The Confidential Prospectus: The first document to prepare for licensing-out a pharma compound in development
By David Scott, expert-trainer of The Pharmaceutical Out-Licensing Course.
Although the first material to be presented to potential partners will be the non-confidential brochure, the first material you should prepare is the Confidential Prospectus.
This prospectus should include a reference to all the available material on the product (including all the studies undertaken), and should clearly set out what the product does, how it is made, and why it has therapeutic and commercial potential. Properly prepared, the confidential prospectus is the product. It will give potential partners a thorough understanding of the product’s commercial and scientific significance, and will form the basis for due diligence discussions during the negotiation process.
This prospectus is best set out using the following chapter headings (these are covered in more detail in the course):
Should be a maximum of two pages and should summarise all the key features of the product. This may be the only part of the report that most people get to read, so it needs to be carefully crafted.
This section should explain how the product works, including details of the mechanics and disease pathways, ideally illustrated with simple diagrams.
Chemistry & pharmacy
Include a diagram of the structure or other key identifiers and a brief review of likely formulations, manufacturing processes and overall costs.
Confirm the current patent position, summarising the overall level of IP protection and the key expiry dates.
This section should start with a summary of the demonstrated properties established from experimental work, and then examine studies in vitro, in vivo and comparative studies. It should review all the data, highlighting key observations, and be illustrated with graphs or photographs of any pivotal results.
Pharmacokinetics & safety
Include a summary of data covering any known or postulated metabolic pathways, general pharmacokinetics and either study results or a statement regarding toxicology, genotoxicity and carcinogenicity. This section should also summarise the present and planned regulatory position.
Where clinical data exist, this will be the most important part of the dossier because the clinical evidence will determine the probable competitive profile for the product. If only limited clinical data are available, these should be linked to the experimental data wherever possible to help build a picture of the likely overall clinical profile.
Use this section to discuss the therapeutic areas that are expected to form the basis of the product’s commercial exploitation. For each market discussed, explain how the available knowledge points to a potential market opportunity for the product, and review the likely medical profile against known or expected competitors. The discussion should highlight any unmet needs in the marketplace that can be met by the new product.
This should set out what the expected data sheet for the product might be, and ideally should include expected indications, side effects (if any), target clinicians, product dosage, costs and an estimate of the likely launch date.
This section should include references to all documents mentioned in the prospectus and should highlight any key documents such as publications in key journals, or any journal reviews highlighting the need for a product of this sort.
The whole document is likely to be about 30-50 pages in length, depending upon how much information you have. Your presentation should be based on the same content and structure as the prospectus so that in meetings you can follow the same order, which will help focus discussions on each section in turn.
Once the prospectus is complete, you can decide what elements are likely to be suitable for a non-confidential brochure. This is essentially a short (3-6 page) ‘teaser’ document which should be designed to give enough information to allow potential partners to say “I have seen enough to know I want to learn more about this opportunity”
Last update: September 2017