Is This Product The One?
Mid-size biotech company supported by an investment firm was assessing the opportunity to acquire a phase 2 biotech product from another biotech company. Management needed to carry-out a due-diligence of this phase 2 biotech product. They requested Larka to handle the due-diligence.
- European company
- Investing in Europe & North America
- 20 employees
- 650mn EUR AUM
- Life Sciences sector investment approach
- Mid-term investment strategy
Larka's Scope Of Intervention
Due Diligence included the following tasks:
- Target Product Profile
- Cell line development report
- Upstream Process Development CMC 2 & 3
- Downstream Process Development CMC 2 & 3
- Formulation report
- Investigational Medicinal Product Dossier Drug Substance & Drug Product
- Manufacturing runs
The CMC development approach, the collected results and the resulting process appeared to be fit for purpose and able to support further product development. Separately, several improvements were proposed to reduce COGS, increase manufacturing flexibility & robustness and ensure smooth supply to the market in case of success.
However, the biotech company decided not to acquire the product as they considered their regulatory background on the clinical program was not strong enough with regard to the FDA.