scPharmaceuticals Provides Business Update

Rhea-AI Summary

scPharmaceuticals Inc. (Nasdaq: SCPH) provided a business update on FUROSCIX^®, its investigational formulation of furosemide intended for subcutaneous administration. The FDA has set a PDUFA date for December 30, 2020. The company has expanded its commercial team and submitted twelve-month drug stability data to the FDA. Recent presentations at the Heart Failure Society of America meeting highlighted FUROSCIX's potential as a cost-effective treatment for heart failure congestion. The company emphasized its commitment to addressing significant unmet medical needs in this area.

Positive

• Expansion of the commercial team with key hires in marketing, sales, and market access.
• Successful submission of twelve-month drug stability data to the FDA.
• Potential cost-effective treatment for heart failure congestion highlighted in recent studies.

Negative

• None.

BURLINGTON, Mass.--(BUSINESS WIRE)--scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize therapies, advance patient care, and reduce healthcare costs, today provided a business update on FUROSCIX^®, its investigational proprietary formulation of furosemide for subcutaneous administration.

“As we look forward to our upcoming December 30, 2020 PDUFA date for FUROSCIX, we are building out what we believe is a world-class commercial team capable of executing a successful product launch, if approved,” stated John Tucker, president and chief executive officer of scPharmaceuticals. “In addition, our three posters at this year’s Heart Failure Society of America virtual meeting contributed to the growing body of evidence suggesting that FUROSCIX has the potential to be a cost-effective treatment for congestion in patients with heart failure outside the hospital. This is a significant unmet medical need highlighted by Drs. Bensimhon and Desai during our recent Key Opinion Leader webinar. We believe FUROSCIX can help to address this need.”

Commercial Preparedness Activities

To prepare for the launch of FUROSCIX, if approved, the Company has made key additions to its commercial team, including vice presidents of marketing, sales and market access. In addition, recruitment for the Company’s field sales team is ongoing and remains closely aligned with currently anticipated regulatory timelines.

12 Month Drug Stability Data

The Company has submitted twelve-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, scPharmaceuticals was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remining three months during the FDA’s review. All drug stability data has now been submitted.

Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting 2020

scPharmaceuticals participated in three virtual poster presentations at the HFSA Virtual Annual Scientific Meeting 2020. Posters included:

1. FUROSCIX Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure - (FREEDOM-HF)
   • The methods for an ongoing, interventional clinical trial evaluating the economic impact of treating patients who present to the emergency department with worsening heart failure due to congestion with FUROSCIX outside the hospital setting are described.
   
   
2. Heart Failure Related Costs and Health Care Resource Utilization Following an Emergency Department (ED) Visit for Worsening Heart Failure: A Claims Data Analysis
   • Patients hospitalized for less than 72 hours after presenting to the ED for worsening heart failure (WHF) have average 30-day all-cause and heart failure related costs of $19,560 and $14,283, respectively.
   
   • Patients presenting to the ED for WHF and not hospitalized have 30-day all-cause and heart failure related outpatient costs of $6,401 and $5,034, respectively.
   
   
3. Successful Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of FUROSCIX in Heart Failure Patients, Caregivers, and Health Care Practitioners
   • Patients with heart failure, caregivers and health care providers followed the Instructions for Use (IFU) to safely and effectively operate the On-Body Infusor for FUROSCIX where-by no patterns of use errors were observed in both trained and untrained participants.

Key Opinion Leader Webinar

On September 29, 2020, scPharmaceuticals hosted a successful key opinion leader (KOL) webinar on FUROSCIX. The webinar featured presentations by Dan Bensimhon, M.D. of Cone Health Medical Group and Nihar Desai, M.D., MPH from the Yale School of Medicine who discussed the current treatment landscape and unmet medical need that exists in treating patients with worsening heart failure due to congestion. A replay of the webinar is available here.

About FUROSCIX

FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX^® (furosemide injection) for subcutaneous administration is currently under development for the treatment of congestion due to fluid overload in adult patients with worsening New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. The FDA has assigned FUROSCIX a PDUFA date of December 30, 2020. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

About scPharmaceuticals

scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on 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 www.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 expected timing of the FDA’s review of the FUROSCIX NDA, the potential timing of, and the Company’s expected progress towards, the advancement of the Company’s device verification, research and validation studies, the Company’s planned efforts to prepare for commercialization of FUROSCIX and the success of such commercialization, and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved. 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 risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of 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, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, the timing of the FDA’s review of the Company’s FUROSCIX NDA and other operations. 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 its Annual Report on Form 10-K for the year ended December 31, 2019 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, and 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.