Upcoming AWS Coverage on Rockwell Medical Post-Earnings Results
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.
Today, AWS is promoting its blog coverage on SNY; touching on RMTI. Get all of our free blog coverage and more by clicking on the link below:
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.
Active Wall Street:
Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.
AWS has not been compensated; directly or indirectly; for producing or publishing this document.
PRESS RELEASE PROCEDURES:
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email firstname.lastname@example.org. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NOT AN OFFERING
This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/.
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Phone number: 1-858-257-3144
Office Address: 3rd floor, 207 Regent Street, London, W1B 3HH, United Kingdom
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.
SOURCE: Active Wall Street