Pharming Group N.V. has entered into a definitive agreement to acquire all North American commercialization rights to its own product Ruconest (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from Valeant Pharmaceuticals International, Inc.
Ruconest is an orphan drug designated therapy developed by Pharming, already approved for the treatment of acute HAE attacks in patients in the USA and EU. This transaction will accelerate Pharming’s development into a profitable specialty pharmaceutical company with its own independent commercial infrastructure, which will form the foundation for growth in the future.
To ensure a seamless transition, Pharming is anticipating that Valeant’s dedicated Ruconest sales force, a total of 11 people, will accept offers to join Pharming to continue the Ruconest sales effort in the USA. Pharming also plans to increase the size of the sales force to drive growth in product sales, together with increased investments in medical science liaison personnel and additional marketing activities, including patient advocacy programmes and the provision of significant unconditional support for the US HAEA and its programmes as well as other HAE centers of excellence in the USA. In addition, Pharming is planning further investment in the acceleration of Ruconest sales efforts to drive growth in the EU, Middle East and Africa markets which Pharming will take over in October from SOBI, as announced on 14 July 2016, and to make Ruconest available in Canada and Mexico.
Valeant and Pharming will work closely on the transition for customers and HAE patients under a transition services agreement entered into at the same time as the transaction. This will enable Pharming to replace core functions currently undertaken by Valeant and its contractors in a timely manner.
Sijmen de Vries, Pharming CEO, commented:
“This is a quantum leap forward for Pharming and marks a significant point in the Company taking control of its own destiny and providing a real prospect of reaching profitability soon. In previous years, milestones and revenues from the US license for Ruconest provided funding for the Company’s independence as well as the production of Ruconest, thereby enabling the best prospect for HAE patients at the time. Now, we are able to take control of our key asset and make it available to all HAE patients in the US with a single-minded focus, dedication, energy and investment. For over a decade Pharming has been instrumental in the HAE market and has been working with physicians treating HAE and HAE patients for many years on the development of a safe and effective recombinant enzyme replacement therapy for HAE sufferers.