Rezafungin acetate - Generic Drug Details

What are the generic sources for rezafungin acetate and what is the scope of freedom to operate?

Rezafungin acetate is the generic ingredient in one branded drug marketed by Mundipharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rezafungin acetate has ninety-two patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for rezafungin acetate

International Patents:	92
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	1
Patent Applications:	3
DailyMed Link:	rezafungin acetate at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

^*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 rezafungin acetate

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

Sponsor	Phase
Mundipharma Research Limited	Phase 1

See all rezafungin acetate clinical trials

Pharmacology for rezafungin acetate

Drug Class

Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for rezafungin acetate

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for rezafungin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	11,712,459		Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	9,526,835		Y	Y
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417-001	Mar 22, 2023		RX	Yes	Yes	8,722,619		Y	Y

International Patents for rezafungin acetate

Country	Patent Number	Title	Estimated Expiration
Australia	2019201072
Slovenia	2827710
Israel	234505	תכשיר פרמצבטי המכיל תרכובת אצ'ינוקנדין ושימוש בתכשיר מיובש בהקפאה המכיל תרכובת אצ'ינוקנדין בהכנת תמיסה מימית לטיפול בזיהום פטריתי (A pharmaceutical composition comprising an echinocandin compound and use of a lyophilized composition comprising an echinocandin compound in the preparation of an aqueous solution for treating a fungal infection)

Rezafungin acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rezafungin Acetate

Introduction

Rezafungin acetate, marketed as REZZAYO, is a novel once-weekly echinocandin antifungal developed by Cidara Therapeutics. This drug has been making significant strides in the treatment and prevention of invasive fungal infections, particularly candidemia and invasive candidiasis. Here, we delve into the market dynamics and financial trajectory of rezafungin acetate.

Regulatory Approvals and Milestones

FDA and European Approvals

Rezafungin acetate received a pivotal approval from the U.S. Food and Drug Administration (FDA) in March 2023 for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. This approval marked the first new treatment option for these conditions in over a decade[3].

In Europe, rezafungin acetate was approved, triggering an $11.14 million milestone payment to Cidara Therapeutics from Mundipharma[2].

Clinical Trials and Efficacy

Phase 2 STRIVE Trial

The Phase 2 STRIVE trial demonstrated that once-weekly intravenous dosing of rezafungin was well-tolerated and safe in patients with candidemia and/or invasive candidiasis. The trial met all its primary objectives, showing evidence of rezafungin's efficacy and safety profile[4].

Phase 3 ReSTORE Trial

The ReSTORE Phase 3 trial showed the non-inferiority of rezafungin compared to caspofungin, a current standard of care, in terms of all-cause mortality. Pooled data analyses from both the ReSTORE and STRIVE trials further supported the efficacy and safety of rezafungin[5].

Market Need and Competition

Unmet Medical Need

Invasive fungal infections, particularly those caused by Candida species, are a significant clinical challenge, especially in immunocompromised patients. Current treatments often have limitations such as toxicity, drug-to-drug interactions, and increasing resistance. Rezafungin acetate addresses these unmet needs with its once-weekly dosing and improved pharmacokinetics[1].

Competitive Landscape

Rezafungin acetate is the only once-weekly echinocandin antifungal available, offering a distinct advantage over daily dosed competitors like micafungin and caspofungin. This unique dosing schedule enhances patient compliance and simplifies treatment management, particularly beneficial for patients who are already on multiple medications[1].

Financial Implications

Milestone Payments

Cidara Therapeutics received an $11.14 million milestone payment following the European approval of REZZAYO. Additionally, the FDA approval triggered a $20.0 million regulatory milestone payment under the terms of their agreement with Melinta Therapeutics[2][3].

Commercial Milestones and Royalties

Cidara is eligible to receive up to $40.0 million in additional regulatory milestones and up to $370.0 million in commercial milestones, plus tiered royalties in the low double digits to mid-teens on U.S. net sales of rezafungin. These revenues are crucial for advancing Cidara’s Cloudbreak drug-Fc conjugate (DFC) platform programs and completing ongoing clinical trials[3].

Research and Development Expenses

In 2022, Cidara’s research and development expenses were $75.5 million, with a significant portion dedicated to the Cloudbreak antiviral platform and the rezafungin clinical trials. Despite the high expenses, the company has managed to balance its financials through strategic partnerships and milestone payments[3].

Market Reception and Commercial Strategy

Commercial Partnership

Cidara Therapeutics has partnered with Melinta Therapeutics for the commercialization of REZZAYO in the U.S. Melinta’s experience in marketing infectious disease products, particularly within hospital and acute care settings, is crucial for making REZZAYO widely available to healthcare providers and patients[3].

Market Access

Since its approval, Melinta has been leveraging its commercial infrastructure to ensure REZZAYO’s availability. The drug’s unique once-weekly dosing and proven efficacy and safety profile are expected to drive its adoption in clinical settings[5].

Future Outlook

Ongoing Clinical Trials

Cidara is progressing with the global Phase 3 ReSPECT prophylaxis trial, which aims to further establish rezafungin’s role in preventing invasive fungal infections. The success of this trial could expand the drug’s utility across various patient populations[1].

Expansion of Cloudbreak Platform

The financial gains from rezafungin’s commercial success will be instrumental in advancing Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs). This platform holds promise for treating other serious diseases, potentially diversifying Cidara’s product pipeline[2].

Key Takeaways

• Regulatory Approvals: Rezafungin acetate has received FDA and European approvals, marking significant milestones.
• Clinical Efficacy: The drug has demonstrated non-inferiority to current standards of care in clinical trials.
• Market Need: Addresses unmet medical needs with its once-weekly dosing and improved pharmacokinetics.
• Financial Trajectory: Milestone payments and potential commercial milestones and royalties are crucial for Cidara’s financial growth.
• Commercial Strategy: Partnership with Melinta Therapeutics is key to REZZAYO’s market access and adoption.

FAQs

What is rezafungin acetate used for?

Rezafungin acetate, marketed as REZZAYO, is used for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options.

What makes rezafungin acetate unique?

Rezafungin acetate is the only once-weekly echinocandin antifungal available, offering improved pharmacokinetics and a simpler dosing schedule compared to daily dosed competitors.

Who are the key partners in the commercialization of REZZAYO?

Cidara Therapeutics has partnered with Melinta Therapeutics for the commercialization of REZZAYO in the U.S.

What are the financial implications of rezafungin acetate’s approvals?

Cidara Therapeutics has received significant milestone payments and is eligible for additional regulatory and commercial milestones, as well as royalties on U.S. net sales.

What is the current status of ongoing clinical trials for rezafungin acetate?

Cidara is progressing with the global Phase 3 ReSPECT prophylaxis trial to further establish rezafungin’s role in preventing invasive fungal infections.

Sources

1. Cidara Therapeutics Highlights New Data from Multiple Rezafungin Studies Presented at ECCMID 2019. Cidara Therapeutics.
2. Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO. Cidara Therapeutics.
3. Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results. Cidara Therapeutics.
4. Cidara Therapeutics Reports Positive Topline Results from Phase 2 STRIVE Trial of Lead Antifungal Rezafungin. Cidara Therapeutics.
5. Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO. Melinta Therapeutics.