OSI avoids ImClone track
OSI confident in testing protocol of Tarceva, a cancer drug similar to Erbitux.
February 22, 2002: 12:09 p.m. ET
|
NEW YORK (CNN/Money) - As biotech ImClone Systems heads for a showdown with regulators, the maker of a similar cancer treatment is distancing its clinical testing program from that of the troubled biotech.
Like ImClone's Erbitux, OSI Pharmaceuticals' Tarceva is an epidermal growth factor receptor (EGFR) inhibitor, which basically means it targets genes important in changing regular cells to cancer cells.
Currently in Phase III testing, Tarceva could be used on a number of different cancers, such as pancreatic, lung, and head and neck.
But the Food and Drug Administration initially rejected Erbitux because of incomplete clinical results. ImClone and its partner Bristol-Myers Squibb will meet with the FDA Feb. 26 to see if the agency will accept more data.
"They decided to take a risk the moment they've hit a road block," Geoff Cooper, vice president for business development at OSI, said Friday.
Speaking at the Biotechnology Industry Organization conference in New York, Cooper said his company is taking a "much more traditional, longer, expensive and thorough development route."
"How you develop drugs has to be consistent with the rules," he added.
Cooper said the Phase III tests by OSI (OSIP: down $1.07 to $37.60, Research, Estimates) are different in design and approach, and each group in the study has more than 1,000 patients. OSI is performing a comparison study against standard chemotherapy.
Cooper said the Erbitux saga has demonstrated there is intense interest in EGFR drugs and that with all the attention on the sector people have maintained confidence
He also noted that Erbitux targets the receptor outside the cell while Tarceva targets the area inside the cell.
OSI has a 50-50 partnership with Genentech for the profits of Tarceva. Genentech paid $95 million upfront in cash and equity and will pay up to $92 million in milestone payments.
OSI will make the drug and Genentech will do nearly all of the marketing.
Cooper said the company has an "extremely aggressive timeline" for the drug, with approval for pancreatic cancer expected in the fourth quarter of 2003 or the first quarter of 2004.
But that will be about a year behind another EGFR drug, AstraZeneca's Iressa.
Cooper acknowledged that the first drug to market usually is the market leader and expects a marketing battle between Iressa and Tarceva.
"Believe me, Genentech is committed," he said. 
|
| SPECIAL: |
|
|
|
|
|
|
RELATED STORIES
