Algeta ASA (ALGETA), the Norwegian drugmaker developing a treatment for prostate cancer with Bayer AG (BAYN), rose the most in seven months after a study indicated the drug may receive a wider approval from regulators.
“It improves confidence in the company’s ability to gain a broad approval,” Richard Parkes, an analyst at Deutsche Bank AG, said by phone. The analysis may lead regulators to grant an approval that covers patients for whom the widely administered Taxotere drug, owned by France’s largest drugmaker Sanofi, has failed to yield results as well as for those who are ineligible to use it, he said.
Administering chemotherapy after Alpharadin, or radium-223 dichloride, had no deleterious effect on patients overall survival, according to the study presented by Doctor Oliver Sartor, Medical Director at the Tulate Cancer Center, at the ESMO 2012 Congress.
“This is not a question as to whether the drug gets approved, it’s about how broad the label is,” said Parkes, who has a buy recommendation on the stock. “Whether the regulators allow that label to encompass just patients that have failed other therapies, like Taxotere, or the ineligible/refuser patient population.”
Algeta and Bayer have said they see “blockbuster” potential for Alpharadin and plan to submit the drug to regulatory authorities in the U.S. and Europe in the second half of this year. Alpharadin is designed to treat bone metastases resulting from prostate cancer, which can lead to spinal-cord compression, paralysis and bladder dysfunction.
“These new analyses continue to build our confidence in radium-223 dichloride’s potential,” Algeta Chief Medical Officer Doctor Gillies O’Bryan-Tear said in a statement.
The treatment also exhibited “significantly better” preserved quality of life versus a placebo in a phase 3 double- blind, randomized, multinational study, according to a presentation at the congress by Doctor Christopher Parker, Consultant Clinical Oncologist at the U.K.’s Royal Marsden Hospital NHS Foundation Trust.
The Norwegian company said on April 12 that it exercised an option to split potential profit from Alpharadin in the U.S. with Bayer, with each partner bearing half the cost of selling and marketing the drug.
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