Shares in Merck KGaA have risen sharply this morning after the firm posted late-stage data which shows that Erbitux improves overall survival in lung cancer patients.

The Darmstadt, Germany-based firm’s Phase III study, called FLEX, using Erbitux (cetuximab) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced (stages IIIb or IV) non-small cell lung cancer. Detailed results are expected to be presented at an upcoming medical conference, but this snippet of news alone is causing much excitement.

Wolfgang Wein, senior executive vice president at the Merck Serono unit, said that NSCLC which has spread from the primary site “is extremely difficult to treat so we are delighted with these results”. He added that Erbitux is the first targeted agent that when combined with platinum-based chemotherapy “has demonstrated a therapeutic benefit in a first-line

NSCLC study that included all histological subtypes” and concluded by noting that these are important results given that recent trials involving other therapies such as tyrosine kinase inhibitors “have failed

to demonstrate a benefit for patients in this setting”.

Merck shares were up 4.4% at 10am and the news is sure to also boost the stock of ImClone Systems, from whom the German firm licenses the drug outside the USA. The FLEX data are especially important given that ImClone and North American partner Bristol-Myers Squibb presented disappointing results from a more-than-600-patient Phase III study of Erbitux plus a taxane and carboplatin in July did not meet its primary endpoint of progression-free survival.

The drug, which is presently approved to treat colon as well as head and neck cancer, brought in 116 million euros for Merck in the second quarter, up 44%, though revenues for ImClone in the USA have dipped of late. However those figures will certainly rise if a submission for the NSCLC indication proves successful.

ImClone settles Erbitux patent case

Staying with Erbitux and ImClone has agreed to pay $65 million in cash to acquire a sublicence and to settle litigation with Repligen and the Massachusetts Institute of Technology related to a patent dispute over the drug. A trial to look at the case was scheduled to begin yesterday, but the companies will ask the court to dismiss it.

As part of the deal, ImClone will receive a royalty-free global sublicence to certain patent rights and Repligen, which said it will receive about $40 million under the settlement, plans to use the money to help grow its bioprocessing business and central nervous system drug portfolio. MIT and Repligen sued ImClone in 2004, over allegations that ImClone used MIT-patented genetic elements in Erbitux that were under exclusive licence to Repligen.