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Concert Pharmaceuticals and
GlaxoSmithKline Form Alliance to Develop Novel Deuterium
Modified Drugs
JUNE 2, 2009 - LEXINGTON, Mass. & LONDON-- Concert
Pharmaceuticals and GlaxoSmithKline (NYSE: GSK) announced today
that they will collaborate to develop and commercialize
deuterium-containing medicines. The deal includes three of
Concert’s research and development programs; namely, CTP-518, a
protease inhibitor for the treatment of HIV expected to enter
Phase I clinical trials in the second half of 2009, a
preclinical compound for chronic renal disease, and a third
research product in Concert’s pipeline. Concert will also
provide GSK with deuterium-modified versions of three GSK
pipeline compounds for GSK to develop.
Under the terms of the agreement, Concert will receive $35
million in upfront payments, including a $16.7 million equity
investment by GSK. Concert is eligible to receive milestones and
tiered, double-digit royalties based on deuterium-containing
products arising from the Concert pipeline programs. In
addition, Concert is eligible to receive milestones as well as
royalties on the sales of deuterium-containing products arising
from the GSK pipeline compounds. Overall, Concert has the
potential to receive in excess of $1 billion in total milestone
and upfront payments from GSK spread across all programs.
For each Concert pipeline program, Concert will have
responsibility for research and development activities through
completion of pre-agreed clinical trials. After the completion
of such clinical trials for each program, or earlier if it
chooses, GSK may elect to obtain an exclusive, worldwide license
to product candidates within the program. At such time, GSK will
assume responsibility for development and commercialization.
Concert will retain full rights to further develop and
commercialize its product candidates in any program GSK chooses
not to license.
“This agreement marks GSK’s continued efforts to access the best
science and technology platforms worldwide,” said Patrick
Vallance, Senior Vice-President Drug Discovery, GSK. “We believe
Concert’s approach to deuterium modification of medicines has
broad potential to enhance certain drug properties and result in
innovative new medicines.”
“We are pleased to collaborate with GSK and to advance
innovative small molecule drug candidates using our deuterium
chemistry approach,” said Roger Tung, Ph.D., President and Chief
Executive Officer of Concert Pharmaceuticals. “This
collaboration is a major step forward in our strategy to advance
a broad pipeline of novel deuterium-modified therapeutics.”
About CTP-518
CTP-518 is a novel HIV protease inhibitor developed from
Concert’s deuterium chemistry platform by replacing certain key
hydrogen atoms of atazanavir with deuterium. Concert has
demonstrated in pre-clinical studies that selective deuterium
modification of atazanavir fully retains its antiviral potency
but can markedly slow hepatic metabolism, thereby increasing
half life and plasma trough levels. As a result, CTP-518 could
potentially avoid the need to use a protease inhibitor boosting
agent such as ritonavir. Current standard of care is to
co-administer HIV protease inhibitors with ritonavir. However,
significant complications are associated with ritonavir.
Importantly, because the relationship between atazanavir trough
plasma levels and clinical virological response is
well-established, Phase 1 testing is expected to provide
clinical validation of CTP-518. CTP-518 has the potential to be
the first HIV protease inhibitor to eliminate the need to
co-dose with a boosting agent.
About Deuterium
Deuterium is a safe, non-radioactive relative of hydrogen that
can be isolated from sea water and has been used extensively in
human metabolic and clinical studies. Since deuterium is an
isotope of hydrogen, deuterium-containing compounds are expected
to have similar pharmacological activity as their hydrogen
analogs. However, as deuterium is heavier than hydrogen, it
therefore forms a stronger chemical bond to a carbon atom of a
molecule. The stronger chemical bond obtained by selective
deuterium modification may substantially improve the drug’s
metabolic properties, potentially resulting in better safety,
tolerability and/or efficacy.
About Concert
Concert Pharmaceuticals is a clinical stage biotechnology
company focused on the application of deuterium chemistry to
create novel small molecule drugs. Concert’s approach leverages
known activity and safety of existing drugs to reduce time, risk
and expense of drug research and development. The Company has a
broad research pipeline encompassing many therapeutic areas
including renal disease, infectious disease, and cardiovascular
disease, among others. Its lead development candidate is the HIV
protease inhibitor CTP-518. Founded in 2006, Concert has raised
more than $96 million from leading venture capitalists and
institutional investors. For more information on Concert
Pharmaceuticals, please visit
www.concertpharma.com.
About GSK
GlaxoSmithKline – one of the world’s leading research-based
pharmaceutical and healthcare companies – is committed to
improving the quality of human life by enabling people to do
more, feel better and live longer. For further information
please visit
www.gsk.com.
Cautionary Statement
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations
are described under 'Risk Factors' in the 'Business Review' in
the company' s Annual Report on Form 20-F for 2008.
CoNCERT and CoNCERT Pharmaceuticals are trademarks of Concert
Pharmaceuticals, Inc
Contacts
Concert Pharmaceuticals, Inc.
Investors:
Justine Koenigsberg, 781-674-5284
or
EU Media:
Mike Sinclair, (020) 7084 5955
or
US Media:
Kathryn Morris, 845-635-9828
or
GlaxoSmithKline
Enquiries:
UK Media enquiries:
Philip Thomson, (020) 8047 5502
or
David Outhwaite, (020) 8047 5502
or
Stephen Rea, (020) 8047 5502
or
US Media enquiries:
Nancy Pekarek, 919-483 2839
or
MaryAnne Rhyne, 919-483 2839
or
Kevin Colgan, 919-483 2839
or
Lisa Behrens, 919-483 2839
or
European Analyst/Investor enquiries:
David Mawdsley, (020) 8047 5564
or
Sally Ferguson, (020) 8047 5543
or
Gary Davies, (020) 8047 5503
or
US Analyst/ Investor enquiries:
Tom Curry, 215-751-5419
or
Jen Hill Baxter, 215-75-7002
Source
Concert Pharmaceuticals
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