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LONDON, UK / ACCESSWIRE / May 22, 2017 / Active Wall St. blog coverage looks at the headline from Sanofi (NYSE: SNY) as the Company announced on May 19, 2017, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion for the marketing authorization of Insulin lispro Sanofi®. Register with us now for your free membership and blog access at:
One of Sanofi's competitors within the Drug Manufacturers - Major space, Rockwell Medical, Inc. (NASDAQ: RMTI), reported on May 09, 2017, results for the quarter ended March 31, 2017. AWS will be initiating a research report on Rockwell Medical in the coming days.
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Insulin lispro Sanofi® is used in the treatment of adults and children with Diabetes Mellitus including those who have been recently diagnosed with diabetes and who are insulin dependent to maintain their blood sugar levels. CHMP's positive opinion is the first major regulatory milestone for Sanofi, for the use of a biosimilar for the treatment of diabetes.
Commenting on the matter, Jorge Insuasty, MD, Senior Vice President, Global Head of Development of Sanofi said:
"We welcome the CHMP positive opinion for Insulin lispro Sanofi® and look forward to the final decision of the European Commission (EC). Our development of this investigational biosimilar product reflects Sanofi's expertise and long-term heritage in developing and manufacturing high-quality insulins for people with type-1 or type-2 diabetes and their physicians."
CHMP's Marketing Authorization
Insulin lispro Sanofi® is the biosimilar of Eli Lilly's Humalog (insulin lispro), which was authorized in the EU on 30 April 1996. Insulin lispro Sanofi® will be marketed in the injection form of 100 units/ml. The CHMP concluded that Insulin lispro Sanofi® is "highly similar" to Eli Lilly's Humalog, and is supported by data showing that it has "comparable quality, safety and efficacy".
CHMP's positive recommendation is based on the data from the Sanofi's clinical development program covering over 1,000 adults with type-1 or type-2 diabetes. This program included a Phase I study of pharmacokinetic/pharmacodynamic (PK/PD) to evaluate the product's similarity in exposure and activity compared to insulin lispro 100 Units/mL as currently approved in the US and EU. This was followed by two multi-center Phase IIIa clinical trials (SORELLA 12 and SORELLA 2) evaluating its safety and efficacy compared to insulin lispro 100 Units/mL as currently approved in the US and EU in adults with type-1 or type-2 diabetes, and a safety study in insulin pumps in adults with type-1 diabetes.
The European Commission would take a final call on the marketing authorization of Insulin lispro Sanofi®. The Commission usually takes around 60 days after the CHMP's recommendation to make a decision.
About Insulin lispro Sanofi®
Insulin lispro Sanofi® is the biosimilar of Eli Lilly's Humalog. The active substance of the biosimilar is insulin lispro, which is a rapid-acting insulin analog. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin lispro is absorbed more rapidly by the body and can therefore act faster than human insulin. It is produced using recombinant DNA technology and has the identical amino acid sequence as its reference product. It was submitted to the European Medicines Agency (EMA) in September 2016 and at present not approved for use by any regulatory authority.
Sanofi's Commitment towards Treatment of Diabetes
Sanofi is a global life sciences Company that discovers, develops, and distributes therapeutic solutions focused on patients' needs. Its global business is divided into five verticals - Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur, and Consumer Healthcare.
According to the World Health Organization (WHO), 9% of adults 18 years and older worldwide were living with diabetes in 2014; which means that there are over 400 million diabetics across the globe. Sanofi has been relentlessly working towards offering all-round therapeutic solutions – medicines, medical devices, services, etc – to patients as it believes diabetes is a public health concern worldwide.
The Company in the last 10 years has invested more than €1 billion, in building the largest industrial complex in the world and center of insulin expertise, near Frankfurt, Germany called the Insulin City. The Company recently inaugurated a €75 million high-tech building equipped with the most modern technology and designed to produce a new type of insulin to treat around 6 million patients.
On Friday, May 19, 2017, the stock closed the trading session at $49.31, marginally climbing 0.33% from its previous closing price of $49.15. A total volume of 1.39 million shares have exchanged hands. Sanofi's stock price surged 13.70% in the last month, 18.00% in the past three months, and 23.70% in the previous six months. Furthermore, on a year to date basis, the stock rallied 25.93%. Shares of the company have a PE ratio of 24.45. The market capital of the stock is $124.90 billion following Friday's closing price.
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