FDA Grants Fast Track Designation to Alpharadin for the Treatment of Castration-Resistant Prostate Cancer Patients with Bone Metastases
(Thomson Reuters ONE) -
Not intended for U.S. Media
Oslo, Norway, 23 August 2011 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, today 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.
###
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(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow/David Dible/Sita Shah mark.swallow(at)citigatedr.co.uk
Citigate Dewe Rogerson
US investor enquiries: +1 646 378 2928
Jessica Lloyd jlloyd(at)troutgroup.com
The Trout Group
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 Alpharadin (radium-223 chloride) is a first-in-class,
highly targeted alpha-pharmaceutical under clinical evaluation to improve
survival in patients with bone metastases from advanced cancer. Its localized
action helps preserve the surrounding healthy tissue thereby limiting side-
effects.
Alpharadin 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 (ALSYMPCA) of Alpharadin 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. Alpharadin 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.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
Press release:
http://hugin.info/134655/R/1540232/470883.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
[HUG#1540232]
Unternehmensinformation / Kurzprofil:
Datum: 23.08.2011 - 08:00 Uhr
Sprache: Deutsch
News-ID 58079
Anzahl Zeichen: 8034
contact information:
Town:
Oslo
Kategorie:
Business News
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"FDA Grants Fast Track Designation to Alpharadin for the Treatment of Castration-Resistant Prostate Cancer Patients with Bone Metastases"
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