By Randall Osborne
On the verge of filing its first new drug application (NDA) with the FDA, Isis Pharmaceuticals Inc. has teamed up with Zeneca LifeSciences Molecules to manufacture antisense oligonucleotides.
"The term is for five years, but it's a renewable deal and we view it as a long-term relationship," said Lynne Parshall, vice president and chief financial officer for Carlsbad, Calif.-based Isis. Financial terms were not disclosed.
Earlier this year, Isis reported positive Phase III trial results with fomivirsen, an antisense drug to treat AIDS-related cytomegalovirus. (See BioWorld Today, Feb. 6, 1998, p. 1.)
The company said it would file its NDA for fomivirsen "over the coming weeks," but the agreement with Manchester, U.K.-based Zeneca, a division of Zeneca Group plc, of London, is for the supply of clinical material, Parshall said.
"We have six drugs in clinical trials, so there's quite a demand," she said.
Fomivirsen is the most advanced in the antisense field. An antisense drug works by binding to a specific sequence of proteins in an mRNA target, thus preventing formation of the disease-causing protein encoded by the target mRNA.
The commercial-scale production of fomivirsen is "certainly something we may discuss with [Zeneca], but we're not yet," Parshall said.
Isis operates its own manufacturing facility in Carlsbad.
"We have come up with a number of [manufacturing] improvements, but we're a research facility, and transferring that technology to people who manufacture for business will continue to lower costs as they continue to improve the process," Parshall said.
Another company producing antisense oligonucleotides on a large scale is Cambridge, Mass.-based Hybridon Inc., she said.
"Between Isis and Zeneca, we'll have at least as large a scale as they have," Parshall said.
Last week, a scientist at Novartis AG, of Basel, Switzerland, was fired for manipulating preclinical data related to three Isis antisense products under development in collaboration with Novartis. (See BioWorld Today, March 18, 1998, p. 1.)
Early reports indicated the development of those drugs would not be delayed, and Parshall said an investigation continues to evaluate how serious the situation might be.
"There's not much we can say about it," she said.
Isis' stock (NASDAQ:ISIP) closed Monday at $15, unchanged. *