Kau Pharmaceuticals and Daiichi Sankyo Enter Agreement for Global Development and Commercialization of KAI-9803

Strategic Insights -

Kau Pharmaceuticals, Inc. and Daiichi Sankyo Company, Limited have announced a partnership for the global development and commercialization of KAI-9803, a delta protein kinase C (delta PKC) inhibitor, for the prevention of myocardial tissue death and associated congestive heart failure in acute myocardial infarction patients. The agreement comes with significant milestones, including an initial payment of $20 million from Sankyo to Kai, as well as potential development and commercialization milestones of up to $300 million. KAI-9803 has been granted fast track status by the U.S. Food and Drug Administration (FDA) and is currently in a phase 1/2 clinical trial to assess safety and efficacy in patients with acute myocardial infarction undergoing revascularization procedures.

Key Takeaways:

  • The partnership for the global development and commercialization of KAI-9803 involves Kau Pharmaceuticals, Inc. and Daiichi Sankyo Company, Limited, with Sankyo's wholly owned subsidiary, Sankyo Company, Limited, taking the lead in development.
  • KAI-9803 is a first-in-class delta PKC inhibitor for the prevention of myocardial tissue death and associated congestive heart failure in acute myocardial infarction patients undergoing revascularization procedures.
  • The compound is currently in a 150-patient, double-blind, placebo-controlled phase 1/2 clinical trial (DELTA-MI) to assess safety and efficacy.
  • The agreement includes an initial payment of $20 million from Sankyo to Kai, as well as potential development and commercialization milestones of up to $300 million for two initial indications.
  • Sankyo will fund all future development, with global development and commercialization rights, and will pay Kai a double-digit royalty on sales.
  • Kai will have the option to perform certain clinical studies, and in North America, will have the right to copromote products in the acute care/hospital setting.
  • Kai may receive $20 million from Sankyo in research support over 5 years to identify new compounds, routes of administration, and indications directed toward the inhibition of delta PKC.

Statistics:

  • KAI-9803 is a small peptide that works by inhibiting the translocation of delta PKC to its specific intracellular receptor.
  • The compound's DELTA-MI clinical trial is expected to evaluate 150 patients with acute heart attack undergoing balloon angioplasty.
  • Delta PKC activation during reperfusion initiates molecular processes leading to cell death, inflammation, and damage in the heart or brain.
  • KAI-9803 is designed to prevent these processes, ultimately reducing the risk of heart failure and related complications.

Sources:

  • "Kau Pharmaceuticals, Inc. and Daiichi Sankyo Company, Limited Announce Agreement for Global Development and Commercialization of KAI-9803" by Health & Medicine Week editors (2006).
  • "KAI-9803: A New Treatment Option for Acute Myocardial Infarction" by Health & Medicine Week editors (2006).
  • Daiichi Sankyo Company, Limited, established on September 28, 2005.