West Coast Editor
Opting for a less crowded piece of water with chances for catching bigger fish, Tularik Inc. is casting aside the development of two compounds - T611 for cytomegalovirus and the anticancer drug T64 - and entering a deal with Tokyo-based Sankyo Company Ltd. to investigate therapeutics that act on orphan G protein-coupled receptors.
Although T64 showed some promise against non-small-cell lung cancer, the indication is competitive, said Traci McCarty, director of investor relations for South San Francisco-based Tularik, which was named after a river in Alaska favored by the company's CEO and co-founder David Goeddel, an avid fly fisherman.
T64 was licensed from Eli Lilly and Co., of Indianapolis, for $3 million.
"It wasn't a huge investment and we're still trying to partner it, actually," McCarty told BioWorld Today. "We still think there's a drug there."
As for T611, she said, the drug "really falls outside our scientific focus. It worked, and we thought, How could we not pursue this?'"
Variability of effects between patients was noted in trials, she added.
"We're talking about bone marrow transplant patients who already are incredibly sick," she said. What's more, Basel, Switzerland-based Roche is already marketing a cytomegalovirus treatment: Valcyte (valganciclovir). "We didn't want to go up against them in a $100 million market," McCarty said.
"Now we're down to two drugs in the clinic," she said.
One is T67, an anticancer drug that binds to B-tubulin (essential to cell division), for which positive Phase II data were offered in May at the meeting of the American Society of Clinical Oncology. In patients with unresectable hepatocellular carcinoma, three of 34 patients had partial responses and 38 percent (13 of 34) had stable disease. Also, five of 27 evaluable patients had a more than 50 percent reduction in alpha-fetoprotein.
Tularik has asked for a meeting with the FDA in the third quarter to discuss plans for a Phase III trial with T67, and a Phase I/II combination study with doxorubicin has begun.
The other drug in the clinic is T607, an analogue of T67, for which Tularik aims to start Phase II trials by the end of this month in hepatocellular carcinoma, non-Hodgkin's lymphoma, gastric cancer and ovarian cancer.
"Liver cancer is a difficult cancer, with 1 million new cases in the world each year," mostly in Asia because of the connection with hepatitis B and C, McCarty noted.
"We have five [investigational new drug application] candidates currently, and we hope to file one by mid-year," she said, with another one or two in the second half of the year. Tularik has 26 leads and 88 targets, she added, acknowledging the company has been rather low profile.
"We haven't been able to talk about them because of their competitive nature," she said. "Also, it's the style of management. [Goeddel, formerly director of molecular biology for Genentech Inc., of South San Francisco] is a scientist first and foremost, and he doesn't talk about anything unless there are data in his hands."
Tularik had $200 million as of the end of the first quarter, with an expected burn rate of $75 million in 2002, which McCarty said would not change as a result of the latest news.
The company's stock (NASDAQ:TLRK) closed Tuesday at $7.15, down $1.15.