Introduction to Sancuso
Sancuso, marketed by Cumberland Pharmaceuticals, is a transdermal patch containing the active ingredient granisetron, a 5-HT3 receptor antagonist. It is primarily used to prevent chemotherapy-induced nausea and vomiting (CINV).
Clinical Trials Update
Ongoing and Recent Trials
Several clinical trials are ongoing or have been recently completed to evaluate the efficacy and safety of Sancuso.
- Pediatric Population: A Phase 1 clinical trial, sponsored by Kyowa Kirin Pharmaceutical Development Ltd, is evaluating the safety and pharmacokinetics of the Sancuso patch in pediatric cancer patients aged 6 to 12 years. This open-label, multi-center, cross-over study aims to assess the PK of transdermal granisetron in this age group[4].
- General Efficacy: Other trials, such as those listed in the EU Clinical Trials Register, are ongoing to further establish the efficacy and safety profile of Sancuso. For instance, a trial with the EudraCT number 2018-003669-32 is currently ongoing in Italy, focusing on various aspects of Sancuso's performance[1].
Trial Outcomes and Implications
These trials are crucial for expanding the understanding of Sancuso's effectiveness and safety, particularly in different patient populations. For example, the pediatric trial could pave the way for Sancuso to be approved for use in younger patients, potentially increasing its market reach.
Market Analysis
Current Market Status
The granisetron market, which includes Sancuso, is driven by several key factors:
- Rise in Chemotherapy and Radiotherapy: The increasing number of cancer cases and subsequent rise in chemotherapy and radiotherapy visits are significant drivers. Chemotherapy-induced nausea and vomiting are common side effects, creating a high demand for 5-HT3 antagonists like granisetron[3].
- Gastroparesis: The growing prevalence of gastroparesis also contributes to the demand for granisetron, as it is sometimes used to manage symptoms associated with this condition[3].
Market Projections
- Growth Rate: The granisetron market is expected to register a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period. This growth is largely attributed to the increasing burden of cancer and the rising need for effective antiemetic treatments[3].
- Regional Performance: North America is anticipated to hold a significant share in the granisetron market due to the high incidence of cancer cases and the increased adoption of granisetron among cancer patients. For instance, the American Cancer Society estimates that 2 million cancer cases will be diagnosed in the United States in 2024, up from 1.9 million in 2023[3].
Financial Performance and Revenue
Cumberland Pharmaceuticals' Financials
Cumberland Pharmaceuticals, the marketer of Sancuso, reported solid financial performance in 2023. Here are some key highlights:
- Revenue: Sancuso generated $8.1 million in revenue for Cumberland Pharmaceuticals in 2023, contributing to the company's total net revenues of $40 million[5].
- Challenges and Opportunities: Despite facing lower net sales of Sancuso due to sales deductions, the company remains optimistic about its growth opportunities and clinical advancements. Cumberland is focused on maximizing its commercial brands, progressing its pipeline, and pursuing acquisitions[5].
Patent and Generic Entry
Patent Protection and Generic Challenges
Sancuso is protected by patents, with the earliest date for generic entry estimated to be January 22, 2025. This date may change due to patent challenges or generic licensing agreements. There have been two patent litigation cases involving the patents protecting Sancuso, indicating strong interest in generic launch[2].
Impact on Market
The potential entry of generic versions of granisetron could impact Sancuso's market share. However, Cumberland Pharmaceuticals' ongoing efforts to expand its product line and pursue new clinical advancements may help mitigate this impact.
Key Takeaways
- Clinical Trials: Ongoing trials are expanding the understanding of Sancuso's safety and efficacy, particularly in pediatric populations.
- Market Growth: The granisetron market is expected to grow at a CAGR of 6.2%, driven by the rise in chemotherapy and radiotherapy visits and the increasing prevalence of gastroparesis.
- Financial Performance: Sancuso contributed significantly to Cumberland Pharmaceuticals' revenue in 2023, despite some challenges related to sales deductions.
- Patent and Generic Entry: The estimated generic entry date is January 22, 2025, which could impact Sancuso's market share but is subject to change based on patent challenges.
FAQs
What is Sancuso used for?
Sancuso is used to prevent chemotherapy-induced nausea and vomiting (CINV).
What is the active ingredient in Sancuso?
The active ingredient in Sancuso is granisetron, a 5-HT3 receptor antagonist.
What is the current market growth rate for granisetron?
The granisetron market is expected to register a CAGR of 6.2% during the forecast period.
When is the estimated generic entry date for Sancuso?
The estimated generic entry date for Sancuso is January 22, 2025, subject to change based on patent challenges or licensing agreements.
Which region is expected to hold a significant share in the granisetron market?
North America is expected to hold a significant share in the granisetron market due to the high incidence of cancer cases and increased adoption of granisetron among cancer patients.
Sources
- EU Clinical Trials Register - EudraCT Number: 2018-003669-32
- DrugPatentWatch - SANCUSO Drug Patent Profile
- Mordor Intelligence - Granisetron Market Size & Share Analysis - Industry Research Report
- Network of Care - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
- Investing.com - Earnings call: Cumberland Pharmaceuticals reports solid 2023 revenue
