With the specialized therapies and innovative drug delivery devices offered by its Endocrinology therapeutic area, the Merck Serono division is pursuing a clear aim: to improve the lives of patients affected by endocrine and metabolic disorders. Sales in this therapeutic area increased by 4.8% to € 229 million over the previous year. The top-selling product is Saizen®, a recombinant human growth hormone, which generated sales of € 172 million. Demand for Saizen® remained strong, especially in Europe, where sales grew 9.3%. The drug is marketed in most countries for the treatment of growth hormone deficiency in children and adults, as well as in children born small for gestational age (SGA), with Turner syndrome or chronic renal failure. According to expert estimates, the prevalence of growth hormone deficiency in children is between 1 in 4,000 and 1 in 10,000. Yet adults are also affected. In the United States alone, more than 50,000 people suffer from growth hormone deficiency and every year, 6,000 new cases are reported. In the United States, the Endocrinology therapeutic area also offers Serostim®. It is used to treat patients suffering from HIV-associated wasting, which is estimated to affect up to 8% of HIV-infected individuals.
Easypod® electronic auto-injection device drives sales growth of Saizen®
The good development of Saizen® was favorably impacted by the increasing use of the electronic auto-injection device Easypod®. This first delivery device of its kind has made once-daily administration easier for patients and medical professionals. In particular, it helps to monitor compliance. Since the launches in Europe, Australia, Latin America, North America and selected Asian markets, the uptake of Easypod® has increased among patients with growth hormone deficiency.
Kuvan® approved in Europe for the treatment of hyperphenylalaninemia
In the fourth quarter of 2008, the European Commission granted marketing authorization for Kuvan® for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency. HPA is an abnormally high concentration of phenylalanine in the blood, which can cause serious brain damage in infants and children, and transient to lasting neurocognitive impairment in adult patients if a strict diet is not adhered to at all times. Kuvan® is the first drug approved in Europe to treat this rare disease.
We are developing Kuvan® in partnership with BioMarin Pharmaceutical of the United States. Kuvan® was previously granted orphan drug designation by both the FDA and the EMEA. Consequently, Kuvan® has market exclusivity in this indication for ten years in the European Union and for seven years in the United States.