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Merck's HIV Drug Gets Positive CHMP Opinion for Higher Dose
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Merck & Co., Inc. (MRK - Free Report) recently announced that the 600 mg film-coated formulation of its marketed drug, Isentress (raltegravir) in combination with other anti-retroviral therapies, has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The drug is meant for the treatment of adults and pediatric patients with HIV-1 infection (weighing at least 40 kg).
In such patients – adult or pediatric – the recommended dosage is 1,200 mg, comprising two 600 mg tablets once daily for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily. Presently, Isentress is approved in a 400 mg twice daily formulation for the treatment of HIV-1 infection in adults.
A final decision on approval is expected in the second half of 2017.
We remind the investors that the once-daily formulation of Isentress (600 mg tablets) is currently under review in the U.S. A decision is expected by May 27, 2017.
Shares of Merck have outperformed the Zacks classified Large Cap Pharma industry in the last one year. The stock has gained 16.1% during the period, while the broader industry witnessed an increase of 4.1%.
Coming back to the latest news, the positive opinion was supported by data from an ongoing phase III pivotal study (ONCEMRK) evaluating the efficacy and safety of Isentress in previously untreated adults with HIV-1 infection. In July last year, Merck announced positive efficacy and safety data from the study. After 48 weeks of treatment, Isentress (given as 2 x 600 mg once-daily) was found to be statistically non-inferior to the marketed formulation approved dose of Isentress 400 mg twice-daily, each in combination therapy with Gilead Sciences Inc.’s (GILD - Free Report) Truvada.
We note that Isentress faces competitive pressure and is being impacted by slowing growth of the integrase class. Sales of Isentress declined 8% in 2016 and 10% in 2015.
Merck currently carries a Zacks Rank #2 (Buy). Other top-placed stocks in the health care sector include VIVUS, Inc. and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.
Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
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Merck's HIV Drug Gets Positive CHMP Opinion for Higher Dose
Merck & Co., Inc. (MRK - Free Report) recently announced that the 600 mg film-coated formulation of its marketed drug, Isentress (raltegravir) in combination with other anti-retroviral therapies, has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The drug is meant for the treatment of adults and pediatric patients with HIV-1 infection (weighing at least 40 kg).
In such patients – adult or pediatric – the recommended dosage is 1,200 mg, comprising two 600 mg tablets once daily for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily. Presently, Isentress is approved in a 400 mg twice daily formulation for the treatment of HIV-1 infection in adults.
A final decision on approval is expected in the second half of 2017.
We remind the investors that the once-daily formulation of Isentress (600 mg tablets) is currently under review in the U.S. A decision is expected by May 27, 2017.
Shares of Merck have outperformed the Zacks classified Large Cap Pharma industry in the last one year. The stock has gained 16.1% during the period, while the broader industry witnessed an increase of 4.1%.
Coming back to the latest news, the positive opinion was supported by data from an ongoing phase III pivotal study (ONCEMRK) evaluating the efficacy and safety of Isentress in previously untreated adults with HIV-1 infection. In July last year, Merck announced positive efficacy and safety data from the study. After 48 weeks of treatment, Isentress (given as 2 x 600 mg once-daily) was found to be statistically non-inferior to the marketed formulation approved dose of Isentress 400 mg twice-daily, each in combination therapy with Gilead Sciences Inc.’s (GILD - Free Report) Truvada.
We note that Isentress faces competitive pressure and is being impacted by slowing growth of the integrase class. Sales of Isentress declined 8% in 2016 and 10% in 2015.
Merck & Company, Inc. Price
Merck & Company, Inc. Price | Merck & Company, Inc. Quote
Zacks Rank & Key Picks
Merck currently carries a Zacks Rank #2 (Buy). Other top-placed stocks in the health care sector include VIVUS, Inc. and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.
Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>