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

Paris (ots/PRNewswire) -

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

option for Japanese people living with type 2 diabetes -

Sanofi 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 ,
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 and in New
York .

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.

ots Originaltext: Sanofi Diabetes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Corporate Media Relations, Marisol Péron,
Tel.: +(33)-1-53-77-45-02, marisol.peron@sanofi.com; Investor
Relations,
Sébastien Martel,
Tel.: +(33)-1-53-77-45-45, ir@sanofi.com; Global Diabetes Division
Communications, Philip McNamara,
Tel: +(1)-908-981-5497, Mobile: +(1)908-210-4047,
philip.mcnamara@sanofi.com