Deal Struck to Distribute Ruconest in Middle East, North Africa

Vanda Pinto, PhD avatar

by Vanda Pinto, PhD |

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Pharming Group has signed an exclusive license agreement with NewBridge Pharmaceuticals to distribute and commercialize Ruconest (conestat alfa), a treatment for acute attacks of hereditary angioedema (HAE), in the Middle East and North Africa.

Under the agreement terms, NewBridge in collaboration with Pharming, will provide access for Ruconest, and NewBridge will be responsible for managing named patient supplies and marketing the therapy in the region.

“Pharming is committed to supporting patients with HAE, along with their caregivers, as they live with this debilitating disease. We are therefore delighted to enter into this agreement with NewBridge to ensure access to Ruconest in new geographies,” Sijmen de Vries, CEO of Pharming Group, said in a press release.

“NewBridge’s extensive experience in the Middle East and North Africa, along with their strategic focus in rare diseases, make them an ideal partner for

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Pharming in the region. We look forward to continuing to expand the global reach of Ruconest, in line with our growth strategy, to serve HAE patients with unmet medical needs,” he said.

Ruconest is a lab-made version of human C1-inhibitor, or rhC1-INH, that is designed to replace the C1-INH protein HAE patients are missing and treat acute swelling attacks caused by its absence.

The therapy is approved in the U.S. and European Union as a treatment for acute HAE attacks in adults and adolescents. In the European Union, it also is approved for the same indication in children as young as 2. The medication is currently marketed in more than 20 countries.

Its approval in children was supported by data from an open-label Phase 2 trial (NCT01359969), showing that a single dose of Ruconest was sufficient to stop nearly 96% of acute attacks. Ruconest also eased attack symptoms relatively quickly, within a median of 60 minutes.

Additional findings from other Phase 2 trials (NCT02247739; NCT00851409) showed that Ruconest was safe and effective when used as a short-term prophylactic (preventive) therapy to prevent HAE attacks in adults and adolescents.

The most common side effects reported in clinical trials of Ruconest included nausea, headache, and diarrhea.

According to its prescribing information, Ruconest should not be used in patients with known or suspected allergies to rabbits or rabbit-derived products, since the protein in its composition is isolated from rabbits’ milk.

In the U.S. and Europe, Ruconest is available to trained patients or caregivers as a self-administration kit.