LEIDEN, The Netherlands,
February 9, 2016 /PRNewswire/ --
Pharming Group N.V. ("Pharming" or "the Company") (Euronext:
PHARM) announced today that it has extended the exclusive
distribution agreement with Cytobioteck S.A.S. ("Cytobioteck"), a
privately owned Bogota, Colombia
based specialty healthcare company, for the distribution of
RUCONEST® (recombinant, non-blood derived human C1
inhibitor) for the treatment of acute attacks of Hereditary
Angioedema (HAE) by adding countries in Central and South America.
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."
About HAE
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.
About RUCONEST®
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
Pharming Group
Sijmen de Vries, Chief Executive Officer
Tel: +31-71-5247400
FTI Consulting (Pharming media relations)
Julia Phillips / Victoria Foster Mitchell
Tel: +44-(0)203 727-1136
Cytobioteck S.A.S.
Osvaldo Piñeros, Chief Executive Officer
Tel: +57-1-6451255
Cytobioteck S.A.S.
Santiago Piñeros, Head of Commercial Operations
Tel: +57-3184559905
PRN NLD