FDA Grants Fast Track Designation to Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer Patients with Bone Metastases

Aug 23, 2011, 02:00 ET from Algeta

OSLO, Norway, August 23, 2011 /PRNewswire/ --

Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, today announced that 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 was a great achievement for Algeta and for Bayer, reinforcing the common belief of radium-223 chloride's potential to become an important treatment for bone metastases initially with prostate cancer. We are pleased that it has now been granted Fast Track designation by the FDA, as this represents an important step towards the filing which we anticipate in mid 2012 ahead of previous expectations."

In June 2011, Algeta and Bayer Pharma AG (Bayer) announced that the phase III trial evaluating radium-233 chloride 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 safety and tolerability of radium-223 chloride were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in its safety profile. 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 radium-223 chloride.  Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.

###

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta's lead product radium-223 chloride is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastasesfrom advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.

Radium-223 chloride is being developed under a development and commercialization agreement with Bayer Pharma AG (formerly Bayer Schering Pharma AG). In June 2011, a global phase III clinical trial of radium-223 chloride to treat bone metastases in patients with castration-resistant prostate cancer (CRPC) was stopped early after meeting its primary endpoint of significantly improving overall survival. Radium-223 chloride is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa trial in combination with docetaxel chemotherapy in for bone metastases CRPC patients.

The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring frequently in certain late-stage cancers, e.g. prostate (in up to 90% patients), breast (up to 60 %) and lung (up to 40%).

Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a future pipeline of tumor-targeting alpha-pharmaceutical candidates.

The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

For further information, please contact


   
    Andrew Kay, CEO                 +47 2300 7990 / +47 4840 1360 (mob)
    Øystein Soug, CFO               +47 2300 7990 / +47 9065 6525 (mob)
                                    post@algeta.com

    International media enquiries:  +44 207 638 9571
    Mark Swallow/David Dible/Sita   sita.shah@citigatedr.co.uk
    Shah
    Citigate Dewe Rogerson
                                     
    US investor enquiries:          +1 646 378 2928
    Jessica Lloyd                   jlloyd@troutgroup.com
    The Trout Group



SOURCE Algeta