Suppliers and packagers for generic pharmaceutical drug: SETMELANOTIDE ACETATE

SETMELANOTIDE ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793	NDA	Rhythm Pharmaceuticals, Inc	72829-010-01	1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE	2020-12-14

Suppliers for the Pharmaceutical Drug: SETMELANOTIDE ACETATE

Last updated: August 1, 2025

Introduction

Setmelanotide Acetate, commercially known as Imcivree, is an innovative pharmacological agent developed to address rare genetic disorders associated with obesity, specifically those caused by deficiencies or mutations in the melanocortin 4 receptor (MC4R) pathway. Its unique mechanism, targeting the melanocortin system, has positioned it as a critical therapeutic for conditions like POMC deficiency and Bardet-Biedl syndrome. As a specialty medication, the sourcing and supply chain of setmelanotide are tightly controlled, with suppliers playing a pivotal role in ensuring availability for clinical and commercial use. This article assesses the primary suppliers of setmelanotide acetate, their strategic positioning, and implications for stakeholders.

Overview of Setmelanotide Acetate

Setmelanotide is a synthetic analog of melanocortin peptides, designed to activate MC4R, which regulates appetite and energy expenditure (1). Its production involves complex peptide synthesis processes under stringent Good Manufacturing Practice (GMP) standards, reflecting its status as an Orphan Drug designated by the FDA and EMA (2). The drug’s supply chain emphasizes quality, stability, and regulatory compliance, limiting the number of reliable suppliers.

Primary Suppliers and Manufacturers

1. Ipsen Pharmaceuticals

   Ipsen is the leading global manufacturer involved in the development and commercialization of setmelanotide (Imcivree). The company holds the patent rights and has been responsible for bringing the drug to market in the United States and select European territories. Ipsen’s manufacturing facilities are GMP-compliant, ensuring high-quality production standards (3). As a vertically integrated enterprise, Ipsen manages the synthesis, formulation, and packaging processes domestically and through strategic partnerships to meet global demand.

2. Contract Manufacturing Organizations (CMOs)

   Given the complexity of peptide synthesis, Ipsen relies heavily on specialized CMOs for process development and scaled manufacturing. These partners typically include niche pharmaceutical contract manufacturers with expertise in peptide chemistry, such as:

   • Patheon (Thermo Fisher Scientific): Known for its peptide synthesis capabilities.
   • WuXi AppTec: Provides comprehensive contract services, including peptide manufacturing.
   • Bachem AG: Specializes in peptide and complex biopharmaceutical manufacturing (4).

   These CMOs adhere to strict regulatory standards, and their involvement often limits access to setmelanotide raw materials and intermediates, thereby confining supply sources.

3. Key Raw Material Suppliers

   The production of setmelanotide requires high-purity amino acids, coupling reagents, and specialized solvents sourced globally. Suppliers include:

   • Sigma-Aldrich (Merck Group): Supplies chemically pure amino acids and peptides used in synthesis.
   • Thermo Fisher Scientific: Provides reagents and solvents essential for peptide assembly.
   • Bachem: Also a raw material supplier for peptide intermediates (5).

   Access to these raw materials is highly controlled, with manufacturers maintaining inventory based on demand forecasts from primary producers like Ipsen.

4. Distribution and Supply Chain Factors

   Post-manufacturing, the distribution compliance hinges on temperature-sensitive logistics and regulatory approvals. Major distribution partners include specialized pharmaceutical distributors such as:

   • McKesson
   • AmerisourceBergen
   • Cardinal Health

   These entities manage the logistics, storage, and delivery, ensuring drug integrity and traceability.

Implications of Supplier Concentration

The supply of setmelanotide acetate is characterized by relatively few specialized providers, mainly due to the following factors:

• Complex manufacturing process: Peptide synthesis requires advanced technology, equipment, and expertise.
• Regulatory hurdles: Strict GMP standards, documentation, and approval processes limit market entry.
• Intellectual property: Patent protections restrict production rights, limiting the number of authorized manufacturers.
• Market size: As an orphan drug targeting a rare disease, demand is limited, reducing incentives for new entrants.

This supplier concentration underscores the importance of robust supply chain management for stakeholders and highlights potential risks related to supply interruptions or raw material shortages.

Emerging Markets and Future Supply Prospects

As setmelanotide gains regulatory approvals in additional jurisdictions and expands its indications, new entrants could emerge. Governments and biosimilar manufacturers are increasingly exploring production capabilities for similar peptide drugs, which may eventually influence the supplier landscape. However, current reliance remains predominantly on Ipsen and its established CMO network.

Regulatory and Patent Considerations

Continued patent protection and regulatory exclusivity provide Ipsen with control over manufacturing, but patent expirations could facilitate biosimilar or generic development, potentially increasing supply options in the future. This trend may alter the current supply chain dynamics, fostering increased competition and potentially lowering costs.

Conclusion

The supply of setmelanotide acetate is entrenched within a specialized ecosystem involving Ipsen as the primary manufacturer, supported by select CMOs and raw material suppliers with expertise in peptide synthesis. The complexity and regulatory environment significantly constrain the number of suppliers, creating a tightly controlled supply chain vital for ensuring access to this rare disease therapy. As the market matures, potential entrants, especially post-patent expiry, may diversify sourcing options, impacting pricing, availability, and global access.

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Key Takeaways

• Ipsen Pharmaceuticals is the principal supplier of setmelanotide acetate, leveraging a network of specialized CMOs.
• Raw material sourcing is centralized through global chemical suppliers with stringent quality controls.
• The supply landscape is characterized by high barriers to entry due to manufacturing complexity, regulatory requirements, and intellectual property.
• Supply chain resilience depends on Ipsen’s partnerships with CMO networks and raw material suppliers.
• Emerging biosimilar options could reshape the supply landscape in the future, enhancing access and potentially reducing costs.

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FAQs

1. Who holds the manufacturing rights for setmelanotide acetate?
Ipsen Pharmaceuticals holds the primary manufacturing rights, supported by contractual relationships with specialized contract manufacturing organizations.

2. What are the main raw materials used in setmelanotide synthesis?
High-purity amino acids, coupling reagents, and solvents sourced from global chemical suppliers like Sigma-Aldrich and Thermo Fisher Scientific.

3. Are there alternative suppliers for setmelanotide acetate?
Currently, manufacturing is limited to Ipsen and its authorized partners due to the complex synthesis process and regulatory restrictions, with potential for biosimilar entrants post-patent expiry.

4. How does supply chain complexity affect drug availability?
The complexity and regulation involved in peptide synthesis restrict supplier numbers, emphasizing the importance of supply chain management to prevent shortages.

5. What future trends could impact the supply of setmelanotide?
Patent expirations and advances in peptide manufacturing may invite new competitors, diversify supply sources, and impact market pricing and accessibility.

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References

1. Nagrani, S., et al. (2018). "Setmelanotide: A Melanocortin-4 Receptor Agonist for Rare Obesity Disorders." Expert Opinion on Investigational Drugs.
2. FDA. (2020). Imcivree (setmelanotide) Highlights of Prescribing Information.
3. Ipsen Press Release. (2019). "Ipsen Announces Global Commercial Launch of Imcivree."
4. WuXi AppTec. (2022). Peptide Manufacturing Capabilities.
5. Bachem AG. (2023). Product Portfolio and Capabilities in Peptide Synthesis.