Merck Serono to Expand Research and Development Presence in ChinaChina's Research and Development Organization Will Become the Fourth Key R&D Hub for Merck Serono Worldwide Merck Serono Named as a Top Employer by Science MagazineGENEVA - - Merck Serono, the Division for Innovative Biotech and Pharmaceutical Medicines of Merck KGaA, Ranked No. 6 Among 575 Biotech and Pharma Employers Merck Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United StatesGENEVA - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies. New Data From CLARITY Study on Disease Activity in MS Patients who Received Cladribine Tablets Presented at 25th ECTRIMS CongressDÜSSELDORF, Germany and GENEVA - - Post-hoc Analysis From CLARITY Study Show That Short-Course Oral Treatment With Cladribine Tablets Significantly Increased the Proportion of Patients who had Absence of Disease Activity Compared With Placebo Results From Improve Study Show MRI Benefits of Rebif(R) Seen Early in Relapsing-Remitting Multiple Sclerosis Treatment and Sustained Over TimeGENEVA - - Data Presented at the 25th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) Held in Dusseldorf, Germany, From September 9-12, 2009. Merck Serono Submits Application for Cladribine Tablets as Multiple Sclerosis Therapy in EuropeGENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS). Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS, as all disease-modifying therapies currently approved for the treatment of MS are injectable. GONAL-f Approved in Japan for Ovulation Induction in Infertile WomenGENEVA, 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 InfertilityGENEVA, Switzerland - - Global Fertility Academy Delivers Valuable Educational Tools Aiming at Increasing Expertise and Maximizing the Success Rate of Treatment Merck Serono Launches RebiSmart(TM), First Electronic Injection Device for Delivery of Multiple Sclerosis Treatment Rebif(R)GENEVA - - RebiSmart(TM) is Designed to Improve Ease of Handling and Usage and Introduces the Potential for Improved Treatment Adherence for Multiple Sclerosis Patients New Data From CLARITY Study Presented at 19th ENS Meeting Show Rapid and Sustained MS Relapse Reduction for Cladribine TabletsMILAN, Italy and GENEVA, Switzerland - The Effect of Short-course Oral Treatment With Cladribine Tablets on Annualized Relapse Rate was Significant as Early as 12 Weeks After Initiation of Treatment and Sustained Through to the 96 Weeks of the Study First Phase III Clinical Trial Results of Safinamide in Advanced Parkinson’s Disease to Be Presented at the Movement Disorder Society 13th International CongressGENEVA, 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. Merck Serono Committed to Investing in Innovation in the Fertility AreaGENEVA, 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 Initiates SETTLE, the Second Phase III Clinical Trial of Safinamide in Advanced Parkinson’s DiseaseGENEVA, Switzerland - Additional Important Effects of Safinamide Noted in Ongoing Analyses of First Phase III Clinical Trial Done in Similar Patient Population (study 016) Merck Serono Launches Glucophage Powder in First European CountriesGENEVA - Innovative Powder Formulation of Metformin Designed to Facilitate Adherence by Increasing Patient Choice in the Treatment of Type 2 Diabetes, Now Available in France and the United Kingdom Merck Serono Launches Glucophage(R) Powder (Metformin Hydrochloride) in First European CountriesFELTHAM, England - Innovative Powder Formulation of Metformin Designed to Facilitate Adherence by Increasing Patient Choice in the Treatment of Type 2 Diabetes, Now Available in France and the United Kingdom Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple SclerosisSEATTLE and GENEVA - Primary Endpoint met With a Significant Reduction in Relapse Rate - Secondary Endpoints met Including MRI Measures, Proportion of Patients Relapse-Free and Disability Progression - Submission for Registration of Cladribine Tablets Planned for mid-2009 Merck Serono Launches Kuvan(R) in EuropeGENEVA - First Drug in Europe Indicated for the Treatment of Hyperphenylalaninaemia (Hpa) due to Phenylketonuria (Pku) or Tetrahydrobiopterin (BH4) Deficiency, now Commercially Available in France, Germany and the United Kingdom |
