scPharmaceuticals has entered into a long-term commercial supply agreement and associated tools manufacturing agreement with Raumedic for the single-use component of its sc2Wear infusor.
scPharmaceuticals is developing the sc2Wear Infusor for subcutaneous administration of products that currently require intravenous or intramuscular administration by a certified healthcare professional.
The sc2Wear drug delivery platform is based on the SenseCore micro-piston pump developed by Sensile Medical (Hägendorf, Switzerland) to which scPharmaceuticals has an exclusive global license for certain therapeutic categories including heart failure and infectious disease.
The sc2Wear Infusor products will be regulated and distributed as pharmaceutical products and require regulatory approval prior to commercial introduction. scPharmaceuticals' initial product, the sc2Wear furosemide Infusor for use in patients with heart failure, is anticipated to be submitted for regulatory approval in early 2017.
scPharmaceuticals, Sensile Medical and Raumedic commenced collaborations in fall of 2014 to develop the single-use component of the Infusor for large scale commercial manufacturing.
These development efforts have successfully concluded and the collaboration between the companies now advances to a commercial scale manufacturing program in preparation for commercial introduction.
"The agreements with Raumedic and Sensile mark an important milestone for wearable patch pumps," said Pieter Muntendam, MD, founder, president and CEO of scPharmaceuticals.
"The micro-piston-based patch pump offers important advantages over other technologies and has the potential to change how patients with heart failure or infections are treated. This partnership prepares us for large-scale commercial manufacturing of the novel drug delivery device."
"Wearable drug delivery devices have the potential to change even more intravenous applications to subcutaneous delivery," said Martin Bayer, CEO of Raumedic.
"Manufacturing of these intricate single-use components in a cost-effective and high quality manner leverages our expertise in precision injection molding and assembly."
"The sc2Wear furosemide Infusor is the first patch pump based on our SenseCore micro-piston pump platform to reach the important milestone of launching a large scale manufacturing program to support commercial introduction in the United States," said Derek Brandt, CEO of Sensile Medical.
"The single-use component manufactured by Raumedic under these agreements combines several of our proprietary technologies, including the micro-piston pump and motor-driven needle insertion and retraction mechanism."
sc2Wear furosemide Infusor is the first product that scPharmaceuticals intends to commercialize. Furosemide is a widely-used diuretic in the treatment of fluid overload (edema) in heart failure.
sc2Wear furosemide was developed to provide a "hospital strength" diuretic option for use in a variety of care settings, including the home. The sc2Wear furosemide Infusor is subject to FDA review and approval.
scPharmaceuticals, based in Lexington, MA, is a privately held biopharmaceutical company developing a portfolio of transformative pharmaceutical products for subcutaneous delivery.
Based on widely used generic drugs that currently require intravenous or intramuscular injections, innovative products will be administered subcutaneously via a proprietary patch pump.