Novartis plans to submit two potential blockbuster drugs for U.S. regulatory approval in early 2006, the drugmaker said prior to its pipeline update in London.
Novartis' plans include filing for FDA approval for an experimental diabetes drug vildagliptin, also known as LAF237, and another drug, the first in a new class of blood pressure-lowering medications, called Aliskiren or SPP100.
Vildagliptin belongs to a new class of drugs called dipeptidyl-peptidase IV, or DPP-IV inhibitors, and possesses blockbuster potential, said Joerg Reinhardt, head of development at Novartis, during a conference call with reporters.
Merck is also developing a drug in this class called sitagliptin.
The blood pressure drug Aliskiren was developed in combination with Speedel, a Swiss biopharmaceutical company.
Reinhardt told reporters he also expects Aliskiren to achieve blockbuster status.
Meanwhile, Novartis chief executive Daniel Vasella reiterated the company's willingness to control U.S. vaccine company Chiron.
"Chiron faces a multitude of challenges it can better address as a Novartis entity," Vasella said during a presentation to analysts in London, according to a Wall Street Journal report.
Newspaper editorial calls for
competitive drug testing
The system for approving and promoting drugs is "badly out of whack" as the nation wastes "billions of dollars on heavily-marketed drugs that have never proved themselves in head-to-head competition against cheaper competitors," The New York Times wrote in an unsigned editorial.
Calling attention to the recent federal study of schizophrenia drugs, the Times editorial called for clinical trials to compare drugs with older drugs rather than placebos to learn more about their efficacy.
"It would make sense to force manufacturers to test their drugs not just against placebos, but also against the drugs they are seeking to displace," the Times wrote. "And surely it would be cost effective for the government to sponsor large studies comparing a slew of expensive drugs with their cheaper alternatives."
A study appearing in the New England Journal of Medicine this week found that an older schizophrenia drug, perphenazine, was as effective as all but one of the newer drugs and caused no greater side effects. The newer drugs included AstraZeneca's Seroquel (quetiapine), Johnson & Johnson's Risperdal (risperidone) and Pfizer's Geodon (ziprasidone).
Only Eli Lilly's Zyprexa had slightly higher efficacy rates, but at the expense of serious side effects.
Taken together, these branded drugs comprise 90 percent of the $10-billion antipsychotic market.