GENEVA, June 21, 2012
-
Merck Serono is a pioneer[1] in vitamin-B combination supplements with Neurobion® indicated in the treatment of vitamin B1, B6 and B12 deficiencies.
-
The company reiterates its commitment to treat vitamin B deficiencies and the associated clinical manifestations.
Merck Serono, a division of Merck in Darmstadt, Germany, today announces that the company is celebrating
the 50th anniversary of Neurobion®, one of the first Vitamin B combinations worldwide. On this occasion, the company and its affiliates worldwide will organize educational activities and information sessions for healthcare professionals to draw attention to the main symptoms and side effects of a lack of B vitamins.
Vitamin-B deficiencies may have various degrees of severity. They may be due to several conditions including among others a vegetarian diet or pathologies like diabetes or alcoholism [2,3,4,5]. Lack of these vitamins can remain undetected for many years. The diagnosis is often made accidentally from associated complications. Early detection aims at preventing the effects of the deficiency and its long-term complications.
The role of a B-vitamin combination for the treatment of the various clinical manifestations of the deficiency, including neuropathies, is supported by several research papers[6,7,8].
Neurobion® is indicated in vitamin deficiencies involving Vitamin B1, B6 or B12 depending upon the combination approved in each country. Some of the Neurobion® brands available in certain countries include diclofenac (Dolo-Neurobion®), dexamethasone (Dexa-Neurobion®) or gabapentin (Gavindol®) in addition to the Vitamin B combinations, and are also indicated for neuropathic pain. The company intends to seek registration in additional countries for such pain-related vitamin-B supplemental treatments.
Neurobion® is a complex of three essential neurotropic B vitamins that was first approved in Austria in 1962 and has been commercialized in various European and international markets with various dosages, compositions and indications. Today, it is marketed in more than 70 countries worldwide. In 2011, over 1.3 billions units of Merck Serono Vitamin B combinations were injected or swallowed worldwide[9].
“Vitamin B 1, 6 and 12 deficiencies and associated clinical manifestations can greatly affect patients’ quality of life,” said Belén Garijo, Head of Global Operations at Merck Serono. “Over 50 years we have continuously worked on developing the Neurobion® family with a variety of innovative formulations and line extensions that meet the individual needs of our patients, including those in emerging countries.”
For example, Merck Serono has developed a dual chamber syringe that allows a better conservation and product resistance to extreme temperatures that can occur in some regions. The dual chamber syringe will be launched in the course of 2012 following the granting of the national marketing authorizations.
All products are not available in all countries and approved indications vary between countries. Please refer to the relevant nationally approved prescribing information.
References:
[1]Registration document of 1962 on file at Merck KGaA.
[2]Stabler SP et al. Vitamin B12 deficiency as a worldwide Problem. Annu. Rev. Nutr. 2004; 24: 299-326.
[3] Hokin BD et al. Cyanocobalamin (vitamin B-12) status in Seventh-day Adventist ministers in Australia. American Journal of Clinical Nutrition 1999; 70: 576S- 578S.
[4] Cook CCH. Alcohol & Alcoholism 1998; 33 (4): 317-336.
[5] Adaikalakoteswari A et al. Disturbance of B-vitamin status in people with type 2 diabetes in Indonesia – Link to renal status, glycemic control and vascular inflammation. Diabetes Research and Clinical Practice 2012; 95 (3): 415-424.
[6]Lahoda and al., Therapeutic possibilities in polyneuropathies, Einhorn-Presse Verlag, Reinbeck, 1985: 57-64.
[7]Eckert and al., Therapy of neuropathies with a vitamin B combination. Symptomatic treatment of painful diseases of the peripheral nervous system with a combination preparation of thiamine, pyridoxine and cyanocobalamin, Fortschr. Med. 1992; 110(29): 544-548.
[8]Janka et al., The influence of Neurobion on temperature sensibility in patients with diabetic polyneuropathy, Int. Rietbrock N, ed. Pharmakologie und klinische Anwendung hochdosierter B-vitamine. Darmstadt: Steinkopff Verlag, 1991:87-97.
[9] IMS data, 2011.
About The Role of Vitamins
Thiamine, or vitamin B1, is necessary for the metabolism of carbohydrates, fats and proteins in most organisms (Stryer, 1988)[1]. The active form of thiamine, thiamine-diphosphate, works as a co-factor for more than 24 enzymes and it required at several stages of anabolic and catabolic intermediary metabolism, such as intracellular glucose metabolism (Frank et al.,2007). Thiamine-diphosphate is essential for ATP production through the Krebs cycle within each cell and is also a modulator of neuronal and neuro-muscular transmission, (Bender, 1999, Beltramo et al. 2008). The best known manifestation of thiamine deficiency is beriberi, a neurological and cardiovascular disease. Absence or severe lack of thiamine in the diet can cause the Wernicke-Korsakoff syndrome, (also known as cerebral beriberi), a striking neuropsychiatric disorder characterized by the paralysis of eye movements, horizontal nytagmus, fever, ataxia, abnormal stance and gait, and finally markedly deranged mental function (Harper, 1979; Stryer 1988)[1]. Natural sources of thiamine are meats (particularly lean pork), liver, poultry, eggs, fish, beans, peas, nuts, and whole grains, whereas little thiamine is present in fruit, vegetables and dairy products (Flodin, 1988)[1].
Vitamin B6 is a water-soluble vitamin which is involved in many metabolic processes. Pyridoxal phosphate (PLP) is the most active B6-vitamer and acts as a coenzyme in more than 180 enzymatic reactions, related to amino acid metabolism and sugar and fatty acid metabolism (Percudani and Peracchi, 2009; Hellmann and Mooney, 2010). Historically vitamin B6 deficiency has been related to pellagra and anemia, which occur in severe vitamin B6 deficiency. Important sources of vitamin B6 are meat, whole-grain products and vegetables[1].
Vitamin B 12 is a ubiquitous enzyme involved in important intracellular enzyme reactions. In the blood, transcobalamin transport vitamin B12 to cells of the body[1]. At the cellular membrane, the complex is internalized (Quadros, 2009) and after enzymatic cleavage the vitamin is finally modified to methylcobalamin (Chanarin, 1990)1. Methylcobalamin together with folate plays a role as a coenzyme for methionine synthase which catalyses the conversion of homocysteine to methionine, which is required for the formation of S-adenosylmethionine, a universal donor for almost 100 different substrates, including DNA, RNA, hormones, proteins and lipids1. Clinical symptoms of B12 deficiency include neurological and hematological signs. Neurological symptoms are considered a manifestation of the disease; they are often presented without significant hematological signs. Vitamin B12 is abundant in meat, diary, products, seafood and in liver, but absent from vegetables and legumes[1].
[1] Vitamin in the prevention of human disease. Edited by W. Hermann and Rima Obeid. 2011
About Neurobion®
Neurobion is a combination of three B vitamins (B1, 6 and B 12) in coated tablets or injectable formulation.
It is a prescription only medicine indicated in the treatment of deficiencies in vitamin B1, B6 and/ or B12. In some countries it is also indicated in the treatment of neuritis and neuralgia (neuropathies), e.g.: Trigeminal neuralgia, intercostal neuralgia, ischialgia, lumbar syndrome, cervical syndrome, shoulder-arm syndrome, radicular neuritis due to degenerative diseases of the vertebral column, facial paresis.
Contra-indications:
Hypersensitivity to any of the active ingredients or excipients of the product, Treatment of children due to the high content of active ingredients. As Neurobion contains benzyl alcohol, it must not be given to premature infants or neonates.
Special warnings and precautions:
In literature neuropathies are described under long term (6-12 months) of more than 50mg daily of vitamin B6. Therefore, under long-term treatment regular monitoring is recommended.
Undesirable effects:
Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria. Gastrointestinal complaints, such as nausea, vomiting, diarrhoea and abdominal pain.
For injectable formulation : Injection site reactions. Individual cases of acne or eczema have been reported after high parenteral doses of vitamin B12. Very rarely: anaphylactic shock.
For detailed information on Dolo-Neurobion®, Dexa-Neurobion® and Gavindol®,please refer to the relevant nationally approved prescribing information.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA. With headquarters in Geneva, Switzerland, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology and rheumatology.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of € 10.3 billion in 2011, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
For more information, please visit http://www.merckserono.com or http://www.merckgroup.com or https://www.facebook.com/MerckSeronoIND/app_221460014534454
“Our organic growth in all three business sectors and all regions shows that our strategy is bearing fruit. We are also well-positioned for future growth,” said Karl-Ludwig Kley, Chairman of the Merck Executive Board. “The fact that we are lifting the forecast for the current full year is due to the good operational performance of our businesses as well as to the imminent acquisition of Sigma-Aldrich.”
Merck India - Biopharma 