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Merck Serono's Fertility Treatment Pergoveris(TM) Approved in European Union
GENEVA, Switzerland, June 29 /PRNewswire/ -- - Pergoveris(TM) is the Only Infertility Treatment to Offer the Benefits of Recombinant Human FSH and LH in a Single Injection Merck Serono S.A. (virt-x: SEO) announced today that the European Commission has granted a marketing authorization for Pergoveris(TM) intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency. Pergoveris(TM) is the first biotechnology product based on the combination of recombinant human FSH (r-hFSH or follitropin alfa 150IU) and recombinant human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection. "The European Commission approval of Pergoveris(TM) is good news for infertile women in Europe who have severe endogenous FSH and LH deficiencies," said Hans Christian Rohde, Head of Global Therapeutic Area Reproductive Health, Merck Serono. "Pergoveris(TM) is the only fertility treatment which combines the benefits of two consistent and pure recombinant products - r-hFSH and r-hLH. The development of Pergoveris(TM) shows our innovative leadership in fertility treatments and ability to provide pure and high quality products". The European Commission decision applies to all 27 countries in the European Union(1), as well as Iceland, Liechtenstein and Norway. Launches of Pergoveris(TM) in the various countries of the European Union will start in the third quarter of 2007. (1) Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, The Republic of Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom Merck Serono and Fertility Treatment Merck Serono, the world leader in reproductive health, is dedicated to providing patient-friendly, innovative products to help couples build families. Merck Serono is the only company to offer a full portfolio of fertility drugs for every stage of the reproductive cycle and recombinant versions of the three hormones needed to treat infertility: GONAL-f(r) FbM (follitropin alfa), to stimulate the ovaries and produce eggs; Luveris(R) (lutropin alfa), to stimulate follicular development in women who are profoundly LH deficient; Cetrotide(R) (cetrorelix acetate) to prevent a premature ovulation; Ovitrelle(R) (choriogonadotropin alfa), to help follicles mature and release eggs; and Crinone(R) (progesterone gel), to help establish and maintain a pregnancy. Forward-looking statements Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Merck Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Merck Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Merck Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation. Merck Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release. About Merck Serono S.A. Merck Serono S.A. is a global biotechnology leader, with sales in over 90 countries. The Company is the world leader in reproductive health, with Gonal-f(R), Luveris(R) and Ovidrel(R)/Ovitrelle(R). It has strong market positions in neurology, with Rebif(R), as well as in metabolism and growth, with Saizen(R), Serostim(R) and Zorbtive(TM). The Company has recently entered the psoriasis area with Raptiva(R). Merck Serono's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases. Bearer shares of Merck Serono S.A., the holding company, are traded on the virt-x (SEO). About Merck Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 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. www.merckserono.net






