Company Website:
http://pranabio.com/
MELBOURNE, Australia -- (Business Wire)
Prana Biotechnology(ASX:PBT) (NASDAQ:PRAN) is pleased to
announce the European Medicines Agency’s Committee for Orphan Medicinal
Products (COMP) has adopted a positive opinion recommending designation
of PBT2 for the treatment of Huntington disease as an orphan medicinal
product to the European Commission (EC).
Following finalisation of relevant documents the European Medicines
Agency forwards the opinion to the EC for its decision on the
designation.
“We welcome the positive opinion from COMP for PBT2 to receive orphan
designation to treat Huntington disease in Europe,” said Prana Chairman
and CEO Geoffrey Kempler.
“Prana is dedicated to progressing development of PBT2 as a treatment
for this terrible disease that devastates lives and families.”
Orphan designation is granted by the EC to encourage the development of
medicines to treat rare diseases. Rare diseases are defined as
life-threatening or chronically debilitating conditions that affect no
more than five in 10,000 people in Europe.
Huntington disease is a neurodegenerative genetic disorder that affects
muscle coordination and leads to cognitive decline and behavioral
symptoms. The Huntington’s
Outreach Project for Education estimates there are between 40-100
cases of Huntington disease per million people in Europe.
The EC offers orphan medicinal product developers incentives including
scientific advice, market exclusivity for 10 years for approved drugs
and reduced fees.
In September last year the US Food and Drug Administration granted PBT2
orphan drug status for the treatment of Huntington disease.
In February last year Prana announced that PBT2 had met its primary end
point of safety and tolerability, and improved measures of cognitive
performance – a secondary endpoint in its REACH2HD Phase 2 clinical
trial involving 109 people with Huntington disease.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into
Alzheimer's disease and other major age-related neurodegenerative
disorders. The Company was incorporated in 1997 and listed on the
Australian Stock Exchange in March 2000 and listed on NASDAQ in
September 2002. Researchers at prominent international institutions
including The University of Melbourne, The Mental Health Research
Institute (Melbourne) and Massachusetts General Hospital, a teaching
hospital of Harvard Medical School, contributed to the discovery of
Prana’s technology.
For further information please visit the Company’s web site at www.pranabio.com
Forward Looking Statements
This press release contains "forward-looking statements" within the
meaning of section 27A of the Securities Act of 1933 and section 21E of
the Securities Exchange Act of 1934.The Company has tried to
identify such forward-looking statements by use of such words as
"expects," "intends," "hopes," "anticipates," "believes," "could,"
"may," "evidences" and "estimates," and other similar expressions, but
these words are not the exclusive means of identifying such statements.Such statements include, but are not limited to any statements
relating to the Company's drug development program, including, but not
limited to the initiation, progress and outcomes of clinical trials of
the Company's drug development program, including, but not limited to,
PBT2, and any other statements that are not historical facts.Such
statements involve risks and uncertainties, including, but not limited
to, those risks and uncertainties relating to the difficulties or delays
in financing, development, testing, regulatory approval, production and
marketing of the Company’s drug components, including, but not limited
to, PBT2, the ability of the Company to procure additional future
sources of financing, unexpected adverse side effects or inadequate
therapeutic efficacy of the Company's drug compounds, including, but not
limited to, PBT2, that could slow or prevent products coming to market,
the uncertainty of patent protection for the Company's intellectual
property or trade secrets, including, but not limited to, the
intellectual property relating to PBT2, and otherrisks detailed
from time to time in the filings the Company makes with Securities and
Exchange Commission including its annual reports on Form 20-F and its
reports on Form 6-K.Such statements are based on management’s
current expectations, but actual results may differ materially due to
various factions including those risks and uncertainties mentioned or
referred to in this press release.Accordingly, you should not
rely on those forward-looking statements as a prediction of actual
future results.
Contacts:
Investor Relations
Buchan Consulting
Rebecca Wilson,
+61 3 9866 4722
rwilson@buchanwe.com.au
Media
Buchan
Consulting
Gavin Lower, +61 3 9866 4722
glower@buchanwe.com.au
Source: Prana Biotechnology Limited
© 2024 Canjex Publishing Ltd. All rights reserved.