Sotatercept-csrk - Biologic Drug Details

Summary for sotatercept-csrk

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for sotatercept-csrk Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for sotatercept-csrk Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	WINREVAIR	sotatercept-csrk	For Injection	761363		2025-11-23	Company disclosures
Merck Sharp & Dohme Llc	WINREVAIR	sotatercept-csrk	For Injection	761363		2025-11-23	Company disclosures

3) Low Certainty: US Patents for sotatercept-csrk Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for the Biologic Drug: Sotatercept-csrk (WINREVAIR™)

Introduction to Sotatercept-csrk (WINREVAIR™)

Sotatercept-csrk, marketed as WINREVAIR™, is a groundbreaking biologic drug approved by the FDA for the treatment of adults with pulmonary arterial hypertension (PAH), a rare and progressive disease. This approval marks a significant milestone in the management of PAH, offering new hope for patients and a strategic win for Merck.

The Disease: Pulmonary Arterial Hypertension (PAH)

PAH is a rare and usually fatal disease characterized by the overproduction of activin proteins, leading to blood vessel narrowing and right ventricle damage. Despite evolving treatments, available medications have had limited impact on mortality rates, making the introduction of WINREVAIR a critical development[2].

Mechanism of Action

WINREVAIR works as an activin signaling inhibitor, directly targeting and trapping the overproduced activin proteins in PAH patients. This mechanism potentially reverses the blood vessel narrowing and right ventricle damage associated with PAH, offering a novel approach to managing the disease[2].

Clinical Trials and Efficacy

The approval of WINREVAIR was based on the STELLAR trial, which demonstrated significant improvements in exercise capacity and multiple secondary outcome measures compared to standard therapies alone. Patients receiving WINREVAIR showed a substantial increase in 6-minute walk distances (+41 meters vs. +1 meter for the placebo group) and lower rates of all-cause death or nonfatal clinical PAH worsening (5% vs. 26%)[2].

The Phase 3 ZENITH trial further reinforced these findings, meeting its primary endpoint of time to first morbidity or mortality event for patients with PAH functional class III or IV. This trial was stopped early due to the positive results, and participants were offered the opportunity to receive WINREVAIR in an open-label extension study[4].

Market Impact and Competition

WINREVAIR's approval is a strategic win for Merck, particularly given the company's acquisition of Acceleron for $11.5 billion in 2021. This move was part of Merck's strategy to bolster its portfolio ahead of the patent expiration of its blockbuster cancer drug, KEYTRUDA, in 2028[2].

The PAH market, though niche with approximately 40,000 patients in the US, presents a lucrative opportunity due to the high cost of treatment. Merck plans to charge a wholesale price of $14,000 per vial of WINREVAIR, translating to around $243,000 per patient annually. This pricing strategy, despite being higher than some estimates of clinical value, is expected to generate significant revenue for Merck[2].

Financial Projections

Analysts forecast that WINREVAIR could generate $2 billion to $5 billion annually by 2030, with 20% of the revenue going to Bristol Myers Squibb in royalties. This financial trajectory is supported by Merck's successful launch of WINREVAIR in the US and the positive EU opinion for its use in adults with PAH[2].

Merck's second-quarter 2024 financial results reflect the strong performance of WINREVAIR, contributing to a 7% increase in total worldwide sales to $16.1 billion. The successful launch of WINREVAIR, along with other key products like KEYTRUDA, has led Merck to raise its full-year 2024 sales outlook to $63.4-$64.4 billion[3].

Pricing and Cost Considerations

The high cost of WINREVAIR has sparked discussions about its value relative to the estimated clinical benefit. The Institute for Clinical and Economic Review estimated the clinical value of WINREVAIR at roughly $35,000 per year, significantly lower than Merck's pricing. However, Merck's experience in marketing its existing PAH drug, Adempas, suggests the company is well-positioned to execute its pricing strategy for WINREVAIR[2].

Safety and Tolerability

While WINREVAIR has shown significant efficacy, it also comes with potential side effects. The drug is well-tolerated but can increase hemoglobin levels and carry bleeding risks. Adverse events noted in clinical trials include bleeding events, telangiectasias, thrombocytopenia, and increases in blood pressure[5].

Market Positioning and Future Outlook

WINREVAIR is poised to become a key part of the redefined standard-of-care for PAH, offering patients better and potentially longer lives. Merck's strategic acquisition and successful launch of WINREVAIR position the company favorably in the PAH market, despite the challenges and uncertainties inherent in the pharmaceutical industry[2].

Key Takeaways

• Innovative Mechanism: WINREVAIR is the first activin signaling inhibitor approved for PAH, offering a novel therapeutic approach.
• Clinical Efficacy: Significant improvements in exercise capacity and reduction in morbidity and mortality rates compared to standard therapies.
• Market Potential: Forecasted to generate $2 billion to $5 billion annually by 2030, with a high wholesale price per vial.
• Financial Impact: Contributed to Merck's strong Q2 2024 financial results and raised full-year sales outlook.
• Safety and Tolerability: Well-tolerated but with potential side effects such as bleeding risks and increased hemoglobin levels.
• Market Positioning: Set to become a key part of PAH standard-of-care, enhancing Merck's portfolio and market presence.

FAQs

Q: What is the mechanism of action of WINREVAIR?

A: WINREVAIR works as an activin signaling inhibitor, directly targeting and trapping the overproduced activin proteins in PAH patients, potentially reversing blood vessel narrowing and right ventricle damage.

Q: What were the key findings of the STELLAR trial for WINREVAIR?

A: The STELLAR trial showed significant improvements in exercise capacity (6-minute walk distances) and multiple secondary outcome measures, including a reduction in all-cause death or nonfatal clinical PAH worsening.

Q: How much is Merck expected to generate from WINREVAIR annually by 2030?

A: Analysts forecast that WINREVAIR could generate $2 billion to $5 billion annually by 2030.

Q: What are the potential side effects of WINREVAIR?

A: WINREVAIR can increase hemoglobin levels and carry bleeding risks, with adverse events including bleeding events, telangiectasias, thrombocytopenia, and increases in blood pressure.

Q: How does the pricing of WINREVAIR compare to its estimated clinical value?

A: The wholesale price of WINREVAIR is around $14,000 per vial, translating to $243,000 per patient annually, which is higher than the estimated clinical value of roughly $35,000 per year.

Sources

1. Merck News: FDA Approves Merck's WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)[1].
2. Cardiac Wire: Merck's Sotatercept Lands PAH Approval[2].
3. Stock Titan: Merck Announces Second-Quarter 2024 Financial Results[3].
4. Merck News: Merck Announces Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint at Interim Analysis[4].
5. American College of Cardiology: Role of Sotatercept in Management of Pulmonary Arterial Hypertension[5].

Last updated: 2024-12-22