Biotech company Pharming Group NV (Pharming) announced that it has entered into an agreement with specialty biopharmaceutical company Santarus, Inc (Santarus) for the commercialization of Rhucin (recombinant human C1 inhibitor; Ruconest in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications.

Under the agreement, Santarus will pay Pharming a USD 15 million upfront fee upon signing. Furthermore, Santarus will pay a USD 5 million milestone payment upon acceptance of the Rhucin Biologic License Application (BLA) by the US Food and Drug Administration (FDA). Additional payments are payable upon completing clinical and commercial milestones. Santarus will purchase its commercial supply of Rhucin from Pharming at a tiered supply price, based on a percentage of net sales of Rhucin.

Pharming is responsible under the agreement for the clinical development of Rhucin for HAE and all HAE related regulatory activities in the US, whereas Santarus will be responsible for regulatory approval in Canada and Mexico. In addition, Santarus and Pharming will share responsibility and costs for the clinical development of Rhucin for the treatment or prevention of renal transplantation rejection. Santarus will be responsible for related regulatory activities in North America.

Sijmen de Vries, CEO of Pharming commented, "We are excited to have taken a significant step closer to making Rhucin, an innovative, highly effective and safe replacement therapy, available for HAE patients in North Amercia. In Santarus we have a commercialization partner with a proven track record in clinical development and commercialization of high value pharmaceutical products. We are confident that they will provide a sound commercialisation platform for Rhucin in North America. We also look forward to working with Santarus on developing Rhucin in its next indication .

Rhucin (recombinant human C1 esterase inhibitor, Ruconest in Europe) is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits. Pharming is developing Rhucin/Ruconest for treatment of patients with acute attacks of Hereditary Angioedema (HAE). HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1-inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 - 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.

Santarus, Inc is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists, endocrinologists and other physicians.

Pharming Group NV is developing innovative products for the treatment of genetic disorders, specialty products for surgical indications, and nutritional products.