Inherited Metabolic Disorders (IMDs) are rare, genetic disorders that require highly specialised medical nutrition for effective management. If you’re working to bring these essential products to market, you know that they are not just supplements – they are lifelines for patients who depend on them. Despite the critical need, widespread access to these products is challenging due to regulatory hurdles, distribution complexities, and market access barriers.

Licensing partnerships offer a solution to overcome these challenges. By partnering with an experienced licensor, you can work to bring clinically validated IMD nutrition products to market more efficiently. By leveraging a partner’s regulatory expertise, established distribution networks, and market access knowledge, you can expand the reach of these essential products and ensure they get to the patients who need them.

Bringing medical nutrition products for IMDs to market comes with several challenges that can slow down or limit patient access.

• Time-consuming regulatory approval processes: Navigating regulatory approval processes is often time-consuming, requiring meticulous attention to varying standards across different markets.
• Differing market access requirements: Pricing, reimbursement, and formulary inclusion policies differ across healthcare systems, requiring strategic navigation to secure funding.
• Unestablished distribution networks: Reliable supply chains are essential for patients, as any disruption could severely impact their health, highlighting the importance of consistent product availability.

• Costly manufacturing and scalability: Investing in the necessary infrastructure for high-quality, scalable production to meet patient demand requires significant costs and time.

Strong licensing partnerships offer both strategic and operational advantages for companies looking to grow their presence in the medical nutrition market for IMDs.

• Streamlined regulatory approvals: Working with a partner with deep experience in regulatory affairs in your target market means you can streamline the process, avoid unnecessary delays, and get your products to market faster while ensuring full compliance with evolving regulatory frameworks.
• Established market presence: An experienced licensor already has strong relationships with healthcare payers, hospitals, and national reimbursement bodies within your target market, making it easier to secure pricing agreements, formulary listings, and reimbursement approvals.
• Efficient distribution: Licensing allows you to leverage your partner’s existing network of hospitals, pharmacies, and direct-to-patient supply chains so that your IMD medical nutrition products remain readily available and accessible.

• Reduces financial and operational risk: Instead of handling every aspect of the product lifecycle alone, you can share the responsibilities with a trusted partner and access their clinically validated, ready-to-commercialise products, allowing you to expand your portfolio and reach new markets.

At Galen, we offer a specialised portfolio of medical nutrition products designed to support the dietary management of inherited metabolic disorders. These clinically validated solutions provide essential nutrients tailored to the unique metabolic needs of patients with IMDs.

• TYR EASY Tablets: A protein substitute designed for the dietary management of tyrosinemia (TYR). These tablets provide a source of essential and non-essential amino acids without tyrosine and phenylalanine, helping patients with tyrosinaemia maintain metabolic balance. Their easy-to-take tablet format supports dietary compliance for patients requiring lifelong nutritional management.
• PKU EASY Microtabs Plus: A phenylalanine-free protein substitute, supplemented with vitamins, minerals and trace elements, formulated for patients with phenylketonuria (PKU). These micro tablets are a convenient and palatable way for patients to meet their protein needs while managing phenylalanine levels. Their small, easy-to-swallow form makes them a flexible and appealing alternative to traditional PKU formulas while complying with the patient’s dietary requirements.

By licensing these products, you can expand their availability to a wider network of healthcare providers so patients in need have reliable access to high-quality medical nutrition solutions.

The medical nutrition landscape for inherited metabolic disorders is rapidly evolving, with increasing demand for personalised formulations and innovative dietary solutions. Advances in metabolic research, improved diagnostic capabilities, and growing awareness of medical nutrition’s role in disease management are driving further expansion in this sector.

Licensing will continue to be a key strategy in ensuring these essential products reach the patients who rely on them. By working with an experienced licensor, you can overcome market barriers, accelerate product availability, and contribute to advancing medical nutrition therapies for IMDs.

If you want to expand your medical nutrition portfolio and improve patient access to IMD-specific solutions, licensing with Galen can help. Contact us today to explore our licensing opportunities.

MAT-GAL-UKI-000272. Date of preparation: April 2025.