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

Pharming Group N.V. and Clinigen Group plc have entered into an international global access collaboration for HAEi. The “HAEi GAP” program will provide access to RUCONEST® (conestat alfa) to eligible patients with 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.”

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 this way we can help to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease.”

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen 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.”

(Source: Pharming Group)