Alacrita

Alacrita and its team members have substantial experience of conducting due diligence and this is regularly deployed to support financial investment and licensing decisions. Some selected examples are detailed below.

Life Science Reagents

For a major UK bioscience investor, Alacrita conducted IP and commercial due diligence on a cell biology reagents investment opportunity. Alacrita reviewed the target company’s patent estate and conducted selective IP searches, revealing a weaker IP position than first thought. Alacrita identified the market segments for the technology, ranking them by commercial attractiveness and unmet need. Following interviews with key players in each priority market segment, it emerged that the market potential was smaller than originally forecast, the rate of market penetration would be slower and the benefit of the target technology would be considered incremental rather than a step change.

Keywords: life science reagents, market potential assessment, IP due diligence.

Regulatory Affairs

For an established generics company looking to acquire the French rights of an existing product franchise, Alacrita conducted regulatory and clinical due diligence on the French dossier. The audit confirmed whether it was possible to register the product through MRP in other EU countries and Alacrita set out what resources/timeframes would be necessary to achieve this.

Keywords: regulatory affairs, clinical, generics, France.

Cell therapy

A VC investor approached Alacrita for expert due diligence support for a $15m investment into a late stage cell therapy company. Alacrita assessed regulatory, manufacturing and IP documentation and analysed the product’s commercial prospects, identifying and characterising the principal areas of risk within the program. Following the assessment, the client made the investment and the company implemented a number of Alacrita’s recommendations to mitigate execution risk. Alacrita conducted the project within a very short time frame and both the client and the target company expressed a high level of satisfaction with the work conducted.

Key words: cell therapy, regenerative medicine, clinical development, intellectual property, manufacturing, market analysis, regulatory affairs, wound healing

Novel Drug formulation

For an established medical device company looking to make a strategic investment, Alacrita conducted commercial, regulatory, IP and technical due diligence on an investment opportunity in the diabetes therapy area. For the commercial due diligence, Alacrita undertook both US and EU market assessments through literature review and primary research with clinicians and patients. The resulting market forecast revealed that the product’s market potential was substantially lower than previously thought. Alacrita reviewed the company’s regulatory strategy for 505 (b)(2) regulatory approval in the US and identified a number of additional areas that needed to be addressed in the development plan. During the IP analysis, Alacrita judged that significant work would be necessary for the product to be considered novel or inventive given the state of the art at the time.

Key words: clinical development, formulation, market analysis, regulatory affairs, diabetes

Oncology cell therapy

Alacrita conducted a Reality Check on a clinical stage cancer biologic for a venture capital investor prior to a proposed $10m investment. The analysis, which was completed within four days, included a review of a comprehensive dataroom encompassing preclinical, clinical, regulatory, manufacturing and IP matters. Alacrita’s report identified the areas of key risk in the project and suggested approaches to their mitigation.

Key words: clinical development, intellectual property, preclinical development, regulatory affairs, oncology

Neurology generic

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.

Key words: business plan, formulation, regulatory affairs, commercialisation