About us
Kedrion Biopharma is an international biopharmaceutical company based in Italy that collects and fractionates plasma to produce and distribute worldwide plasma-derived products for the prevention and treatment of rare and debilitating diseases and conditions such as Hemophilia, Primary Immunodeficiencies and Rh sensitization.
Kedrion operates in Turkey through its subsidiary Kedrion Betaphar offering a portfolio of medicines and licensed products to treat Immunology, Neurology, Hematology, Intensive care and Transplantation patients.
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About us
Kedrion around the world
Vision
Our Mission
Our commitments
Social Responsibility
Transparency
Quality and Safety
PRODUCT PORTFOLIO
As a result of its solid and successful experience as partner with the Italian Health System, its significant expansion into international operations and a fundamental commitment to research and development, Kedrion’s line of plasma-derived products is broad and diverse.
With treatments for many rare and debilitating diseases and conditions from hemolytic disease in newborns to immune deficiencies to hemophilia, Kedrion offers a wide and expanding array of treatments and therapies.
RARE DISEASES
RARE DISEASES
HEMATOLOGY / HEMOPHILIA
Trade name in Turkey:
- Aimafix 500 IU/ 10 ml IV infüzyon için liyofilize toz içeren flakon
Trade name in Turkey:
- Emoclot 500 IU/ 10 ml IV İnfüzyonluk çözelti hazırlamak için Toz ve çözücü
- Emoclot 1000IU/10 ml IV İnfüzyonluk çözelti hazırlamak için Toz ve çözücü
IMMUNOLOGY / NEUROLOGY
Trade name in Turkey:
- Ig Vena 1g/20 mL IV Infüzyon için Çözelti
- Ig Vena 2,5g/50 mL IV Infüzyon íçin Çözelti
- Ig Vena 5g/100 mL IV Infüzyon için Çözelti
- Ig Vena 10g/200 mL IV Infüzyon için Çözelti
MOTHER AND CHILD HEALTH
MOTHER AND CHILD HEALTH
Trade name in Turkey:
- Immunorho 300 mikrogram (1500 IU)/2 ml IM Enjeksiyon için Liyofilize Toz İçeren Flakon
Trade name in Turkey:
- IM Enjeksiyon için Çözelti İçeren Kullanıma Hazır Şırınga
INTENSIVE CARE & TRANSPLANTATION
INTENSIVE CARE & TRANSPLANTATION
Trade name in Turkey:
- Uman Albumin 20g/ 100 ml 50 ml IV İnfüzyon için Çözelti İçeren Flakon
- Uman Albumin 20g/ 100 ml 100 ml IV İnfüzyon için Çözelti İçeren Flakon
Therapeutic AREAS
Our continuing commitment to research, development and innovation aims to meet the therapeutic needs of the largest number of patients living with a rare disease or debilitating condition across the world.
Rare Diseases
Rare diseases are serious, often chronic and progressive, diseases. There are thousands of rare diseases. To date, six to seven thousand rare diseases have been discovered and new diseases are regularly described in medical literature. The number of rare diseases also depends on the degree of specificity used when classifying the different entities/disorders. Until now, in the field of medicine, a disease is defined as an alteration of the state of health, presenting as a unique pattern of symptoms with a single treatment. Whether a pattern is considered unique depends entirely on the level of definition of our analysis.
For many rare diseases, symptoms and signs may be observed at birth or in childhood, as is the case of Hemophilia and Primary Immunodeficiencies.
References:
Hemophilia is a congenital bleeding disorder that results in the blood failing to clot normally. It is caused by a deficiency of a protein in the blood called a clotting factor. People with hemophilia bleed easily and often excessively. Untreated, hemophilia can be life-threatening. There are two main types of hemophilia: “Hemophilia A” is the most common type and is caused by the deficiency of what is known as Clotting Factor VIII; “hemophilia B” is caused by deficiency of Clotting Factor IX.
Hemophilia occurs in about 1 in 10,000 births and it is much more common in males because it is an “X-linked” disorder. The number of affected persons worldwide is estimated to be about 400,000. Hemophilia A is more common than hemophilia B, representing 80-85% of all cases.
Diagnosis
Hemophilia should be suspected in patients presenting with a history of:
- Easy bruising in early childhood.
- Spontaneous bleeding (bleeding for no apparent/known reason), especially into the joints, muscles, and soft tissues.
- Excessive bleeding following trauma or surgery.
A definitive diagnosis depends on a blood analysis to determine deficiency of Clotting Factor VIII or IX.
Because each type of Hemophilia requires a different therapy, accurate diagnosis is essential.
Therapy
Hemophilia can be very successfully managed by simply replacing the deficient clotting factor. Therapy can be either “on demand” – the treatment of active bleeding, or “prophylactic” – regular maintenance of clotting factor levels to prevent bleeding. In developed countries where these factors are readily available, the life expectancy of males suffering from Hemophilia is essentially the same as for males in the general population.
Both clotting factors can be isolated from donated human plasma and they can also be engineered by means of recombinant DNA technology. There are many commercial brands from which to choose and that choice is generally made based on availability, access, price and on the risk of developing antibodies that render the factor ineffective.
References:
Srivastava A. et al. Guidelines for the management of Hemophilia. Haemophilia (2012), 1–47.
Mannucci PM et al. How we choose factor VIII to treat Hemophilia. Blood (2012) volume 119, number 18, 4108-4114
The most common bleeding disorder is von Willebrand disease (VWD). It is congenital and caused by deficiency or abnormality in a plasma protein central to blood clotting known as the von Willebrand Factor (named after the Finnish physician who first identified the disorder).
Von Willebrand Factor (VWF) is the “glue” that helps platelets in the blood stick together with the vessel wall, to form a clot where a blood vessel has been ruptured. It also binds and stabilizes the clotting factor Factor VIII, so in patients with VWD, the lack of VWF activity results in premature elimination of Factor VIII in the circulation, thereby resulting in a dual defect in the body’s ability to stop bleeding. People with VWD produce normal amounts of Factor VIII, but with deficient VWF the clotting factor does not stay in the system long enough to adequately carry out its function, as in patients with type 1 and III VWD.
There are three generally recognized forms of the disease:
- Type I: The most common and mildest form of Von Willebrand Disease. Levels of von Willebrand Factor are lower than normal, and levels of Factor VIII may also be reduced.
- Type II: In this form of Von Willebrand Disease, there is normal and sufficient Von Willebrand Factor but it is abnormal and does not work properly. The abnormality in the factor can vary and accordingly there are several subtypes of Type II Von Willebrand Disease – important to determine because treatment varies with the subtype.
- Type III: The most severe form of Von Willebrand Disease in which VWF is nearly or completely absent along with very low levels of Factor VIII.
People with Von Willebrand Disease can bruise easily; suffer frequent nosebleeds that can be difficult to stop; have heavy menstrual bleeding; and experience heavier and longer than normal bleeding after injury, surgery, childbirth, or dental work. In its most severe form, it can lead to spontaneous joint and organ bleeding and can be life-threatening.
Some patients respond favorably to injection of desmopressin acetate (DDAVP) but the most effective treatment and prophylaxis for VWD – especially in its more severe forms – is therapy with plasma-derived Von Willebrand Factor products.
References:
Federici AB. Classification and clinical aspects of von Willebrand disease. In: Textbook of Haemophilia 2nd Edition, Lee CA, Berntorp E, Hoots K (eds). Oxford: Wiley-Blackwell 2010. 302–308.
Disorders of the Immune System fall generally in three categories:
- Overactive or inappropriate immune response.
- Deficient immune response.
- Autoimmune (self-attacking) response.
- Asthma and allergies are examples of an overactive immune system reacting to a non-threatening foreign substance.
- Immune deficiencies (Immunodeficiencies) and autoimmune disorders are generally more serious and can be life-altering.
Immunodeficiencies
When one of the parts of the immune system is missing or does not work well, we say that the immune system is deficient. Most often this involves missing or defective T- or B-lymphoctyes or inadequate production of antibodies. The result is that the body is vulnerable to infections that might otherwise be easily defeated.
Immunodeficiencies can be “Primary”, i.e., present at birth and usually genetic, or “Secondary”. Secondary Immunodeficiencies have many causes, including disease, malnutrition, aging, certain medications, chemo- and radiation therapy, and stress. Probably the most well-known cause of immunodeficiency, though not the most common, is the Human Immunodeficiency Virus (HIV), which can cause AIDS (Acquired Immune Deficiency Syndrome).
There are some 185 Primary Immunodeficiencies recognized by the World Health Organization. Most common are those involving the production of antibodies and are called Primary Antibody Deficiencies (PAD’s). These disorders vary greatly in their underlying defects, but many of them can be managed and their symptoms mitigated by regular infusions of Immunoglobulin.
Kedrion’s ongoing research and development has resulted in several Immunoglobulin therapies for these conditions. Replacement therapy with Immunoglobulin in Primary Antibody Deficiencies increases life expectancy and reduces infection frequency and severity.
References:
Abbas K. et al. “Le basi dell’Immunologia. Fisiopatologia del sistema immunitario”. Ed. Masson Elsevier 2006.
Autoimmune Diseases
The human body can sometimes become its own worst enemy. For reasons still not fully understood the human immune system can lose some of its ability for distinguishing between self and non-self and begin attacking normal healthy cells in the body. This is a condition known as Autoimmune Disease.
There are many Autoimmune Diseases that affect millions of people and their incidence seems to be growing worldwide.
The following Autoimmune Diseases are ones for which intravenous Immunoglobulin (IVIg) therapy is indicated and approved:
- Idiopathic Thrombocytopenic Purpura (ITP). Also known as Immune Thrombocytopenic Purpura or Autoimmune Thrombocytopenic Purpura, ITP is an autoimmune bleeding disorder resulting when the immune system attacks its own blood platelets, which are important to the clotting process. For reasons not well understood, lymphocytes produce antibodies that attach to the platelets, which then do not clot effectively and are subsequently recognized as “foreign” and destroyed in the spleen. Frequent and abnormal bleeding is typical and often results in many small bruises that can look like a rash (purpura). Children are generally affected with an acute form of the disorder that resolves spontaneously in a few months while in adults it is usually a chronic condition requiring long term treatment. The disease is rare, with an incidence of 3 cases per 100,000 inhabitants per year in those aged under 16 years and 1.6 to 2.68 cases per 100,000 inhabitants per year in adults, with a slight female preponderance.
- References:
Navarro RP et al.; Considerations for the Optimal Use of Immunoglobulin. Am J Manag Care. 2012;18:S67-S78
Abrahamson PE. The incidence of idiopathic thrombocytopenic purpura among adults: a population-based study and literature review. Eur J Haematol..2009 Aug;83(2):83-9.
- Kawasaki Disease. Also known as Mucocutaneous Lymph Node Syndrome, is a form of vasculitis characterized by inflammation of blood vessels throughout the body. It primarily affects children under the age of five (and rarely over the age of eight).
With proper treatment the prognosis for these children is good, but without treatment about a quarter of them will develop cardiac problems, including coronary artery aneurysms. Kawasaki Disease has become the leading cause of acquired heart disease in children in the developed world.
The cause of Kawasaki Disease is still unknown with researchers divided on whether it is an infection or an autoimmune response, but effective treatment includes Primarily Intravenous Immunoglobulin. - References:
Uehara R, Belay ED. “Epidemiology of Kawasaki disease in Asia, Europe, and the United States” J Epidemiol 2012; 22 (2): 79-85
Takahashi K et al.; Pathogenesis of Kawasaki disease. Clinical and Experimental Immunology, 2011; 164 (Suppl. 1): 20–22
Newburger JW. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association. Pediatrics. 2004;114:1708–1733
Guillain-Barré Syndrome
This is a rare (affecting just 1-2 people in 100,000) Autoimmune Disease in which the immune system attacks the myelin or outer covering of nerves (and sometimes the nerves themselves) of the Peripheral Nervous System. The damage leads to tingling and weakness in the legs and can proceed to even life-threatening paralysis.
Symptoms generally reach their most severe within days or weeks when they stabilize for a period of days, weeks or even months. Most people recover from even the most severe cases, but recovery can take as little as a few weeks or as much as a few years. The cause of the autoimmune response is unknown but it is sometimes triggered by infection, surgery or vaccination.
One treatment for Guillain-Barré syndrome that can reduce symptoms and hasten recovery is high dose Immunoglobulin therapy.
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP can be thought of us a chronic form of the Autoimmune Disorder Guillain-Barré syndrome caused by demyelination of peripheral nerves, resulting in loss of sensation, motor weakness, and sensory symptoms.
Its estimated prevalence ranges from 0.8 to 8.4 per 100,000 people. CIDP is often disabling with over 50% of patients having temporary disability and about 10% eventually becoming persistently disabled or dying because of the disease.
The cause of CIDP remains unknown, but there are data supporting an immune pathogenesis. Plasmapheresis (plasma exchange), oral corticosteroids and Intravenous Immunoglobulin (IVIg) therapy are effective treatments, but should be started early to avoid permanent nerve damage.
References:
Pithadia AB et al.; Guillain-Barre syndrome (GBS). Pharmacological Report 2010; 62: 220 – 232
Köller H et al.; Chronic inflammatory demyelinating polyneuropathy. N Engl J Med.2005 Mar 31;352(13):1343-56.
Mahdi-Rogers M et al.; Overview of the pathogenesis and treatment of chronic inflammatory demyelinating polyneuropathy with intravenous immunoglobulins. Biologics. 2010 Mar 24;4:45-9.
E. Nobile Orazio. Intravenous immunoglobulin versus intravenous methylprednisolone for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial. Lancet Neurol 2012; 11 (6): 493-502
Mother and Child Health
Our Mother and Child Health area focuses on Hemolytic Disease of the Fetus and Newborn and on vertical (mother to child) transmission of Hepatitis B.
These are serious and debilitating diseases, which represent a real threat to the fetus or newborn and, in the most severe cases, can lead to death.
Nowadays both diseases are easily preventable through the screening of all pregnant women – to detect situations at risk – and the eventual administration of a correct prophylaxis.
However, despite the existence of an effective and non-invasive treatment, access to therapy is still scarce or lacking in many countries worldwide.
Maternal-fetal red cell antigen incompatibility can lead to alloimmunization, maternal Immunoglobulin transplacental transfer, and Hemolytic Disease of the Fetus and Newborn (HDFN).
Hemolytic Disease of the Fetus and Newborn (HDFN), also called Erythroblastosis Fetalis, is a condition that can arise when a mother and her unborn child have different and incompatible blood types. If even a few of the fetus’s red blood cells cross over the placenta and get into the mother’s circulation during the pregnancy, they are recognized by her immune system as “foreign” and it will produce antibodies to attack them. If these antibodies cross back over into the fetus, they will begin to destroy fetal red blood cells.
Since it takes time for antibodies to develop, the first child might not be seriously affected, but the mother’s immune system will now be sensitized to these incompatible red blood cells and subsequent pregnancies involving similar incompatibility will be seriously threatened.
The most serious type of HDFN is the one caused by Rh incompatibility in which the mother has Type Rh Negative blood and the fetus, Rh Positive. Although HDFN can be extremely serious, it is rare and preventable.
Passive Immunization with anti-D antigen Immune Globulin protects Rh(D)-negative women from sensitization against Rh(D)-positive red blood cells.
The use of Routine Antenatal Anti-D Prophylaxis (RAADP) has sharply decreased the incidence of and mortality from HDFN due to RhD allosensitization. However, despite the advent of anti-Rh(D) immunoglobulin prophylaxis, severe morbidity and death because of Rh disease have only been reduced by approximately 50% globally during the last 50 years.
References
Visser et al. The continuing burden of Rh disease 50 years after the introduction of anti-Rh(D) immunoglobin prophylaxis: call to action. Am J Obstet Gynecol. 2019 Sep;221(3):227.
Liumbruno et al. The role of antenatal immunoprophylaxis in the prevention of maternal-foetal anti-Rh(D) alloimmunisation. Blood Transfus 2010; 8:8-16
Bowman JM. Controversies in Rh prophylaxis: who needs Rh immune globulin and when should it be given? Am J Obstet Gynecol 1985; 151: 289-94.
Clarke CA, Donohoe WTA, McConnell RB, et al. Further experimental studies on the prevention of Rh haemolytic disease. Br Med J 1963; 1: 979-84.
Women HBV positive can transmit HBV to their babies. In areas endemic for HBV, such as Western Pacific Region and Africa, up to 20% of the general population is chronically infected, with perinatal/neonatal and childhood infections existing as a primary route for expanding the reservoir of carriers.
Chronic HBV infection, even if asymptomatic for decades, can result in eventual death from cirrhosis and hepatocellular carcinoma (HCC). Mother-to-child transmission of HBV has been associated with an increased risk of HCC. Consequently, in Asian and African countries with a high incidence of perinatal and early childhood infection, death from cirrhosis or HCC (more than half due to HBV infection) is common, among the top ten causes of death. Thus, from the outset, prevention of chronic infection in children has been a key component of HBV immunization strategies.
The currently recommended practice to reduce mother-to-child HBV vertical transmission relies on the administration of HBV vaccine and concurrent administration of hepatitis B immune globulin (HBIG) at the time of or shortly after birth. A small but growing body of data suggests that maternal treatment with NA therapy in the third trimester of pregnancy in addition to vaccine and HBIG for the infant may also reduce HBV transmission to the infant.
References
Silverman, N, Glob. libr. women’s med.,ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10181.
Lee C., Gong Y., Brok J. et al. Effect of hepatitis B immunization in newborn infants of mothers positive for HBsAg: systematic review and meta-analysis, BMJ 2006;332:328-336
Beasley R.P. Rocks along the road to the control of HBV and HCC. Ann Epidemiology 2009;19:231-234 Red Book, current version 2018-2021
Guidelines For The Prevention, Care And Treatment Of Persons With Chronic Hepatitis B Infection, Who, March 2015
Intensive Care and Transplantation
Intensive care, also called critical care, is the close monitoring and treatment given to patients with acute, life-threatening illness or injury such as shock, burns, accidents, sepsis, severe breathing problems and complex surgery as liver transplantation.
Chronic hepatitis B (CHB) caused by hepatitis B virus (HBV) infection remains a major global health problem affecting an estimated 350 million people worldwide with more than 786000 individuals dying annually due to complications of CHB, including cirrhosis and liver cancer. CHB is the leading cause of hepatocellular carcinoma (HCC) accounting for at least 50% of newly diagnosed cases. Furthermore, HCC is the third leading cause of cancer-related mortality in the world with a dismal 5-year survival and the fastest growing rate of cancer death in North America.
Liver transplantation (LT) is the most effective treatment in patients with CHB-related liver failure, cirrhosis and HCC. However, HBV reactivation following LT emerges as a major clinical challenge. Prophylaxis with high-dose hepatitis B immunoglobulin (HBIG) and anti-viral drugs have achieved remarkable progress in LT by suppressing viral replication and improving long-term survival.
Before its introduction, reinfection with HBV after transplantation occurred in more than 80% of recipients and the 5-year graft and patient survival rates were only 50%. Now, with the use of the HBIg/nucleoside/nucleotide analogue prophylaxis, transplant programs in North America and Europe can expect prevention of HBV recurrence in greater than 90% of their patients.
Hepatitis B is contagious, but it can be transmitted from mothers to infants at the time of birth. This transmission can be markedly reduced by the immediate postpartum administration of HBIg to the infant either alone or, as currently recommended, concomitant administration of hepatitis B vaccine.
References:
El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012;142:1264–1273.e1. [PMC free article] [PubMed] [Google Scholar]
Durantel D, Zoulim F. New antiviral targets for innovative treatment concepts for hepatitis B virus and hepatitis delta virus. J Hepatol. 2016;64:S117–S131. [PubMed] [Google Scholar]
Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone AM, et al. Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer. Cancer. 2016;122:1312–1337. [PMC free article] [PubMed] [Google Scholar]
Song GW, Ahn CS, Lee SG, Hwang S, Kim KH, Moon DB, Ha TY, Jung DH, Park GC, Kang SH, et al. Correlation between risk of hepatitis B virus recurrence and tissue expression of covalently closed circular DNA in living donor liver transplant recipients treated with high-dose hepatitis B immunoglobulin. Transplant Proc. 2014;46:3548–3553. [PubMed] [Google Scholar]
Nair S, Perrillo RP. In: BoyerTD, ed: Hepatology (4th edn). Philadelphia: Saunders, 2003: 959.
Realdi G, Fattovich G, Hadziyannis S, et al. Survival and prognostic factors in 366 patients with compensated cirrhosis type B: a multicenter study. The Investigators of the European Concerted Action onViral Hepatitis (EUROHEP). J Hepatol 1994; 21: 656^666.
Arianeb Mehrabi, “The role of HBIg as hepatitis B reinfection prophylaxis following liver transplantation” Langenbeck’s Archives of Surgery June 2012, Volume 397, Issue 5, pp 697-710.
American Academy of Pediatrics. Hepatitis B. In: Peter G, editor. 1997 Red Book. Report of the Committee on Infectious Diseases. 24th ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1997. pp. 247–260.
Albumin is the most abundant circulating protein in the human body, making up about 50% of the total plasma protein content.
Albumin has been the first plasmaprotein produced from human plasma for therapeutic use. The scientific evidence of recent years has clearly shown that albumin is endowed with a long series of clinically relevant functions: alongside the well-known oncotic power, albumin performs many other activities that are grouped under the definition of non-oncotic properties. These include : Binding , Transport and detoxification, Antioxidant action, Modulation of the inflammatory and immunological response, Antithrombotic action, Capillary permeability and endothelial stabilization, Adjustment of acid-base balance.
The oncotic activity, together with the long circulating half-life and total half-life make albumin an excellent plasma expander, which is currently the main reason for its use in clinical practice expecially in critical situations. The non-oncotic activities play an important therapeutic role in many medical conditions where the condition of deficient plasma volume is associated with a pro- inflammatory state as in liver cirrhosis, sepsi/septic shock, burns.
All these properties makes albumin an important medicine for many clinical conditions for which other fluids are either contro-indicated or have no important therapeutic effect.
References:
Quinlan GJ, Martin GS, Evans TW. Albumin: biochemical properties and therapeutic potential. Hepatology 2005; 41:1211–1219.
Fanali G, Di Masi A, Trezza V, et al. Human serum albumin: from bench to bedside. Mol Aspects Med 2012; 33: 209-90.
Vincent J-L, Russell JA, Jacob M, et al. Critical Care 2014;18:231-41
Garcia-Martinez R, Caraceni P, Bernardi M, Gines P, Arroyo V, Jalan R. Albumin: pathophysiologic basis of its role in the treatment of cirrhosis and its complications. Hepatology 2013; 58:1836-46.
Taverna M, Marie AL, Mira JP, Guidet B. Specific antioxidant properties of human serum albumin. Ann Intensive Care. 2013
Schött U, Solomon C, Fries D, Bentzer P. The endothelial glycocalyx and its disruption, protection and regeneration: a narrative review. Scand J Trauma Resusc Emerg Med. 2016 Apr 12;24:48.
Antithrombin is a plasma protein that inactivates Thrombin, a plasma enzyme that is important in the clotting process. Antithrombin therefore acts as a powerful anticoagulant and is used to treat acquired antithrombin deficiency from Disseminated Intravascular Coagulation (DIC) as the result of sepsis, multiple trauma, severe burns, pregnancy complications, extensive surgery, etc.
Antithrombin is also used in patients with congenital antithrombin deficiency for the prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations (especially during surgery or during the peri-partum period) and for the prevention of progression of deep vein thrombosis and thromboembolism in association with heparin, when indicated.
PCC is a complex of human plasma coagulation factors for treatment of bleeding and perioperative prophylaxis of bleeding in acquired prothrombin deficiency, when rapid correction of the deficiency is required.
PCC is also used for treatment of bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation factor product is not available.
References:
Rita Garcia-Martinez. Albumin: Pathophysiologic Basis of Its Role in the Treatment of Cirrhosis and Its Complications. Hepatology, Month 2013
Afshari A. Antithrombin III for critically ill patients (Review). The Cochrane Library 2009, Issue 2
Sibylle A. Management of severe perioperative bleeding. Eur J Anaesthesiol 2013; 30:270–382
Rabies is a prolifically deadly zoonotic disease. Rabies-related human deaths are infrequent due to prophylaxis using vaccines and human rabies immunoglobulin (HRIG), providing nearly 100% success rates. Fatalities from rabies occurs when patients fail to seek medical attention. While this does not occur often, preventable deaths were reported within the last year.
Given the rarity of this disease and, therefore, the low incidence of cases reported in medical clinics, hospitals and pharmacies, it is essential for healthcare professionals to have a correct knowledge of the pathology – to immediately recognize its symptoms – and the measures to be taken to procure and administer Human Rabies Immunoglobulins based prophylaxis in combination with the rabies vaccine.
References:
The burden of rabies. Last reviewed September 25, 2017. Accessed March 4, 2019. https://www.cdc.gov/features/dsrabies/index.html
News
Kedrion grows in North America as it completes acquisition of Prometic
Kedrion has announced that it has completed the acquisition in North America of the Prometic life sciences business.
Prometic, which has a team of 130 employees in Laval, Québec, has developed the first ever FDA-approved treatment for Congenital Plasminogen Deficiency. The new drug, called Ryplazim®,, has been approved for the treatment of all the clinical manifestations of Plasminogen Deficiency, which can lead to blindness, respiratory failure and other severe complications.
Kedrion is now working toward a launch in the United States in early 2022.
“We are very pleased to have completed this important and strategic acquisition, which will bring badly needed therapies to patients who suffer from this rare disease,” said Kedrion’s Chairman Paolo Marcucci,.
The Prometic transaction, Mr. Marcucci added, “is part of our strategy to deepen our commitment and expand our presence across North America, from which we already derive nearly half of our group revenues.”
With the acquisition of Prometic BioTherapeutics Inc., Kedrion has finalized a series of transactions that began last June with the announcement that it was acquiring from Liminal Biosciences Inc. the plasma purification plant at Laval in Québec, and the license to distribute the new product in the United States.
“The Prometic deal brings more cutting-edge purification technology to our group,” said Mr. Marcucci. “But most of all it allows us to reach long-suffering patients who until today have had no effective treatment for the often debilitating condition of Congenital Plasminogen Deficiency.”
Val Romberg, Kedrion’s CEO, also said the most important aspect of the Prometic acquisition was the ability to reach patients in need, “Ryplazim is very significant because it really allows us to fulfil our mission of putting patients first. This is the first drug to ever be approved by the FDA for the treatment of the rare Congenital Plasminogen Deficiency, Type 1, so we are very honored to help speed the product to market.”
Mr. Romberg noted that along with the Laval plant in Québec, Kedrion had also acquired two plasma collection centers in Amherst, New York and in Winnipeg, Manitoba. “We are excited to have new colleagues joining the Kedrion family, and we look forward to working together to get this new treatment to patients as soon as possible,” he said.
Kedrion Biopharma expands its commitment in Turkey
In a reception held by the Ambassador of Italy to Turkey, His Excellency Massimo Gaiani, at the Italian Embassy in Ankara on October 14, Kedrion Biopharma’s Turkish subsidiary Kedrion Betaphar has announced that the company will establish a bigger direct presence in Turkey, with a reinforced and enlarged direct product portfolio, the hiring of Turkish executives and technicians, and plans to offer more therapies for Turkish patients with rare diseases.
Kedrion Betaphar has already acquired all product licenses from its former business partner, a move that implies employing more local staff and thus contributing to the country’s economy in a more tangible way.
Among distinguished guests attending the event were local clinicians, pharmacists, research centers, industrial associations, business partners and representatives from other major Italian pharma companies with a presence in the country. Corporate representatives from Kedrion Biopharma and local executives from Kedrion Betaphar also attended.
“I am very glad that an Italian company has decided to make an important investment in Turkey in the strategical health sector,” stated the Ambassador. “We are particularly proud also because the know-how provided by Kedrion will help patients in Turkey suffering from rare diseases. This is certainly another sign of the strong economic and commercial ties that link our two Countries and of the interesting opportunities that Turkey can disclose for Italian Companies in every field.”
“We are excited to be growing our presence in Turkey, which is one of the most important members of the G-20. Kedrion is thus building a more solid bridge between Italy and Turkey, and we are pleased to commemorate this milestone together with the Italian ambassador,” said Paolo Marcucci, Chairman of Kedrion Biopharma. “With our decision to have a direct presence here, we have paved the way towards new achievements: and more investments are foreseen to enlarge further our product offer for all therapeutic areas” he added.
With its commercial office located in Istanbul, Kedrion Betaphar has its company headquarters in Ankara, where very soon the staff will be moved to new premises and where a new warehouse will be built for product storage and sorting.
Mahmut Arslan, the Vice President of Betaphar, said he was certain that Kedrion’s expanded footprint in Turkey would yield positive benefits for patients across the country.
“Increasing our presence in Turkey,” said Kedrion Betaphar CEO Riza Ommaty “also means having the possibility to support Turkish patients more closely. We are the 7th fastest growing pharmaceutical company in Turkey in the last year according to IMS data and this is an honor but also a big responsibility towards patients communities.” Recently, Kedrion acquired Prometic from Liminal BioSciences Inc. in Canada. Prometic is the owner of the rights to market of a new Plasminogen concentrate that is the first product FDA-approved for the treatment of patients living with Congenital Plasminogen Deficiency type 1. “Plasminogen Deficiency is a problem in our country like elsewhere and so we really look forward to make this therapy available to patients in Turkey in the medium-term,” said again Riza.
Kedrıon supports World Prımary Immunodefıcıency Week
Always close to those who live with rare diseases, Kedrion Biopharma is proud to support World Primary Immunodeficiency Week (PI WEEK 2021), scheduled for April 22 – 29. This is a global campaign aimed at promoting and protecting the health of patients with Primary Immunodeficiencies (PI) by improving – first and foremost – early diagnosis and prompt access to treatment.
Educational initiatives, awareness activities and medical-scientific round tables will be held throughout the week, for the second consecutive year in virtual mode, promoted by patient associations, academia, companies and institutions around the world. The main topics of these meetings include: the importance of plasma availability to ensure that people with PID receive the treatment they need; the safety and protection of patients, focusing particularly on the key role of vaccination to protect the most vulnerable people during this pandemic; enhance the quality of life of patients through research, early diagnosis and improved access to treatment.In line with this perspective aimed at safeguarding and improving the quality of life of patients, Kedrion has continued its commitment to this therapeutic area over the past year, as confirmed/testified by the enrollment – on March 31, 2021 – of the first patient in a phase 3 clinical study geared towards demonstrating the efficacy, safety and pharmacokinetics of a 10% Intravenous Immunoglobulin (IVIg) in pediatric patients with IDP.
Even during the most difficult moments of this pandemic, , we have continued to collaborate in the same spirit with the International Patients Organization for Primary Immunodeficiencies (IPOPI) by confirming our support to PID GENIUS; the first app designed and developed by IDP patients with the technical and economic support of our company. At the same time, we have backed a number of initiatives organized by patient associations in various countries around the world, including for example the United States, , where we have renewed our support to the American Immunodeficiency Foundation (IDF) and the Jeffrey Modell Foundation.
World Hemophılıa Day 2021, Kedrıon alongsıde patıents
On the occasion of World Hemophilia Day 2021, which will be celebrated worldwide on April 17, 2021 and which, for the second year running, will take place in the COVID-19 pandemic, Kedrion Biopharma is proud to convey its closeness – across and beyond physical distances – to patients, their families and their associations.
The theme chosen by the World Federation of Hemophilia (WFH) is “Adapting to change – Sustaining care in a new world,” to illustrate the need to adapt to a continuously changing and rapidly evolving world, marked by new social, environmental and developmental challenges that will closely impact the global health ecosystem and the daily lives of patients.
In Italy, Kedrion has paid tribute to this anniversary by supporting the event entitled “Chronically rare: resources must be pursued,” scheduled on April 15 in live streaming at the Sala Mastai of the Palazzo dell’Informazione in Rome and organized by the Italian Federation of Hemophilia Societies (FedEmo) together with the Italian Association of Hemophilia Centers (AICE) and the Paracelsus Foundation, under the patronage of the Italian Ministry of Health. The round table will analyze and discuss all aspects relating to possible demedicalization in Italy; starting from the creation of synergies leading to existing community nursing services, and with the support of innovative health technologies such as telemedicine, the aim is to organize and manage at local level system approach which essentially should be shared at national level.
The difficulties brought on by by the pandemic have not prevented us from continuing to guarantee our support to patient associations and to the medical-scientific community. In Italy, this commitment has resulted in offering support to varied initiatives aimed at promoting an ever greater centrality and participation of patients, including: the “Words in Hemophilia: Towards Patient Engagement” project, currently underway at the “EngageMinds HUB” Research Center of the Università Cattolica del Sacro Cuore in Milan; and #KoalaACasaTua, a home delivery service for medicines distributed by Kedrion for the treatment of Hemophilia which has been operating since April 2020 with the aim of safeguarding the health of the more vulnerable
In Turkey, where Kedrion has consolidated its direct presence in recent years, we continue our commitment alongside the local medical community to improve knowledge and awareness in the field of coagulation disorders, by focusing the discussion on the role of replacement therapy in the treatment of Hemophilia A.
In the rest of Europe and worldwide, for several years now we have been supporting the PARTNERS project promoted by the European Hemophilia Consortium (EHC) and, at the same time, we have been supporting the World Federation of Hemophilia (WFH) in order to improve access to treatment for coagulation disorders,
With the same goal in mind, Kedrion continues to work alongside the Italian National Blood Center (CNS) and several Italian Regions on ethical, transparent projects to support disadvantaged countries, which in 2020 included Albania, Afghanistan, Armenia, El Salvador and – most recently – Palestine.
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