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Clinigen Group

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Clinigen Group and Pharming Initiate “HAEi GAP” Global Access Program for RUCONEST®

Unique patient organization-driven program will enable patients with hereditary angeoedema (HAE) who cannot access effective treatments to receive medication for the first time.

Burton-on-Trent, United Kingdom, May 21, 2015 --( Clinigen Group plc (“Clinigen” or the “Group”, AIM: CLIN) and Pharming Group N.V. (“Pharming or the Company”, Euronext: PHARM) have entered into an international global access collaboration for HAEi, the International Patient Organization for C1- Inhibitor Deficiencies. The “HAEi GAP” will provide access to RUCONEST® (conestat alfa) to eligible patients with hereditary angioedema (HAE), who currently do not have access to effective medication to treat acute attacks of the disease.

HAEi GAP is the first global access program for HAE and the first to be driven by a patient organization. The program enables patients in countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant “Named Patient Program” mechanism.

“HAEi is committed to securing access to HAE medications for patients across the globe,” said Anthony J. Castaldo, President of HAEi. “We are extremely proud to have established HAEi GAP with our current partners and will continue to work with other manufacturers with the hope of expanding the program in the future.”

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: “HAEi’s ground-breaking program will ensure that HAE sufferers worldwide can gain access to effective and potentially life-saving treatment. Our secure supply chain and regulatory expertise will enable us to work closely with Pharming to supply patients with RUCONEST ethically and legitimately, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug. We look forward to working with both HAEi and Pharming on this unique project.”

Sijmen de Vries, CEO, Pharming said: “We are delighted to be the first partners of HAEi and to initiate this program by providing access to RUCONEST, a recombinant human C1- inhibitor, approved by EMA and FDA for the treatment of acute attacks of HAE in patients. In this way we can help to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease.”

About Clinigen Group
The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering ‘the right drug, to the right patient at the right time’. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines. The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.

The Managed Access Programs business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.
Contact Information
Instinctif Partners (Clinigen media relations)
Melanie Toyne-Sewell/Jen Lewis/Emma Barlow
+44 (0) 20 7457 2020

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