N4 Pharma Plc Regulatory News (N4P)

10 October 2017

N4 Pharma Plc

("N4 Pharma" or the "Company")

Sildenafil PCT Update

N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to announce the publication of the PCT Patent Application ("Patent Application") in respect of its proposed reformulation of sildenafil.

The Patent Application deals specifically with N4 Pharma's plans to reformulate sildenafil to allow for an initial faster onset of drug in plasma, followed by a further release where the sildenafil is delivered into plasma more steadily and over a longer time period. 

N4 Pharma's reformulation of sildenafil would see a faster acting and longer lasting version of current market leader Viagra. In addition it is expected that, unlike Viagra, the new formulation can be taken with or without food. The Company believes that these innovations would make its reformulation attractive to both the end consumer and pharmaceutical partners in the final development and commercialisation of the drug. This is supported by market research undertaken by Black Swan Analysis earlier this year with clinicians in the UK and US who are currently prescribing sildenafil and competing products Vardenafil and Tadalafil which suggested that between 12% and 25% of clinicians in the UK (depending on the product) would switch patients to N4 Pharma's product and between 19% and 28% of clinicians in the US would do the same.

Following formal publication of the Patent Application, which has a priority date of 2 June 2016, the next stage in granting the final patent is 2 October 2018. This is the deadline for entry of the patent application into national phases and the start of the detailed review in each key territory.

Further to its announcement on 15 May 2017 regarding its patent application for Paroxetine, after further reviewing the clinical and commercial potential for this product, the Board has decided not to continue with this application and focus the Company's resources in its other areas of generic reformulation and vaccines.

Nigel Theobald, CEO of N4 Pharma, commented: "The publication of the Patent Application marks another important step in our lead product sildenafil as we head towards our initial human pilot clinical trials within the next few months. With the Patent Application now formally published, we can talk more freely with investors and other interested parties about what our reformulated sildenafil will hope to achieve in terms of its pharmacokinetic properties and where it might sit amongst competitors in this highly lucrative market."

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About N4 Pharma

N4 Pharma is a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance.

N4 Pharma's reformulation work falls under two divisions:

• generic, already commercialised, drugs; and

• delivery of novel and existing vaccines.

N4 Pharma has identified a number of established drugs that could be improved upon through its reformulation techniques. N4 Pharma's most advanced reformulation is for sildenafil, widely marketed as Viagra, where N4 Pharma is seeking to improve the speed at which the drug takes effect whilst also extending its duration of action.

N4 Pharma's reformulation approach should take approximately three years to obtain regulatory approval as opposed to the traditional process for new drugs of on average ten years. The cost and risk profile of this model is also significantly less than the traditional process. N4 Pharma's business model is to take reformulated drugs from its portfolio through to the stage where it will license its newly reformulated drugs to pharmaceutical companies to commercialise them. N4 Pharma's revenues should be derived from up front milestone and royalty payments associated with the licence.