Built on a Foundation of Shared Success
Our partnership ethos is built on a foundation of shared success, offering comprehensive support powered by a robust infrastructure designed to streamline commercial operations.
Built on a Foundation of Shared Success
Our partnership ethos is built on a foundation of shared success, offering comprehensive support powered by a robust infrastructure designed to streamline commercial operations.
Partnering
Empowering Commercial Success for Pharmaceutical and Biotech Partners
Unlocking Commercial Potential for Biotech and Pharmaceutical Companies
scPharmaceuticals is a successful commercial-stage pharmaceutical company looking to partner with late-stage cardiovascular and renal R&D companies aiming to develop and commercialize treatments for patients.
Partnering
Empowering Commercial Success for Pharmaceutical and Biotech Partners
Unlocking Commercial Potential for Biotech and Pharmaceutical Companies
scPharmaceuticals is a successful commercial-stage pharmaceutical company looking to partner with late-stage cardiovascular and renal R&D companies aiming to develop and commercialize treatments for patients.
Navigate Commercial Complexities with a Trusted Partner
scPharmaceuticals understands the unique challenges and aspirations of your journey because we’ve been in your shoes – having to make the decision to partner to bring our innovation to market or transition to a fully integrated commercial pharmaceutical company.
Comprehensive Expertise Driving Molecules to Market and Beyond
scPharmaceuticals specializes in transforming science into viable treatments without the excessive costs associated with traditional commercialization.
Our leadership and team comprise seasoned executives, commercialization experts, regulatory and medical affairs professionals, researchers, clinicians, and academics with extensive experience in all aspects of drug development, from preclinical research to product development, regulatory and compliance to launch, distribution and post-marketing surveillance.
scPharmaceuticals’ Journey to
Commercialization Success
The success rate from Phase I to Phase II is between 52%-63%, from Phase II to Phase III is about 28%-31%, and from Phase III to FDA approval is around 58%¹. ²There is a dreaded term called the “Valley of Death,” the critical phase between clinical trials and commercialization. We crossed it – successfully with FUROSCIX®.
¹Mullard, A. (2016). Parsing clinical success rates. Nature Reviews Drug Discovery, 15(7), 447. https://doi.org/10.1038/nrd.2016.136
²Wong, Chi Heem, et al. “Estimation of Clinical Trial Success Rates and Related Parameters.” Biostatistics, vol. 20, no. 2, 31 Jan. 2018, pp. 273–286, academic.oup.com/biostatistics/article/20/2/273/4817524#131976077, https://doi.org/10.1093/biostatistics/kxx069.
- 2020
- 2021
- 2022
- 2023
- 2024
- 2025
-
2020
FUROSCIX Resubmission
- FUROSCIX NDA Resubmission
- Receives Complete Response Letter from FDA for FUROSCIX®
-
2021
FREEDOM-HF Results
- Positive Top-Line Results from FREEDOM-HF Study
-
2022
FUROSCIX Approval and Financing
- Resubmission of FUROSCIX® (furosemide injection) New Drug Application
- Positive Results from the AT HOME-HF Phase 2 Pilot Study in Heart Failure
- FDA Approval of FUROSCIX® (furosemide injection)
- $100 Million Debt Financing Agreement with Oaktree
-
2023
FUROSCIX Launch
- Launch and Commercial Availability of FUROSCIX® (furosemide injection)
- Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion
-
2024
Indication Expansion Progress
- First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection
- Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease
- Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector
- FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX Indication in Heart Failure
- Financings Totaling Up to $125 Million with Perceptive Advisors
-
2025
Continued FUROSCIX Growth
- Chronic Kidney Disease indication PDUFA date of March 6, 2025
Why scPharmaceuticals is the Perfect Partner
Areas of Interest for Cardiovascular and Renal Partnerships
- Home & Outpatient
- Therapeutics
- Drug/Device combos
- Diagnostics & Monitoring Devices
- Late-Stage Development & Commercial
- Health Tech
Our Proven Model – The Commercial Benefit for Late-stage R&D Companies
With a sharp focus on pricing, competition, and market dynamics, we strategically position our products for success, managing risks and optimizing for the market’ s evolving demands.
Comprehensive Commercial Capabilities
Leveraging detailed, bottoms-up market analysis, we develop comprehensive brand and medical affairs plans with clear strategic objectives and critical success factors to ensure robust operational and tactical execution across diverse stakeholders and channels.
- ‘How to Win’ approach, guided by data-driven strategies and customer feedback, directs go-to-market options, capability requirements, and financial investments.
- Core Communication Platform (CCP) provides a blueprint for cohesive messaging across market development, medical communications, marketing, and brand personality efforts.
- Customer Engagement Platform (CEP) designed to educate, inform, and engage customers, our strategy sets our partners on a clear path to market success.
Patient-Focused Distribution
scPharmaceuticals provides partners efficient, compliant product delivery through expert navigation of pharmacy laws and targeted market strategies, maximizing your reach and resonance with key audiences.
- Deep understanding of manufacturing and pharmacy laws to distribute products effectively and within compliance.
- Specialized approach gives products the best chance of reaching their intended market efficiently.
- Targeted specialty pharmacy network and hub-and-spoke distribution model are designed for precise product delivery that facilitates a focused connection to key markets.
- With insights into pharmacy regulations and strategic use of inside sales, we navigate market complexities, especially for Medicare, to not only reach, but also assure the product resonates with the intended audiences.
Extensive US Reach & Influence
Our strong relationships with regulators, healthcare professionals, key opinion leaders, payers, providers, foundations, and patient advocacy groups enable seamless market navigation and smooth product introduction, enhancing access to treatments, driving market expansion, and promoting equity in care.
Effective Communication
Our team provides broad coverage across the United States and dedicated specialty pharmacies supporting patient access nationwide.
Comprehensive Approach
We implement disease awareness programs, patient support initiatives for improved adherence, and tailored therapies to address unmet needs.
Cross-functional Communication
Cross-functional communication ensures optimal payer engagement and market strategy execution.
Access to Pharmaceutical and Biotech Focused Investors
We can connect you with top-tier investors, securing the financial backing needed to accelerate your products to market.
What Does a Perfect Partner Look Like for scPharmaceuticals?
Late-stage cardiovascular- and renal-focused products ready to engage in strategic commercial partnerships so they can concentrate on development while we expertly manage their commercialization journey.
The need for a focused commercial success blueprint that enables efficient scale-up and access to markets.
Companies seeking impactful market entry, a competitive edge, and without the overhead of building an internal commercial team to provide a provide a seamless pathway to commercial success
Your Growth. Our Expertise.
By partnering with us, you’re not just a number. We are a value-driven, dedicated ally with an established clinical, medical, and commercial infrastructure who deeply understands your mission and is focused on your success.
What Does a Perfect Partner Look Like for scPharmaceuticals?
Late-stage cardiovascular- and renal-focused products ready to engage in strategic commercial partnerships so they can concentrate on development while we expertly manage their commercialization journey.
The need for a focused commercial success blueprint that enables efficient scale-up and access to markets.
Companies seeking impactful market entry, a competitive edge, and without the overhead of building an internal commercial team to provide a provide a seamless pathway to commercial success
Your Growth. Our Expertise.
By partnering with us, you’re not just a number. We are a value-driven, dedicated ally with an established clinical, medical, and commercial infrastructure who deeply understands your mission and is focused on your success.
