Pharming Group has completed the acquisition of all North American commercialisation rights for Ruconest from certain subsidiaries of Valeant Pharmaceuticals for $125m.

The acquisition also includes all rights in the US, Mexico and Canada.

Developed by Pharming, Ruconest is an FDA-approved orphan drug designated therapy to treat acute hereditary angioedema (HAE) attacks in patients in the US and EU.

Pharming CEO Sijmen de Vries said: “Now that we have taken full ownership of our key asset and by integrating the Valeant US sales team members and building that team, we will work with a single-minded focus, energy and investments to bring this treatment to all eligible HAE patients in the US.

“For well over a decade Pharming has been dedicated to the HAE market and has been working with HAE physicians and patients on the development of a safe and effective recombinant enzyme replacement therapy.”

The drug recently met its primary endpoints for both once-weekly and twice-weekly dosing regimens in a Phase II clinical trial and highlighted positive data in prophylaxis of HAE.

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“The drug recently met its primary endpoints for both once-weekly and twice-weekly dosing regimens in a Phase II clinical trial and highlighted positive data in prophylaxis of HAE.”

If approved in the indication, it will be able to enter this $700m per year additional market.

The drug has the potential to be the only recombinant C1 esterase inhibitor approved to target both the acute and HAE prophylaxis markets.

Following the acquisition, Pharming will now sell Ruconest directly in the US and is planning further investment to accelerate the drug sales efforts to drive growth in the European, Middle Eastern and African markets.

In connection with the closing of the deal, Valeant and Pharming have signed an agreement to work for customers and HAE patients.

Valeant acquired the North American licence rights to Ruconest through the acquisition of Salix Pharmaceuticals on 1 April last year.

Salix had licensed exclusive rights from Pharming to commercialise Ruconest in North America and market it for the treatment of acute HAE-attack symptoms.