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European Patent Awarded to Biohit Oyj’s Acetium

20.07.2012 16:45

Biohit Oyj Stock Exchange and Press Release        

The period in which objections must be filed concerning the European patent granted to Acetium, developed by Biohit Oyj, has expired, with no notices filed. This means that Acetium has been granted extensive patent protection in Europe. Patents are also pending outside Europe. 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 (see Additional information).

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 in SJG 2012”, www.hsinitiative.org).

The unique GastroPanel-Acetium pairing is a prime example of the successful combination of academic research and a Finnish company seeking entry into international markets.  Robust, fundamental and applied research on major healthcare issues, and the numerous innovations and product development based upon it, offer a credible, firm foundation for the company’s global success (www.biohithealthcare.com/ About Us/ History: Aggressive innovation and patenting strategy).

Contact information:
Semi Korpela, M. Sc. (Econ.), CEO
Biohit Oyj, tel: +358 9 773 861, semi.korpela@biohit.fi
Osmo Suovaniemi, MD, Professor, Chairman of the Board
Biohit Oyj

Additional information
Diseases of the gastrointestinal tract are a major cause of high healthcare costs globally, and the costs are growing uncontrollably. Due to late diagnosis, the treatment practices of many cancers – particularly cancers of the gastrointestinal tract – are inadequate. Many patients either do not receive safe, effective treatment or are dissatisfied with the treatment they get. The ageing of the population is leading to an increase in gastrointestinal cancers as well as vitamin B12 and calcium deficiency resulting from an achlorhydric stomach. In addition, more diseases are caused by these deficiencies. This puts a rapidly growing burden on well-being and national health and reduces people’s ability to remain in longer-term employment.

In Finland, approximately 940 people are diagnosed with oesophageal and stomach cancer every year, and 730 people die from these diseases. At an early and curable stage, these cancers are often asymptomatic or involve minor symptoms,  which is why they are too frequently treated for excessively long periods with various self-remedies, such as extensively marketed medications that reduce gastric acid secretion or various dietary supplements.

The GastroPanel test detects both Helicobacter pylori infection and atrophy of the gastric mucosa, and, functional disorder (atrophic gastritis) caused by an autoimmune disease, which in turn cause an achlorhydric stomach. Microbes from the mouth can colonise an achlorhydric stomach and use sugar and alcohol to produce carcinogenic acetaldehyde, which is one of the major risk factors of gastric and oesophageal cancer.

The 13C urea breath test, stool antigen tests and antibody tests extensively used to diagnose various abdominal complaints (dyspepsia) do not detect atrophic gastritis (achlorhydric stomach), which is the major risk factor for gastric and oesophageal cancer. 
Based on the results of the Finnish Setti study, it has been estimated that the treatment and prognosis of stomach cancer among patients aged over 45 could be significantly improved in Finland by using the GastroPanel test as the primary examination for patients with abdominal complaints, and for screening and regular checkups for anyone aged over 45. This would allow the referral of  at-risk patients for gastroscopy examinations in time to enable cancers to be detected at an early stage.  Regular checkups offer a wealth of reliable and valuable information that may be relevant for the patient's future health and quality of life.

If the patient has developed severe atrophic gastritis, the condition is typically permanent, and the patient will require follow-up tests due to the risk of cancer. These patients can reduce their risk of developing gastric and oesophageal cancer by taking Acetium capsules.
Measures to reduce the risk of gastric and oesophageal cancer include the GastroPanel test and the use of Acetium capsules which, when taken in connection with food and alcohol intake, effectively bind (neutralise) carcinogenic acetaldehyde in the stomach.

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

1. an achlorhydric or low-acid stomach caused by atrophic gastritis resulting from Helicobacter pylori infection or an autoimmune disease, which can be diagnosed with GastroPanel (500 million worldwide),
2. an untreated chronic Helicobacter pylori infection, which can be reliably diagnosed with GastroPanel (more than 500 million people worldwide),
3. 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,
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, and depending on age, 2 – 12% suffer from achlorhydric stomachs (www.biohithealthcare.com: Paragraph: Appearance of carcinogens in an achlorhydric stomach in “GastroPanel biomarkers in SJG 2012”).

It will take years before any conclusive data on the effectiveness of the Acetium capsule in the prevention of gastric and oesophageal cancer is available. Population studies on at-risk groups must be conducted, in which every means available will be used to reduce exposure to acetaldehyde. Since acetaldehyde is classified a group I carcinogen, randomised intervention studies are not an option for ethical reasons.

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 (visit www.acetium.com to test your exposure to acetaldehyde).

International research groups recommend blood sample biomarker tests for the diagnosis and screening of gastric diseases (www.biohithealthcare.com/ Investors/Stock Exchange Releases/ 08/06/2012).

Unlike the Helicobacter pylori examinations still used (13C urea breath test and stool antigen test) to diagnose dyspepsia (various upper abdominal complaints) and Helicobacter infection, the GastroPanel biomarker test reliably detects H. pylori infection and reveals atrophic gastritis and associated cancer and other risks.

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 to prevent colorectal cancer (www.hsinitiative.org). 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.

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 thyroid disease, celiac disease, rheumatoid arthritis and type 1 diabetes; or vice versa, a person with an autoimmune thyroid disease 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 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 2011

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.
2. 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.
3. 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.
4. 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.

Information on Biohit Oyj – Biohit HealthCare – Innovating for Health
Biohit Oyj is a Finnish biotechnology company established in 1988. The company operates in the global market. On 14 December 2011 Biohit sold its liquid handling business in order to focus on its highly promising health care business. 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 improve the quality of life of people by means of the prevention of disease, human suffering and financial loss. Our duty is also to innovate and develop the marketing and availability of our products and services.

Biohit works with scientific communities to produce new technologies, products and services based on research results and innovations that can be used to develop safe and cost-effective diagnostic tests for the early detection and prevention of diseases of the gastrointestinal tract. (www.biohithealthcare.com: ”State of the art GastroPanel and Acetium innovations for the unmet need”, www.biohit.fi / ”GastroPanel biomarkers: Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers”, Scandinavian Journal of Gastroenterology. 2012; 47: 136 – 147, www.biohithealthcare.com: Diagnostics/Product Brochures and www.biohithealthcare.com: About us/ History: Aggressive innovation and patenting strategy).

Biohit is headquartered in Helsinki and its subsidiary is located in the UK. Since 1999, Biohit's Series B share has been quoted on NASDAQ OMX Helsinki in the Small cap/Healthcare group, and is traded under the code BIOBV (www.biohithealthcare.com/investors).