Pharming Group of the Netherlands has signed up Santarus of the USA to market its hereditary angioedema drug Rhucin in North America, including Mexico.
Under the terms of the agreement, Santarus will pay Pharming a $15 million upfront fee and a $5 million milestone payment upon acceptance by the US Food and Drug Administration of the Biologic License Application for Rhucin (recombinant human C1 inhibitor). The treatment is a human protein developed through Pharming's proprietary technology in the milk of transgenic rabbits.
Santarus will make further payments upon completion of clinical and commercial milestones and will purchase Rhucin from Pharming at a tiered supply price, based on a percentage of net sales. The Leiden-headquartered firm will be responsible for the clinical development of Rhucin for HAE and all HAE-related regulatory activities in the USA, whereas Santarus will look after approvals in Canada and Mexico.
In addition, the companies will share responsibility and costs for developing Rhucin for the treatment or prevention of renal transplantation rejection. Santarus will be responsible for regulatory activities in North America. Sijmen de Vries, Pharming's chief executive, said the group has taken "a significant step closer" to making Rhucin available in North America and in Santarus "we have a commercialisation partner with a proven track record".
At the end of June, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on the treatment, where it is known as Ruconest. The $15 million upfront fee will come in very handy as Pharming had declared earlier that it will repay 10.9 million euros in convertible bonds by the end of October.
Santarius acquires Covella Pharma
It was a busy day for Santarus which also acquired Covella Pharmaceuticals and its early-stage anti-VLA-1 antibody which has potential as a drug candidate in "multiple inflammatory and autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation". The acquisition is valued at $1.8 million in cash and stock.
The Pharming and Covella deals come days after Santarus purchased the rights to the FDA-approved type 2 diabetes drug Cycloset (bromocriptine) from S2 Therapeutics and VeroScience. The drug and Rhucin could help the company soften the blow of the loss of patent protection on its biggest earner, the antiulcerant Zergerid (omeprazole).