Merck Serono Audited

Rebismart ™, our electronic injection device for the self-administration of Rebif ®, is easy and convenient to use. (photo)

Rebismart ™, our electronic

injection device for the

self-administration of Rebif®, is

easy and convenient to use.

Merck Serono is the largest division of Merck. It markets innovative prescription drugs of chemical and biotechnological origin. The division offers its leading brands in around 150 countries. Merck Serono focuses on highly specialized therapeutic areas such as Neurodegenerative Diseases, Oncology, Fertility, Endocrinology and Rheumatology.

Key products by therapeutic area

  • Oncology: Erbitux® (solid tumors)
  • Neurodegenerative Diseases: Rebif®, Movectro® (multiple sclerosis)
  • Fertility: Gonal-f®, Pergoveris™, Luveris®, Ovitrelle®, Crinone®, Cetrotide® (infertility treatment)
  • Endocrinology: Saizen® (growth hormone disorders), Serostim® (HIV-associated wasting), Kuvan® (metabolic disorder hyperphenylalaninemia), Egrifta™ (HIV-associated lipodystrophy)
  • CardioMetabolic Care: Concor® franchise (cardiovascular diseases), Glucophage® franchise (type 2 diabetes), Euthyrox® (thyroid disorders)

Key developments in 2010

  • Sales of Erbitux® rise by 18% to EUR 820 million, Rebif® sales increase by 8.6% to EUR 1,668 million
  • Russian and Australian regulatory authorities approve cladribine tablets as the world’s first oral disease-modifying treatment for multiple sclerosis (brand name: Movectro®)
  • The Committee for Medicinal Products for Human Use of the EMA adopts a final negative opinion regarding the marketing authorization application for cladribine tablets in January 2011. In the United States, the FDA accepts the application for review; FDA feedback on the application is expected by the end of February 2011
  • The Japanese drug regulatory authorities approve extended usage for Erbitux® in combination with chemotherapy for first-line treatment of metastatic colorectal cancer (KRAS wild-type tumors)
  • Following a suspected unexpected serious adverse reaction we temporarily suspended all studies with the cancer immunotherapy Stimuvax® in March. Phase III trials resumed in non-small cell lung cancer in June
  • Egrifta™ approved in the United States to reduce excess abdominal fat in HIV patients with lipodystrophy