Specialty Biopharma Secures EU Licensing for New Misoprostol Formulation

Client Challenge

A specialty biopharmaceutical company focused on the repurposing and reformulation of medicinal products developed a proprietary new formulation of misoprostol for labor induction corresponding to the dose and presentation recommended by the World Health Organization. The company sought help to run the out-licensing process for their product. To succeed, they also wanted assistance to understand the market access and pricing challenges in a competitive European market. In parallel, the company needed support with data generation and regulatory dossier submission.

Our Approach

The Alira Health Market Access, Regulatory, and Transaction Advisory teams worked collaboratively on this effort, combining their specific expertise to address the client’s needs. The teams executed on the following steps:

• Performed a thorough competitive landscape analysis, including products with the same indication and the off-label use of a reference product, and price and reimbursement analysis in Europe to prepare for negotiations with potential partners
• Developed a strong value proposition for the client’s product to persuade partners of the new formulation’s added value
• Conducted an extensive evaluation of all potential targets operating in women’s health/ obstetrics and gynecology (OBGYN) in Europe
• Coordinated and managed a competitive process to secure a licensing and supply agreement with the right regional partner
• Performed a gap analysis to identify missing data for regulatory approval in the EU, participated in study design, and prepared the regulatory dossier for submission to the relevant health authorities

Outcomes

With guidance from Alira Health, the client signed a licensing agreement with a regional partner expert in women’s health/OBGYN covering the leading EU markets. With the agreement secured, Alira Health supported the client with the preparation and submission of the market authorization application dossier to the health authorities.

Key Success Factors

Alira Health’s healthcare specialization coupled with transaction advisory, market access, regulatory, and commercial expertise enabled them to conduct a comprehensive assessment of the product and the commercial opportunity, develop a unique value proposition in a highly competitive market, select the right partner, and manage the out-licensing process.

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