In a race to develop a promising new weapon in the war on cancer, both Amgen Inc. and Genentech Inc. have unveiled promising results from the first human tests of their developmental biotechnology drugs designed to combat chronic bleeding by patients undergoing chemotherapy.
At stake is a potential market of $500 million to $1 billion a year, analysts say, and help for many chemotherapy patients, including those with leukemia and breast, lung, and intestinal cancers.
But both companies remain more than a year behind a third rival, Genetics Institute Inc., which last week released encouraging results from a different biotechnology drug that also seems to stop chronic bleeding after chemotherapy.
Cambridge, Mass.-based Genetics Institute has asked the Food and Drug Administration for early approval to sell its drug, Neumega, based on encouraging phase-two test results. And that drug "could be on the market next year," said Jim McCamant, editor of the Medical Technology Stock Letter. Thousand Oaks-based Amgen and South San Francisco-based Genentech face two to three years of tests before their drugs could get the green light for sales, he said.
"Genentech and Amgen have basically identical drugs and are very close" in the race to develop them, McCamant said. "But Genetics Institute is substantially ahead" of both.
All three companies are trying to solve a long-standing problem in cancer treatment. Doctors have been frustrated by having to slow or stop chemotherapy when their patients develop chronic bleeding because of a shortage of platelets, the oval disks that make the blood clot. Chemotherapy kills both cancer cells and good cells, often leaving patients with such a low platelet counts that their blood won't clot, which can lead to intestinal bleeding, brain hemorrhages and sometimes death.
The only option doctors have is to halt chemotherapy, give patients platelet transfusions--which can cost $1,000 a treatment and carry the risk of hepatitis or HIV infection--and hope that the body won't eventually reject the new platelets. Meanwhile, the cancer cells can keep growing. The hope is that the new drugs will allow doctors to keep chemotherapy going--maybe even boost chemotherapy doses--without the risk of chronic bleeding.
The Amgen and Genentech drugs are considered to be similar, gene-spliced copies of a body protein, whereas the Genetics Institute drug is a copy of the hormone interleukin-11 and may encourage a wider variety of cells in a different stage of blood platelet production.
The test results, from 51 lung cancer patients at UCLA, Emory and Duke universities, showed the patients' minimum platelet counts were 70% higher after being treated with Amgen's drug, MGDF, and that after chemotherapy their platelet counts returned to normal after 13 days, compared with 28 days without the drug.
Genentech released results on 14 patients at the Anderson Cancer Center in Houston. They showed as much as a 158% increase in platelets. Genentech's drug is called TPO.
In a separate project, Amgen said Monday that it has begun human tests of its well-publicized antiobesity drug, leptin, on between 100 and 200 patients. This round, primarily to test the drug's safety, will last until early next year.
On Nasdaq, Amgen's stock closed Monday at $59.50 a share, down 37.5 cents. Genentech's stock closed at $52.625, down 12.5 cents on the New York Stock Exchange.