The specialized therapies and user-friendly injection devices offered by the Business Unit Endocrinology can help improve the lives of patients with endocrine and metabolic disorders. Sales increased by 21% over 2009 to EUR 317 million thanks to strong growth in all regions. Our top-selling endocrinology product is Saizen®, a recombinant human growth hormone. Saizen® is approved in 79 countries for indications including the treatment of pediatric and adult growth hormone deficiency, Turner syndrome, growth failure in children associated with chronic renal failure, as well as to treat children born small for gestational age (SGA). According to estimates, growth hormone deficiency affects 330,000 children globally and 90,000 adults in Europe. Sales of Saizen® increased sharply by 18% to EUR 226 million. Our top-selling markets were Europe and North America. Latin America as well as Asia, Africa, Australasia showed strong, double-digit growth, also on an organic basis. The ongoing success of Saizen® was favorably impacted by the high acceptance of our electronic injection device Easypod™, which is now available in around 40 countries, including China, where it was approved in July. In order to make Saizen® even more user-friendly, we developed a ready-to-use liquid formulation that eliminates the need to prepare the powder for injection. Saizen® solution for injection was approved in Canada in April. A decentralized procedure was completed in the European Union in October, allowing national approvals in 18 EU member states in the coming months. To ensure flexibility in meeting the individual needs of patients, the new formulation is available in cartridges of 6 mg, 12 mg and 20 mg, designed for exclusive use with Easypod™ and our needle-free auto-injector Cool.click™2.
With Kuvan® (sapropterin) for the treatment of hyperphenylalaninemia in patients with either phenylketonuria (PKU), a congenital metabolic disorder, or a deficiency of the key coenzyme tetrahydrobiopterin (BH4), we began offering the first drug for this orphan disease in Europe in 2009. According to estimates, around 50,000 people are affected in Europe; 20% to 50% of PKU patients could benefit from treatment with Kuvan®, which Merck Serono markets in around 30 countries. In 2010, the product was approved in Switzerland and Croatia as well as a number of countries outside of Europe, including Australia, China (only for BH4 deficiency), Israel, Mexico and Venezuela. Global sales rose to EUR 20 million.
Egrifta™ approved in the United States
Our drug Serostim® is used in the United States to treat patients suffering from HIV-associated wasting, which is estimated to affect up to 8% of HIV-infected individuals. Sales of Serostim® increased by 8.1% to EUR 70 million.
In November, the U.S. Food and Drug Administration (FDA) approved Egrifta™ (tesamorelin for injection) as the first, and so far only, treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. Egrifta™ was developed by Theratechnologies, a Canadian biopharmaceutical company, and will be marketed in the United States exclusively by our subsidiary EMD Serono.
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