Merck Serono invests €300 million in state of the art biotechnology center

The company, which is part of Merck KGaA, announced in the midst of the world’s greatest global economic downturn it had just made the biggest single investment in its corporate history. On top of the €1 billion it spends on R&D each year, hundreds of millions of euros are being ploughed into the construction of a state-of-the art facility to produce the company’s current and future biotechnology products. The existing site, where Merck Serono has produced its multiple sclerosis biotech product Rebif since 1999, has already achieved the ISO1401 international standard for environmental excellence and the expansion will be built to the same standard. “We want to leave as small an ecological foot print as possible” Mr Kley remarked.
Merck Serono is expanding its Biotech Center at Corsier-sur-Vevey, Switzerland, to develop two new production suites with 120,000 litres of bioreactor capacity and its own high tech waste water treatment station. The site will create 200 new jobs as well as boosting the local economy by providing work for contractors. “The new site is going to produce pure therapeutic proteins faster and more efficiently than has ever been possible before,” commented Mr Kley.
The driving force behind the expansion is the company’s need to meet a growing demand for its flagship cancer drug Erbitux which it sells globally, with the exception of the US and Canada where it is marketed by Lilly and Imclone. The monoclonal antibody, which targets the epidermal growth factor receptor (EGFR), has proved effective at shrinking tumours in metastatic colorectal cancer, lung cancer and head and neck cancer. It is also being researched for treatment of other solid tumours. Once reserved for use when all other treatments have failed, Merck Serono has now sought approval for first-line use of Erbitux in these indications on the back of promising phase III studies and it is already available for first-line use in mCRC.
Erbitux to be manufactured ‘in house’ from 2012
Erbitux is currently produced for Merck Serono by Boehringer Ingelheim in Germany but will struggle to keep up with demand, said Mr Kley. Once the new site is fully operational in 2012, Erbitux will also be manufactured in-house.
Merck Serono saw a 13 per cent growth in sales of Erbitux in Q3 this year amounting to €134 million. Sales for 2007 reached €480 million. But Elmar Schnee anticipates a more rapid rise following publication this year of the EXTREME study of first-line Erbitux in non-squamous cancers of the head and neck and with presentation of emerging data from the1125-patient, phase III FLEX study of first-line use in non small cell lung cancer.
At last year’s ASCO the trial revealed that even patients with the most advanced disease extended their survival by over a month. This week new data from FLEX were presented at a major multidisciplinary US symposium on thoracic oncology, revealing that patients with advanced disease who developed the prognostic marker of early skin rash after receiving the drug had a median overall survival of 15 months. At the same meeting a phase II study from MD Anderson Center in the US showed patients with less advanced Stage III NSCLC, who added Erbitux to chemotherapy, had a median survival time of 22.7 months and 49.3% were still alive at 2 years. Merck Serono is aiming to be a major player in lung cancer which affects almost a billion people world wide not only with Erbitux but also with Stimuvax, the first therapeutic vaccine for lung cancer, which it is developing for lung cancer patients at an earlier stage. Currently in phase III trials, results are expected in 2013.
Speaking on the day the corner stone of the new building was laid, Merck Serono President Elmar Schnee said: “We want to make a difference by bringing new therapeutic innovations to market that improve quality of life and prolong survival for cancer patients. Our ambition is to prolong life so that cancer becomes a chronic disease that can be controlled rather than a fatal disease.” Besides Erbitux and Rebif, other biotech products in the pipeline such as Stimuvax, a therapeutic vaccine for early lung cancer and cladribine an oral treatment for multiple sclerosis will also be produced in house. The company also has treatments for auto-immune disorders and inflammatory conditions in development.

Olwen Glynn Owen - Pharmiweb Field Reporter