Sales of Merck Serono’s medications to treat infertility amounted to € 817 million in 2012, corresponding to organic growth of 13.4%. The complete portfolio of gonadotropins consists of recombinant hormones for injection used at different stages from follicular development to early pregnancy. Gonal-f® (follitropin alfa) inducing ovarian follicular growth and maturation, continued to perform strongly in all regions, growing by a total of 12.2% organically to € 612 million. In the United States, sales were further boosted by year-on-year price increases. The division continued the worldwide rollout of the pre-filled pen injectors for Gonal-f® as well as Ovidrel® and Luveris® (family of pens) designed to facilitate easy daily administration during fertility treatment. Since 2009, Merck Serono has been sponsoring the Grant for Fertility Innovation dedicated to research projects focused on clinical research that can help to increase the take-home baby rate of patients undergoing fertility treatment. The program was expanded to € 4 million for 2012/2013.
The Endocrinology portfolio, comprising a range of products to treat endocrine and metabolic disorders, reported sales of € 399 million, increasing 11.9% organically with contributions coming from all regions. Sales of Saizen® (somatropin for injection) indicated for the treatment of growth hormone deficiency, were up 7.4% organically, amounting to € 250 million. Supported by the Merck Serono injection devices, Saizen® maintained its average market share despite broad-based competition. Particular growth drivers included higher volumes in Emerging Markets and price increases in the United States. Kuvan® (sapropterin dihydrochloride) is indicated for the treatment of hyperphenylalaninemia or a deficiency of tetrahydrobiopterin. Sales continue to grow rapidly. The rollout in Asia and Latin America is ongoing. Egrifta® (tesamorelin for injection), which is used as a therapy for reducing excess abdominal fat in HIV patients with lipodystrophy, also contributed to growth. We market this product only in the United States.
The General Medicine business comprises drugs for treating diabetes, cardiovascular diseases and thyroid disorders, as well as other globally and regionally marketed products. In 2012, sales increased by € 69 million (3.8% organically) to € 1,886 million. Strong volume growth in the Emerging Markets region, which accounted for 56% of sales, was offset by pricing declines as well as lower volumes in Europe, especially in southern European markets and France.
Globally, around 366 million people have diabetes, and the prevalence of this disease is rising. Glucophage® (metformin) remains the drug of choice for first-line treatment of type 2 diabetes. Thanks to the strong performance of this oral antidiabetic franchise, it became the third-largest absolute growth contributor to Merck Serono’s 2012 top-line performance. Sales rose by 14.7% organically to € 400 million, supported by strong sales in the Emerging Markets region and Japan.
The branded Concor® products such as Concor® COR and Lodoz®, which contain the active ingredient bisoprolol, achieved sales of € 380 million. This translates into an organic decline of 6.0%, which was primarily the result of price cuts in addition to lower volumes in France and southern European markets. By contrast, sales of Concor® in Emerging Markets grew by around 10%.
Merck Serono is the world’s largest supplier of drugs to treat thyroid disorders. Globally, more than 300 million people suffer from hypothyroidism. Sales of products to treat thyroid disorders, including Euthyrox®, posted double-digit sales growth, driven primarily by higher volumes in Emerging Markets.
On December 15, 2011, Merck received a Warning Letter from the United States Food and Drug Administration (FDA) related to inspections of production facilities in Tiburtina, Italy, and Aubonne and Vevey, Switzerland. These sites contribute to the production of Rebif® and other products for distribution in the United States. The letter primarily addressed several processes related to the manufacturing of Rebif®, which the FDA concluded were not in full compliance with good manufacturing practice standards. Merck is working closely with the FDA to address its observations. The agency completed its initial evaluation of the company’s responses. In its reply, the FDA stated that “We agree that your proposed corrective actions, if implemented appropriately, should adequately address the violations at issue.” Since that initial evaluation, all commitments to the corrective action plan submitted to the FDA have been completed on schedule and a final update was provided to the FDA in September, 2012. FDA re-inspections took place during the fourth quarter of 2012 and are expected to be completed in the first half of 2013 to confirm the complete implementation of the proposed corrective actions.
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