Merck KGaA announced that the European Commission has granted a marketing authorization for Pergoveris intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.
Pergoveris 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, a Merck press release stated.
"The European Commission approval of Pergoveris 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 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 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, as well as Iceland, Liechtenstein and Norway. Launches of Pergoveris in the various countries of the European Union will start in the third quarter of 2007.
Merck Serono, a division of Merck, Darmstadt, Germany, and 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 FbM (follitropin alfa), to stimulate the ovaries and produce eggs; Luveris (lutropin alfa), to stimulate follicular development in women who are profoundly LH deficient; Cetrotide (cetrorelix acetate) to prevent a premature ovulation; Ovitrelle (choriogonadotropin alfa), to help follicles mature and release eggs; and Crinone (progesterone gel), to help establish and maintain a pregnancy.