Mavacamten - Generic Drug Details

What are the generic drug sources for mavacamten and what is the scope of freedom to operate?

Mavacamten is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mavacamten has sixty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for mavacamten

International Patents:	67
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	15
Patent Applications:	24
What excipients (inactive ingredients) are in mavacamten?	mavacamten excipients list
DailyMed Link:	mavacamten at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for mavacamten

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for mavacamten

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bristol-Myers Squibb	Phase 4
Bristol-Myers Squibb	Phase 3
Bristol-Myers Squibb	Phase 1

See all mavacamten clinical trials

Pharmacology for mavacamten

Drug Class	Cardiac Myosin Inhibitor
Mechanism of Action	Cardiac Myosin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mavacamten

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for mavacamten

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No	RE50050		Y	Y
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No

EU/EMA Drug Approvals for mavacamten

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Camzyos	mavacamten	EMEA/H/C/005457 Treatment of symptomatic obstructive hypertrophic cardiomyopathy.	Authorised	no	no	no	2023-06-26

International Patents for mavacamten

Country	Patent Number	Title	Estimated Expiration
Australia	2018264088	Pyrimidinedione compounds against cardiac conditions
Morocco	38789	Composés de pyrimidine-dione contre les affections cardiaques
South Korea	20230144117	심장 상태에 대한 피리미딘디온 화합물 (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS)
Hong Kong	1223930	對抗心臟疾病的嘧啶化合物 (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS)
Israel	302299	תרכובות פירימידינדיאון נגד הפרעות לבביות (Pyrimidinedione compounds against cardiac conditions)

Supplementary Protection Certificates for mavacamten

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3010910	PA2023535	Lithuania		PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	LUC00324	Luxembourg		PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
3010910	301253	Netherlands		PRODUCT NAME: MAVACAMTEN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1716 20230627
3010910	C03010910/01	Switzerland		PRODUCT NAME: MAVACAMTENUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68477 25.04.2023
3010910	39/2023	Austria		PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 (MITTTEILUNG) 20230627

Market Dynamics and Financial Trajectory for Mavacamten

Introduction to Mavacamten

Mavacamten, marketed as Camzyos, is a novel, oral, allosteric modulator of cardiac myosin developed by MyoKardia and now owned by Bristol Myers Squibb. It is designed to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM), a chronic heart disease with significant morbidity and patient impact[2][3].

Market Need and Unmet Medical Need

Hypertrophic cardiomyopathy, particularly the obstructive form, has a high unmet medical need. Existing therapies are largely generic and used for a broad range of cardiovascular diseases, but they do not specifically target oHCM. Mavacamten fills this gap by offering a targeted treatment that can significantly reduce left ventricular outflow tract (LVOT) obstruction and improve patient symptoms and functional capacity[1][2].

Clinical Trial Outcomes and Approval

The efficacy of mavacamten has been demonstrated through several clinical trials, including the Phase 2 PIONEER-HCM study and the pivotal Phase 3 EXPLORER-HCM trial. These studies showed significant reductions in LVOT obstruction, improvements in symptoms, and enhanced functional capacity. The EXPLORER-HCM trial, in particular, highlighted that mavacamten could reduce the need for surgical intervention, with only 18% of participants still needing surgery after 16 weeks, compared to 77% in the placebo group[1][2].

Following these positive outcomes, the FDA approved Camzyos (mavacamten) for the treatment of symptomatic oHCM in 2021[3].

Market Position and Competition

Mavacamten is poised to stand relatively unchallenged in the oHCM market. It does not displace current therapy options but rather complements them, such as beta blockers and calcium channel blockers. This positioning allows mavacamten to address a specific demographic that was previously underserved by clinical trial development[1].

Sales Projections and Financial Impact

GlobalData estimates that mavacamten could achieve sales of around $958 million by 2025, driven by its strong performance in clinical trials and the high unmet medical need in oHCM. This makes it a significant medium- and long-term growth driver for Bristol Myers Squibb[1].

The acquisition of MyoKardia by Bristol Myers Squibb for $13.1 billion in cash underscores the potential commercial opportunity of mavacamten. The deal is expected to be accretive to Bristol Myers Squibb’s non-GAAP earnings starting in 2023, further strengthening the company’s cardiovascular franchise[3].

Pharmacoeconomic Analysis

The cost-effectiveness of mavacamten has been evaluated in several analyses. A pharmacoeconomic review by CADTH indicated that while mavacamten is more costly than existing treatments, it also offers greater effectiveness. The incremental cost-effectiveness ratio (ICER) for mavacamten plus beta-blockers or calcium channel blockers compared to beta-blockers or calcium channel blockers alone was estimated to be around $576,295 per quality-adjusted life-year (QALY) in the second-line setting. However, this analysis highlighted the need for a significant price reduction to make mavacamten cost-effective at a willingness-to-pay threshold of $50,000 per QALY[4].

Long-Term Follow-Up Data

Recent long-term follow-up data from the VALOR-HCM LTE and EXPLORER-HCM studies have reinforced the durable response of mavacamten in patients with symptomatic oHCM. These studies demonstrated continued reductions in the need for invasive surgical interventions and sustained improvements in patient outcomes over extended periods, further solidifying the drug's market position[5].

Market Uptake and Adoption

The market uptake of mavacamten is expected to be significant, although it is subject to various factors including pricing, reimbursement policies, and physician adoption. The sponsor's base case assumes that a substantial percentage of eligible patients will receive mavacamten, with estimates suggesting 9%, 19%, and 36% of eligible patients in the first, second, and third years, respectively[4].

Conclusion

Mavacamten is set to dominate the market for treating symptomatic obstructive hypertrophic cardiomyopathy due to its unique mechanism of action, strong clinical trial outcomes, and the significant unmet medical need it addresses. With projected sales of nearly $1 billion by 2025 and a robust long-term financial trajectory, mavacamten is a critical component of Bristol Myers Squibb's cardiovascular franchise.

Key Takeaways

• Unique Mechanism: Mavacamten is a first-in-class cardiac myosin inhibitor specifically targeting oHCM.
• Strong Clinical Outcomes: Significant reductions in LVOT obstruction and improvements in patient symptoms and functional capacity.
• Market Position: Poised to stand relatively unchallenged in the oHCM market.
• Sales Projections: Estimated sales of around $958 million by 2025.
• Financial Impact: Expected to be accretive to Bristol Myers Squibb’s non-GAAP earnings starting in 2023.
• Pharmacoeconomic Analysis: More costly but more effective than existing treatments, with a need for price adjustments for cost-effectiveness.
• Long-Term Data: Demonstrates sustained improvements in patient outcomes over extended periods.

FAQs

Q: What is the primary indication for mavacamten? A: Mavacamten is primarily indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Q: How does mavacamten compare to existing treatments for oHCM? A: Mavacamten does not displace current therapies but complements them, offering a targeted treatment that reduces LVOT obstruction and improves patient symptoms and functional capacity.

Q: What are the projected sales for mavacamten by 2025? A: GlobalData estimates that mavacamten could achieve sales of around $958 million by 2025.

Q: What is the cost-effectiveness of mavacamten compared to existing treatments? A: Mavacamten is more costly but more effective than existing treatments, with an ICER of around $576,295 per QALY in the second-line setting.

Q: What are the long-term follow-up data indicating for mavacamten? A: Long-term follow-up data show sustained reductions in the need for invasive surgical interventions and continued improvements in patient outcomes over extended periods.

Sources

1. Bristol Myers Squibb's Mavacamten Poised to Stand unchallenged - Dicardiology
2. Clinical Trial Results from MyoKardia's Phase 2 PIONEER-HCM Study of Mavacamten - Biospace
3. Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash - Bristol Myers Squibb News
4. Pharmacoeconomic Review - Mavacamten (Camzyos) - NCBI
5. Long-Term Follow-Up Data from Two Phase 3 Studies of CAMZYOS (mavacamten) - Bristol Myers Squibb News