7 novembre, 2006 21:47

Drug & Device Development

Amgen sees "game changer" in bone drug

Last Updated: 2006-11-07 11:01:10 -0400 (Reuters Health)

By Deena Beasley

NEW YORK (Reuters) - Amgen Inc.'s experimental drug to treat osteoporosis and prevent cancer from spreading to bones is a potential "game changer" for the company, Cynthia Schwalm, head of Amgen's oncology unit, said on Monday.

The drug, denosumab, which is also being studied as a treatment for bone cancer, has the potential for sales "in the multiple billions of dollars" per year, she said at the Reuters Health Summit in New York.

Amgen, the world's largest biotechnology company, plans to file for regulatory approval of the drug as a bone cancer treatment in 2009, Schwalm said.

"The ability to prevent bone metastases is a whole new paradigm," she said.

If approved, denosumab could catapult Amgen into a sphere dominated by big pharmaceutical companies which sell most of the products aimed at big patient populations served by primary care doctors.

"It's a game changer for us for two reasons. Number one, it has the potential to be a multibillion dollar product playing in two very large arenas, and secondly, we'll be actively engaging in primary care," Schwalm said, adding the company would "probably create a new business structure" to market the drug.

She said Amgen would probably deploy its own sales force, rather than seek a partner for the drug.

Schwalm also said the company's launch in October of colon cancer drug Vectibix has exceeded its expectations, with about 1,000 patients treated so far.

"We have had a great initial uptake of the product. The oncology community will be waiting to see the outcome of treatment over the past couple of months."

Schwalm said the initial uptake was largely driven by an unexpected number of doctors prescribing Vectibix to patients who had failed all other therapies.

There was a large group of end-stage patients that Amgen didn't expect doctors to treat, she said. "We don't think at the end of the day that spike is going to maintain its trajectory."

Schwalm said the company is confident it can overtake Erbitux, a rival drug sold by ImClone Systems Inc. and partner Bristol-Myers Squibb.

"We don't see any problem becoming the market leader," she said.

(Additional reporting by Toni Clarke and Bill Berkrot)