Lyxumia(R) is First Diabetes Therapy of its Class Approved in Japan for use in Combination with Basal Insulin

AsiaNet 53574

PARIS, June 28, 2013 /PRN=KYODO JBN/--

    - First once-daily prandial GLP-1 receptor agonist offering a new treatment

option for Japanese people living with type 2 diabetes -

    Sanofi (EURONEXT : SAN and NYSE : SNY) announced today that Japan's

Ministry of Health, Labour and Welfare (MHLW) has approved the manufacturing

and distribution of Lyxumia(R) (lixisenatide) for the treatment of type 2

diabetes. Lyxumia, the first once-daily prandial GLP-1 receptor agonist (RA),

is also the first GLP-1 RA approved in Japan for use in combination with basal

insulin. Lyxumia is indicated for patients with type 2 diabetes mellitus when

the following do not provide adequate glycemic control: diet and exercise and

sulfonylureas (with and without biguanides) or diet and exercise and soluble

prolonged-acting or intermediate-acting insulin (with and without

sulfonylureas).

    "Lyxumia, as the first GLP-1 receptor agonist approved in Japan for use in

combination with basal insulin, will be a valuable new treatment option for

many of the country's 6 million plus people living with type 2 diabetes," said

Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi. "The MHLW

decision immediately enables the use of Lyxumia, which works in a way that

complements basal insulin."

    Although basal insulin treatment provides effective control of overall

glucose excursions by primarily targeting fasting plasma glucose (FPG),[1],[2]

as diabetes progresses over time, patients treated with basal insulin may no

longer stay at their HbA1c goals, despite good control of FPG. When this

happens, adding a medicine such as Lyxumia, which targets post-prandial

glucose, may be an effective strategy to further lower blood glucose levels and

reach HbA1c goals.

    MHLW approval in Japan is supported by the international GetGoal program,

which included a total of 11 clinical trials involving more than 5,000 patients

with type 2 diabetes. Among these trials is the pivotal Phase III study

GetGoal-L-Asia, which included 159 patients from Japan.[3]

    Lyxumia is now approved in Mexico, the European Union, Australia and Japan.

The New Drug Application for lixisenatide in the United States is currently

being reviewed.

    About Lyxumia(R) (lixisenatide)

    Lyxumia(R) (lixisenatide) is a glucagon-like peptide-1 receptor agonist

(GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1

is a naturally-occurring 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.

    Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:

ZEAL), http://www.zealandpharma.com, and is approved in Europe for the

treatment of adults with type 2 diabetes mellitus to achieve glycemic control

in combination with oral glucose-lowering medicinal products and/or basal

insulin when these, together with diet and exercise, do not provide adequate

glycemic control. Lyxumia is also approved in Mexico and Australia for the

treatment of adults with type 2 diabetes. Lyxumia is the proprietary name

approved by the European Medicines Agency and other health authorities for the

GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the United

States is under consideration.

    About Sanofi Diabetes

    Sanofi strives to help people manage the complex challenge of diabetes by

delivering innovative, integrated and personalized solutions. Driven by

valuable insights that come from listening to and engaging with people living

with diabetes, the Company is forming partnerships to offer diagnostics,

therapies, services and devices, including innovative blood glucose monitoring

systems. Sanofi markets both injectable and oral medications for people with

type 1 or type 2 diabetes.

    About Sanofi

    Sanofi, an integrated global healthcare leader, discovers, develops and

distributes therapeutic solutions focused on patients' needs. Sanofi has core

strengths in the field of healthcare with seven growth platforms: diabetes

solutions, human vaccines, innovative drugs, consumer healthcare, emerging

markets, animal health and the new Genzyme. Sanofi is listed in Paris

(EURONEXT: SAN) and in New York (NYSE: SNY).

    References

     1) Aronoff et al. Glucose metabolism and regulation: Beyond insulin and

glucagon. Diabetes Spectrum 2004; 17(3): 183-190.

     2) Riddle et al. Contributions of basal and postprandial hyperglycemia

over a wide range of A1c levels before and after treatment intensification in

type 2 diabetes. Diabetes Care 2011; 34(12): 2508-2514.

     3) Seino Y et al. Randomized, double-blind, placebo-controlled trial of

the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type

2 diabetes insufficiently controlled on basal insulin with or without a

sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab 2012; 14(10): 910-977.

     SOURCE: Sanofi Diabetes