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Last updated on April 20, 2014 at 8:28 EDT

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

August 23, 2011

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


Source: PR Newswire