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N4 Pharma PLC - Commencement of Sildenafil Clinical Trial

Wed, 18th Apr 2018 07:00

RNS Number : 2328L
N4 Pharma PLC
18 April 2018

N4 Pharma Plc

("N4 Pharma" or the "Company")

Commencement of Sildenafil Clinical Trial

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 start of its proof of concept clinical trial for its lead product, sildenafil, (the "Trial") following the completion of the validation of the reformulated sildenafil in accordance with the specifications submitted to the MHRA.


The Trial will comprise a four way crossover study in 12 healthy subjects comparing N4 Pharma's reformulated 100mg sildenafil to Viagra™ 50mg in both fed and fasted conditions. The Trial aims to measure the level of the drug in plasma achieved by N4 Pharma's reformulated product compared to Viagra™ over a 24 hour period.


The Trial is expected to take 8 to 10 weeks with provisional results data available in July 2018 with the final clinical study report expected at the end of August 2018.


The data gathered from the Trial will enable the Company to establish whether its reformulation has been sufficiently successful to allow N4 Pharma to prepare for a pre-IND meeting with the FDA towards the end of this year or whether further amendments to the reformulation may be required to optimise efficacy.


Nigel Theobald, CEO of N4 Pharma, commented: "We are delighted that N4 Pharma's first clinical trial has begun on our lead product, sildenafil. Slight delays in receiving the base ingredients to the reformulation, which had a knock effect on the validation of the product, has seen the timetable slip slightly. However, there should be no material impact on any move towards commercialisation assuming successful Trial results.


"The Board continues to believe that the improvements sought to be evidenced through the Trial will make our reformulation that much more attractive to both the end consumer and pharmaceutical partners in the final development and commercialisation of the drug in this highly lucrative market.


"We look forward to providing a further update as soon as we receive the full results which are expected in late August."




N4 Pharma Plc

Nigel Theobald, CEO


Via Alma PR

Stockdale Securities

Tom Griffiths

Tel: +44(0)20 7601 6100


Alma PR

Josh Royston

Robyn Fisher


Tel: +44(0)778 090 1979

Tel: +44(0)754 070 6191





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.

Sildenafil Market Research:  


·     Market research undertaken by Black Swan Analysis in 2017 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.

·     The size of the addressable market for sildenafil: the erectile dysfunction market had global annual sales of approximately $4.6 billion* in 2016 and is expected to fall to $3.2 billion by 2022 due to the anticipated patent expiry of Viagra™ and Cialis.


*Source: Evaluate Pharma






The Medicines and Healthcare products Regulatory Agency



Pre-Investigational New Product



Food and Drug Administration






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