who are receiving dialysis. Approximately 88% of dialysis patients and 79% of patients on hemodialysis are expected to develop sHPT. Hence, an approval will provide Parsabiv access to a large population of eligible patients.
We expect investors to focus on further regulatory updates by the company pertaining to Parsabiv.
Amgen Inc. Price
Amgen Inc. Price | Amgen Inc. Quote
Zacks Rank & Key Picks
Amgen currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Kite Pharma, Inc. and Enzo Biochem, Inc. (ENZ - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kite Pharma’s loss estimates widened from $5.50 to $5.48 for 2016 and from $7.00 to $6.85 for 2017 over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 7.89%. Its share price increased 8.6% in the past one month.
Enzo Biochem’s loss estimates widened from 17 cents to 16 cents for 2016 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>