Major products Audited

Merck Serono’s largest single product, Rebif® (interferon beta-1a), for the treatment of relapsing forms of MS grew 7.5% organically to € 1,893 million (2011: € 1,691 million). The main contributors were growing sales in the United States, as a result of price increases made in January, May and November. North America remained the largest market for Rebif®, accounting for 52% of sales. In Europe, where Rebif® continues to be the most frequently prescribed MS treatment in major markets, sales declined slightly from the previous year’s level. Stable volumes could not offset continued pricing pressure. Sales in the Emerging Markets and Rest of World regions, which account for less than 10% of global sales, remained roughly at the previous year’s level.

Rebif® is marketed by Merck Serono worldwide. In 2002, Serono entered into a co-promotion agreement with Pfizer for Rebif® in the United States. The term of the agreement ends on December 31, 2013 unless extended. EMD Serono (a subsidiary of Merck KGaA) and Pfizer are in a dispute about the term of the agreement based on the parties’ interpretations of the provisions governing extension. During 2011, a lower court in the United States agreed with Pfizer and ruled that the Pfizer agreement extends through 2015. Subsequently, EMD Serono appealed this decision. The ruling from the appellate court is still pending. If EMD Serono prevails on appeal, this case will proceed before the lower court.

Erbitux®, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved for the treatment of metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN). Sales grew 1.9% organically in 2012, amounting to € 887 million (2011: € 855 million). The majority of sales continue to be generated by use in first-line mCRC. In Europe, accounting for 56% of global sales, sales declined 1.5% organically due to increasing competition in the second-line mCRC segment as well as public budget constraints. Across the Emerging Markets region, sales grew 7.4% organically as a result of increasing patient numbers, mainly in mCRC. In Japan, which belongs to the Rest of World region and generates 13% of total sales, intensifying competitive pressure in the mCRC indication led to an organic sales decline of 6.5%.

Merck licensed the right to market Erbitux® outside the United States and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux®.

Merck Serono | Key products, organic growth rates