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Abbreviated New Drug Application submitted to the FDA for Nemaura’s Transdermal Therapeutic System for treating Alzheimer’s Disease.

An application for an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration has been submitted for Nemaura’s transdermal therapeutic system for treating Alzheimer’s disease. It is one of three transdermal patches in the company’s pipeline (the other two treat Parkinson’s disease and hypertension, respectively). The application was made by a multinational pharmaceutical company with over 200 medications in its portfolio to whom Nemaura has licensed the transdermal patch for treating Alzheimer’s disease.

Nemaura’s proprietary matrix transdermal technology allows relatively unstable drugs to be stabilised and incorporated into patch technology. The end product has to be rugged and capable of providing consistent drug release across a wide range of skin types. “Transdermal systems are very complex—there is enormous variation from one patient to another”, explained Dr Faz Chowdhury, CEO of Nemaura Pharma. “Our success in producing such systems demonstrates the highly specialised skills we have as a company”.

Patches have particular benefits for patients with Alzheimer’s disease. It means they no longer have to remember to take medication several times a day. Patients or carers can write the time at which the patch has been applied onto the patch itself, to remind them of when it needs to be changed. Cholinesterase inhibitors are the mainstay of treatment for Alzheimer’s disease. But when given orally, particularly at higher doses, they can prompt nausea and vomiting, and so impair absorption of the active agent. In contrast, transdermal patches achieve a constant blood plasma drug profile, and can minimise side effects by avoiding first-pass metabolism.

If the application is approved, the transdermal therapeutic system can be manufactured and marketed as a generic product in the USA. “Our licensee is in a position to launch this product in the USA immediately”, said Chowdhury.

Cautionary Statement Regarding Forward Looking Statements.

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations, and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.

Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s matrix transdermal patch technology, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the matrix transdermal patch technology, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its matrix transdermal patch technology.

Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.

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