West Coast Editor

SAN FRANCISCO - Saying there "couldn't be a better time" for biotechnology, Chiron Corp.'s co-founder William Rutter told first-day attendees of the Allicense meeting here that more patient involvement in health care along with pooled treatment data could be part of a landscape that includes earlier drug approvals, "perhaps after a strong Phase II trial."

Marketing clearance would include more testing along with close monitoring of patients, he added, so that any problems could be detected early and the label adjusted if necessary.

Despite huge advances in science, company leaders "still don't seem to be able to make a good call on whether a product is going to be wildly successful or not," Rutter allowed. The situation is bound to change, he said, but meanwhile, pharma firms are trying to defend their franchise, grasping at chances to improve "what are already pretty doggone good products."

Combination drugs have not worked out particularly well. "They sound good at the preclinical level and even at the clinical level, [but] these large trials turn out to be very difficult to manage," Rutter noted.

Witness the Phase III failure in December of the would-be blockbuster torcetrapib, New York-based Pfizer Inc.'s cholesterol ester transfer protein inhibitor, intended to back up the pharma giant's Lipitor (atorvastatin), which loses patent protection in 2010. (See BioWorld Today, Dec. 5, 2006.)

The biotech sector took a hit in the combo zone last month when Amgen Inc., of Thousand Oaks, Calif., stopped its Phase IIIb colorectal-cancer trial with Vectibix (panitumumab) and the VEGF inhibitor Avastin (bevacizumab) because of lack of efficacy and concerns about toxicity. Amgen's Vectibix was approved for colorectal cancer in September, and the FDA cleared Avastin for the same indication in early 2004. (See BioWorld Today, Feb. 27, 2004, Sept. 29, 2006, and March 26, 2007.)

In one sense, Rutter said, drug developers find themselves caught in the crossfire created by pharmacogenomics and the regulators. The "FDA is demanding 100 percent benefit [from a therapy] or at least neutrality, and from a pharmacogenomics point of view, that's going to be increasingly hard to find," as closer testing reveals certain groups that are hurt by a particular compound, he said.

Also, it's "very difficult to monitor huge populations on a pre-approval basis, and on a post-approval basis, one gets into the liabilities associated with the small populations that are disadvantaged," Rutter said. The tricky situation will only worsen, resulting in "a real intensity on metrics" and on using such tools as point-of-care diagnostics, which have heated up lately, he said.

Rutter pointed to the "presumptive" acquisition of Biosite Inc. at a price tag five times the amount of the company's sales. As of Wednesday, San Diego-based Biosite was still the subject of a bidding war between Inverness Medical Innovations Inc., of Waltham, Mass., and Beckman Coulter Inc., of Fullerton, Calif. (See BioWorld Today, April 11, 2007.)

Solutions will come through better organized and more available treatment data on individuals and across populations, Rutter said, putting in a pitch for iMetrikus Inc., which he founded in Carlsbad, Calif. The health care technology firm's flagship MediCompass enables an interactive personal health record with access to a broad base of information, which "really empowers any point-of-care system," said Rutter, who founded Emeryville, Calif.-based Chiron (now Novartis AG, of Basel, Switzerland) with Edward Penhoet and Pablo Valenzuela in 1981.

Day one of the Allicense meeting also included a talk by Maria Freire, president and CEO of the Global Alliance for TB Drug Development, which forms partnerships to find new drugs for tuberculosis. Her topic was "Acquiring, In-Licensing, Co-Developing: What Biotech Can Learn from Public-Private Partnerships."

Freire found that getting the industry on board with the TB push was not easy.

"I thought biotechs would understand the whole thing," she said. "They would understand, first of all, that we were willing to pay. I thought the biotechs would understand that we had the next-generation market, and we could help them penetrate" such areas as China, India and South Africa."

She also expected biotech firms "would be needing the kind of support and capital [that would] bring them into a set of expertise [and] buttress their own mainline development," Freire said. "What I found was that pharma was very interested in playing, but biotech was very nervous" - and for a good reason.

"The heart of the issue [for biotech firms] is, how do I ensure that if I develop it for TB, it won't be used off-label for the indication I care about?" she said. "And the solution for that problem might very well be fixed-dose combinations."

But many were drawn by the potential for funding. "The first thing I found out is, the bottom line is $25 million," Freire said. "I don't know why, but everybody wants $25 million. I'm willing to put $25 million on the table, but not in one fell swoop. [There have to be] deliverables, moving forward, and checks and balances."

Among her group's board members are Bruce Carter, president of CEO of Seattle-based Zymogenetics Inc., and George Scangos, president and CEO of South San Francisco-based Exelixis Inc.

"It's very complicated to get people [in biotech] to understand that this actually could be a win-win situation, but they're finding out," Freire said.

The Allicense meeting, sponsored by Recombinant Capital, of Walnut Creek, Calif., listed about 330 registrants and continues through today in the Fairmont Hotel.

No Comments