Pharming extends distribution agreement for Ruconest®Tuesday, February 9, 2016
Pharming entered into the original exclusive distribution agreement with Cytobioteck in May 2015 for the distribution of RUCONEST® in Colombia and Venezuela. Under the extended agreement, Cytobioteck will also exclusively distribute RUCONEST® in Argentina, Costa Rica, the Dominican Republic and Panama. Cytobioteck will continue to drive all regulatory processes and purchase its commercial supplies of RUCONEST® from Pharming at a fixed transfer price.
Sijmen de Vries, Pharming’s CEO, commented: “We are very pleased that we have been able to extend the agreement with Cytobioteck for the distribution of RUCONEST® in Central and South America. Over the past year Cytobioteck have made good progress with the regulatory processes in Colombia and Venezuela and several emergency treatments have already been provided to HAE patients in these countries in accordance with local regulations.”
Cytobioteck’s CEO, Dr. Osvaldo Piñeros, commented: “We look forward to being able to provide HAE patients with RUCONEST® in Argentina, Costa Rica, the Dominican Republic and Panama, in addition to Colombia and Venezuela. Our role is to deliver the best therapies available for our patients and we believe RUCONEST® provides a significant treatment option for HAE patients as the one and only recombinant, non-blood derived C1-esterase inhibitor replacement therapy with a proven and consistent efficacy and safety profile.”
Hereditary Angioedema (HAE) is a rare genetic disorder. It is characterized by spontaneous and recurrent episodes of swelling (edema attacks) of the skin in different parts of the body, as well as in the airways and internal organs. Edema of the skin usually affects the extremities, the face, and the genitals. Patients suffering from this kind of edema often withdraw from their social lives because of the disfiguration, discomfort and pain these symptoms may cause. Almost all HAE patients suffer from bouts of severe abdominal pain, nausea, vomiting and diarrhea caused by swelling of the intestinal wall.
Edema of the throat, nose or tongue is particularly dangerous and potentially life-threatening and can lead to obstruction of the airway passages. Although there is currently no known cure for HAE, it is possible to treat the symptoms associated with edema attacks. HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide. Experts believe that a lot of patients are still seeking the right diagnosis: although HAE is (in principle) easy to diagnose, it is frequently identified very late or not discovered at all. The reason HAE is often misdiagnosed is because the symptoms are similar to those of many other common conditions such as allergies or appendicitis. By the time it is diagnosed correctly, the patient has often been through a long lasting ordeal.
RUCONEST® (C1 Esterase Inhibitor [Recombinant]/ conestat alfa) 50 IU/kg is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST® contains C1 esterase inhibitor at 50 IU/kg.
When administered at the onset of HAE attack symptoms at the recommended dose, RUCONEST works to return a patient’s C1-INH levels to normal range and quickly begins to relieve the symptoms of an HAE attack with a low recurrence of symptoms. RUCONEST is the first and only plasma-free, recombinant C1-INH approval from the U.S. Food and Drug Administration (FDA) and was approved in July 2014 and by the European Medicines Agency (EMA) in October 2010.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the USA, Israel, South Korea, all 28 EU countries plus Norway, Iceland, and Liechtenstein.
RUCONEST is commercialized by Pharming in Austria, Germany and The Netherlands.
RUCONEST is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia, and Ukraine.
RUCONEST is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama and Venezuela, by Cytobioteck.
RUCONEST is distributed in South Korea by HyupJin Corporation.
RUCONEST is partnered with Salix Pharmaceuticals, Ltd. (“Salix”) in North America. Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX) completed its acquisition of Salix Pharmaceuticals, Ltd. on April 1, 2015.
RUCONEST is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE, in a phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications.
Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe, Fabry’s and Gaucher’s diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A.
For more information, please visit http://www.pharming.com
About Cytobioteck S.A.S.
Cytobioteck is a company focused on delivering new therapies to patients struggling with rare and orphan diseases of a low prevalence but of a high impact in those who suffer from them. Our mission is to benefit these patients so their future is ensured to improve and their life quality. As a result, our vision is to grow as the leader in the region delivering orphan drugs.
As of 2016, Cytobioteck has expanded his operations and is currently delivering drugs to México, Colombia, Venezuela, Perú, Argentina, Brazil and Central America (Panamá, Costa Rica, República Dominicana), being able to introduce orphan drugs in the market and obtaining full reimbursement from the authorities for the most expensive products in the globe.
For more information, please visit: http://www.cytobioteck.com