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July 22 Puma Biotechnology Inc said its
experimental breast cancer drug met its main goal in a
Shares of the company, which doesn't have any drug in the
market, tripled to $176.94 in extended trading.
Puma said on Tuesday it plans to file for marketing approval
of neratinib, codenamed PB272, in the first half of 2015.
Adjuvant treatment with the drug showed a statistically
significant improvement in disease-free survival of 33 percent
versus patients on placebo, according to trial data.
Adjuvant treatment, or additional treatment, is given after
the primary treatment.
Patients in the trial were treated with neratinib after
adjuvant treatment with cancer drug trastuzumab in women with
early-stage HER2-positive breast cancer.
Cancer cells with above-normal levels of the HER2 protein
increases breast cancer risks.
Breast cancer is the leading cause of cancer deaths among
women worldwide, with about one million new cases reported each
Neratinib, licensed from Pfizer Inc, is also being
studied in patients with non-small cell lung cancer and other
solid tumors that have a HER2 mutation.
Puma also said it has amended its licensing agreement with
Pfizer under which it will have to pay the larger drugmaker
annual royalties on net sales of neratinib at a fixed rate in
low- to mid-teen percentage rate.
Puma was obligated to pay Pfizer incremental annual
royalties between 10 and 20 percent of net sales of neratinib,
under the original agreement.
Under the amended agreement, Puma will be solely responsible
for ongoing clinical trials expenses.
Puma said it expects research and development expenses to
increase by about $30 million.
(Reporting by Shailesh Kuber in Bangalore; Editing by Joyjeet