Ligand and SQ Innovation announced the two companies have entered into long-term, exclusive commercial license and supply agreements for use of Ligand’s Captisol® technology in the formulation of high-concentration furosemide for the treatment of edema in patients with heart failure. SQ Innovation is developing a novel drug-device combination for cost-effective subcutaneous delivery of diuretics that currently require intravenous administration by a certified healthcare professional. Ligand is eligible to receive potential milestone payments and royalties, as well as revenue from materials sales of Captisol.
“Solubility challenges, such as those faced by furosemide, are precisely what our Captisol technology is designed to address,” said John Higgins, CEO of Ligand. “We are delighted to add SQ Innovation to our growing list of partner companies for our technology platforms, with more than 200 programs funded by partners, or Shots on Goal.”
“A heart failure patient should not have to be in hospital to receive effective diuretic therapy for fluid overload,” said Bertram Pitt MD, professor of medicine emeritus at the University of Michigan School of Medicine, Ann Arbor, MI. “A treatment option that provides IV strength diuresis without the need for venous access would enable the development of novel strategies, which could reduce hospitalizations for HF with a resultant improvement in quality of life and a reduction in health care costs.”
“The novel Captisol-enabled furosemide formulation allows us to take advantage of the mature and cost-effective drug-delivery products of the diabetes/insulin space,” said Pieter Muntendam MD, CEO of SQ Innovation AG. “Once approved, this new furosemide option may reduce the economic and patient burden of heart failure in the U.S. and Europe.”
Heart failure is a common, complex and serious condition affecting approximately 6.2 million people in the U.S. and 26 million people worldwide. Many patients with heart failure experience episodes of worsening symptoms due to fluid overload. Current therapy options for these episodes include an increase in oral medication or, when oral treatment is not sufficiently effective, intravenous treatment, typically delivered in an emergency room or hospital. Subcutaneous infusion by means of a mini pump adhered to the skin may offer a solution for patients who otherwise do not require hospital care.
Fluid overload in heart failure is responsible for approximately $14 billion in Medicare spending, or approximately 3.9% of the Medicare budget, making it one of the most expensive therapies for the elderly. The high spending is attributable to in-patient care for diuretic treatment which accounts for approximately 7% of Medicare hospital admissions. In addition, a hospital stay is associated with risks of adverse outcomes due to rapid muscle loss and functional decline experienced by many elderly patients during their hospital stay and recovery.
Furosemide is the leading diuretic used in patients with heart failure. It is administered as a daily oral therapy in most patients with heart failure, and intravenously in the hospital when oral medicine is insufficient to reduce fluid overload. Furosemide is poorly soluble, particularly at the neutral pH level required for subcutaneous delivery. Until now furosemide products suitable for human use have a low concentration and require 8-10mL to deliver the common therapeutic dose of 80mg. Although delivery of 8-10mL of fluids is possible in principle, there is currently no FDA-approved product in a drug cartridge or delivered by a patch pump with a volume greater than 3.5mL.