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Pharming Group Supports hae day :-) 2016


News provided by

Pharming Group N.V.

16 May, 2016, 05:00 GMT

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LEIDEN, The Netherlands, May 16, 2016 /PRNewswire/ --

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT: PHARM) today announced its support of the Fifth Annual International Hereditary Angioedema Day.

- hae day :-) - 

hae day :-) takes place on 16 May 2016 and aims to raise awareness around Hereditary Angioedema (HAE).

hae day :-) is coordinated by the HAEi, the International Patient Organization for C1-Inhibitor Deficiency, along with direct support of its Member Organizations and encourages patient organizations from across the globe to organize awareness-raising activities around the theme "Many faces, one family". This specific day aims to raise awareness of HAE among the general public and medical community in order to create an environment with earlier and faster diagnosis, improved patient care, knowledge and therapy conditions that ensure HAE patients and their families can lead normal lives.

HAE is a rare, very disabling and potentially life-threatening genetic disorder. People living with this condition suffer from recurrent and disabling attacks of swelling that can affect abdomen, face, extremities, urogenital tract, and less-frequently obstruction in the upper airways.  

As part of its global commitment to improving the lives of patients with HAE and their caregivers, Pharming participates in the HAEi Global Access Program initiative (http://haei.org/hae/global_access_program/) as well as in several multi-country studies and projects aimed at improving patients' quality of life.

"HAE is a complicated disease that can sometimes take many years to diagnose. As frequently indicated by experts, HAE has many different faces. For this reason, hae day :-) is an important event, which raises awareness of this serious condition and helps to ensure that patients are diagnosed earlier and treated safely", said Dr Sijmen de Vries, CEO of Pharming Group NV. "At Pharming, we have been collaborating with the HAE community since 2000. We are delighted to support this year's fifth anniversary of hae day :-). We are very proud of the difference in patients' and their families' lives that we can make together with HAEi and its local affiliates."

"HAEi is excited to celebrate the 5th anniversary of hae day :-)," said Henrik Balle Boysen, Executive Director of HAEi. "We are pleased that over the years hae day :-) events have fostered increased awareness about this debilitating and potentially fatal condition. We are confident that hae day :-) 2016, along with other supportive initiatives, will continue the momentum towards more timely diagnosis and improved access to life-saving therapies."  

To learn more about the hae day :-) events happening in your regional area, please visit http://www.haeday.org.

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, because although HAE is (in principle) easy to diagnose, it is frequently identified very late or not discovered at all. HAE is often misdiagnosed 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 ordeal.

To learn more about HAE, please visit http://haei.org/.

Please see Prescribing Information for RUCONEST as applicable for various jurisdictions. 

http://www.pharming.com/products/ruconest

http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM405634.pdf

About Pharming Group N.V. 

Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. Pharming's lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema ("HAE") attacks in patients in the EU, Norway, Iceland and Liechtenstein, the USA, Israel and South Korea.

In other territories where it has not yet obtained marketing authorization, RUCONEST® is available through the international HAE patient organization's Global Access Programme (HAEi-GAP) on a named-patient basis.

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 North America, Canada and Mexico by Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX), following Valeant's acquisition of Salix Pharmaceuticals, Ltd.

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 and in Israel by Megapharm.

RUCONEST® is being investigated in a Phase II randomized, double blind placebo-controlled clinical trial for prophylactic treatment of HAE and is being evaluated for other indications as well. The Phase II study was fully recruited shortly after the year-end 2015.

RUCONEST® is also being investigated 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's technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy ("ERT") for Pompe and Fabry's diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present.

Pharming has a long term partnership with the Shanghai Institute of Pharmaceutical Industry ("SIPI"), a Sinopharm company, for joint global development of new products, starting with recombinant human Factor VIII for the treatment of Haemophilia A. Pre-clinical development and manufacturing will take place to global standards at SIPI and are funded by SIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership.

Pharming has declared that the Netherlands is its "Home Member State" pursuant to the amended article 5:25a paragraph 2 of the Dutch Financial Supervision Act.

Additional information is available on the Pharming website: http://www.pharming.com

Pharming Disclosure Notice 

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.  

Contacts: 

Pharming Group N.V. 
Sijmen de Vries, CEO: T: +31-71-524-7400

FTI Consulting:
Julia Phillips/ Victoria Foster Mitchell, T: +44-203-727-1136


PRN NLD

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