Merck Serono Fertility Treatment Pergoveris® Receives Marketing Approval in Russia

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Merck Serono S A

15 Mar, 2012, 08:00 GMT

GENEVA, March 15, 2012 /PRNewswire/ --

  • Pergoveris® 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® 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® (recombinant human follitropin alfa and recombinant human lutropin alfa). Pergoveris® 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 (≥ 3000 IU per cycle) or advanced (≥ 35 years) maternal age.

"The approval of Pergoveris® 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®, 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® 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 (≥ 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.

About Pergoveris®

Pergoveris® (follitropin alfa/lutropin alfa) is the first biotechnology product based on the combination of recombinant human FSH and recombinant human LH which allows administration of both substances in a single subcutaneous injection.

Approved in more than 40 countries, Pergoveris®'s main indication is for the treatment of women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency. Pergoveris® is not registered in the US.

About Merck Serono and Fertility Treatment

Merck Serono is the world leader in fertility treatments, and 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® (follitropin alfa), to stimulate the ovaries and produce eggs in women and spermatogenesis induction in men; Luveris® (lutropin alfa), to stimulate follicular development in women who are profoundly LH deficient; Ovitrelle® (choriogonadotropin alfa), to help follicles mature and release eggs; Pergoveris® (follitropin alfa/lutropin alfa) to stimulate follicular development in women with severe LH and FSH deficiency; Cetrotide® (cetrorelix acetate) to prevent a premature ovulation; and Crinone® (progesterone gel), to help establish and maintain a pregnancy. Not all products are available in all markets.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta®, tesamorelin), as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 10.3 billion in 2011, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 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 shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merckserono.com or http://www.merckgroup.com

References

[1]Tarlatzis B.C., Zepiridis L., Grimbizis G., Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update 2003; 9:61-76.

[2]Keay, S. D., Liversedge, N. H., Mathur, R. S. and Jenkins, J. M. (1997), Assisted conception following poor ovarian response to gonadotrophin stimulation. BJOG: An International Journal of Obstetrics & Gynaecology, 104: 521-527. doi: 10.1111/j.1471-0528.1997.tb11525.x

[3]de Mouzon J, Goossens V., Bhattacharya S., Castilla J.A., Ferraretti A.P., Korsak V., Kupka M., Nygren K.G., Nyboe Andersen A., and The European IVF-monitoring (EIM) Consortium, for the European Society of Human Reproduction and Embryology (ESHRE), Assisted reproductive technology in Europe, 2006: results generated from European registers by ESHRE. Hum Reprod 2010; 25:8; 1851-1862

[4]Boivin J., Bunting L., Collins J. A., Nygren K.G., International estimates of infertility prevalence and treatment seeking: potential need and demand for infertility medical care. Hum Reprod 2007;22(6):1506-1512.

[5]Fertility - The Real Story Report,http://www.fertility.com/en/download_fertility_the_real_story_report.html, accessed March 9, 2012

[6] Russian Association of Human Reproduction 2009 report, http://www.rahr.ru, accessed March 9, 2012