Breaking News

Pharming Earns Santarus Milestone

November 26, 2012

BLA planned for Ruconest

Pharming Group and Santarus have met the primary endpoint in a Phase III study of Ruconest (recombinant human C1 esterase inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE), triggering a $10 million milestone payment to Pharming. Pharming is eligible to receive an additional $5 million upon FDA acceptance of the BLA for review. The companies expect to submit the BLA for Ruconest in the 1H13.
Sijmen de Vries, Pharming’s chief executive officer, said, "We are pleased to have received this US$10 million milestone from our partner Santarus, which significantly strengthens our balance sheet and signals the beginning of a new chapter in the development of the company."

Related Contract Manufacturing:

Related Compliance:

blog comments powered by Disqus
  • CMO Systems

    CMO Systems

    Philip K. Burns, CRO Consulting||April 5, 2016
    A CMO system includes four aspects of the product lifecycle: regulatory, technical, compliance, and operations.

  • Injectables: The New Oral?

    Injectables: The New Oral?

    Tugrul Kararli, Kurt Sedo, Josef Bossart, PharmaCircle LLC||April 5, 2016
    The growth trend of injectables continues across the pharma landscape.

  • Biopharmaceutical Contract Manufacturing Contract Negotiations

    Biopharmaceutical Contract Manufacturing Contract Negotiations

    William Downey, HighTech Business Decisions||April 5, 2016
    Navigating the complexities of supply agreements.