Market Dynamics and Financial Trajectory for Ertugliflozin (Steglatro)
Introduction to Ertugliflozin
Ertugliflozin, marketed as Steglatro, is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor developed by Pfizer and Merck for the treatment of type 2 diabetes. It was approved by the U.S. FDA in December 2017 and received EU approval in March 2018[1][4].
Market Entry and Competition
Steglatro entered a crowded SGLT-2 inhibitor market, competing with established drugs like Invokana (canagliflozin), Jardiance (empagliflozin), and Farxiga (dapagliflozin). Despite being a late entrant, Steglatro has several strengths that help it gain market share. It is available in various formulations, including fixed-dose combinations with Januvia (sitagliptin) as Steglujan and with metformin as Segluromet[1][4].
Clinical Efficacy and Differentiators
Steglatro has demonstrated significant clinical efficacy, particularly in combination therapies. The VERTIS SITA and VERTIS Factorial trials showed substantial HbA1C reductions when Steglatro was combined with Januvia and metformin, respectively. Additionally, Steglatro has shown monotherapy efficacy and significant weight loss and blood pressure-lowering effects[1].
Cardiovascular Benefits
A key differentiator for SGLT-2 inhibitors is their cardiovascular benefits. While Steglatro's cardiovascular outcomes study (VERTIS CV) was ongoing at the time of its approval, other SGLT-2 inhibitors like Jardiance and Farxiga have already demonstrated cardiovascular benefits in landmark trials such as the EMPA-REG OUTCOME and DECLARE studies. Positive cardiovascular data are crucial for consolidating Steglatro's market position[1][2].
Market Forecast and Sales Projections
The 2018 Drugs to Watch report by Clarivate Analytics predicted that Steglatro would achieve significant sales by 2022. According to the report, Steglatro was forecasted to generate $1.087 billion in sales by 2022, placing it among the top SGLT-2 inhibitors in the market. This forecast was later revised upward to $1.275 billion, reflecting the growing demand for SGLT-2 inhibitors[1].
Real-World Evidence and Market Impact
Real-world evidence suggests that SGLT-2 inhibitors, including Steglatro, can significantly reduce heart failure hospitalizations and deaths. This evidence supports the use of these drugs earlier in the treatment regimen, potentially increasing the patient base and driving market growth[1].
Pricing and Cost Considerations
The wholesale acquisition costs for Steglatro and its fixed-dose combinations were set at $8.94 per day for Steglatro, $17.45 per day for Steglujan, and $8.94 per day for Segluromet. These costs do not include discounts that may be applied, which can affect the final retail price and patient affordability[4].
Collaboration and Revenue Sharing
Pfizer and Merck entered into a worldwide collaboration (excluding Japan) for the co-development and co-promotion of ertugliflozin. The agreement involves a 60/40 revenue and cost-sharing model between Merck and Pfizer, respectively, with Pfizer eligible for additional milestone payments[4].
Market Performance and Growth
By 2017, Farxiga and Jardiance had already achieved blockbuster status, with sales of $1.074 billion and $1.141 billion, respectively. The rapid rise in sales of SGLT-2 inhibitors is expected to continue, with Steglatro contributing significantly to this growth. The market is driven by the drugs' convenient oral administration, strong HbA1c efficacy, weight loss, and antihypertensive effects[1].
Challenges and Risks
Despite its potential, Steglatro faces challenges such as competition from established brands and the need for positive cardiovascular outcomes data to fully establish its market position. Additionally, general industry conditions, economic factors, and potential side effects can impact its financial trajectory[1][4].
Financial Projections and Industry Impact
The financial projections for Steglatro are optimistic, with the drug expected to be a significant contributor to the growing SGLT-2 inhibitor market. The market for these drugs is predicted to expand rapidly, driven by their clinical benefits and the increasing prevalence of type 2 diabetes.
Key Statistics
- Sales Forecast: $1.275 billion by 2022[1].
- Market Share: Expected to be among the top SGLT-2 inhibitors[1].
- Clinical Efficacy: Significant HbA1C reductions and weight loss[1].
- Cardiovascular Benefits: Ongoing study (VERTIS CV) expected to provide positive outcomes[1].
Conclusion
Ertugliflozin (Steglatro) has entered the SGLT-2 inhibitor market with strong clinical data and a robust market forecast. Its ability to reduce HbA1C levels, promote weight loss, and lower blood pressure, combined with its potential cardiovascular benefits, positions it well in a rapidly growing market.
Key Takeaways
- Strong Clinical Efficacy: Steglatro has shown significant HbA1C reductions and other clinical benefits.
- Market Competition: Enters a crowded market but has differentiators such as fixed-dose combinations.
- Cardiovascular Benefits: Ongoing studies expected to provide positive outcomes.
- Financial Projections: Forecasted to achieve $1.275 billion in sales by 2022.
- Collaboration: Pfizer and Merck collaborate on development and promotion.
FAQs
Q: What is ertugliflozin (Steglatro) used for?
A: Ertugliflozin (Steglatro) is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[3].
Q: How does Steglatro compare to other SGLT-2 inhibitors?
A: Steglatro has shown similar efficacy to other SGLT-2 inhibitors but has the advantage of fixed-dose combinations with Januvia and metformin, and it is expected to contribute significantly to the growing market[1].
Q: What are the key clinical benefits of Steglatro?
A: Steglatro reduces HbA1C levels, promotes weight loss, and lowers blood pressure. It also has potential cardiovascular benefits, although these are still under study[1][2].
Q: How is Steglatro priced?
A: The wholesale acquisition cost for Steglatro is $8.94 per day, with similar pricing for its fixed-dose combinations. Actual retail costs may vary based on discounts and other factors[4].
Q: What is the collaboration between Pfizer and Merck for Steglatro?
A: Pfizer and Merck have a worldwide collaboration (excluding Japan) for the co-development and co-promotion of ertugliflozin, with a 60/40 revenue and cost-sharing model[4].
Sources
- Clarivate Analytics: Pfizer and Merck’s Steglatro for type 2 diabetes: a valuable addition to the rapidly rising SGLT-2 inhibitor market.
- Frontiers in Medicine: Sodium-Glucose Co-transporter-2 Inhibitors and Nephroprotection.
- FDA: 209803Orig1s000 209805Orig1s000 209806Orig1s000.
- Pfizer: FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes.
