Alzheimer's due diligence

Our client, a major pension fund, was considering an investment opportunity in a Phase III neuroscience company. The company was developing a small molecule to provide symptomatic relief of Alzheimer’s Disease. The key question the client was asking was the likelihood of clinical success in an ongoing Phase III clinical trial. Alacrita’s senior partners selected a neuroscience consultant from our network of pharma consultants.

The Consultant had deep experience in neurology, psychiatry and molecular neurobiology and twenty years of experience in drug development from first-in-human studies through multiple Phase III clinical trials across a range of CNS indications. Most recently, he had been Chief Medical Officer and SVP Drug Development of a neuroscience company.

The diligence team reviewed the contents of the dataroom, including Investor Presentation, Investigator’s Brochure, Phase III Protocol and Statistical Analysis Plan, Phase II Clinical Study Reports, publications, Regulatory Correspondence. Our work focused on:

  •  Assessment of the appropriateness of clinical design, mitigation of adverse events and safety factors;
  •  Identified the risk factors facing the AD clinical program;
  •  Determined completeness and appropriateness of regulatory response
  •  Assessed likelihood of clinical success and review overall development strategy.

Alacrita completed the due diligence within two weeks and held an interim telephone call with the client’s investment team to provide initial, verbal feedback. We then received further clarification from the company and provided a written report to the client, setting out the major risk factors. We held a final telephone call with the client’s team to explain our findings and answer any questions.

Neurology generics due diligence

For a VC investor, Alacrita assessed technical, regulatory and market risks in a neuroscience specialty pharma company developing a range of products through the 505 (b)(2) regulatory pathway. The team provided a judgement on the likely investor returns under two possible scenarios, and advised on the most likely exit triggers/timing. The client expressed a high level of satisfaction with the work.

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