scPharmaceuticals Initiates Commercial Scale Manufacturing Program for its sc2Wear™ Furosemide Infusor
FOR IMMEDIATE RELEASE: Lexington, MA, December 20, 2016 /PRNewswire — scPharmaceuticals, Inc., a privately held biopharmaceutical company developing transformative pharmaceutical products for subcutaneous delivery announced today that it entered into a long-term commercial supply agreement and associated tools manufacturing agreement with Raumedic AG (Helmbrechts, Germany) for the single-use component of its sc2WearTM 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 SenseCoreTM 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. This avoids material risks and costs associated with the current delivery options. Our lead products are the first subcutaneous formulation of furosemide (the most widely used parenteral diuretic in treating heart failure), and ceftriaxone (the most widely used parenteral antibiotic used outside the hospital setting). Our novel furosemide formulation enables convenient anytime anywhere use, for example in an outpatient setting instead of the emergency room or other in-patient settings. For ceftriaxone and other antibiotics, subcutaneous administration eliminates the need for PICCs (peripherally inserted central catheters), which are associated with serious complications, frequent adverse events and high medical cost. For further information on how we are transforming the administration of parenteral drugs, go to www.scpharmaceuticals.com.
About Sensile Medical:
Sensile Medical AG is a leading company in the area of advanced micro pump technology developing a broad range of customer-specific delivery and dosing solutions. These pumps are ideally suited for large-volume subcutaneous delivery of modern pharmaceutical and biotech products for self-administration by patients. Due to Sensile Medical’s unique SenseCore technology the products are highly cost-efficient, accurate and safe. They are increasingly used in drug delivery, medical and consumer applications. Founded in 2004, Sensile Medical is located in Hägendorf, Switzerland. You can find more information at www.sensile-medical.com.
Raumedic AG is a development partner and manufacturer of tubing, molded parts, catheters and components for the medical and pharmaceutical industry. The company processes medical-grade thermoplastic polymers and silicones at a total of four production sites in Germany and in the USA. Furthermore, the medical engineering company develops and produces high-precision pressure measurement systems with microchip technology for the indication areas of neuromonitoring and traumatology.
With 60 years of experience in the fields of extrusion, injection molding and assembly, as well as the commitment of currently 700 employees worldwide, Raumedic is optimally equipped to transform the ideas of its customers into well-engineered product solutions. Customer satisfaction and compliance with all relevant statutory and official requirements are the focus of Raumedic’s conception of quality. The basis of this is a quality management system according to ISO 13485 and 108,000 f² (10,000 m²) of clean room production according to ISO 14644 (class 7). You can find more information at: www.raumedic.com
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