Introduction
The client requested a drug due diligence investigation on the entry of generic drugs into the market. The dominant poly-ADP ribose polymerase (PARP) inhibitor drug is nearing patent expiration in several countries. The investigation includes an Initial Base study and Quarterly Monitoring Modules.
Diagnose
To effectively address the impending market changes, the first step in our due diligence investigation was to diagnose the comprehensive information required. This phase focused on understanding the drug's application in cancer treatment across discovery, clinical, and market stages, laying the foundation for the subsequent strategic analysis.
The challenge was to gather comprehensive information on the drug's usage in cancer treatment across discovery, clinical, and market stages. This information is crucial for managing risks, identifying collaboration opportunities, and planning for the post-patent period. The required data includes:
- Generic entries or Para-IV filers
- Ongoing research to develop formulation; combination; treatment areas, derivatives/salt forms.
- Identification of bulk or API suppliers for manufacturing with regulatory certification.
- Adverse Drug Reactions (ADR) with quarterly updates.
Design
With a clear understanding of the diagnostic requirements, the next step was to design a comprehensive strategy to gather and analyze the necessary data efficiently. This phase was critical to deliver actionable insights for the client's strategic planning.
Evalueserve implemented a comprehensive strategy to deliver strategic outputs:
- Drug/Formulation/API Data: Extensive searches for patents, clinical trial data, and information on drug forms, salts, and new formulations.
- API Suppliers: Using automation tools and quick searches to identify the best API suppliers and certifications from various countries like ISO and GMP certification.
- Adverse Drug Reactions: We are collecting details from multiple websites and proposing quarterly monitoring studies based on updated timelines.
- Monitoring and Patent Watch: Our strategy includes continuous monitoring of relevant and competitor patents, demonstrating our proactive approach to anticipating future needs and challenges using Searchstream.
Deploy
Following the strategy's design, the deployment phase involved a deep-dive analysis to assess competitor activity and regulatory landscapes. This phase provided detailed insights critical for the client's decision-making process.
A deep dive analysis assessed competitor activity concerning generics entry, focusing on:
- Drug/Formulation/API Data: API manufacturers/suppliers, company news, M&A activities, key developments, company websites, annual reports, SEC filings, conference proceedings, and product/market information.
- Bioequivalence Data/Generic Entry
- Generic Approvals/Regulatory Authority Data
- Legal Status: Including opposition, prosecution, and litigation cases.
Impact
The deployment of the strategic analysis resulted in significant findings that informed the client's market strategies. The impact of this comprehensive study is outlined in the following section, highlighting the tangible benefits achieved through informed decision-making.
- Understanding Technologies: The study helped the client understand technologies and companies providing suitable delivery solutions.
- Competitors and Partnership Deals: Insights on competitors' IP portfolios and collaborations/partnerships, including Drug Master Files (DMF).
- Market Entry Timing: Monitoring legal status and understanding regulatory approval helped clients plan their product launch to avoid litigation.
Conclusion
Evalueserve's comprehensive due diligence goes beyond just patents, providing a deeper understanding of the market that benefits client through strategic planning and informed decisions to hold success in the competitive off-patent drug market.
