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FDA Grants Fast Track Designation to Alpharadin

FDA Grants Fast Track Designation to Alpharadin

FDA Grants Fast Track Designation to Alpharadin

FDA Grants Fast Track Designation to Alpharadin

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Algeta ASA, has announced that Alpharadin (radium-223 chloride) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases.

Andrew Kay, Algeta’s President and CEO, said: “The positive results at the pre-planned interim analysis of the pivotal phase III study, ALSYMPCA, (ALpharadin in SYMptomatic Prostate Cancer) was a great achievement for Algeta and for Bayer, reinforcing the common belief of Alpharadin’s potential to become an important treatment for bone metastases initially with prostate cancer. We are pleased that Alpharadin now has been granted Fast Track designation by the FDA, as this represents an important step towards Alpharadin filing which we anticipate mid 2012 ahead of previous expectations.”

In June 2011, Algeta and Bayer Pharma AG (Bayer) announced that the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating Alpharadin for treating symptomatic bone metastases in CRPC patients met its primary endpoint by significantly improving overall survival.

The trial was stopped early based on this positive result and a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis.

The overall survival result was statistically significant (two-sided p-value = 0.0022, hazard ratio = 0.699, the median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo). Patients on the placebo arm have been offered treatment with Alpharadin.

The safety and tolerability of Alpharadin were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of Alpharadin. The complete results from the study will be presented at an upcoming scientific meeting.

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need so that important new drugs are available earlier. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.

The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

In September 2009, Bayer signed an agreement with Algeta for the development and commercialization of Alpharadin.

Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize Alpharadin globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.