Darmstadt/Germany (PROTEXT) - Merck KGaA today announced thatFem7 Combi, the second in its family of transdermal hormone-replacement therapies to alleviate menopausal symptoms, receiveda positive opinion from the European Health Authorities (MutualRecognition Procedure). National marketing authorizations inEurope will follow later this year. Fem7 Combi, the world's first seven-day combination-hormonepatch, was approved last year in France. Sales in France are setto begin in June 2001 with product launches in other EU countriesfollowing later in the year. The first sales of the Fem7 Combiare expected this month in Switzerland and Chile, where healthauthorities also have approved the hormone-replacement patch. Fem7 Combi contains a sequential combination of estrogen andprogestagen for continuous use, combining the hormones estradiolhemihydrate and levonorgestrel. The treatment consists of twophases - two seven-day patches containing only estradiol for thefirst two weeks of the cycle followed by two seven-day patchescontaining both estradiol and levonorgestrel for the last twoweeks of the cycle. The flexible transparent matrix patchesrequire less estrogen than tablets because the hormone isabsorbed directly through the skin, avoiding first metabolism bythe liver. Estradiol, which also is produced naturally by the human body,substitutes for the loss of estrogen production in menopausalwomen and alleviates symptoms such as hot flashes and sweats.Levonorgestrel is a synthetic progestin, which is added tocontrol the estrogen-induced growth of the endometrium. Merck launched its first seven-day hormone-replacement patch,the estrogen-based Fem7 for the treatment of menopausalcomplaints, in the UK in 1996 and in the rest of Europe and LatinAmerica in 1998. Yet another hormone-replacement patch - in which bothestradiol and levonorgestrel are administered through the entirecycle - is in preparation for submission to health authorities inboth Europe and the USA. Sales are expected to begin in 2002.Merck will have the European marketing rights for this third-generation hormone-replacement patch while its partner in theproject, Solvay Pharmaceuticals Inc. of Atlanta, Georgia, willmarket the patch in the USA. Together, the three types of hormone-replacement patches areexpected to have total annual peak sales of about EUR 140million. Merck also is developing other hormone delivery methods, suchas gels and tablets, to treat complaints that arise duringmenopause. Merck acquired Monaco-based Théramex, the French market leaderin hormone-replacement therapies, in December 1999 to develop itsposition in the world market of Women's Health, which is growingat a rate of about 11 percent annually. Headquartered in Darmstadt/Germany, the Merck Group generatesannual sales of EUR 6.7 billion in the fields of Pharmaceuticals,Specialty Chemicals, Lab Products and Lab Distribution. Foundedin 1668, the Merck Group is represented today by more than 200operating companies in 52 countries and employs 33,500 peopleworld-wide. The company groups its operating activities underMerck KGaA, in which E. Merck, as a general partner, holds theMerck family's 74 percent equity interest in Merck KGaA. TheMerck Group strongly believes that promotion of its employees'self-initiative and self-responsibility, application-orientedresearch and development and close customer relationships in themarkets are the keys to long-term corporate success.
Contact: Phyllis Carter Phone +49 6151 72 5000 Fax +49 615172 7707 E-mail phyllis.carter@merck.de M
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