Merck KGaA pulls second lung cancer drug filing

FRANKFURT Tue Sep 18, 2012 4:57am EDT

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FRANKFURT (Reuters) - German drugmaker Merck KGaA has withdrawn its second attempt to win European approval for use of its Erbitux drug against lung cancer, capping a string of setbacks in its drug development.

Merck said on Tuesday it gave up the new attempt it made in March to win EU approval for the use of its second best-selling drug Erbitux against lung cancer, which had targeted a quarter of the patients it had initially tried to address.

"The decision to withdraw the application was based on feedback from European regulatory authorities, indicating that further data would be required," Merck said in a statement.

It shares fell 1.5 percent to 93.42 euros at 0823 GMT, underperforming a 0.6 percent higher European healthcare index.

Among patients with metastatic non-small cell lung cancer (NSCLC) it had selected those with so-called high epidermal growth factor receptor (EGFR) expression as determined by a genetic test of the tumour tissue for the second approval bid.

Earlier this year, the head of Merck's drugs unit, Stefan Oschmann, said the chances of approval were below 50 percent.

In 2009 Merck failed to win EU marketing approval for the use of Erbitux against lung tumours, the most common form of cancer and also one of the most deadly.

Both its first request and the one withdrawn on Tuesday focused on the non-small cell (NSCLC) type of the disease - accounting for about 80 percent of lung cancer cases - and on patients whose tumours have started spreading to other parts of the body.

The company also said that it was planning for cancer drug candidate TH-302, which it had licensed in from Threshold Pharmaceutical in February, to advance to the third and last phase of testing on humans required for regulatory approval. The drug will be tested against advanced pancreatic cancer.

Erbitux had sales of 855 million euros ($1.12 billion) in 2011 from treating bowel cancer and head and neck cancer. The company said last month it expected currency-adjusted growth in Erbitux sales of 1-4 percent this year.

As a result of recent lack of success in bringing new drugs to market, the company in February announced plans to cut costs across all its businesses, which also include specialty chemicals. It had previously replaced the head of its drugs unit.

(Reporting by Ludwig Burger and Harro ten Wolde; Editing by Helen Massy-Beresford)

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