Advancing FUROSCIX® with the SmartDose® Drug Delivery System

Forecast 2018 year-end cash of $82 - $87 million and 2019 expenditures of $8 - $10 million per quarter

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scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care and reduce healthcare costs, today announced it has signed a development agreement with West Pharmaceutical Services, Inc. (West) to incorporate West’s SmartDose®Drug Delivery System with FUROSCIX. FUROSCIX is scPharmaceuticals’ lead program for the treatment of edema in patients with heart failure.

“We are pleased to announce the successful completion of preliminary feasibility studies of FUROSCIX with the SmartDose Drug Delivery System and the execution of a development agreement with West. We look forward to advancing FUROSCIX with the West on-body drug delivery system technology,” said John Tucker, president and chief executive officer of scPharmaceuticals. “We believe the features and functionality of the SmartDose system improves the overall patient experience with FUROSCIX. Heart failure remains a large market opportunity with high unmet patient need and significant associated healthcare costs. We anticipate filing a New Drug Application for FUROSCIX with the next-generation technology in 2020, subject to meeting with the Food and Drug Administration (FDA) to define the regulatory path.”

Based on the Company’s interactions with the FDA since June 2018, including the previously disclosed clarifications on additional human factors and validation studies necessary to advance FUROSCIX using the existing delivery technology, scPharmaceuticals elected to expedite the advancement of a next-generation on-body delivery system with a pre-filled cartridge. The development agreement with West represents an important milestone in advancing the FUROSCIX program.

scPharmaceuticals recently completed preliminary feasibility studies on the West SmartDose drug delivery system, confirming its ability to successfully deliver FUROSCIX. scPharmaceuticals’ feasibility testing included drug stability in the pre-filled cartridge, drug compatibility, and overall performance within FUROSCIX delivery specifications. The West SmartDose drug delivery system, previously approved by the FDA for use in the US with another combination product, allows patients to self-administer medication in accordance with their prescribed treatment. West developed this wearable technology with extensive human factors testing and analysis to understand the interaction between the patient and the delivery system. The SmartDose drug delivery system adheres to the patient's body enabling the patient to be hands free during administration.

"West and scPharmaceuticals have a shared objective to deliver injectable medicines to improve patient lives, so we are excited to announce this development agreement today,” said Karen Flynn, senior vice president and chief commercial officer, West. “West is very pleased that scPharmaceuticals has selected the SmartDose drug delivery system for FUROSCIX and looks forward to working together on this project."

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