Biohit Oyj - Company Announcement

Acetium lozenge – a promising novel method to assist smoking cessation

Biohit Oyj Stock Exchange Release November 4, 2015 at 9:30 a.m. local time (EET)

The smoking intervention study of Biohit Oyj of nearly two years of duration
using Acetium lozenge has been completed. Acetium lozenge is used to bind
cigarette-smoke derived acetaldehyde in the saliva into a harmless compound, in
addition to its beneficial effects on oral health. According to some
preliminary observations, the Acetium lozenge is considered to be a promising
novel intervention method to assist in smoking cessation. 

Biohit Oyj started a randomized, double-blind trial in late 2013 (Biohit Oyj to
start a clinical intervention trial with Acetium® lozenge aimed at smoking
cessation, November 29, 2013), in which the effectiveness of Acetium lozenge
was studied in a new indication i.e., to help with smoking cessation. Results
of the study were evaluated according to how many study subjects quit smoking
and how long was the duration of their smoking abstinence. 

The study was based on a novel hypothesis that acetaldehyde, in addition to
nicotine, is a significant factor maintaining smoking dependence (1).
Acetaldehyde dissolved into saliva during smoking, might act with certain
natural amino acids to form condensation compounds called Harmans. These
inhibit monoamine oxidase (MAO) - an enzyme in the central nervous system,
which plays a key role in mediating the rewarding effects of smoking in the
brain. It has been suggested that cigarette smoke-derived acetaldehyde has
reinforcing effects on nicotine addiction and thereby help maintaining the
behavioural sensitization to tobacco. Blood Harman levels among smokers are
2-10 times higher than in non-smokers (1). It was reasoned that an effective
elimination of acetaldehyde in the saliva (2) could interfere with this
reaction by using the Acetium lozenge. 

A cohort of 423 smokers volunteered in the study and they were randomly
allocated into two groups of equal size. Of these two study arms, one group
used Acetium lozenge during smoking and the other used placebo in a
double-blind setting. The results were analysed separately for the study
subjects who followed the protocol to perfection, and for those who did so with
minor violations. 

The principal investigator, Chief Medical Director of Biohit Oyj, Professor
Kari Syrjänen: ‘Regardless the mode of data analysis, the Acetium lozenge was
more effective than placebo as a trigger for quitting smoking.  In the
intervention group, 42.9 % could stop smoking as compared to 31.1% in the
placebo group (i.e. Acetium was 37.9% more effective). Compared to the placebo,
the likelihood of smoking cessation among Acetium users during the trial was up
to1.65-fold (i.e., 65% higher probability). This figure  favourably competes
with those reported in large international studies for nicotine replacement
therapy (NRT) (3). If confirmed in adequately powered studies (approximately
1500 smokers will be required), these result represents a breakthrough in the
development of smoking intervention methods.' 

CEO Semi Korpela, Biohit Oyj: 'Unlike many commonly used current intervention
methods, causing severe side effects (some medical treatment) or maintaining
the nicotine addiction in different forms (e.g. nicotine gums and -patches),
the Acetium lozenge is a product, which has no known side effects. For this
reason, there are no restrictions for use or a maximum allowable dosage, and a
smoker can use it simultaneously with cigarettes until making the decision to
quit smoking. Regardless of the techniques used, the decision to quit smoking,
however, has to be made in person. Despite the fact that Acetium lozenge 
efficiently binds carcinogenic acetaldehyde dissolved into saliva from 
cigarette smoke, transforming it into a harmless compound, and in addition,
promotes oral health (unlike the currently available medications and nicotine
products), Biohit Oyj recommends quitting the smoking because of its health
hazards.' 

Study Protocol:
http://www.biohithealthcare.com/resource/files/research/protocol-acetium-smoking
-quit.pdf 



References:

1.    Talhout R, Opperhuizen A, van Amsterdam JG. Role of acetaldehyde in
tobacco smoke addiction. Eur Neuropsychopharmacol 2007;17:627-636. 

2.    Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating
carcinogenic acetaldehyde by cysteine from saliva during smoking. Cancer
Epidemiol Biomarkers Prev 2006;15:146-149. 

3.    Lemmens V, Oenema A, Klepp KI, Brug J. Effectiveness of smoking cessation
interventions among adults: a systematic review of reviews. Eur J Cancer Prev
2008;17:535-544. 



Additional information:


Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen
kari.syrjanen@biohit.fi

CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com


Biohit in brief

Biohit Oyj is a globally operating Finnish biotechnology company. Biohit's
mission is “Innovating for Health” - we produce innovative products and
services to promote research and early diagnosis. Biohit is headquartered in
Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B
share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group.
www.biohithealthcare.com