Bayer's Prostate Drug Alpharadin Gets FDA Fast-Track Designation (AMGN)
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Bayer AG (OTCBB: BAYRY) shares are getting a boost Tuesday following news the company and partner Algeta ASA have received fast-track designation from the U.S. FDA for their experimental prostate cancer therapy, Alpharadin.
Estimated potential sales for the drug, according to the WSJ, are about $1 billion annually.
Data from a trial showed Alpharadin improved overall survival in patients with castration-resistant prostate cancer and symptomatic bone metastases. The trial was stopped early due to impressive results.
Analysts estimate the market for Alpharadin is between €500 million and €1.2 billion, or $718 million to $1.72 billion.
Bayer said it plans to apply approval applications in all major markets by mid-2012. FDA approval is expected in 2012, while EMA approval should come in 2013.
The drug will be a competitor to Amgen's (Nasdaq: AMGN) Xgeva (denosumab). Monday morning, Amgen reported receiving a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application to expand the indication for Xgeva. Xgeva is also indicated to treat castrate-resistant prostate cancer.
Amgen shares are up nearly 3 percent Tuesday. Bayer shares are up about 2 percent in Europe.
Estimated potential sales for the drug, according to the WSJ, are about $1 billion annually.
Data from a trial showed Alpharadin improved overall survival in patients with castration-resistant prostate cancer and symptomatic bone metastases. The trial was stopped early due to impressive results.
Analysts estimate the market for Alpharadin is between €500 million and €1.2 billion, or $718 million to $1.72 billion.
Bayer said it plans to apply approval applications in all major markets by mid-2012. FDA approval is expected in 2012, while EMA approval should come in 2013.
The drug will be a competitor to Amgen's (Nasdaq: AMGN) Xgeva (denosumab). Monday morning, Amgen reported receiving a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application to expand the indication for Xgeva. Xgeva is also indicated to treat castrate-resistant prostate cancer.
Amgen shares are up nearly 3 percent Tuesday. Bayer shares are up about 2 percent in Europe.
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