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2016-05-09

Saniona: Saniona initiates extended preclinical research studies on backup compound to AN363; AN363 is put on hold

Saniona, a leading biotech company in the field of ion channels, today
announces that it plans to initiate extended non GLP preclinical
studies on a backup compound to AN363. Saniona will at the same time
put the ongoing investigations on the AN363 compound on hold.

"We remain highly enthusiastic about the concept of using GABAA ?2, ?3
subtype specific compounds for chronic pain. The toxicology finding
with AN363 at high doses in rats has not been reported in animal or
human studies with other compounds with a similar pharmacology
profile including the close analogue AN721. We therefore have good
reasons to believe that the unexplained findings with AN363 is not a
class effect," says Jørgen Drejer, CEO of Saniona.

Saniona has finalized the preclinical toxicology studies for AN363. In
September 2015, Saniona announced that it has decided to further
investigate one of the specific findings in rats, which occurred at
higher doses. This finding was not observed in dogs even at the
maximum dose.

Although the data supports that AN363 could be given safely to humans
in single doses, Saniona is concerned about using AN363 in multiple
doses for chronic pain in humans without having a clear understanding
of the observed finding in rats. During the last seven months,
Saniona has performed a number of additional investigations together
with international recognised experts in the field without coming to
any firm explanation of the findings. Rather than continuing this
expensive and time consuming process without any guarantee for
success, Saniona has concluded that a more constructive path forward
is to focus on another compound from the broad preclinical program.
Saniona has now decided to initiate extended non GLP preclinical
studies on a backup compound to AN363 with the aim to bring this
compound forward towards clinical development. As a consequence,
AN363 development is put on hold.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail:
tf@saniona.com

About Saniona

Saniona is a research and development company focused on drugs for
diseases of the central nervous system, autoimmune diseases,
metabolic diseases and treatment of pain. The company has a
significant portfolio of potential drug candidates at pre-clinical
and clinical stage. The research is focused on ion channels, which
makes up a unique protein class that enables and controls the passage
of charged ions across cell membranes. Saniona has ongoing
collaboration agreements with Upsher-Smith Laboratories, Inc.,
Productos Medix, S.A de S.V and Saniona's Boston based spinout
Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Inc.
Saniona is based in Copenhagen, Denmark, where it has a research
center of high international standard. Saniona is listed at
AktieTorget since April 2014 and has about 3,000 shareholders. The
company's share is traded under the ticker SANION. Read more at
www.saniona.com.

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http://news.cision.com/saniona/r/saniona-initiates-extended-preclinical-...
http://mb.cision.com/Main/11240/2004845/512855.pdf

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