Pharming Group N.V. has entered into a definitive agreement with Swedish Orphan Biovitrum AB (publ) (“Sobi”) to reacquire the commercial rights to Pharming’s product, Ruconest, in all remaining territories, which includes all remaining EU markets. Under the agreement, the license is being terminated with effect from 1 January 2020 in all 36 countries with a smooth handover planned in the countries where Sobi has sales activities.
Following the strategic decision to reaquire the North American commercial rights for Ruconest in December 2016 from its licensee Valeant Pharmaceuticals International (now “Bausch Health”), Pharming has increased US sales significantly. It is anticipated that, while not of the same commercial scale as the US, a growth increase in the additional 36 territories can be expected. The transaction will be accretive to earnings immediately.
Ruconest has been licensed for a total of 60 countries in this region since 2010, and was launched in a number of these countries. Commercialization rights for Ruconest in 24 of the 60 countries have been returned to Pharming in previous years.
In order to ensure that existing Ruconest patients can continue to receive their therapy, Pharming will be cooperating with Sobi to replace all contracts for distribution and other services as quickly as possible, and to transfer existing reimbursement approvals where possible. While Pharming will be responsible for the distribution of Ruconest in the 36 reaquired territories from 1 January 2020, it may be some time before all activities and full control have been transferred. No personnel will be transferring between the two companies.
Sijmen de Vries, CEO of Pharming, said:
“Our strategic decision to reacquire the commercial rights to Ruconest means we own commercial rights to our lead asset for the treatment of HAE in all countries, except some markets in Latin America, Israel and South Korea. The transaction will enable us to drive further growth of Ruconest. In addition, we will expand our existing commercial infrastructure in Europe to support the expected launch of future products from our pipeline.”