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2016-06-09

Saniona AB: Saniona's partner TRC initiates Phase 2a study for NS2359 in cocaine addiction

PRESS RELEASE

June 9, 2016

Saniona, a leading biotech company in the field of ion channels, today
announces that the University of Pennsylvania Treatment Research Center (TRC)
has initiated recruitment of patients in a Phase 2a study for Saniona's
compound, NS2359, for treatment of cocaine addiction. Today there are no
approved drugs to treat cocaine addiction. The trial comprises a total of up
to 80 patients.

"We are very excited about the initiation of this important Phase 2a study.
TRC is world class within clinical trials on drug addiction. The two
principal investigators are recognized leaders in addiction research. Dr.
Berrettini is an internationally-recognized expert in the genetics of
addiction and Dr. Kampman is a highly respected top researcher in conducting
clinical studies of cocaine addiction. TRC has secured funding for initiation
of this trial which demonstrates their commitment and belief in the concept"
says Jørgen Drejer, CEO of Saniona.

"Cocaine addiction is a significant public health problem, responsible for
substantial medical, psychiatric, and economic costs. There are no
medications proven efficacious for the treatment of cocaine addiction. The
development of an effective pharmacotherapy for cocaine-addicted patients has
the potential to significantly impact the public health by addressing the
needs of hundreds of thousands of Americans," says Kyle M. Kampman, MD,
Medical Director of the TRC.

"We are eagerly looking forward to test NS2359 for treatment of cocaine
addiction. The scientific rational is clear and supported by preclinical and
clinical evidence. We believe that NS2359 may be able to reduce cocaine
craving and blunt the euphoric effects of cocaine without causing euphoria
itself. Therefore, NS2359 represents a very promising candidate, which would
be the first approved drug to treat cocaine addiction," says Dr. Wade
Berrettini, principal investigator at University of Pennsylvania.

The study is conducted by TRC at the University of Pennsylvania's treatment
facility at the PENN / VA Center for the Studies of Addiction (CSA). The
primary objective of the Phase 2a study is to examine whether NS2359 leads to
abstinence from cocaine during the last 2 weeks of treatment. The secondary
objective is to investigate whether NS2359 provides a reduction in craving
for more cocaine, a reduction in withdrawal symptoms, a reduction in alcohol
consumptions and smoking and whether NS2359 provides improved cognitive
ability. The double blind, placebo controlled study comprises a total of up
to 80 patients, where half of the patients will receive NS2359 and half of
the patients will receive matching placebo for a total of 8 weeks. All
patients will be offered weekly individual therapy sessions in relation to
the trial. Further details about the trial will be made available at
https://clinicaltrials.gov/.

The study is supported by grants from the Dana Foundation and the Groff
Foundation.

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 Nasdaq First North Premier and has about 4,400
shareholders. Pareto Securities is Certified Advisor for Saniona. The
company's share is traded under the ticker SANION. Read more at
www.saniona.com.

About NS2359
NS2359 is a triple reuptake inhibitor, which blocks the reuptake of dopamine,
norepinephrine, and serotonin in a similar manner to cocaine. However, NS2359
dissociates slowly from these transporters and has a long human half-life (up
to 10 days) which makes frequent dosing unnecessary. NS2359s pharmacological
profile means that it may be able to reduce cocaine withdrawal symptoms,
reduce cocaine craving and reduce cocaine-induced euphoria. In preclinical
trials, NS2359 has been shown to reduce the reinforcing effects of cocaine
and may have effects on cue induced drug craving. Furthermore, human trials
with NS2359 have shown that NS2359 has little abuse potential and does not
have adverse interactions with cocaine. Thus, NS2359 is a very promising
medication for the treatment of cocaine dependence.

About the Treatment Research Center at the University of Pennsylvania, TRC
TRC is a clinical outpatient treatment center that is part of the PENN / VA
Center for the Studies of Addiction (CSA). TRC has a modern treatment
facility with a fully certified clinical laboratory and a state of the art
data management unit. The Investigators have been leaders in addiction
pharmacotherapy research for over 35 years and highly experienced clinicians
and research associates staff the center. TRC has an active recruitment
process and network in place for cocaine addiction. The center screen about
250 cocaine dependent patients per year of which about 100 cocaine dependent
patients are randomized into research protocols. TRC offers a comprehensive
biopsychosocial evaluation in relation to clinical programs comprising a
physical exam and ECG, an outpatient medical detoxification stabilization
unit, and daily individual and group therapy sessions that are made available
to patients eligible for one of the treatment-research studies.

Further details about NS2359 and cocaine addiction
Cocaine addition

Cocaine dependence continues to be a significant public health problem. In
2012, the National Survey on Drug Use and Health revealed that in the US
639,000 persons used cocaine or crack cocaine for the first time, 1.6 million
people had used cocaine at least once during the month prior to the survey,
and 1.1 million persons were classified as dependent on or abusing cocaine.
Cocaine abuse and dependence leads to significant morbidity and mortality.
Medical problems associated with cocaine use include an increased risk of
HIV, hepatitis, and serious pulmonary and cardiovascular disease[i]. Other
problems associated with cocaine use include increased rates of crime,
violence, poverty, and family disruption[ii]. The standard treatment for
cocaine dependence consists of individual and group psychotherapy and
self-help groups. Although progress has been made in developing new
psychosocial treatments for cocaine dependence, psychotherapy alone does not
provide substantial benefit for many patients[iii]. Dropout rates in
outpatient treatment programs are very high[iv]. Even among patients who
complete treatment, relapse is common[v]. Thus, medications have been sought
to augment psychosocial treatment. Currently, there are no medications
approved for the treatment of cocaine dependence.

Mode of action and rationale for treatment of cocaine addiction

NS2359 is a triple reuptake inhibitor, which blocks the reuptake of dopamine,
norepinephrine, and serotonin in a similar manner to cocaine. Compared to
cocaine, NS2359 has greater affinities at the three transporters. However, in
contrast to cocaine, NS2359 dissociates slowly from all three transporters
and it has a very long human half-life (up to 10 days). Therefore, NS2359 has
the potential to block binding of cocaine to these transporters and blunt
cocaine reward, even with episodic non-compliance. Furthermore, it may be
able to blunt cocaine withdrawal symptoms, which have been associated with
reduced dopamine and serotonin activity in newly abstinent cocaine dependent
patients[vi]. In addition, as a long acting medication with a mechanism of
action similar to that of cocaine, NS2359 may be able reduce cocaine craving
and blunt the euphoric effects of cocaine without causing euphoria itself.

Effective medications exist for the treatment of nicotine addiction and opioid
addiction. These effective medications have the ability to do one or more of
three things: 1) reduce drug withdrawal symptoms, 2) reduce drug craving, and
3) reduce the euphoria associated with the abused drug. The pharmacological
profile of NS2359 suggest that NS2359 may fulfil all three characteristics
for an effective medication for cocaine addiction. NS2359 has the potential
to reduce cocaine withdrawal symptoms (characterized by deficient mono-amine
transmission in key brain areas); reduce cue-induced drug cravings; and
prevent the euphoria induced by cocaine. NS2359 has a unique long human
half-life (up to 10 days) which makes frequent dosing unnecessary.

Preclinical and clinical evidence for treatment of cocaine addiction

In preclinical studies, NS2359 has demonstrated clear efficacy against cocaine
craving behavior in cocaine dependent rodents and monkeys. Preclinical
studies have shown that NS2359 reduces cocaine self-administration in Rhesus
monkeys and substitutes for cocaine in both rat and monkey
drug-discrimination.

NS2359 was originally developed under an agreement with NIDA for the treatment
of cocaine addiction. NeuroSearch discontinued the agreement with NIDA in
relation to the outlicense of NS2359 to GlaxoSmithKline in 2004.
GlaxoSmithKline performed additional non-clinical and clinical studies under
the name GSK372475 in order to investigate NS2359's potential as an
antidepressant agent and for the treatment of adults with ADHD. NeuroSearch
regained the rights to NS2359 from GlaxoSmithKline in 2009 since the Phase 2
studies indicated that NS2359 had no advantage over current treatment for
major depression disorders and adult with ADHD. In total NS2359 has been
administered to more than 600 individuals as part of eleven Phase 1 studies
(5 single dose and 6 repeat-dose studies) and three Phase 2 studies. These
studies indicate that the drug is safe and well tolerated in humans for
administration up to 10 weeks. These studies provide also promising evidence
for using NS2359 as a treatment for cocaine dependence. NS2359 did not cause
euphoria in any of the multiple Phase 1 studies or the Phase 2 clinical
trials for major depressive disorder[vii]and adult attention deficit
disorder[viii]. Furthermore, in a human laboratory drug discrimination study,
NS2359 exhibited no abuse liability in comparison with 15 or 30 mg of
amphetamine. In a NIDA sponsored Phase 1 human laboratory interaction study,
NS2359 was able to reduce the rewarding valence of 20 or 40 mg of cocaine,
and it attenuated the cardiovascular effects...

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