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.

About scPharmaceuticals:
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.

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.

About Raumedic:
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

For More Information:
Katherine Taudvin

Director Corporate Development

Email: ktaudvin@scpharma.com

Telephone: (781) 301-6706


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