Merck Serono Received European Approval for Three Pre-filled, Ready-To-Use Pen Injectors for Fertility Treatment

GENEVA, July 4, 2011 /PRNewswire/ --

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This "family of pens" is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: GONAL-f^® (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris^® (lutropin alfa) 450 IU and Ovidrel^®/ Ovitrelle^® 250 micrograms (choriogonadotropin alfa).  

"Merck Serono is continuously working on improving its administration devices in order to meet patients' and healthcare professionals' needs", said Dr. Bharat Tewarie, Senior Vice President Global Business Unit Fertility and Metabolic Endocrinology at Merck Serono. "Fertility treatment specialists were involved from the beginning in the development of the new devices for the Merck Serono gonadotropins portfolio for fertility treatment.  We are pleased to introduce today the specially designed injection devices that combine key features recommended by them."

The newly approved prefilled pens were designed to facilitate daily administration by patients during their fertility treatment. The pens immediately confirm that a complete dose was delivered, or indicate the missing amount if an incomplete dose is injected.  Other key features include a new graduated scale on reservoir for patients to check the amount of medication remaining in the pen and a bi-directional dose dial allowing them to correct the dose dialed, if needed^[1,2].

With a complete portfolio of gonadotropins, Merck Serono offers fertility specialists the ability to tailor treatment to patients' needs. Since the birth of the first IVF baby, nearly 4.3 million babies worldwide have been born with help from in-vitro fertilization techniques^[3]. Merck Serono has helped thousands of infertile couples to realize their dream of becoming parents, and continues to seek new solutions that meet patients' treatment needs.

The New GONAL-f^® prefilled pens are approved and launched in Australia, New Zealand, Canada and Switzerland, and are approved in Europe. Ovidrel^® / Ovitrelle® prefilled pen is approved in Australia, New Zealand and Europe. Luveris^® prefilled pen is approved in Australia, Canada and Europe.

^[1] Christen et al. Expert Opinion in Drug Delivery 2011.

^[2] Abbotts  et al. Patients Preference and Adherence

^[3] ESHRE, Focus on Reproduction - Sept. 2010

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; 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.

About GONAL-f®

GONAL-f is a highly consistent recombinant human follicle-stimulating hormone (r-hFSH) available in Filled by Mass (FbM) form, prescribed to supplement or replace naturally occurring FSH, an essential hormone to treat infertility.

GONAL-f has been approved in 100 countries worldwide - among which 74 countries have approved GONAL-f prefilled pen - including Europe and the US with indications of stimulation of the growth of ovarian follicles and ovulation in women. It is the most widely prescribed gonadotropin in the world.

For males, GONAL-f has been approved in 77 countries worldwide, including Japan, for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In certain markets where GONAL-f is approved for this indication, the therapy needs to be in combination with human Chorionic Gonadotropin (hCG).

In the US, GONAL-f^® Multi-Dose, available as the GONAL-f^® 1050 IU vial or GONAL-f^® 450 IU vial is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure as well as for ovulation induction and the development of multiple follicles in the ovulatory female patient participating in an Assisted Reproductive Technology (ART).  GONAL-f^® RFF Pen and 75 IU vial is approved for women only in the US.

Important: GONAL-f (follitropin alfa for injection) should only be prescribed by physicians specializing in fertility or reproductive health. As all medicines,  GONAL-f is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including: Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. GONAL-f is contraindicated in patients who exhibit prior hypersensitivity to FSH preparations and tumours of the hypothalamus or the pituitary gland. It is also contraindicated for women with ovarian enlargement or ovarian cyst of unknown aetiology, Gynaecological haemorrhages of unknown aetiology and ovarian, uterine or mammary carcinoma. Nursing women should not use GONAL-f. Common side effects in women include OHSS, ovarian cysts, headache, abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea and injection site disorders. For complete product details, see full prescribing information.

About Luveris®

Luveris® (lutropin alfa) is a recombinant human luteinising hormone (r-hLH) developed to support follicular growth in women with severe FSH and LH deficiency. In the body, LH causes the release of eggs (ovulation) during the menstrual cycle. Luveris® is used together with FSH, which also stimulates ovulation. Luveris® is approved in more than 70 countries.

About Ovitrelle®/Ovidrel®

Ovitrelle®/Ovidrel® is the world's first and only recombinant chorionic gonadotropin (r-hCG).  Ovitrelle®/Ovidrel® is administered after the stimulation for the growth of follicles (or eggs) by another hormone (FSH). Approved in more than 80 countries, Ovitrelle®/Ovidrel® is indicated to induce final follicular maturation and trigger ovulation in women with no ovulation, and to induce final follicular maturation for women undergoing ART, such as in-vitro fertilization.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 9.3 billion in 2010, 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 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.

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

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.

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

Merck Serono is a division of Merck.