scPharmaceuticals LLC has entered into a strategic partnership and product development agreement with Switzerland-based, Sensile Medical Holding AG to develop an innovative new therapeutic option for patients with heart failure. The terms of the agreement were not disclosed.
The drug-device combination uses the Sensile SenseCore technology in a wearable minipump that delivers the pharmaceutical drug product under the skin using a very small needle. The pharmaceutical product is a proprietary reformulation of a proven diuretic that already forms the cornerstone of heart failure therapy. Diuretics remove excess fluid retained by the body by increasing urinary output. The diuretic that will be used with the minipump is a novel formulation of the diuretic furosemide, which has been in clinical use for nearly 50 years. Furosemide is currently used in tablet form or in solution for intravenous administration. Furosemide required a proprietary reformulation to render it suitable for subcutaneous administration.
Under the product development agreement, Sensile and scPharmaceuticals will collaborate to develop and manufacture minipump devices for use by scPharmaceuticals for its furosemide drug product for subcutaneous administration. scPharmaceuticals also expects to submit its New Drug Application (NDA) for the furosemide drug device combination no later than Q1 of 2015.
"Hospitalization for heart failure is expected to be one of the most important reasons for the projected increase in health care costs over the next decade as our population ages and the epidemic of obesity and diabetes continues unabated," said Dr Bertram Pitt, Professor of Medicine Emeritus at the University of Michigan School of Medicine and one of the co-founders of scPharmaceuticals. "This innovative product is expected to provide rapid and more effective diuretic therapy that can be used at home under physician guidance when the patient experiences symptoms of decompensation. We expect that this innovative approach will in many cases avert the need for emergency or in-hospital care, and for those patients who still require hospitalization, their hospital stay will be shortened and their outcomes improved."
"The reformulated furosemide product represents an excellent example of how an important new medical paradigm can be created by delivering a proven drug for the first time by subcutaneous delivery," said Derek Brandt, chief executive officer of Sensile Medical AG, Hagendorf, Switzerland. "It illustrates the importance of drug delivery technology to create novel, more cost-effective therapies aimed to save the healthcare system money and improve patient outcomes."
"The Affordable Care Act has created an urgent need for novel therapies that offer benefits comparable to those achieved by intravenously administered drugs in the hospital, but which can be administered anytime anywhere by the patient," said Pieter Muntendam, MD, president and chief executive officer of scPharmaceuticals. “Although numerous technologies have been pursued for small and convenient minipumps, the SenseCore minipump technology stands out because of its precision and the unique and cost-effective two component design of a versatile reusable battery-operated engine and the low cost disposable component that includes the drug delivery component."
scPharmaceuticals LLC is developing a portfolio of innovative products by reformulating existing drugs to make them suitable for subcutaneous administration using the minipump delivery system.
Sensile Medical AG is a leading company in the area of micro-pumps and patch-pumps. These pumps are increasingly being used to enable Large-Volume Sub-Cutaneous delivery of modern pharmaceutical and biotech products for self-administration by patients.