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Phase III Results For Bayer/Algeta's Alpharadin Hint Of Labeling Down The Line

This article was originally published in The Pink Sheet Daily

Executive Summary

In what's become a crowded field of drugs for advanced prostate cancer, Algeta takes aim at symptomatic bone metastases.

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Opening A Window: Algeta Must Find Xofigo’s Place In The Prostate Cancer Market

Bayer/Algeta’s Xofigo was cleared for castration-resistant prostate cancer patients with symptomatic bone metastases, but uptake of the radiotherapeutic will require referrals from most providers to a licensed radiation site and the company must find a way for the drug to be used instead of or in sequence with chemo and other prostate cancer therapies.

Bayer/Algeta’s Xofigo Brings New Mechanism To Prostate Cancer Field

FDA approved the first alpha particle-emitting radioactive therapeutic agent, Bayer/Algeta’s Xofigo (radium Ra 223 dichloride), for prostate cancer patients with symptomatic bone metastases, three months ahead of the expected PDUFA date.

New Products, Emerging Markets Spur Pharmaceutical Growth For Bayer

During its recent earnings call, the German conglomerate pointed to five drugs recently launched or now awaiting regulatory approval as driving its pharmaceutical sales growth from 2013 to 2015, along with strengthening performance in emerging markets.

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