Nov 8th remarks by Roger Perlmutter
UPDATE 1-Reuters Summit-Amgen confident of 4 drug approvals
Tue Nov 8, 2005 05:54 PM ET
(For other news from the Reuters Health Summit, click on today.reuters.com (Adds quotes, background, byline)
By Deena Beasley
NEW YORK, Nov 8 (Reuters) - Amgen Inc.'s (AMGN.O: Quote, Profile, Research) head of research and development said on Tuesday that the biotechnology company has four drugs in late stages of development that are certain to be approved by regulators.
The products, "unambiguously have data that will support registration," Roger Perlmutter, Amgen's executive vice president of research and development, said at the Reuters Health Summit in New York.
The four products are panitumumab, an antibody being studied as a treatment for colon cancer, osteoporosis treatment denosumab, AMG 706, a cancer drug designed to cut off the blood supply to tumors and AMG 531, which stimulates blood platelet production.
The company has such a rich pipeline that it will have to pick and choose which ones to pursue first, Perlmutter said.
Amgen said last week that panitumumab, which it is developing with Abgenix Inc. (ABGX.O: Quote, Profile, Research) , was shown to slow tumor growth in patients with advanced colon cancer who did not respond to chemotherapy.
The drug is also being studied in patients with earlier stage disease, in combination with chemotherapy and Genentech Inc.'s (DNA.N: Quote, Profile, Research) colon cancer drug Avastin. An early look at the first 150 patients in that trial is expected by year-end.
"I think you will find response rates that are really quite impressive," Perlmutter said.
He also said panitumumab will have advantages over Imclone Sytems Inc.'s (IMCL.O: Quote, Profile, Research) similar drug, Erbitux, because of potentially fewer side effects and more convenient dosing.
A U.S. Food and Drug Administration application for panitumumab is expected to be completed early next year.
AMG 706 is being studied in patients with gastrointestinal tumors who have become resistant to Gleevec, a cancer drug sold by Novartis AG (NOVN.VX: Quote, Profile, Research) .
Perlmutter said the drug is "better than Avastin," because it inhibits all of the tumor growth receptors, rather than just the one that Avastin blocks.
Phase 3 results are expected by mid-2006 from a trial of AMG 531 as a treatment for immune thrombocytopenic purpura, a bleeding disorder in which the blood does not clot as it should, Perlmutter said.
The company's development program for denosumab is its largest ever. The drug is being studied in post-menopausal osteoporosis, as well as breast and prostate cancer that has spread to the bone.
The effects of denosumab "are really dramatic," Perlmutter said. The drug is given subcutaneously just once every six months and suppresses bone turnover in hours, he said.
"It's a flu shot for osteoporosis," Perlmutter said. Patients can have trouble with current osteoporosis drugs, which must be taken first thing in the morning and can cause throat irritation.
A Phase 3 trial of denosumab in more than 8,000 patients is underway and results are expected in 2007.
The drug has also been shown to be "extraordinarily effective" in reducing bone turnover and fractures in patients with breast cancer that has spread to the bone, Perlmutter said.
The drug can prevent tumors from taking root in the bone because it keeps bone from degrading, he said.
Amgen is also studying denosumab in inflammatory diseases, like rheumatoid arthritis.
(Additional reporting by Bill Berkrot)
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