Last Updated: 2003-06-17 8:03:16 -0400 (Reuters Health)
FRANKFURT/NEW YORK (Reuters) - German drugmaker Merck KGaA and Canada's Biomira Inc said on Tuesday a Phase III trial on breast cancer vaccine Theratope failed to meet key targets for disease progression and overall survival.
Results of the trial, involving 1,030 women at more than 120 sites in 10 countries, were seen as important to Merck, which is battling failures in its research pipeline as well as generic competition to its diabetes drug Glucophage.
Merck stock -- which had touched a 12-month high of 30.10 euros earlier this month -- traded 5.1 percent lower at 27.40 euros by 0821 GMT, underperforming Germany's mid-cap MDAX index, which was up 0.2 percent.
"I think this is clearly negative. It was always regarded as a high risk area, but it was a wild card for Merck, which if successful could have meant peak sales of up to $1 billion," said Merrill Lynch analyst Andreas Schmidt.
"There have been some failures recently, and the company's research focus is very narrow, and that too in a very risky area," Schmidt said.
Biomira shares, which have more than doubled in value since the beginning of the month, closed at C$5.35 in Toronto ahead of the announcement.
The companies said in a statement that one subset of patients in the group -- women on hormonal treatment following chemotherapy -- appeared to show a favourable trend to improvement in survival.
Merck and Biomira said further analysis of this subset was underway, as was additional analysis of complete trial data. They said they would discuss how to proceed based on discussions with regulators.
Merck licensed the drug from Biomira in May 2001.
A Merck spokesman played down the significance of the failure. "Expectations in high-risk area of cancer vaccines were not high, as we have expressed in the past," he said.
However the setback took away some of the gloss from Merck's recent success with cancer drug Erbitux.
The future of Merck's research pipeline rests squarely on the colo-rectal cancer drug, on which the company revealed promising data earlier this month at an American cancer researchers' meeting.
Otherwise, research news from Merck in recent months has been dismal. It has announced the end of trials on three anti-diabetes drugs and has stopped development of an anti-depressant on which it was collaborating with GlaxoSmithKline Plc.
Merck and Biomira continue to work on another cancer vaccine, BLP25, which is undergoing trials for non-small cell lung cancer and prostate cancer. Results from both trials are expected later this year or in early 2004.