Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Reuters NewMedia - Thursday, December 19, 2002
The Swiss healthcare group said its manufacturing plant in Boulder, Colorado, has been working to meet the challenges required to make the complex drug, called Fuzeon, but initial yields were lower and cycle times longer than projected.
Roche is developing the drug with Durham, North Carolina-based Trimeris Inc. and a decision by US regulators on their marketing application is expected by March 16, 2003. Fuzeon is designed for AIDS patients who have become resistant to other drugs.
The companies said they plan by the end of 2003 to be able to supply the drug to as many as 15,000 patients, compared with the 25,000 Roche said it was targeting earlier this year. The new estimate includes a six-month cushion of "safety supply" to ensure continuity of treatment.
Sales next year will be in the lower half of the current Wall Street range of $57 million to $164 million, Bob Bonczek, chief financial officer at Trimeris, said during a conference call. The estimate will be affected by the drug's pricing, which has not yet been decided, he added.
Patient groups and AIDS activists have been clamoring for the injectable drug, which offers hope when people become resistant to existing antiretroviral therapies.
"In the first year, we will have a managed launch of the drug," Roche spokeswoman Heather Van Ness said.
Fuzeon is the first of a new class of antiretroviral drugs called "fusion inhibitors." Unlike existing anti-HIV drugs that work inside the cell, it is designed to block HIV from entering healthy human immune cells.
By the end of 2004, the companies said they expect to be able to supply the drug to a maximum of 32,000 AIDS patients, with the patient population rising to 39,000 in 2005.
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