By Randall Osborne
After a scientist working for its collaborator Novartis AG was caught manipulating preclinical data and fired, Isis Pharmaceuticals Inc. told stockholders development of three cancer compounds in the partnership will not be delayed and said it was looking into the situation further.
A letter from Carlsbad, Calif.-based Isis to shareholders said the studies affected by the individual scientist's improper management of data "may have" included the xenograft studies for cancer compounds, on which Isis and Novartis, of Basel, Switzerland, are collaborating.
Gloria Stone, assistant director of external affairs for Novartis, said 10 compounds were affected, and she confirmed that the Isis products — antisense cancer compounds known as ISIS 3521, ISIS 5132 and ISIS 2503 — are among them.
"But we've done a fairly thorough analysis, and we believe development can continue without impact or delay," Stone told BioWorld Today.
David Crossen, an analyst with NationsBanc Montgomery Securities Inc., of San Francisco, said it's "impossible, really, to say" what the impact might be, until the FDA examines the situation.
"The FDA will scan all that data and if there are uncertainties, they'll say, 'You have to go back [and conduct the research again]," Crossen said.
"You can't simply say preclinical data doesn't count in the regulatory process, and in this industry, a little bit of delay can be pretty dramatic," he said.
Jane Green, director of investor relations for Isis, said both companies are talking with regulatory authorities.
"We have a significant amount of work here to do, preparing data packages that look at what happens if we expunge the [manipulated] data," Green said.
Investigation Continues In Switzerland
Isis has sent a senior-level scientist to Novartis' headquarters in Switzerland to take part in the ongoing investigation, she added.
Stone said Novartis found the data manipulation during an internal review, and the scientist responsible "was restricted to one area of the animal studies."
The researcher had been with Novartis or one of its pre-merger companies for a total of more than 20 years, Stone said.
"We don't really know [why he did it]," she said. "Personal gain, in terms of reputation, maybe. It's a shame."
Green said neither Isis nor Novartis had "any reason to believe it was for financial gain. It's very sad. He threw away his career."
Crossen said data manipulation "probably happens more often than we realize. There's a lot of pressure to come up with that data."
Isis has another collaboration, valued at $20 million, with Atlanta-based Ciba Vision Corp., a division of Novartis, to develop Isis' lead product, fomivirsen, for AIDS-related cytomegalovirus retinitis. (See BioWorld Today ,July 16, 1997, p. 1.)
Isis' stock (NASDAQ:ISIP) closed Tuesday at $14.812, down $0.437. *