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Sanofi Starts Olipudase Alfa Study, Praluent Ok'd in Japan
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Sanofi’s (SNY - Free Report) specialty care global business unit, Sanofi Genzyme, announced the dosing of the first adult patient in a pivotal phase II/III study (ASCEND) on its experimental enzyme replacement therapy, olipudase alfa. It is being evaluated for the treatment of non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B (NPD B).
The multi-national, multi-center, double-blinded, placebo-controlled study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of olipudase alfa when given intravenously once every 2 weeks for 52 weeks in adults with ASMD, specifically NPD B. In the study, 36 patients will be enrolled to assess the effect of the candidate on spleen size, lung function and other important clinical parameters.
Last June, Sanofi Genzyme had announced the initiation of a phase I/II study in pediatric patients with ASMD, specifically NPD B.
Sanofi Genzyme’s progress with the candidate is encouraging. Given the lack of approved treatments for ASMD, there exists a significant unmet need for drugs addressing this rare and debilitating disease.
We remind investors that olipudase alfa has been granted Breakthrough Therapy status by the FDA. The regulatory agency usually grants Breakthrough Therapy status to expedite the development and review of a candidate that is believed to have the potential to treat serious or life-threatening conditions.
PCSK9 Inhibitor Praluent Gains Japanese Approval
Early this week, Sanofi and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare has approved Praluent for the treatment of patients with hypercholesterolemia and familial hypercholesterolemia who are at high cardiovascular risk and in whom treatment with statins (HMG-CoA reductase inhibitors) is not sufficient.
Per the companies’ press release, Praluent 75 mg and 150 mg will be available in Japan as a single-dose pre-filled pen and syringe. We note that Praluent is already approved both in the U.S. and EU. Investor focus is expected to remain on the sales ramp up of Praluent given that the drug’s sales are yet to pick up.
Sanofi is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Innoviva, Inc. (INVA - Free Report) and Pfizer Inc. (PFE - Free Report) . While Innoviva sports a Zacks Rank #1 (Strong Buy), Pfizer carries a Zacks Rank #2 (Buy).
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Sanofi Starts Olipudase Alfa Study, Praluent Ok'd in Japan
Sanofi’s (SNY - Free Report) specialty care global business unit, Sanofi Genzyme, announced the dosing of the first adult patient in a pivotal phase II/III study (ASCEND) on its experimental enzyme replacement therapy, olipudase alfa. It is being evaluated for the treatment of non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B (NPD B).
The multi-national, multi-center, double-blinded, placebo-controlled study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of olipudase alfa when given intravenously once every 2 weeks for 52 weeks in adults with ASMD, specifically NPD B. In the study, 36 patients will be enrolled to assess the effect of the candidate on spleen size, lung function and other important clinical parameters.
Last June, Sanofi Genzyme had announced the initiation of a phase I/II study in pediatric patients with ASMD, specifically NPD B.
Sanofi Genzyme’s progress with the candidate is encouraging. Given the lack of approved treatments for ASMD, there exists a significant unmet need for drugs addressing this rare and debilitating disease.
We remind investors that olipudase alfa has been granted Breakthrough Therapy status by the FDA. The regulatory agency usually grants Breakthrough Therapy status to expedite the development and review of a candidate that is believed to have the potential to treat serious or life-threatening conditions.
PCSK9 Inhibitor Praluent Gains Japanese Approval
Early this week, Sanofi and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare has approved Praluent for the treatment of patients with hypercholesterolemia and familial hypercholesterolemia who are at high cardiovascular risk and in whom treatment with statins (HMG-CoA reductase inhibitors) is not sufficient.
Per the companies’ press release, Praluent 75 mg and 150 mg will be available in Japan as a single-dose pre-filled pen and syringe. We note that Praluent is already approved both in the U.S. and EU. Investor focus is expected to remain on the sales ramp up of Praluent given that the drug’s sales are yet to pick up.
Sanofi is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Innoviva, Inc. (INVA - Free Report) and Pfizer Inc. (PFE - Free Report) . While Innoviva sports a Zacks Rank #1 (Strong Buy), Pfizer carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>