Merck Serono Fertility Treatment Pergoveris® Receives Marketing Approval in Russia

GENEVA, March 15, 2012 /PRNewswire/ --

- Pergoveris(R)approved for the treatment of women suffering from severe deficiencyin reproductive hormones preventing them from naturally ovulating, and for women undergoing assisted reproductive technologies who do not respond well to standard treatment - Pergoveris(R) to be launched in Russia in the second quarter of 2012

Merck Serono, a division of Merck, Darmstadt, Germany, today announced that the Ministry of Health and Social Development of the Russian Federation has granted marketing authorization for Pergoveris(R) (recombinant human follitropin alfa and recombinant human lutropin alfa). Pergoveris(R) is indicated for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle-stimulating hormone (FSH) deficiency, and for controlled ovarian stimulation in sub-optimal responders in assisted reproductive technologies (ART), who have previously had a sub-optimal response to controlled ovarian stimulation characterized by at least one of the following: small number (<7) of pre-ovulatory follicles, use of high FSH doses (greater than or equal to 3000 IU per cycle) or advanced (greater than or equal to 35 years) maternal age.

"The approval of Pergoveris(R) in Russia is part of our commitment to bring our biotechnological drugs to patients worldwide," said Belén Garijo, Head of Global Operations at Merck Serono. "Complementing the portfolio of fertility drugs already available in Russia, Pergoveris(R), with its unique formulation of recombinant LH and FSH, represents an additional treatment option for Russian women suffering from hormonal deficiencies or those who do not respond to current treatments, preventing them from getting pregnant", she added.

Pergoveris(R) is the only biotechnology medicine combining recombinant FSH 150IU and recombinant human LH 75IU that allows administration of both substances in a single subcutaneous injection. LH and FSH are hormones that are normally produced by the pituitary gland and play an important role in the female reproductive system. In the absence of endogenous FSH and LH, production and full development of follicles in the ovaries, ovulation and endometrial growth to support implantation of a fertilized egg are unlikely to occur.

While severe LH and FSH deficiency is a rare disorder of the reproductive function caused by an endocrine deficiency, sub-optimal or low ovarian response has been showed to be a first sign of ovarian ageing.[1] In patients undergoing In Vitro Fertilization (IVF) treatment, the prevalence of low ovarian response ranges from 9 to 24%.[2] Sub-optimal response can be observed following a first cycle of standard controlled ovarian stimulation, when there are insufficient mature follicles to proceed to oocyte retrieval.Often, patients undergoing IVF are of advanced maternal age (greater than or equal to 35 years).[3]

Infertility is defined by the World Health Organization as the inability for a couple to achieve conception or bring a pregnancy to term after a year or more of regular, unprotected sexual intercourse. Today it is estimated that 9% of couples worldwide experience difficulties to conceive a child, representing potentially 72 million couples.[4] Since the birth of the first IVF baby in 1978, it is estimated that over 3.75 million babies have been born worldwide thanks to ART.

In Russia, awareness of infertility and treatment options is one of the lowest worldwide,[5] but the demand to treat infertility is rising rapidly.[6] Besides having a complete portfolio of medicinal products to help treat the various causes of infertility, Merck Serono is committed to providing support to advance the management of infertility in Russia, through educational initiatives, research grants, information websites, and the introduction of additional therapies, and improved devices to facilitate self-injection of treatments by patients.

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