Clinigen ties up international collaboration agreement

STAFFORDSHIRE pharmaceutical group, Clinigen has tied up an international collaboration agreement with Pharming Group for the treatment of hereditary angioedema (HAE).

The collaboration deal will provide access to the drug conestat alfa – trade name Ruconest – and is for distribution to patients who currently do not have access to effective medication to treat acute attacks of HAE.

HAEi GAP is the first global access program for HAE and the first to be driven by a patient organisation. 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 process.

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.”

Sijmen de Vries, CEO, Pharming said the group was pleased to be one of the first partners of HAEi and to participate in the distribution process.

“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,” he said.

HAE is a very rare and potentially life-threatening genetic condition with symptoms that include swelling in various body parts of the body such as the hands, feet, face and airway.

In addition, people can suffer bouts of abdominal pain, sickness and vomiting due to swelling in the intestinal wall. Airway swelling is especially dangerous because it can lead to possible asphyxiation.

It is relatively rare and occurs in about 1 in 10,000 to 1 in 50,000 people.