Biohit Oyj - Company Announcement

Biohit Oyj starts two clinical trials with Acetium® capsule for prevention of migraine-type headache

Biohit Oyj Stock Exchange Release April 29, 2014 at 4:30 pm local time (EEST)

Biohit Oyj initiates two clinical trials for prevention of migraine-type
headache attacks, testing the efficacy of Acetium® capsule in novel clinical
indications. The purpose of the trial is to assess the effect of Acetium®
capsule in prevention of headache attacks   among patients suffering from
migraine or cluster/Horton headache. Both studies will be conducted as
multi-center clinical trials in collaboration with Terveystalo Oy and Aava
Medical Center altogether in six cities in Finland. 

The study hypothesis is based on the fact that acetaldehyde liberates histamine
from the mast cells which are ubiquitous in all human tissues.  Histamine in
turn is a well-known trigger of the acute attacks of vascular-type headaches
(migraine, cluster).  By preventing the local effects of acetaldehyde with
Acetium® capsules, it might be possible to prevent the headache attacks in
these two categories of patients. 

Both studies will be conducted as placebo-controlled, double-blind clinical
trials, where half of the subjects will receive the active compound and the
other half will receive a placebo. 

  -- Acetium® capsule in prevention of headache attacks among patients with
     cluster headache:
     altogether, 100 subjects with clinically diagnosed cluster headache will be
     enrolled in the study.

  -- Acetium® capsule in prevention of headache attacks among migraine patients:
     a cohort of 200 patients with clinically diagnosed aural or non-aural
     migraine will be enrolled.

Both studies will be initiated in May, and then also publicly announced at
Biohit website.  Enrollment in either study takes place via medical centers,
which include Terveystalo Helsinki Kamppi, Tampere, Turku, Jyväskylä, Oulu and
Aava Medical Center, Helsinki. 

The principal investigator in both trials is docent Mikko Kallela, specialist
in neurology (Helsinki University Central Hospital, Department of Neurology),
and the investigator-in-charge in each center is a neurology specialist. 

The principal investigator, Mikko Kallela: ´The study hypothesis is entirely
new and represents a previously unexplored innovation. The role of histamine
and mast cells of the meningeal matrix as a trigger of acute attacks of cluster
and migraine headache can be very important. These two trials enable us to
evaluate the validity of this novel concept in a clinical setting.´ 

CEO Semi Korpela, Biohit Oyj: ´Over 10% of the population suffer migraine-type
headaches and it is a major cause of sickness leaves.  Acetium® capsules have
no reported adverse effects, which makes long-term use safe.  According to a
spontaneous feedback from the field, many Acetium® users (taking one capsule in
the morning, one in the evening) have obtained relief for their headache
attacks. Acetium® capsules are available in pharmacies without doctor's
prescription.´ 


Study protocols:

  -- Efficacy of Acetium® Capsule in Prevention of Headache Attacks in Migraine
     Patients. Randomized Intervention Trial with a Medical Device (Acetium®
     Capsules). (Acetium® in Migraine Prevention Study)
http://www.biohithealthcare.com/resource/files/research/protocol-migraine.pdf 
  -- The Efficacy of Acetium® Capsule in Prevention of Cluster Headache.
     Randomized Intervention Trial with a Medical Device (Acetium® Capsules). 
     (Acetium® in Prevention of Cluster Headache Study)
http://www.biohithealthcare.com/resource/files/research/protocol-cluster.pdf 


Additional information:

Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen, MD, PhD
tel. +358 9 773 861
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 OMX Helsinki in the Small cap/Healthcare
group. www.biohithealthcare.com