07.01.10
#4 - Merck Serono
Frankfurter Str. 250
D-64293 Darmstadt Germany
Tel: (49) 6151-72-0
Fax: (49) 6151-72-2000
www.merck.de
Headcount | 33,062 | |
Year Established | 1668 | |
Bio/pharma Revenues | $7,454 | +2%/+7% |
Royalty Revenues | $457 | -8%/-3% |
Total Revenues | $10,804 | -3%/+3% |
Net Income | $526 | -6%/-1% |
R&D Budget | $1,678 | +6%/+12% |
Revenues converted at average exchange rate / based on reported currency (Euro)
2009 Top Selling Drugs | |||
Drug | Indication | Sales | (+/-%) |
Rebif | multiple sclerosis | $2,1449 | +9% |
Erbitux | oncology | $972 | +17% |
Gonal-f | female fertility | $678 | flat |
Concor group | heart failure | $551 | -14% |
Glucophage | diabetes | $406 | -5% |
Euthyrox | thyroid | $173 | -9% |
Account for 66% of total bio/pharma sales, up from 64% in 2008.
PROFILE
"We don’t live on an island of the blessed, around which the rushing waters of the crisis flow,” wrote Dr. Karl Lurwig Kley, Merck KgA’s chairman, in what is surely the most lyrical prose in any shareholder letter in 2009.
Merck Serono weathered a tough year better than some of its competitors, and better than some other divisions of parent company Merck KgA. Pharma revs grew 7% in its reported currency (+2% after exchange rate), and MS treatment Rebif passed the $2 billion mark for annual sales, aided by Rebifsmart, a new electronic self-injection device not yet approved in the U.S.
Erbitux, which Merck Serono sells outside the U.S., nearly reached $1 billion in 2009 sales, and is sure to pass that milestone in 2010 as the company adds more indications in Europe — but not non-small cell lung cancer (NSCLC), an indication the EU nixed in July 2009 — and develops the Japanese market. Unfortunately, the rest of its major products were flat or down for the year. We covered the company’s decision to withdraw psoriasis drug Raptiva from the market in last year’s report (it happened in February 2009), but a pair of new drugs also faced regulatory problems in the past 12 months.
In November 2009, the FDA sent a “refuse to file” letter to Merck Serono for its NDA of cladribine tablets for MS. Neither the agency nor the company revealed the contents of that letter (neither party is obliged to), and the NDA was resubmitted in June 2010. The seven-month delay hurts, as it will likely leave Novartis’ new competitor, Gilenia, with a head start. An advisory panel recommended approval of Gilenia in June 2010.
Merck Serono also had to suspend clinical trials of its cancer vaccine, Stimuvax, in March 2010. A patient in Phase II developed encephalitis, forcing recruitment for Phase III trials to be held up. The FDA cleared Merck and partner Oncothyreon to proceed with a trial against NSCLC, but kept a hold on trials against breast cancer and multiple myeloma.
In addition to getting its development pipeline back on track in the west, Merck Serono also took steps to expand its R&D capabilities in the east. In November 2009, the company announced plans to build a global R&d center in Beijing, investing more than $200 million and adding 200 staffers in the next four years. The biomarker-focused center will lead drug development in Asia for both local and global trials.
It’s not an island of the blessed, but Merck Serono has some growth prospects ahead.
Return to Top Biopharma Report homepage.