Biohit Oyj - Company Announcement

Biohit and ProGalénika to co-operate

Finnish health care company Biohit Oyj and Mexican pharmaceutical company
ProGalénika have signed an agreement to initiate collaboration. 

Finnish health care company Biohit Oyj and Mexican pharmaceutical company
ProGalénika have signed an agreement to initiate collaboration. The agreement
covers exclusively the distribution and production of Biohit product Acetium in
Mexico, Argentina, Brazil, Colombia and Venezuela. The contract is divided in
two phases. The first phase starts with ProGalénika functioning as distributor
and in the second phase ProGalénika in addition takes care of the production
locally. 

Acetium is a unique and patented product to bind carcinogenic acetaldehyde. The
agreement gives ProGalénika the exclusive rights to distribute and manufacture
Acetium products in the market area. However, the agreement will come into
force when the Mexican authorities approve the Acetium product registration.
This is expected by Q4 2013. 

CEO of Biohit Semi Korpela: "Our partnership with ProGalénika opens the door to
the large and growing Latin American market, with Mexico being the lead country
during the initial phase. This agreement will strengthen the sales of the
carcinogenic acetaldehyde binding Acetium. "

ProGalénika President and CEO Bernardo Frisbie: "Stomach cancer remains one of
the major cancer causing mortality in most of the countries in the Latin
American region. Acetium is a unique product. This is a truly new opportunity
to create a prevention culture with the only available solution for this
serious health risk imposed by carcinogenic acetaldehyde.” 


Additional information:
CEO Semi Korpela, Biohit Oyj
Tel. +358 40 773 861
semi.korpela@biohit.fi
www.biohithealtcare.com



Biohit Oyj in brief

Biohit Oyj is a Finnish biotechnology company operating globally that was
established in 1988. Biohit's mission is “Innovating for Health” and “Cancer
Prevention”. The purpose of the company is to take social responsibility and
produce innovation, new technologies and analysis systems for use in medicine,
research institutions and industry, helping to promote research and diagnostics
and to improve the quality of life of people by means of preventing disease,
human suffering and financial loss. We are committed to responsibility and it
is our duty to innovate and develop the marketing and availability of our
products and services. Biohit is headquartered in Helsinki and its subsidiaries
are located China and UK. Since 1999, Biohit's Series B shares (BIOBV) have
been listed in the NASDAQ OMX Helsinki Oy Small cap/Healthcare sector. 



ProGalénika  in brief

ProGalénika is a Mexican company specialized in the Pharmaceutical Industry
offering cutting edge, innovative, and differentiated products and services.
ProGalénika is born from the desire of its partners to build a novel, unique
and outstanding Mexican company based on their knowledge and experience, having
worked for large global companies and having collaborated with several of them
in their entry into Mexico and the Latin American region. ProGalénika
​​operates in Mexico and has thorough knowledge, operational experience and a
solid network in several Latin American countries (primarily Argentina, Brazil,
Chile, Colombia, Central America, Ecuador, Peru and Venezuela). More
information on ProGalenika at www.progalenika.com 







Additional Information

The L-cysteine in Acetium capsules dissolves slowly into the gastric fluid,
efficiently binding (neutralising) carcinogenic acetaldehyde in an achlorhydric
stomach. This contributes to the prevention of stomach and oesophageal cancer.
Such cancers are typically diagnosed late, which results in a particularly poor
prognosis. 

The science behind the Acetium innovation is strong and there is a great need
for this product. Identifying the specific carcinogenic substance is crucial to
preventing a particular cancer. Insufficient ability to remove acetaldehyde
caused by point mutation provides a human model for acetaldehyde exposure,
helping to explain the high incidence rates of upper gastrointestinal tract
cancers in alcohol drinkers. The consistent epidemiological and biochemical
results obtained from this model prompted the World Health Organization's
International Agency for Research on Cancer (IARC) in October 2009 to classify
the acetaldehyde found in, and generated endogenously from, alcoholic beverages
as a Group I carcinogen, i.e. as carcinogenic as asbestos, formaldehyde and
benzene. One principle applies to all Group I carcinogens: every available
means should be used to reduce exposure to these substances. Exposure to
acetaldehyde is linked to more than three million new gastrointestinal cancers
per year globally, which represents approximately 25 per cent of all cancers
(visit www.acetium.com to test your exposure to acetaldehyde). 

The Acetium capsule is the only product in the world proven to reduce exposure
to acetaldehyde. Acetium is intended e.g. for persons suffering from an
achlorhydric stomach caused by atrophy of the gastric mucosa and functional
disorder (atrophic gastritis). An anacidic stomach is the most significant risk
factor in stomach and oesophageal cancer. The risk group includes approximately
500 million people globally. An achlorhydric stomach caused by atrophic
gastritis can be easily diagnosed from blood samples, using the GastroPanel
biomarker test developed by Biohit Oyj. 

The Acetium and GastroPanel innovations provide new opportunities for safe and
cost-effective health care, as well as opportunities to tap into large and
growing markets in cooperation with other Finnish and international companies
and researchers (see Additional information and www.biohithealthcare.com:
”State-of-the-art GastroPanel and Acetium innovations for the unmet need” and
”GastroPanel biomarkers). 

Acetium capsules, which are available in pharmacies without prescription, are
recommended to those with 

1 the long-term need to use medications that reduce gastric acid (HCl)
secretion (PPI medication and H2 blockers); approximately 5-10% of Western
population use these occasionally or regularly, and possibly more than 500,000
people in Finland, 

2. an achlorhydric or low-acid stomach caused by atrophic gastritis resulting
from Helicopacter pylori infection or an autoimmune disease, which can be
diagnosed with GastroPanel (500 million worldwide) 

3. an untreated chronic Helicobacter pylori infection, which can be reliably
diagnosed with GastroPanel (more than 500 million people worldwide), 

4. people who have undergone stomach surgery (over a million people worldwide),

5. people with gene mutation affecting acetaldehyde metabolism: 30-50% of
Asians show ALDH2 deficiency. 

Although data on the effectiveness of Acetium in the prevention of gastric and
oesophageal cancer is not yet available, there is conclusive scientific
evidence to suggest that acetaldehyde, a group I carcinogen, causes cancer, and
that acetaldehyde is generated in an achlorhydric stomach, which is a known
risk factor for gastric and oesophageal cancer. Exposure to acetaldehyde is
linked to more than three million new gastrointestinal cancers per year
globally, which represents approximately 25 per cent of all cancers. 

Acetium and GastroPanel innovations support each other. GastroPanel biomarker
finds atrophic gastritis in corpus, which leads towards anacidic stomach. The
anacidic condition in stomach will most likely not heal and can stay forever.
Like above it is mentioned, cancer risk linked to anacidic stomach can be
reduced by eating Acetium capsules while eating and drinking. 

Unlike the Helicobacter pylori examinations still being used (13C urea breath
test and stool antigen test), the GastroPanel biomarker test reliably detects
H. pylori infection,the typically asymptomatic condition atrophic gastritis,
and associated risks, including cancer. 

As much as 20-40% of the Western population suffers from dyspepsia, which,
according to conventional medical practice, requires gastroscopy. There are no
resources available, nor is there any need for such examinations or high-risk
experimental medications. The GastroPanel biomarker test allows only ill and
at-risk patients to be referred for gastroscopy and treatment. This increases
patient safety, and saves 40-70% of scarce and expensive endoscopy capacity to
be used for colonoscopies for early diagnosis and prevention of colorectal
cancer. Particularly with elderly people, problems in the colon are often the
cause of dyspepsia complaints. It is therefore advisable to supplement
GastroPanel with a ColonView test to select at-risk patients for colonoscopy
(www.biohithealthcare.com: Diagnostics / Product brochures). 

The April 2012 Maastricht IV consensus report of the European Helicobacter
Pylori Study Group recommends blood sample biomarker tests as a reliable method
of diagnosis of diseases of the stomach mucosa and associated risk conditions. 
Researchers recommend biomarker tests for the diagnosis and follow-up of
Helicobacter pylori infection and especially for atrophic gastritis that causes
achlorhydric stomachs, in addition to recommending the screening of
asymptomatic patients (www.biohit.fi: Investors/ Stock Exchange Releases:
08/06/2012). 

The international Healthy Stomach Initiative group's 16 gastroenterology
experts from 12 countries (www.hsinitiative.org) came to the same conclusions.
Biomarker tests can be used to diagnose and screen atrophic gastritis and
related risks in both asymptomatic patients and patients with abdominal
discomfort (www.biohithealthcare.com: Investors/ Stock Exchange Releases:
17/02/2012 Biohit Oyj's GastroPanel biomarker test recommended). 

The state-of-the-art, highly informative, safe and cost-effective GastroPanel
biomarker test for diagnosing dyspepsia (various upper abdominal complaints)
and Helicobacter pylori infection does not involve any of the problems
described below. 

•The 13C urea breath test (UBT), stool antigen test and antibody tests alone do
not detect atrophic gastritis of the corpus caused by H. pylori infection or
autoimmune disease, or atrophic gastritis of the antrum caused by H. pylori
infection. Atrophic gastritis is almost always asymptomatic and usually
incurable. 

• Undiagnosed atrophic gastritis of the corpus (achlorhydric stomach) may cause
gastric and oesophageal cancer and malabsorption of vitamin B12, iron,
magnesium, calcium and certain drugs. 

• Calcium deficiency causes osteoporosis. Vitamin B12 deficiency can cause
pernicious anaemia, dementia, depression and damage to the peripheral nervous
system. 

• The absorption of several drugs such as dipyridamole, some iron products and
antifungals (fluconazole, itraconazole), thyroxine and atazanavir is
considerably impaired in an achlorhydric stomach. Particularly in senior
citizens, the risk of severe intestinal infections (such as giardiasis,
malaria, Clostridium difficile and E. coli EHEC) increases. 

• Atrophic gastritis in the gastric antrum increases the risk of peptic ulcer
disease and gastric cancer. If both the antrum and corpus mucosa are atrophic,
this condition poses the highest risk for gastric cancer known to date. In some
cases, gastric cancer is directly caused by H. pylori and gastritis. Less than
1% of the population has hereditary gastric cancer. 

• Furthermore, none of the aforementioned three H. pylori tests provide any
information on excessive gastric acid secretion, which in patients with
gastro-oesophageal reflux disease may cause complications from this disease.
Such complications are often asymptomatic and include ulcerative oesophagitis
and Barrett's oesophagus, which may lead to oesophageal cancer if left
untreated. If complications of the gastroesophageal reflux disease are
suspected due to excessive acid secretion, or if the patient has atrophic
gastritis or symptomatic Helicobacter pylori infection, gastroscopy is required
to rule out cancer and other risks. 

• In addition, the 13C urea breath test and stool antigen test may give up to
40% false negative results: in other words, the infection including cancer and
other risks may be left undiagnosed if the patient has atrophic gastritis, MALT
lymphoma or bleeding peptic ulcer disease, or if the patient is currently
receiving antibiotics or PPI treatment. 

In order to prevent medical malpractice, unnecessary costs and even unnecessary
deaths caused by cancer, the current Helicobacter pylori tests should be
replaced by the GastroPanel biomarker examination. With the GastroPanel tests
readily available, treating patients suffering from stomach discomfort without
further diagnosis can no longer be justified. Risky self-treatment of stomach
discomforts may delay the diagnosis of, for example, precancerous gastric
lesions until the disease has progressed beyond treatment. Approximately
one-third of the population in Finland suffer from stomach discomfort. Tens of
thousands of patients from this group receive proton pump inhibitor (PPI)
treatment or take prescription-free PPI medication, regardless of the fact that
they already have an achlorhydric stomach caused by atrophic gastritis and the
associated risks of cancer and other diseases. 

Proton pump inhibitor (PPI) medications, both prescribed and those available
without prescription, come with the following warning: ”If the patient has
alarming symptoms (e.g. significant unintentional weight loss, persistent
continuous vomiting, difficulty swallowing, blood in vomit or in stool) and a
suspected or diagnosed peptic ulcer, any malignant conditions must be ruled out
because PPI treatment can alleviate the symptoms and delay diagnosis.” This
warning is justified but insufficient to lower the extremely high mortality
rate in patients with stomach and oesophageal cancer. When “alarming symptoms”
have appeared, the cancer has usually advanced to a non-curable stage. Despite
this warning and without ruling out atrophic gastritis (achlorhydric stomach),
stomach discomfort is very often treated with PPI and other medications that
reduce gastric acid (HCl). Furthermore, atrophic gastritis and the associated
cancer risk caused by both a Helicobacter pylori infection and an autoimmune
disease typically cause few or no symptoms. 

Osteoporosis and vitamin B12 deficiency represent a major public health problem
among the elderly, and may typically be caused by asymptomatic undiagnosed
atrophic gastritis. A person with an autoimmune atrophic gastritis of the
corpus may simultaneously suffer from an another autoimmune disease, such as
thyroiditis, celiac disease, rheumatoid arthritis and type 1 diabetes; or vice
versa, a person with thyroiditis and type 1 diabetes often suffers from
autoimmune asymptomatic atrophic gastritis and the resulting risk of gastric
and oesophageal cancer as well as vitamin B12 deficiency. GastroPanel helps to
detect at-risk patients in time and refer them to gastroscopy and treatment. 


Literature on Acetium and acetaldehyde

1. Salaspuro V, Hietala J, Kaihovaara P, Pihlajarinne H, Marvola M, Salaspuro
M. Removal of acetaldehyde from saliva by a slow-release buccal tablet of
L-cysteine. Int J Cancer 2002; 97:361-4. 
3. Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating carcinogenic
acetaldehyde by cysteine from saliva during smoking. Cancer Epid Biomark Prev
2006; 15:146-9. 
4. Kartal A, Hietala J, Laakso I, Kaihovaara P, Salaspuro V, Sakkinen M, et al.
Formulation and in vivo evaluation of L-cysteine chewing gums for binding
carcinogenic acetaldehyde in the saliva during smoking. J Pharm Pharmacol.
2007;59:1353-8. 
5. Linderborg K, Marvola T, Marvola M, Salaspuro M, Färkkilä M, Väkeväinen S.
Reducing carcinogenic acetaldehyde exposure in the achlorhydric stomach with
cysteine. Alcoholicm Clin Exp Res, 2011;35:1-7. 


Literature on GastroPanel

1.Malfertheiner et al. Management of Helicobacter pylori infection. The
Maastricht IV/ Florence Consensus Report. gut-bmj.com on May 18, 2012. European
Helicobacter Pylori Study Group, ESPSG 
2.Agreus et al. Rationale in diagnosis and screening of atrophic gastritis with
stomach-specific plasma biomarkers, Scandinavian Journal of Gastroenterology
2012; 47: 136 - 147) 
3.WHO. http://www.iarc.fr/en/media-centre/pr/2009/pdfs/pr196_E.pdf