Santarus, Pharming in License and Supply Pact

Santarus has signed exclusive license and supply agreements with Pharming Group NV granting Santarus the right to commercialize Rhucin (recombinant human C1 inhibitor) in North America for the treatment of acute attacks of hereditary angioedema (HAE) and other future indications.

Santarus will pay Pharming a $15 million upfront fee, along with a $5 million milestone payment upon acceptance of the Rhucin’s BLA by the 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 U.S., while 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, Pharming’s chief executive officer, remarked, “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.”

Santarus also made news by acquiring Covella Pharmaceuticals, giving it the worldwide rights to a novel biologic drug candidate, an anti-VLA-1 antibody that has shown activity in multiple preclinical models of inflammatory and autoimmune diseases.

“The addition of these two promising product candidates to our development pipeline reflects an important step toward transforming Santarus into a premier biopharmaceutical company focused on specialty markets,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We believe that these biologic products offer significant future revenue potential with attractive proprietary positions, including 12 years of data exclusivity if approved by the FDA, strong intellectual property and significant manufacturing barriers to competition. With successful clinical development and commercialization, these product candidates have the potential to address substantial unmet medical needs and dramatically enhance shareholder value.”