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Amgen Drug for Lung Cancer Suspended After Deaths (Update3)

By David Olmos

Nov. 20 (Bloomberg) -- Amgen Inc.'s decision to suspend a clinical trial of its experimental cancer drug motesanib because of higher deaths among patients sets back the company's efforts to expand in the market for oncology treatments.

Amgen, the world's largest biotechnology company by sales, and Japan's Takeda Pharmaceutical Co. were testing the drug as a first-line treatment in combination with chemotherapy for non- small cell lung cancer, the companies said yesterday. The trial was halted after an independent monitoring committee's review of 600 patients found higher early mortality rates among those getting the drug compared with those on a placebo, said Christine Regan, an Amgen spokeswoman, in a telephone interview.

Amgen, based in Thousand Oaks, California, has made a major push the past seven years to develop treatments for cancer and now has eight oncology medicines in late-stage clinical trials needed to gain U.S. regulatory approval, with many more therapies in earlier-stage studies, she said.

``The news is clearly disappointing'' because the drug is considered a ``future growth driver'' for Amgen's sales in oncology, Christopher James, an analyst at Rodman & Renshaw in New York, said in a note to investors today.

The suspended trial had reached the last of three rounds of human tests generally required for regulatory approval.

Motesanib and the bone treatment denosumab are at the forefront of Amgen's efforts to become a major provider of cancer medicines. Amgen has said it plans to seek approval in the U.S., Europe and other markets later this year or in 2009 for denosumab as a treatment for preventing fractures in older patients with osteoporosis. Amgen is also conducting studies to see if denosumab can help prevent cancer from spreading from some parts of the body into the bones.

Future Growth

``We believe Amgen's pipeline remains full with compounds the company can leverage and provide future growth for the oncology franchise,'' James wrote.

Amgen fell $3.51, or 6.5 percent, to $50.13 at 4 p.m. New York time in Nasdaq Stock Market composite trading.

Motesanib is an experimental drug that works by starving tumor cells of the blood supply they need to grow. The medicine blocks a protein known as VEGF, involved in the growth of blood vessels that feed tumors.

The suspended study was one of three ``important trials'' for which Amgen is expecting key clinical data in 2009 and 2010, Robert Bradway, Amgen's chief financial officer, told analysts at the Credit Suisse Healthcare Conference on Nov. 14.

The work on motesanib is part of a ``broad, co-development program'' between Amgen and Takeda, Japan's largest drugmaker, the companies said in a statement.

Takeda's View

``We will analyze the data, talk to the committee and make a decision on whether to continue or halt development,'' Ayako Iwamuro, a spokeswoman for Osaka, Japan-based Takeda, said today in a telephone interview.

Amgen said the suspension applied only to patients with the squamous non-small cell form of cancer. This type of cancer begins in the lung's flat, thin squamous cells, which look like fish scales. The committee didn't recommend suspension of the study for patients with the non-squamous form of the cancer, the company said.

The independent monitoring committee will review updated results after three months, Regan said.

``While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,'' said Roger M. Perlmutter, Amgen's executive vice president of research and development, in a statement.

Lung cancer kills an estimated 161,000 Americans each year, according to the National Cancer Institute. About 215,000 new cases are diagnosed annually. Non-small cell is the most common form of the disease.

Amgen also is testing motesanib as an initial therapy, combined with chemotherapy, for treating patients with advanced breast cancer.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net

Last Updated: November 20, 2008 16:21 EST

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