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Biohit and ProGalenika to Co-Operate

HELSINKI, Finland, Dec. 7, 2012 (GLOBE NEWSWIRE) -- Finnish health care company Biohit Oyj and Mexican pharmaceutical company ProGalenika 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 ProGalenika functioning as distributor and in the second phase ProGalenika in addition takes care of the production locally.

Acetium is a unique and patented product to bind carcinogenic acetaldehyde. The agreement gives ProGalenika 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 ProGalenika 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. "

ProGalenika 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.

ProGalenika in brief

ProGalenika is a Mexican company specialized in the Pharmaceutical Industry offering cutting edge, innovative, and differentiated products and services. ProGalenika 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.
ProGalenika 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, Farkkila M, Vakevainen 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

Source:Biohit Oyj