N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to announce the filing of its Patent Cooperation Treaty (“PCT”) patent application for its sildenafil reformulation and provide an update on the work done by the Company in the year to date as it moves towards clinical trials. In addition, the Company is pleased to announce the filing of two new patents expanding its potential reformulation product pipeline to five.
Nigel Theobald, CEO of N4 Pharma, commented: “Our reformulation work has progressed positively over the last few months and, with the completion of our lab work on sildenafil, all our efforts will be focused on finalising the scope of work and deliverables for our clinical trials.
“Our new patent applications take our potential product pipeline to five, with each product addressing significant established markets for a range of complications from erectile dysfunction to hypertension and the side effects of menopause.
“With the funds raised from the recent share placing, we are well placed to take our programme forward and I look forward to providing further updates on our various projects as and when appropriate.”
N4 Pharma Plc (AIM:N4P) CEO Nigel Theobald interview with Share Talk on Admission to AIM – 3 May 2017
Since the start of this year, work has continued on the Company’s sildenafil reformulation and the Company has now filed its PCT patent application seeking worldwide protection of the Company’s reformulation methodology. This follows the successful completion of the laboratory dissolution testing of the formulation to establish the correct dissolution profile required for the reformulated product.
The next phase for the sildenafil product is to move into clinical trials with healthy volunteers to determine the precise level of the drug in blood plasma to then take those results to the relevant regulatory authorities, such as the Food and Drug Administration (“FDA”) in the USA and the Medicines and Healthcare Regulatory Agency (“MHRA”) in the UK. The Company is in the process of discussing the parameters for these trials as well as working through all the regulatory requirements and necessary approvals before they can formally commence and will make further announcements in due course as and when the timing of commencement of the trials becomes clearer.
New Product Patent Filings
N4 Pharma has also filed two new patent applications in respect of the reformulation of two other drugs.
The first is for a reformulation of the anti-depressant drug, paroxetine, to develop a new product for the treatment of hot flashes and night sweats in menopausal women. Paroxetine has already been approved for these treatments by the FDA.
The second is for a reformulation of another anti-depressant drug, duloxetine, for the treatment of premature ejaculation (“PE”). This product differs slightly to our standard approach in that, although duloxetine has been researched to show its efficacy for PE, no clinical trials have been performed to date since there is no patent protection for the generic drug. Our reformulation will provide patent protection, thereby allowing a partner to undertake the required trials knowing that the final product will be commercially protected.
Both of these conditions ideally require the product to be faster acting and longer lasting and our formulations will give us strong patent protection if granted in this area. The market for menopausal hot flashes drugs is forecast to grow annually from $3.8bn in 2014 to $5.3bn by 2023¹. In the case of duloxetine, PE is believed to affect up to 30 per cent of American males, equivalent to approximately 20 million adults per year.
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.
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