Prne
September 15th, 2009
GENEVA - In the news release, “Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan” issued on 16 Sep 2009 07:00 GMT, by Merck Serono S A SWX:SEO over PR Newswire, we are advised by a representative of the company that the last sentence of the fourth paragraph has been changed from “In Japan, easypod(R) will be launched in September 2009″ to “In Japan, easypod(R) will be launched in the course of 2009″ as originally issued inadvertently. Complete, corrected release follows:
Merck Serono, a division of Merck KGaA Darmstadt, Germany, today announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency (PMDA), have granted a marketing authorization for easypod(R) in Japan. Easypod(R) was developed for exclusive use with cartridges of Saizen(R) (somatropin), Merck Serono’s human recombinant growth hormone for the treatment of growth hormone deficiency.
Easypod(R) is an innovative electronic auto injection device designed to improve ease of usage, reliability and convenience for patients who need daily subcutaneous injections of Saizen(R). It allows patients to self-inject in just three simple key steps. Additionally, a built-in dose memory automatically records the number of doses administered, allowing physicians and caregivers to accurately monitor patient adherence to therapy.
“Easypod is both an easy to use and intelligent device enabling physicians to track patients’ adherence to Saizen therapy, which is an essential component for optimal treatment outcomes,” said Franck Latrille, Executive Vice President, Head of Commercial International at Merck Serono. “We are pleased to offer this innovative and successful device today to patients in Japan.”
Easypod(R) is registered in 39 other countries worldwide including European countries and the United States. In Japan, easypod(R) will be launched in the course of 2009.
About Growth Hormone Deficiency
Growth hormone (GH) plays a central role in the growth process and maturation from child- to adulthood and regulates a number of metabolic and physiologic processes during the whole life. In children lack of GH will result in delayed maturation and short stature, whilst in adults the signs are more subtle, and include several psychological features, such as depression, anxiety, poor memory, and social isolation, as well as the physiological problems of weakness, poor vitality, easy fatigue, and weight gain. The current prevalence of pediatric GH disorder is estimated globally to be 100,000 children[1] and in Europe 50,000 adults suffer from the condition[2].
1 Journal of Clinical Endocrinology and Metabolism 1997;V.82 No.2:349
2 GH and IGF Research 2001; 11: 137-165
About Saizen(R)
Saizen(R) (somatropin) is a recombinant human growth hormone (GH) and is therapeutically equivalent to the natural GH produced by the body.
Saizen(R) is currently registered in 78 countries for the treatment of: - GH deficiency in children - GH deficiency in adult patients - Children born Small for Gestational Age - Turner’s syndrome - GH deficiency in children associated with chronic renal failure
The registered indications vary slightly from one country to another.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of around EUR 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 EUR 7.6 billion in 2008, a history that began in 1668, and a future shaped by 33,000 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.
For more information, please visit www.merckserono.com or www.merck.de
www.merckserono.com
Source: Merck Serono S A
Merck Serono, 9 Chemin des Mines Media Relations, 1202 Geneva Tel.: +41-22-414-36-00, Switzerland
Filed under Biotechnology, FDA Approval, Government and Policy, Health, Health Care / Hospitals, Pharmaceuticals | Tags: Geneva, Japan, Merck Serono S A, Switzerland | Comment Below
Related Press Releases Merck Serono Growth Hormone Injection Device easypod(R) Approved in JapanSeptember 15th, 2009 GENEVA - Merck Serono, a division of Merck KGaA Darmstadt, Germany, today announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency (PMDA), have granted a marketing authorization for easypod(R) in Japan. Easypod(R) was developed for exclusive use with cartridges of Saizen(R) (somatropin), Merck Serono's human recombinant growth hormone for the treatment of growth hormone deficiency. GONAL-f Approved in Japan for Ovulation Induction in Infertile WomenJuly 15th, 2009 GENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the Japanese Ministry of Health, Labor and Welfare has granted approval to extend the indication of GONAL-f(R) (follitropin alfa for injection) to infertile women suffering from irregular or no ovulation (oligoovulation or anovulation) due to a dysfunction in the hypothalamic- pituitary system or polycystic ovarian syndrome. GONAL-f is a recombinant follicle-stimulating hormone currently approved in Japan for the treatment of male infertility. Merck Serono Launches "Global Fertility Academy" to Provide Education and Training for the Treatment of InfertilityJune 30th, 2009 GENEVA, Switzerland -
- Global Fertility Academy Delivers Valuable Educational Tools Aiming at Increasing Expertise and Maximizing the Success Rate of Treatment
- Web-based e-Learning Modules Complemented by Individualized Practical Training Sessions at Leading Fertility Centers Worldwide
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the launch of the Global Fertility Academy, the first global professional educational program in fertility run by worldwide leading experts in this area.(1) Specifically developed for physicians active in treating infertility, such as reproductive endocrinologists, obstetricians/gynecologists and embryologists, the Global Fertility Academy aims at improving their knowledge of clinical standards in fertility and maximizing the success rates of treatment by providing valuable educational tools and sharing best practices. The Global Fertility Academy is available to healthcare professionals outside of the United States and Great Britain. First Phase III Clinical Trial Results of Safinamide in Advanced Parkinson's Disease to Be Presented at the Movement Disorder Society 13th International CongressJune 2nd, 2009 GENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner Newron Pharmaceuticals S.p.A. (SWX: NWRN) announced today that detailed results of the first Phase III clinical trial of safinamide as adjunctive treatment in mid- to late-stage Parkinson's disease (PD) (Study 016) will be presented at the Movement Disorder Society's 13th International Congress of Parkinson's Disease and Movement Disorders to be held in Paris, France, from June 7-11, 2009. Poxel SAS Set up to Find Innovative Solutions for Metabolic Diseases ManagementMay 27th, 2009 LYONS, France - Poxel SAS is Set up in Lyons - France
Poxel is a research integrated pharmaceutical Company (RIPCO), spun out from Merck Serono a division of Merck KGaA, Germany, following the decision of Merck Serono to no longer invest in diabetes research and development. It aims to advance promising assets for cardio-metabolic diseases (with a primary focus on Type 2 diabetes) from Research to Phase 2 Clinical Proof-of-Concept, before out-licensing these projects to major pharmaceutical companies. Merck Serono to Support First International Thyroid Awareness WeekMay 24th, 2009 GENEVA, Switzerland - 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. Merck Serono Committed to Investing in Innovation in the Fertility AreaMay 17th, 2009 GENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, confirms its commitment to investing in the therapeutic area of fertility, after Merck KGaA informed earlier today the Oslo Stock Exchange of its withdrawal of the voluntary cash tender offer for MediCult A/S, a leader in Assisted Reproductive Technologies (ART), as the required share threshold was not reached in the set timeframe. "Merck Serono has a proud heritage of leadership in the field of fertility and will actively pursue opportunities that will contribute to bring further innovation to physicians and patients, and increase the success rate of fertility treatments," said Dr. Merck Serono: New Phase III Data for Cladribine Tablets to be Presented at the American Academy of Neurology 61st Annual Meeting in April 2009March 29th, 2009 GENEVA, Switzerland - CLARITY (CLAdRIbine tablets Treating MS OrallY) Study Data to be
Presented as Late-Breaking Oral Presentation
GENEVA, Switzerland, March 30 /PRNewswire/ --
Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
announced today that the American Academy of Neurology (AAN) has accepted a
late-breaking abstract regarding cladribine tablets, its oral investigational
treatment of multiple sclerosis, for an oral presentation at the AAN 61st
Annual Meeting in Seattle. The abstract is entitled "Results from the CLARITY study: a
Phase III, randomized, double-blind study to evaluate the safety and efficacy
of oral cladribine in relapsing-remitting multiple sclerosis". Merck Serono Launches Strategic Venture Capital FundMarch 22nd, 2009 GENEVA, Switzerland - New Venture Capital Fund Will Invest in Biotech Start-up Companies
Focused on Merck Serono's Core Therapeutic Areas
Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
announced today the formation of 'Merck Serono Ventures', a strategic,
corporate venture capital fund to invest in emerging biotechnology companies. The fund will support biotech start-up companies that have the potential to
provide innovative products in Merck Serono's core therapeutic areas, in
particular in Neurodegenerative Diseases, Oncology and Autoimmune &
Inflammatory Diseases. Merck Serono and Fast Forward, LLC Announce Collaboration to Accelerate Development of Treatments for Multiple SclerosisMarch 17th, 2009 GENEVA, Switzerland - Merck Serono and Fast Forward Agree to Work Together to Speed Research
and Development on a Select Group of High Potential MS Research Projects With
Support of up to $19 Million in Funding
Merck Serono, a division of Merck KGaA, Darmstadt Germany, and Fast
Forward, LLC, a wholly-owned subsidiary of the American National Multiple
Sclerosis Society, today announced a collaborative partnership to evaluate
and fund promising multiple sclerosis (MS) research projects. Proposals will
be jointly developed by Merck Serono and Fast Forward.
Related News German drug, chemical maker Merck second quarter net profit falls 48 percent to euro109 millionJuly 24th, 2009 Merck Q2 net profit falls 48 percent to euro109 MFRANKFURT — German drug and chemical maker Merck KGaA said Friday its second quarter net profit fell 48 percent as higher research costs and one-time effects from the acquisition of Serono weighed on the bottom line. The Darmstadt-based company reported a net profit of euro108 million ($153 million) in the April-June period compared with euro207 million a year earlier. Merck and Schering-Plough say antitrust regulators want more details on $41.1B combinationJune 22nd, 2009 FTC requests more info from Merck, Schering-PloughNEW YORK — Drugmakers Merck and Co. and Schering-Plough Corp., which are in the process of a $41.1 billion tie-up, said Monday the Federal Trade Commission has asked for more information about the deal. Schering-Plough shareholders back $41.1 billion acquisition by partner Merck & Co.August 7th, 2009 Schering-Plough shareholders OK purchase by MerckTRENTON, N.J. — Shareholders of drugmaker Schering-Plough almost unanimously support being bought by bigger New Jersey neighbor Merck. Merck, Portola Pharmaceuticals sign deal worth up to $420 million to develop anticlotting drugJuly 9th, 2009 Merck, Portola in $420M deal for anticlotting drugWHITEHOUSE STATION, N.J. — Merck & Co. German pharma, chemical company Merck sees 1st-quarter net profit drop 76 percentApril 27th, 2009 Merck 1Q net profit falls 76 percentFRANKFURT — German pharmaceutical and chemical company Merck KGaA said Monday that its first-quarter net profit dropped by 76 percent as demand for chemicals in particular declined. Darmstadt-based Merck said net profit for the January-March quarter fell to euro57 million ($75 million) from euro239 million a year earlier. Merck to structure itself into 5 units following close of $41.1 billion Schering-Plough dealAugust 31st, 2009 Merck to form 5 divisions after Schering buyoutNEW YORK — Richard T. Clark, current president and CEO of Merck, says the company will restructure into five divisions after it completes the buyout of rival Schering-Plough for $41.1 billion. Drugmaker Merck seeks EU approval for $41B acquisition of Schering-Plough, expects ruling soonSeptember 21st, 2009 Merck seeks EU approval to buy Schering-PloughTRENTON, N.J. — Drugmaker Merck & Co. Shareholders of Merck, Schering-Plough to vote on combination, would create No. 2 drugmakerAugust 7th, 2009 Merck takeover of Schering-Plough up for voteTRENTON, N.J. — Shareholders will decide Friday whether two New Jersey drug companies will become the world's second-biggest drugmaker. Sanofi-Aventis to buy out partner Merck from Merial joint venture for $4 billion in cashJuly 30th, 2009 Sanofi-Aventis pays Merck $4B for share in MerialPARIS — Pharmaceuticals company Sanofi-Aventis SA said Thursday it has agreed to pay $4 billion in cash to U.S. drugmaker Merck & Co. Merck mulls selling off veterinary products, its own or Schering-Plough's, before $41B mergerJune 3rd, 2009 Merck may sell animal drug assets before mergerWHITEHOUSE STATION, N.J. — Drugmaker Merck & Co.
|
|
