Pharming and Cytobioteck Announce Distribution Agreement for Ruconest

LEIDEN, The Netherlands, May 25, 2015 /PRNewswire/ --

Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) announced today that it has entered into an exclusive distribution agreement with Cytobioteck S.A.S. ("Cytobioteck"), a privately owned Bogota, Colombia based specialty healthcare company, for the distribution of RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in Colombia and Venezuela.

Under the agreement, Cytobioteck will drive all regulatory processes and will 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 Cytobioteck will be engaged in the distribution of RUCONEST in Colombia and Venezuela, two countries where a considerable number of patients with HAE have been diagnosed.

"This will be the key agreement to bring comfort and relief to patients with HAE in the region," Cytobioteck's CEO Osvaldo Piñeros commented. He also added: "Our job is to deliver the best therapies available for our patients, and we will continue to do so with Pharming as a valuable and strategic ally."

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 all 27 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 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 2015, 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.
Dana Cardozo, Head of Media Relations
Tel: +57-3168303191

PRN NLD