$150 million investment by Merck KGaA to expand R&D presence in China

Last week, Merck KGaA announced plans to strengthen its global research and development capabilities of its Merck Serono division by establishing a global R&D center in Beijing, China.

Merck is planning to invest more than $150 million and create more than 200 new qualified jobs over the next four years to set up the China R&D center and conduct R&D activities in China.

"The creation of the China R&D center marks a new milestone in Merck Serono's commitment to China, where there is a rising demand for more healthcare options," said Elmar Schnee, Executive Board Member with responsibility for the Pharmaceuticals business sector. "We are committed to investing in areas that can help China to address some of its public health needs that currently are not met."

"China is a country with talented scientists and high-quality research," added Bernhard Kirschbaum, Executive Vice President, Research and Development for Merck Serono. "We will recruit more R&D talent in China and build a world-class organization in China that will extend our global R&D expertise and capabilities."

The China R&D organization will become one of the key R&D hubs for Merck Serono worldwide. Key hubs so far are Germany, Switzerland and the United States.

The China team will lead drug development for China and other Asian countries, for local clinical trials as well as for the participation in global clinical trials. The team also will ensure the management of collaborations with research institutions in China and continue to look for partnerships with local academic institutions and companies. Research activities conducted in the China R&D center will mainly focus on biomarker research including pharmacogenomics and bioanalytics activities.

Merck Serono already has some research collaborations in China and plans to further develop its collaboration network and build its R&D strategy on more innovation opportunities by tapping into the Chinese scientific expertise.

Merck Serono China currently employs more than 1,000 persons nationwide.

Merck Serono China offers a portfolio of innovative medicines, including the division‚s leading brands serving patients with cancer (Erbitux^®), multiple sclerosis (Rebif^®), infertility (Gonal-f^®), endocrine and metabolic disorders (Saizen^®), as well as cardiometabolic diseases (Concor^®, Euthyrox^®).

1st oral treatment for MS submitted for FDA approval by Merck KGaA

Germany's Merck KGaA filed for approval of its multiple sclerosis pill cladribine in the US in a bid to bring the first oral treatment against the debilitating disease to market.

The drugs-to-chemicals hybrid said last week that it submitted a New Drug Application with the FDA, two months after regulatory filing in Europe.

As reported by Reuters, the move follows a pivotal Phase III clinical trial, which in January showed that cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.

In a best-case scenario, the pill would come to the U.S. market in the second quarter of 2010, and European market launch would ideally be in the last quarter of 2010, said Elmar Schnee, the head of Merck's drugs unit, earlier this month.

The filing helps the German drugmaker make headway over Swiss rival Novartis, which is planning to seek U.S. and European approval for an MS pill known as FTY720 at the end of this year.

According to some analysts, cladribine and FTY720 are expected to take a sizable chunk of the $8.6 billion market for MS treatments, currently dominated by injectables from Teva, Biogen Idec, Bayer, and Merck KGaA itself.

(At Stinson Brand Innovation, we work with the Merck Chemicals group to support its global biosciences marketing and sales strategy for the brands Calbiochem, Novabiochem, and Novagen. These life science research products are used worldwide in university laboratories, as well as in pharmaceutical and biotech industries.)