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
