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that eltrombopag (Promacta) had a long-term benefit for patients with a rare bleeding disorder called immune thrombocytopenic purpura (ITP). This drug is vying for FDA approval in the U.S., and aims to compete with Amgen’s romiplostim (Nplate). The Glaxo/Ligand alternative would be the only one that can be taken as an oral pill, instead of as an injection.
The Glaxo/Ligand drug showed it was able to boost counts of platelets in the blood, which help form clots. This led to less bleeding, and helped wean patients off steroid medications that carry nasty side effects when taken chronically over a long period of time. Patients who got the drug were eight times more likely to have sustained healthy platelet counts over six months than those who got a placebo.
“We believe reduction in the use of other medications is a particularly important finding that will serve to increase its utilization in other indications like HCV, if approved,” said Christopher James, an analyst with Rodman & Renshaw in New York, in a note to clients.
This Cambridge, MA-based company said its experimental drug romidepsin reached its goal in a Phase II clinical trial of patients with cutaneous T-cell lymphoma. Researchers at Stanford Cancer Center found 30 of 72 patients (42 percent) had their tumors completely or partially go away. A second study sponsored by the National Cancer Institute supported the finding with a 40 percent tumor response rate. The company anticipates filing an application by year’s end with the FDA to begin marketing the product. About 1,500 people are diagnosed with cutaneous T-cell lymphoma in the U.S. each year, according to The Leukemia & Lymphoma Society.
Seattle-based ZymoGenetics (NASDAQ: ZGEN) said its sole marketed product was able to be safely given to patients with excess surgical bleeding, without provoking an immune system reaction. The study was of 205 patients who were at increased risk for having reactions against the standard product derived from cow blood, marketed by King Pharmaceuticals as Thrombin-JMI.
The study found that none of the patients developed immune reactions against the ZymoGenetics drug, marketed as Recothrom, which is made differently, through genetically engineered copies of a human clotting protein. The product has gotten off to a slow start in the marketplace, and is expected to generate $7 million in sales this year, the company has said.
Seattle-based Cell Therapeutics (NASDAQ: CTIC) has a drug that’s working well for patients with non-Hodgkin’s lymphoma. The question is whether they can raise enough money to commercialize it, long after most investors have written the company off, driving its stock down to pennies a share.
At the ASH meeting, researchers said ibritumomab tiuxetan (Zevalin) was able to cause long-lasting remissions in a clinical trial of 409 patients. Among patients who had their tumors completely wiped out, patients on the Zevalin group stayed in remission for a median time of at least 67 months, compared with 31 months for patients in a control group.
The world’s largest biotech company, with research and development operations in Seattle and Cambridge, MA, reported some follow-up data on its drug for the bleeding disorder, ITP.
The company found that 160 out of 215 patients (74 percent) were able to boost their platelet counts to a healthy level to stop bleeding. The average treatment period was almost a year and a half (76 weeks). The platelet counts were sustained at that level or higher for at least a year in 41 percent of patients, the company said.
Almost one-third of patients (29 percent) had serious adverse events in the trial, and about seven percent of those were considered drug-related, the company said. The most common side effects were headache, contusions, and fatigue.
“We believe these data support the long-term use of Nplate for adult chronic ITP patients,” said James, the analyst with Rodman & Renshaw. He forecasts it will generate $424 million in sales in 2012, its fourth year on the market.
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