FDA Approves Adlyxin

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes

PARIS, July 27, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."

The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.

Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.

Adlyxin is approved under the proprietary name, Lyxumia® in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.

About Adlyxin

Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise. GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

About Sanofi Diabetes & Cardiovascular

Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE: Sanofi

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Novel Therapeutic Advances for Management of Diabetes Mellitus

Diabetes mellitus (DM) has become one of the most challenging health problems in the 21st century. It is a serious public health problem globally, but the good news is that various advances are being made in prevention, detection, and treatment of diabetes. Though prevention is always better than cure, yet sometimes prevention is not possible and the cure seems to take ages. The interest to find a possible cure for diabetes has eventually led to exploration of various new scientific areas of research.

Volanesorsen

Volanesorsen (formerly ISIS-APOCIIIRx)is an antisense drug in development intended to treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents.Elevation in triglycerides has always increased the risk of cardiovascular disorders as well as type 2 diabetes mellitus (T2DM). Researchers from the University of Pennsylvania have found the therapeutic effect of lipid-lowering medication sin improving insulin sensitivity in people with T2DM. Volanesorsen is an oral medication that can help to control the blood sugar levels. Itis believed to improve the insulin sensitivity and significantly decrease the patients’ overall glycated hemoglobin (HbA1c). After taking the medication for 12 weeks, researchers found that adult T2DM patients receiving volanesorsen experienced 69% reduction in triglycerides, and 57% improvement in whole-body insulin sensitivity.Researchers concluded that decrease in triglycerides was strongly related to improved insulin sensitivity and improved HbA1c.

PEGylated Lispro

PEGylated lispro (LY2605541) has been developed by the addition of polyethylene glycol (PEG) to insulin lispro, leading to its extended half-life. Early phase evaluations of PEGyalted lispro confirm its non-inferiority to glargine with a potential weight advantage when used in T2DM. Since insulin therapy is anabolic and its initiation is commonly associated with weight gain, an insulin preparation associated with a beneficial weight profile would represent a particularly valuable therapeutic entity.

Pre-clinical studies indicate that LY2605541 has low mitogenic potency, exerting a preferential hepatic effect on glucose homeostasis. However, LY2605541 appears to cause elevated transaminases and derangement of lipid profiles. On the basis of these initial observations, LY2605541 requires further extensive clinical evaluation to fully assess its risk/benefit profile in the management ofdiabetes.

Islet Transplantation

A novel technology has been developed to help treat type 1 diabetes mellitus (T1DM) and potentially negate the need for insulin injections. Islets are organoids that produce multiple hormones, including insulin, and donated islets are already treating severe cases of T1DMeffectively. Islet transplantation can transform the lives of T1DM patients, and may result in long-term freedom from insulin injections with excellent glucose control.

Natural Products

Plants possessing antidiabetic properties may be suitable as an adjunct to the existing therapies or as a prospective source of new hypoglycemic compounds. Many new bioactive drugs isolated from plants demonstrate antidiabetic activity equal to known oral hypoglycemic agents such as tolbutamide and chlorpropamide. Several plant species with terpenoids, flavonoids, phenols, coumarins, and other bioactive constituents have shown their potency in reducing blood glucose levels. Plants likeAllium sativum(Liliaceae),Gymnema sylvestre(Asclepiadaceae),Murraya koenigii(Rutaceae),Allium cepa(Liliaceae),Withania somnifera (Solanaceae), andFerula foetida (Umbelliferae) have exhibited antidiabetic properties when assessed in experimental models of diabetes. These traditional approaches might prove to bebeneficial in treatment of diabetic complications.

Great strides have been made clinically in the management of diabetes. Extensive research may lead to discovery of newer and better options for diabetes. With new technologies revolutionizing the treatment possibilities, the search for an effective medication is not far ahead.

Turacoz Healthcare Solutions aims to create awareness for such healthcare issues like diabetes mellitus which pose a serious threat to people, irrespective of race, gender, or age. We consider it our corporate responsibility to share the knowledge related to therapeutic research and development, and keep you updated with the recent medical advancements in the healthcare industry.“Being aware of a disease and its deleterious consequences”is the first-step towards its prevention. So stay healthy and stay long.

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