Novartis could cut drug development by a year

By Sam Cage

NEW YORK (Reuters) - A new way of conducting clinical trials could allow Novartis AG (NOVN.VX) to cut the time needed to develop some drugs by a year, the Swiss drug maker's designated development head said on Wednesday.

The new approach, which uses disease models to predict measurable markers and responses, could apply in areas like oncology and genetic diseases and allow mid-stage trials to be shortened or even, in some cases, omitted completely.

"We can get back to at least the one year advantage that we gained in the early stages and not lose that in Phase II and Phase III. And that's pretty realistic," Trevor Mundel, who will become Novartis's development head in December, told the Reuters Health Summit in New York.

"I think for us the importance are those situations where we can omit Phase II or we can really reduce Phase II and move straight into Phase III," Mundel said.

It does not apply in all indications, but Novartis pushes the approach whenever it can, he added.

Mundel was speaking after a Novartis investor day, where the Swiss company gave an update on its new products, but said U.S. regulators have asked for more information on cancer drug Afinitor.

The financial crisis has also opened up some interesting opportunities for large pharmaceutical companies like Novartis to gain access to promising drugs from the biotech industry.

Some cash-burning biotech companies are struggling to stay afloat as traditional sources of funding, like venture capital or initial public offerings, dry up.

"I think that with the new circumstances, the drying up of venture capital, a lot of these biotechs are open to pretty interesting and risk mitigating deal structures," Mundel said.

"It's nice to have something cheaper, but of course we have to look if we actually need it," Novartis research head Mark Fishman added.

(For summit blog: summitnotebook.reuters.com/)