Merck will continue to develop one of the most watched drugs in the pharmaceutical industry, saying that it would push an experimental medicine designed to raise so-called “good” cholesterol into late-stage trials.
The US drugmaker yesterday disclosed for the first time that it would start expensive and pivotal phase III clinical trial programmes for anacetrapib, a drug that raises HDL, or good cholesterol, to help treat heart disease. It also helps to lower LDL, or bad cholesterol.
The progress and fate of anacetrapib has been watched closely by the industry and medical community following the surprising failure a year ago of US rival Pfizer’s similar drug torcetrapib.
Roche, the Swiss pharmaceutical company, is developing a similar drug. Any drug that raises HDL is seen as a likely blockbuster.
Pfizer scrapped the drug after it recorded increased deaths and heart problems in a pivotal trial and had spent more than $1bn.
Alongside its high-risk development of anacetrapib, Merck is pursuing lower-risk options in its bid to treat cholesterol.
These include Cordaptive, for which Merck expects US approval next year. It also expects to file for US approval next year for a combination of Cordaptive and simvastatin, a generic drug that lowers bad cholesterol.
In spite of Merck’s confidence, investors will be watching closely for signs of emerging side effects.
Dr Peter Kim, chief scientist, said Merck that has been trying to find out what went wrong with Pfizer’s torcetrapib.
He said that Merck’s drug anacetrapib does not raise blood pressure like torcetrapib, and does not have its other questionable effects.
But Merck said it would not yet start a large study to show health improvement form anacetrapib, as it gathered more data on how the drug works.
Merck added that it was confident that Cordaptive's anti-flushing compound would not disrupt the body's clotting ability and cause side effects from that.
It also said it remained confident of filing next year for regulatory approval on anti-obesity drug taranabant, despite seeing some increased psychiatric side-effects in preliminary trials.
Next year is the third year in the company's five-year turnaround plan based on successful new drug launches to boost growth. The strategy is working, said Dick Clark, chief executive, reiterating last week's financial outlook, but he added that Merck must keep its focus.
Quoting Winston Churchill, Mr Clark said, "However beautiful the strategy, you should occasionally look at the results."
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