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Merck Serono Launches Thyroid Disorder Awareness Campaign: Millions at risk as thyroid disorders remain undiagnosed - But Serono USA refuses community request for tesamorelin early access program
  26 May 2009

FROM JULES: Serono Refuses Tesamorelin Early Access. community advocates in the USA have been trying hard for a long time without success in advocating with Serono USA based in Massachusetts to request an early access program to tesamorelin, which is a growth-hormone releasing factor and reduces belly fat and was developed by Theratechnologies a small biotech in Montreal, Canada and purchased by Merck Serono. Serono appears to be refusing the patient advocacy community their request for early access availability. This is the usual behavior by Serono as this company and its growth hormone drug Serostim have a checkered history. Before Merck was involved there is a history of fraudulent use, sales, and undue profitmaking associated with the highpriced Serostim. Serono officials based in Massachusetts told community in a meeting last year "we have changed", but refusing an early access program appears to reflect the same old behavior.

A campaign backed by Merck Serono is looking to raise awareness of thyroid disorders, which affects more than 300 million, although over half are thought to be unaware of the problem.

The first ever International Thyroid Awareness Week began yesterday and the company is working with the Thyroid Federation International to raise awareness of thyroid dysfunctions and their consequences. The campaign was launched last month at the European Congress of Endocrinology meeting in Istanbul where academics and the president of TFI, Yvonne Andersson, noted that millions of people are suffering needlessly because they are unaware of the symptoms and impact of thyroid disorders.

One of the problems is that the symptoms are common to other conditions, so the correct diagnosis can be missed. People with an underactive thyroid (hypothyroidism) may feel tired, depressed, gain weight unexpectedly and have fertility problems, while heart disease, psychosis and coma can occur if the problem is not tackled. The risk of heart attacks and stroke is increased by overactive thyroid (hyperthyroidism) and can also have a devasting effect on pregnant women and the developing foetus.

Ms Andersson told the briefing in Istanbul that thyroid dysfunctions can be easily detected with a simple, and in most countries cheap, blood test to check a patient's TSH (thyroid stimulating hormone). Treatment is normally required for life but can be successfully managed, with treatments such as Merck's Euthyrox (levothyroxine) and Thyrozol (thiamazole).

Ms Andersson told PharmaTimes World News that she has been inspired by the leaps that patient organisations have made in areas such as cervical cancer and hopes that working with medical professionals and spreading the word through awareness campaigns can help tackle a disorder that is "worryingly under-recognised".

"Merck Serono To Support First International Thyroid Awareness Week"

press announcement from company

Geneva, Switzerland, May 25, 2009 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that in the frame of the first International Thyroid Awareness Week, from May 25 to 31, the company in cooperation with Thyroid Federation International (TFI) will launch an awareness campaign, also supported by the European Thyroid Association (ETA) and the Latin American Thyroid Society (LATS), to raise awareness of thyroid dysfunctions and their consequences, in approximately 40 countries worldwide. Together with the international patient organization TFI, Merck Serono will provide information on these under-diagnosed diseases through professional educational sessions and distribution of information to the public. These materials will be distributed in several languages and are available online for download.

"There are millions of people around the world who may be suffering needlessly because they are unaware of the symptoms and impact of thyroid disorders. Since thyroid hormones regulate the metabolism, an overactive or underactive thyroid gland can produce a wide variety of symptoms; but more importantly is that left untreated these symptoms can potentially lead to life-threatening complications", said Yvonne Andersson, President of TFI. "By raising awareness of the common signs and symptoms of thyroid dysfunctions, we want to encourage people to seek medical advice if they believe they might be at risk." Today, it is estimated that 300 million people suffer from thyroid dysfunctions and over half are presumed to be unaware of their condition. An under- or overactive thyroid News Release Page 2 of 3 (hypothyroidism and hyperthyroidism) may occur at any time in life. Women in particular are five to eight times more likely to be affected than men. If left untreated, both hypothyroidism and hyperthyroidism can lead to serious complications, among which are cardiovascular diseases. Untreated thyroid disorders can also affect both pregnant women and the developing fetus.

"Most thyroid diseases are life-long conditions affecting patients' quality of life.

However because symptoms may be mild or non-specific, such as tiredness, weight gain, intolerance to cold or even depression, diagnosis is often missed or delayed", said Dr. Richard Douge, Executive Vice President Global Marketing at Merck Serono.

"However thyroid dysfunctions can be easily detected through a blood test and successfully managed with medical care".

Merck Serono has a longstanding commitment to the treatment of thyroid diseases dating back to 1894 when its first thyroid medicine was launched. Today the company markets Euthyrox® (levothyroxine sodium) and Novothyral® (levothyroxine sodium, liothyronine sodium) for the treatment of hypothyroidism, Thyrozol® (thiamazole) for hyperthyroidism, JodidTM (potassium iodide) for iodine deficiency (a cause of enlargement of the thyroid gland leading to goiter) and Jodthyrox® (levothyroxine sodium and potassium iodide) for the treatment of goiter. In 1994, with the support of the International Council for the Control of Iodine Deficiency Disorders (ICCIDD), the International Children's fund (UNICEF) and the World Health Organization (WHO), the company contributed to the first international survey on the prevalence of iodine deficiency using the company's emblematic ThyroMobil, a mobile van equipped with an ultrasound scanner for thyroid screening, to collect data among the population on four continents. Currently, Merck Serono has launched an educational campaign in China and intends to support an epidemiological project to shed light on the prevalence of thyroid disorders in China.

More information on thyroid disorders and their impact on patients' life are available News Release Page 3 of 3 About the Thyroid Federation International (TFI) The Thyroid Federation International first convened in Toronto at the 11th International Thyroid Congress in September 1995. Diana Meltzer Abramsky, who in 1980 founded the Thyroid Foundation of Canada in Kingston, Ontario Canada, first advocated the vision of a world thyroid patient organization to deal with the problems of thyroid disease in a global perspective. Since then the Federation has grown to include thyroid organizations in many parts of the world, including Europe, North and South America, Australia and Japan.

TFI is an independent, worldwide network of patient-support organizations. The Federation works together for the benefit of those affected by thyroid disorders by providing information and raising awareness, by encouraging and assisting the formation of patient-oriented groups, and by working closely with the medical professions. TFI has a Medical Advisory Board, which consists of some of the most eminent thyroid specialists in the world.

For more information, please visit About Merck Serono Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of around 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck Merck is a global pharmaceutical and chemical company with total revenues of 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 employees in 60 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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