scPharmaceuticals Inc. Announces Development Agreement with West Pharmaceutical Services for Next-Generation FUROSCIX® On-Bo...
January 29 2019 - 8:00AM
Advancing FUROSCIX® with the SmartDose® Drug
Delivery System
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."
About FUROSCIX®
FUROSCIX is a proprietary furosemide solution formulated to a
neutral pH to allow for subcutaneous infusion via a wearable,
pre-programed drug delivery system that is applied to the abdomen
for subcutaneous drug administration. FUROSCIX is being
developed for treatment of edema, or fluid overload, in patients
with heart failure. FUROSCIX has the potential to provide an
outpatient alternative for the treatment of worsening heart failure
due to edema.
About scPharmaceuticals
scPharmaceuticals is a clinical-stage pharmaceutical company
focused on developing and commercializing products that reduce
healthcare costs and improve health outcomes. The Company
develops, internally and through strategic partnerships, products
for the subcutaneous, self-administration of IV-strength treatments
in heart failure and infectious disease. scPharmaceuticals is
headquartered in Burlington, MA. For more information, please
visit scPharmaceuticals.com.
Forward-Looking Statement
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements include, but are not limited
to, statements regarding the advancement of, and potential timing
of regulatory filings for, FUROSCIX with the West SmartDose Drug
Delivery System as a next-generation infusor technology, the
Company’s plans to meet with the FDA to discuss the regulatory path
for FUROSCIX with the West SmartDose Drug Delivery System; and the
ability of the SmartDose Drug Delivery System to successfully
deliver FUROSCIX to patients and improve the patient experience.
Any forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the Company
conducting the ability of the West SmartDose Drug Delivery System
to appropriately deliver therapy, the receipt of regulatory
approval for FUROSCIX with the West SmartDose Drug Delivery System
or any of our other product candidates or, if approved,
successfully commercialize such products, the risk of cessation or
delay of any of the ongoing or planned clinical trials and/or our
development of our product candidates, and the risk that the
results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our product
candidates. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our actual
results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in the
Company’s most recent Annual Report on Form 10-K on file with the
Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties and other important factors in the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
Contacts:Troy Ignelzi, scPharmaceuticals
Inc.781-301-7216tignelzi@scpharma.com
Christopher F. Brinzey, Westwicke, an ICR
Company339-970-2843chris.brinzey@westwicke.com
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