Expanding Pharmaceutical Portfolio: Oakley's Successful Dossier Acquisition and Licensing in the GCC Region

Abstract:

This case study highlights Oakley Business Development's role in assisting a client based in the GCC region with the identification, negotiation, and licensing of approved dossiers from either the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Oakley's task was to secure regulatory filing opportunities within the GCC region by acquiring or licensing the identified dossiers. The study emphasizes Oakley's comprehensive due diligence review, negotiation expertise, and successful drafting of license agreements. With a minimum requirement of six licenses, Oakley achieved agreements for 14 molecules, generating an estimated USD 13.94 million in annual forecasted turnover within the first year.

Introduction:

The pharmaceutical industry in the GCC region offers significant growth potential, attracting companies seeking market expansion opportunities. This case study examines Oakley Business Development's collaboration with a client from the GCC region, where Oakley played a vital role in identifying, negotiating, and licensing approved dossiers for regulatory filing. By leveraging their expertise and network, Oakley successfully facilitated the acquisition or licensing of multiple dossiers, driving the client's market entry and growth in the region.

Objective:

The primary objective of this case study is to showcase Oakley Business Development's role in supporting a client from the GCC region in acquiring or licensing approved dossiers for regulatory filing within the region. The study focuses on Oakley's due diligence review, negotiation capabilities, and the drafting of license agreements. Additionally, it highlights Oakley's remarkable achievement of securing agreements for 14 molecules, exceeding the initial requirement of six licenses and projecting substantial annual turnover within the first year.

Methods:

This case study employs a qualitative approach, drawing information from interviews with key stakeholders from Oakley Business Development and the GCC-based client. Primary data sources include project managers, licensing experts, and company representatives involved in the collaboration. Secondary data sources comprise industry publications, regulatory guidelines, and relevant documentation related to dossier acquisition and licensing.

Results:

1. Identification of Approved Dossiers: Oakley diligently identified dossiers approved by either the EMA or FDA based on the client's prepared list of generic pharmaceuticals. Leveraging their industry expertise and network, Oakley compiled a targeted selection of dossiers suitable for regulatory filing within the GCC region.

2. Due Diligence and Negotiation: Oakley conducted comprehensive due diligence reviews of the identified dossiers, ensuring their suitability for the client's requirements. Oakley's negotiation experts engaged in discussions with dossier owners, successfully securing favorable commercial terms for acquisition or licensing. Their expertise in navigating complex negotiations played a critical role in achieving favorable outcomes.

3. Drafting License Agreements: Once negotiation terms were agreed upon, Oakley's legal team drafted robust and comprehensive license agreements. These agreements outlined the rights and responsibilities of both parties and ensured compliance with regulatory requirements, enabling the client's regulatory filings in the GCC region.

4. Successful Licensing Achievements: In surpassing the minimum requirement of six licenses within the first year, Oakley achieved agreements for 14 molecules. This remarkable success not only exceeded expectations but also forecasted an estimated annual turnover of USD 13.94 million, providing significant growth opportunities for the client within the GCC market.

Conclusion:

Oakley Business Development's collaboration with the GCC-based client exemplifies their commitment to supporting market expansion and growth in the pharmaceutical industry. By identifying, negotiating, and licensing approved dossiers for regulatory filing within the GCC region, Oakley facilitated the client's successful market entry. The case study highlights Oakley's expertise in due diligence review, negotiation, and license agreement drafting, showcasing their ability to drive favorable outcomes for clients. This case study serves as a testament to Oakley's proficiency in dossier acquisition and licensing, fostering business growth and market success for pharmaceutical companies operating in the GCC region.