Pharming Group said today it has agreed to acquire all North American commercialization rights to its marketed orphan drug Ruconest® (recombinant human C1 esterase inhibitor) from Valeant Pharmaceuticals International for up to $125 million.

Pharming said the deal would accelerate its shift into a profitable specialty pharmaceutical company, with its own independent commercial infrastructure that will underpin future growth.

Ruconest, developed by Pharming, is approved in the U.S. and the EU for the treatment of acute hereditary angioedema (HAE) attacks. The drug has generated annualized net product sales of approximately $25 million as of the end of the second quarter, within a market Pharming said is valued at about $700 million.

Pharming reasons that it can enter another $700 million market if it can win approval for an additional indication. On July 18, Pharming trumpeted positive results in a Phase II trial of Ruconest for prophylaxis of HAE, with the drug meeting its primary endpoints for both once-weekly and twice-weekly dosing regimens.

Pharming agreed to pay Valeant $60 million upfront upon closing of the deal, which is expected in the fourth quarter of this year, and up to $65 million in potential payments tied to achieving sales milestones.

The acquisition will be funded through a combination of straight debt and new equity capital of between $80 million and $100 million, the buyer added.

Pharming said it expects Valeant’s 11-member Ruconest sales force will join the buyer and continue selling the drug in the U.S. That sales force will be increased, the company said, with Pharming also planning to spend more on medical science liaison personnel and additional marketing activities, including patient advocacy programs and “significant” unconditional support for the U.S. Hereditary Angioedema Association, its programs, and other HAE centers of excellence in the U.S.

Also planned, Pharming added, is additional spending to make Ruconest available in Canada and Mexico, as well as generating more sales in the E.U., Middle East, and Africa markets that Pharming will take over from Sobi in October.

The deal has already completed prenotification and clearance procedures under the Hart–Scott–Rodino Antitrust Improvements Act 1976, Pharming said.

Pharming said it anticipates that the deal will add to its 2016 earnings, and enable the company to reach profitability as much as 3 years earlier than under the license with Valeant.

Valeant acquired North American rights to Ruconest when it acquired Salix Pharmaceuticals last year, in a deal completed April 1, 2015. Salix previously acquired those rights by acquiring Santarus, with which Pharming entered into an agreement in 2010 covering development and commercialization of Ruconest® in the U.S., Canada, and Mexico.

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