N4 Pharma Plc Regulatory News (N4P)

09 May 2018

N4 Pharma Plc

("N4 Pharma" or the "Company")

Filing of Patent

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company which improves the delivery of existing drugs and novel vaccines and therapeutics, is pleased to announce the filing of its Patent Cooperation Treaty ("PCT") patent application for the oral reformulation of duloxetine, marketed under the brand Cymbalta, for the treatment of premature ejaculation ("PE").

While duloxetine is indicated as an anti-depressant drug, studies have been performed to show that it has promise as a treatment for premature ejaculation. N4 Pharma's reformulation is based on the same product principle as its sildenafil reformulation, that it will be faster acting and longer lasting and, therefore provides the required product profile to treat premature ejaculation effectively. Once the patent has been granted, the formulations will provide patent protection which, in future, would allow a licensing partner of the Company to undertake the required clinical trials to obtain a licence for this indication knowing that the final product will be commercially protected.

Epidemiological surveys in the USA and other countries suggest that premature ejaculation as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) is the most common male sexual dysfunction, with prevalence rates of approximately 20%-30%. The highest prevalence, 31% (among men aged 18-59 years), was found by the USA National Health and Social Life Survey study while the lowest, 18%, was found in a five country European observational study, which included the UK. Across all the major markets, between 20% and 40% of men at some point in their lives have reported symptoms of premature ejaculation, or a complaint of premature ejaculation*.

Nigel Theobald, CEO of N4 Pharma, commented: "We are excited to have reached this important milestone in the patent process for our duloxetine application. Erectile dysfunction and premature ejaculation are often co-morbid in that they both impact negatively on a male's sex life. Our sildenafil clinical trial results will help to provide useful information to allow us to investigate possible formulation work on our duloxetine product. Continuing the patent process is a crucial step in helping us build a portfolio of generic reformulation opportunities."

*Source: Commercial assessment report, by Avondale Consultancy

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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 and therapeutics.

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 for generics 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.

N4 Pharma's business model for vaccines is to undertake the required clinical work to demonstrate the capability of its delivery system as a cancer vaccine or therapeutic treatment so that it can license the technology to major players developing treatments in this area, again in return for up front milestone and royalty payments associated with the licence.

Premature Ejaculation Market Research*:

- A high prevalence of men experiencing PE, ~20-30%, with only those severally affected by it seeking treatment from their GP or Primary Care Physician.

- Treatment for the condition can take the form of nonpharmacological techniques, or pharmacologic treatments that in some cases can be an off-licence prescription.

- For the Duloxetine reformulation product, the addressable market will be primarily severally affected PE patients who are prescribed a treatment. In terms of actual patient numbers based on research in the UK and factored for the other markets, this would equate to 1.28 million across the 6 major markets.

- A top line commercial assessment for a new product entering the PE market was calculated based on some key assumptions related to dose price, market share and total number of pills per patients across all 6 markets. These assumptions were based on insight from customer research. The total revenue generated would be £83.58 million for a peak share of 25% which equates to 312,474 patients.

*Source: Commercial assessment report, by Avondale Consultancy