27 July 2017
N4 Pharma Plc
("N4 Pharma" or the "Company")
Update on Sildenafil clinical plans
N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to announce the appointment of Bio-Images Drug Delivery Limited ("BDD") to undertake a pilot clinical trial ("Pilot Trial") in a limited number of healthy male volunteers to obtain preliminary data on two potential reformulations of Sildenafil in line with the Company's patent applications.
BDD operate a phase 1 clinical trials unit based in Glasgow Royal Infirmary and are specialists in conducting clinical studies for investigational medicinal products.
The Pilot Trial is due to take place in early 2018 with results expected by the end of April 2018.
Assuming a positive outcome from the Pilot Trial, the Company would then use the resulting data as the basis to determine the full requirements for a pivotal Clinical Study ("Clinical Study"). This Clinical Study, together with the data from the Pilot Trial, would form the basis of the Company's dialogue with the Food and Drug Administration and relevant European regulatory authorities prior to seeking to commercialise our product with the right licensing partner. The Clinical Study could take from 12 to 18 months and would form the basis for a marketing authorisation submission.
Nigel Theobald, CEO of N4 Pharma, commented:
"BDD are an ideal partner to perform our pilot clinical trials. They provide us with the opportunity to test a range of potential reformulations to establish which best delivers our target product profile.
"The erectile dysfunction market had global annual sales of approximately $4.6 billion in 2016. A faster acting, longer lasting version of Sildenafil has the ability to be a major new product in the erectile dysfunction market."
Enquiries:
N4 Pharma CEO, Nigel Theobald |
Via Alma PR |
Stockdale Securities Tom Griffiths |
Tel: +44(0)207 601 6100 |
Beaufort Securities Elliot Hance |
Tel: +44(0)207 382 8300 |
Alma PR Josh Royston Robyn Fisher |
Tel: +44(0)778 090 1979 Tel: +44(0)754 070 6191 |
About N4 Pharma
N4 Pharma was formed in 2014 by Nigel Theobald, the former Chief Executive of AIM quoted Oxford Pharmascience Group plc. It 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.
About BDD
BDD is a specialist drug delivery company with expertise in modified drug release and gamma scintigraphy. BDD Scintigraphy is a powerful, fast and incredibly effective tool that can be coupled with pharmacokinetics to provide a clear picture of formulation behaviour in man. The data generated from a scintigraphic clinical study can provide information on site and time of disintegration of tablets, Gastro Intestinal transit and the effects of food and regional absorption. Data from scintigraphic studies can be used to validate product claims, guide development strategies, provide valuable marketing data and provide information on regional absorption.
