Ariad Pharmaceuticals Inc. (ARIA)’s most- advanced experimental medicine extended the lives of sarcoma patients and reduced the risk of the disease progressing, according to a study presented today.
Merck & Co., Ariad’s marketing partner, plans to apply for U.S. and European Union approval this year based on the results, the companies said in a statement. Some data from the study, presented at the American Society of Clinical Oncology’s meeting in Chicago, were reported in January, driving up shares of Cambridge, Massachusetts-based Ariad the most in 18 months.
The pill, ridaforolimus, is designed to maintain benefits from chemotherapy in patients with sarcomas, cancers of the soft tissue and bone. The drug may have $300 million in sales by 2015, said Phil Nadeau, a Cowen & Co. analyst in New York.
“With this early, interim look at survival, you’ve already got a very strong trend,” Ariad Chief Executive Officer Harvey Berger said in a telephone interview. “I have every expectation that once the remaining patients are followed up over the next year that this will continue to bear out.”
Ariad gained 2 cents to $7.91 at 4 p.m. New York time in Nasdaq Stock Market trading. The shares are up 55 percent this year. Merck, based in Whitehouse Station, New Jersey, declined 26 cents to $35.56 in New York Stock Exchange composite trading.
The study also showed ridaforolimus shrank tumor lesions by 1.3 percent, compared with an increase in size of 10.3 percent for those on placebo. Overall survival and tumor lesion size were secondary endpoints in the trial, the last of three phases of testing generally needed for U.S. regulatory approval. The primary endpoint, survival without progression of the disease, was reported in January.
The pill was shown to reduce the risk of death or progression in sarcomas by 28 percent, and patients lived about three weeks longer without their cancer getting worse. The most common side effects were mouth sores; thrombocytopenia, or a low level of platelets in the blood; anemia; and hyperglycemia, the companies said. There were six deaths in the ridaforolimus arm related to pulmonary disorders, and none in the placebo group.
Drugs in this class, called mTOR inhibitors, are known to be associated with pulmonary disorders, Berger said.
Sarcomas are a rare form of cancer, with an estimated 13,000 Americans newly diagnosed in 2010, according to National Cancer Institute estimates. Soft tissue sarcomas are more common and more deadly than bone sarcomas, often because their symptoms don’t appear until later stages of the disease.
Merck licensed ridaforolimus from Ariad and controls the drug’s worldwide commercialization and development in cancer.
Merck & Co., Ariad’s marketing partner, plans to apply for U.S. and European Union approval this year based on the results, the companies said in a statement. Some data from the study, presented at the American Society of Clinical Oncology’s meeting in Chicago, were reported in January, driving up shares of Cambridge, Massachusetts-based Ariad the most in 18 months.
The pill, ridaforolimus, is designed to maintain benefits from chemotherapy in patients with sarcomas, cancers of the soft tissue and bone. The drug may have $300 million in sales by 2015, said Phil Nadeau, a Cowen & Co. analyst in New York.
“With this early, interim look at survival, you’ve already got a very strong trend,” Ariad Chief Executive Officer Harvey Berger said in a telephone interview. “I have every expectation that once the remaining patients are followed up over the next year that this will continue to bear out.”
Ariad gained 2 cents to $7.91 at 4 p.m. New York time in Nasdaq Stock Market trading. The shares are up 55 percent this year. Merck, based in Whitehouse Station, New Jersey, declined 26 cents to $35.56 in New York Stock Exchange composite trading.
Median Survival
The study of 711 patients showed a median overall survival in those taking ridaforolimus of 21.4 months, compared with 19.2 months for the placebo group, though the result wasn’t statistically significant and the follow-up is ongoing.The study also showed ridaforolimus shrank tumor lesions by 1.3 percent, compared with an increase in size of 10.3 percent for those on placebo. Overall survival and tumor lesion size were secondary endpoints in the trial, the last of three phases of testing generally needed for U.S. regulatory approval. The primary endpoint, survival without progression of the disease, was reported in January.
The pill was shown to reduce the risk of death or progression in sarcomas by 28 percent, and patients lived about three weeks longer without their cancer getting worse. The most common side effects were mouth sores; thrombocytopenia, or a low level of platelets in the blood; anemia; and hyperglycemia, the companies said. There were six deaths in the ridaforolimus arm related to pulmonary disorders, and none in the placebo group.
Drugs in this class, called mTOR inhibitors, are known to be associated with pulmonary disorders, Berger said.
Physician’s Decision
“This is neither new nor alarming and is a class effect of all mTOR inhibitors,” he said. It’s a physician’s decision whether to prescribe these medicines based on patient history, he said.Sarcomas are a rare form of cancer, with an estimated 13,000 Americans newly diagnosed in 2010, according to National Cancer Institute estimates. Soft tissue sarcomas are more common and more deadly than bone sarcomas, often because their symptoms don’t appear until later stages of the disease.
Merck licensed ridaforolimus from Ariad and controls the drug’s worldwide commercialization and development in cancer.
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