Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Reuters NewMedia - January 6, 2004
Jon Cox
T-1249, the drug whose clinical trials were halted, and HIV/AIDS drug Fuzeon belong to a new class of drugs, known as fusion inhibitors, which are far more complex and costly to make than conventional treatments.
"We see the opportunity with the fusion inhibitors to make what really is a quantum leap in terms of delivery -- of moving toward weekly administration as a target," said David Reddy, HIV global franchise leader for Roche .
"This isn't just months, we are talking years in terms of the strategy we are taking," he added in a telephone interview with Reuters.
Roche and Trimeris have already brought Fuzeon to the market. Despite initially disappointing sales, Roche expects Fuzeon to generate peak annual sales of 500 million francs ($405 million) to 1.0 billion Swiss francs.
While T-1249 remained a potential candidate, Roche was looking at other molecules that have shown greater potency and could be easier to administer, Reddy said.
Investors had expected T-1249 to be more potent and easier to administer than Fuzeon. But Reddy denied that Roche may now struggle to maintain momentum in its HIV business.
He said the priority was to overcome initial concerns on administering Fuzeon, which must be injected twice daily.
"This is very much where we are focused now, we firmly believe in its place in therapy -- driven by the unprecedented clinical results we have seen," Reddy said.
He said Roche was working on the life cycle management of the product as well as the development of the next generation of molecules, of which T-1249 remained a candidate.
Fuzeon requires 106 chemical steps to manufacture, 10 times more than is needed to make a typical drug.
"We now have no issues with the manufacturing of (Fuzeon)," Reddy said, adding plans were in place for expansion.
"It is fair to tell you we are on track with manufacturing or in fact slightly ahead of plan," he added.
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