Merck Serono and Bristol-Myers Squibb Company Sign Diabetes Pact

Published: Mar 20, 2013

Darmstadt, Germany, March 19, 2013 – Merck Serono, a division of Merck in Darmstadt, Germany, today announced a collaboration for promotion of the type 2 diabetes drug Glucophage® (metformin hydrochloride) under different formulations in China. Under terms of the agreement, Merck Serono and Bristol-Myers Squibb will co-promote Glucophage in China through a profit-sharing arrangement. Glucophage has been marketed by Bristol- Myers Squibb-SASS in China since 1999. The two companies will utilize their existing resources and complementary strengths, with Bristol-Myers Squibb-SASS continuing to manufacture Glucophage’s IR® (immediate release) formulation. The collaboration will seek to expand the geographic distribution of Glucophage as well as provide diabetes-related health and medical information including education for health professionals. In addition, the co-promotion will significantly increase outreach to hospitals. Other terms of the agreement were not disclosed

“The incidence of type 2 diabetes in China is growing at a tremendous rate. This new collaboration will help ensure that we continue to be a leading solution provider for these patients. Both BMS and Merck Serono have long experience in the field of diabetes and this makes for a powerful partnership as we aim to improve the lives of patients in China,” said Belen Garijo, Merck Serono’s Chief Operating Officer. “Merck Serono's solid position in Emerging Markets will be further strengthened by the diabetes partnership in China.” “We believe the collaboration between Bristol-Myers Squibb and Merck Serono will expand access for Chinese patients to Glucophage,” said Jean-Christophe Pointeau, President, Bristol-Myers Squibb China: “The combined promotion efforts of the two companies will help reach more patients in urban and rural communities who have had less access to treatment and who can benefit from metformin, an established standard of care for treating Type 2 diabetes.” According to a recent estimate by the International Diabetes Federation (IDF), China now has the most people with diabetes of any country in the world. It has become a major public health problem in China with more than 90 million people suffering from the disease1. Current estimates are that more than 60% of patients with type 2 diabetes are undiagnosed2, possibly due to a combination of poor public awareness and limited opportunities for diagnosis

Merck Serono has a long history in the treatment of type 2 diabetes, which is the most common form of diabetes, accounting for at least 90% of all cases of diabetes3. The company developed metformin in 1957 and started its first commercialization under the brand name Glucophage in France. Since 2005, the IDF has recommended metformin as the treatment of choice for first-line therapy in its first ever evidence-based global guidelines for the management of type 2 diabetes4. To respond to patients’ individual needs, the company continued to develop new formulations and presentations of metformin including Glucophage XR®, an extended-release formulation; Glucophage Powder formulation in sachets; and Glucovance® (metformin and glibenclamide), a fixed-dose combination therapy. The availability, indications and prescribing information for these prescription-only medicines vary from country to country. BMS and Merck Serono intend to launch Glucophage XR in China in the near future

This partnership is a significant milestone for Merck Serono and the Merck Group as they strengthen their commitment to China

Notes 1 International Diabetes Federation. press-statement-china-study 2 Yang W, et al. N Engl J Med. 2010; 362(12): 1090-101

3, retrieved March 2013 4 International Diabetes Federation. Global Guideline for Type 2 Diabetes. Brussels: International Diabetes Federation, 2005 About Diabetes Diabetes has reached epidemic proportion in many regions of the world. According to the latest data released by the IDF, global studies demonstrate that the number of people with diabetes has reached 366 million in 20113 with 4 .6 million deaths in 20113. Among adults, it is the leading cause of new cases of blindness, kidney failure, and amputations of feet and legs. A person with diabetes has a shorter life expectancy and has about twice the risk of dying on any given day as a person of similar age without diabetes7

About Glucophage® Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus particularly in overweight patients when diet and exercise alone have failed. In adults, Glucophage® may be given alone or with oral antidiabetic agents, or with insulin. In children from 10 years old and adolescents, Glucophage® may be given alone or with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with Glucophage® as first-line therapy after diet failure

The most commonly reported side effects with Glucophage are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases; metallic taste, mild erythema, decrease of vitamin B12 absorption and lactic acidosis may also occur. Glucophage is contraindicated in patients with renal disease or renal dysfunction

Please refer to local monograph as prescribing information may vary from country to country

About Merck Serono Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology, immuno-oncology and immunology

About Merck Merck is a global pharmaceutical, chemical and life science company with total revenues of €11.2 billion in 2012, a history that began in 1668, and a future shaped by approximately 39,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since

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