Healthcare group Roche says it expects to receive new data on its key Pegasys drug for hepatitis C by early March.This content was published on January 30, 2002 - 10:49
Roche said the figures would pave the way for the product's launch in the second half of the year.
The Swiss-based group is relying on the interferon drug to revive its fortunes after a dismal year of product setbacks and weak sales.
The drug's launch has been delayed several times, and the company still needs to provide "bioequivalence'" data to the United States Food and Drug Administration (FDA) to prove that material from a new production plant is identical to earlier batches.
Jonathan Knowles, head of research, said Roche would be in a position to go back to the FDA with the information by the end of the first quarter.
"Things are looking good ... I'm quietly confident,'' Knowles said.
Last October, Roche pushed back the expected launch date for Pegasys to the second half of 2002 because of the bioequivalence problem. It had already delayed its forecast for initial sales to the first half 2002.
The delay is a blow to Roche because US-based rival Schering-Plough has already launched its alternative PEG-Rebetron product onto the US market.
Industry analysts fear Roche will not be able to make an impact with its product until 2003.
Extension of deal
The news on Pegasys coincided with the announcement of a new deal struck between Roche and Iceland's deCODE Genetics. The two companies revealed they were extending their partnership to develop new drugs for a further three years.
They added that they would now be concentrating their resources on just four diseases.
The Reykjavik-based company is searching for disease-gene links by analysing Iceland's unique genetic heritage, which has remained stable since the Vikings arrived in the ninth and 10th centuries.
The two firms were originally hunting for genes associated with 12 disease areas under the programme launched in 1998.
A deCODE spokesman declined to specify which diseases had been selected from this initial list, but he said they included projects where scientists had made key genetic discoveries.
The existing alliance has already produced promising leads for treating disorders including schizophrenia, obesity, osteoporosis, Alzheimer's and cardiovascular disease.
The spokesman added that deCODE would take over the eight disease programmes not being pursued by Roche for its own in-house drug development work.
No financial terms have been given for the accord, which extends an agreement that would have expired at the end of this month. Roche's Icelandic partner will receive unspecified payments as compounds pass development milestones, plus royalties on eventual sales.
swissinfo with agencies