Afamelanotide - Generic Drug Details

What are the generic sources for afamelanotide and what is the scope of patent protection?

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

Afamelanotide has thirty-four patent family members in eighteen countries.

There is one drug master file entry for afamelanotide. One supplier is listed for this compound.

Summary for afamelanotide

International Patents:	34
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	22
Patent Applications:	1,059
What excipients (inactive ingredients) are in afamelanotide?	afamelanotide excipients list
DailyMed Link:	afamelanotide at DailyMed

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

Constraining patent/regulatory exclusivity:

INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)

Dosage:

IMPLANT;SUBCUTANEOUS

^*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 afamelanotide

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

Sponsor	Phase
Clinuvel, Inc.	Phase 3
Clinuvel (UK) Ltd.	Phase 2
Clinuvel, Inc.	Phase 2

See all afamelanotide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for afamelanotide

D02BB	Protectives against UV-radiation for systemic use
D02B	PROTECTIVES AGAINST UV-RADIATION
D02	EMOLLIENTS AND PROTECTIVES
D	Dermatologicals

US Patents and Regulatory Information for afamelanotide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	10,076,555
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	8,334,265

Expired US Patents for afamelanotide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019	10,076,555

EU/EMA Drug Approvals for afamelanotide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Clinuvel Europe Limited	Scenesse	afamelanotide	EMEA/H/C/002548 Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).	Authorised	no	no	yes	2014-12-22

International Patents for afamelanotide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2056855	MÉTHODE DE TRAITEMENT DE PHOTODERMATOSES (METHOD OF TREATMENT OF PHOTODERMATOSES)
Denmark	2865422
Denmark	1789076
Poland	2865422
Slovenia	1789076
New Zealand	575133	METHOD OF TREATMENT OF PHOTODERMATOSES USING AN ALPHA-MSH ANALOGUE

Supplementary Protection Certificates for afamelanotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	18C1014	France		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
2865422	1890011-8	Sweden		PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422	2018C/012	Belgium		PRODUCT NAME: AFAMELANOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422	405 8-2018	Slovakia		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141229
2865422	2018/008	Ireland		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	12/2018	Austria		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 (MITTEILUNG) 20141229

Market Dynamics and Financial Trajectory for Afamelanotide

Introduction

Afamelanotide, marketed under the brand name SCENESSE®, is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). It is primarily used to prevent phototoxicity and reduce pain from light exposure, particularly in patients with erythropoietic protoporphyria (EPP). Here, we delve into the market dynamics and financial trajectory of this drug.

Regulatory Approvals and Market Expansion

Afamelanotide has received significant regulatory approvals, which have been pivotal in its market expansion. It was approved by the Italian Medicines Agency (AIFA) in 2010 for EPP and later by the US Food and Drug Administration (FDA) in October 2019 for reducing pain caused by light exposure in EPP patients[4].

The drug has been launched in Europe since 2016, following the European Commission's marketing authorization in 2014. In the USA, commercial operations commenced in April 2020 after FDA approval, marking a significant milestone in expanding access to EPP patients globally[3].

Clinical Trials and Development

Afamelanotide has undergone extensive clinical trials to establish its efficacy and safety. Phase III trials for EPP and polymorphous light eruption, as well as Phase II trials for actinic keratosis and squamous cell carcinoma, have been conducted. The drug has also been trialed for phototoxicity associated with systemic photodynamic therapy and solar urticaria[4].

The development of a depot formulation, which releases the peptide slowly under the skin, has been crucial in overcoming the drug's short half-life, making it more practical for patient use[4].

Market Performance and Revenue Growth

CLINUVEL Pharmaceuticals Ltd, the company behind SCENESSE®, has seen significant revenue growth since the drug's commercial launch. In the financial year ending June 2023 (FY2023), revenues from ordinary activities increased by 19% to AU$78.3 million, marking the seventh consecutive year of revenue growth[2].

Financial Highlights

• Revenue Growth: CLINUVEL has achieved a seven-year compound annual growth rate of revenues of 42%, significantly outpacing the growth in expenses[2].
• Profit Increase: The company reported a 33% increase in profit before tax and a 47% increase in net profit after tax in FY2023, reaching AU$45.6 million and AU$30.6 million, respectively[2].
• Cash Reserves: The company's cash reserves have seen a solid rise of 29% to AU$157 million, further consolidating its financial strength[2].

Commercial Strategy and Diversification

CLINUVEL has implemented a focused strategy to develop and commercialize SCENESSE®, addressing an unmet need in the treatment of EPP. The company is expanding its product development pipeline to include other indications where afamelanotide may provide clinical benefits, such as actinic keratosis and squamous cell carcinoma[3].

Diversification Initiatives

• New Products: CLINUVEL is developing new products, including PRÉNUMBRA® Instant for arterial ischemic stroke and CYACÊLLE, its first PhotoCosmetic product, which was pilot-launched in March 2023[2].
• DNA Repair Program: The company is also advancing its DNA Repair program, which has shown promising results in reducing markers of photodamage in patients with xeroderma pigmentosum[2].

Global Access and Regulatory Approvals

CLINUVEL is actively pursuing regulatory approvals in other jurisdictions to expand access to SCENESSE® for EPP patients worldwide. The approvals from leading regulatory bodies in the USA and Europe have validated the drug's safety profile, facilitating its global expansion[3].

Financial Independence and Growth Trajectory

CLINUVEL ranks among the few financially independent biopharmaceutical companies on a solid growth trajectory. The company's financial performance has been bolstered by its highest cash reserves to date, enabling it to self-finance its initiatives and advance its diversification objectives[5].

Key Indicators

• Earnings Per Share: AU$0.62 in FY2023, reflecting the company's strong financial health[2].
• Return on Equity: 19% in FY2023, indicating efficient use of shareholder equity[2].
• Quick Ratio: 7:1, highlighting the company's liquidity and ability to meet its short-term obligations[2].

Conclusion

Afamelanotide, under the brand name SCENESSE®, has established a strong market presence through its regulatory approvals, clinical efficacy, and commercial success. CLINUVEL Pharmaceuticals Ltd's strategic focus on diversification, coupled with its robust financial performance, positions the company for continued growth and expansion in the biopharmaceutical sector.

Key Takeaways

• Regulatory Approvals: SCENESSE® has received approvals from key regulatory bodies in Europe and the USA.
• Revenue Growth: CLINUVEL has seen consistent revenue growth since the commercial launch of SCENESSE®.
• Financial Strength: The company has significant cash reserves and a strong balance sheet.
• Diversification: CLINUVEL is expanding its product pipeline to address multiple patient groups and conditions.
• Global Expansion: The company is actively pursuing regulatory approvals to expand access to SCENESSE® globally.

FAQs

Q1: What is afamelanotide used for?

Afamelanotide, marketed as SCENESSE®, is used to prevent phototoxicity and reduce pain from light exposure, particularly in patients with erythropoietic protoporphyria (EPP)[4].

Q2: Who is the manufacturer of SCENESSE®?

CLINUVEL Pharmaceuticals Ltd is the manufacturer of SCENESSE®[3].

Q3: What are the key regulatory approvals for SCENESSE®?

SCENESSE® has been approved by the European Commission, the Italian Medicines Agency (AIFA), and the US Food and Drug Administration (FDA)[3][4].

Q4: How has CLINUVEL's revenue grown since the launch of SCENESSE®?

CLINUVEL has achieved a seven-year compound annual growth rate of revenues of 42% since the commercial launch of SCENESSE®[2].

Q5: What are CLINUVEL's plans for diversification?

CLINUVEL is developing new products, including PRÉNUMBRA® Instant and CYACÊLLE, and advancing its DNA Repair program to address multiple patient groups and conditions[2].

Sources

1. Australian Public Assessment Report for Afamelanotide - TGA, 2021.
2. CLINUVEL Pharmaceuticals Ltd 2023 Annual Report - ASX, 2023.
3. CLINUVEL Pharmaceuticals Ltd - For personal use only - ASX, 2020.
4. Afamelanotide - Wikipedia.
5. Appendix 4E and Annual Report to Shareholders 2024 - Listcorp, 2024.