CLIN.L Regulatory News (CLIN)

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26 June 2019

MHRA licenses two Melatonin products indicated forshort-term jet-lag treatment in adults

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has been granted marketing authorisations for Melatonin 1mg/ml Oral Solution and Melatonin 3mg Film-Coated Tablets by the Medicines and Healthcare products Regulatory Agency (MHRA). Both forms are indicated for the short-term treatment of jet-lag in adults.

Obtaining marketing authorisations for a previously unlicensed product is an example of the unlicensed to licensed (UL2L) strategy in the Commercial Medicines business and follows the successful launch of previous products in the portfolio, including Glycopyrronium Bromide Oral Solution.

Supplying products on an unlicensed basis allows the Group to identify where unmet medical need and patient demand is high. Melatonin 1mg/ml Oral Solution and Melatonin 3mg Film-Coated Tablets were identified and assessed for technical and commercial feasibility to determine their suitability to add to the commercialisation pipeline. The Group then used its in-house product development capabilities, regulatory and commercialisation expertise, to develop dossiers to submit to the MHRA to demonstrate their safety, efficacy and quality.

With the marketing authorisations granted in the UK, Melatonin 1mg/ml Oral Solution and Melatonin 3mg Film-Coated Tablets can satisfy a previously unmet clinical need for patients and allows the Group to market them by selling directly to wholesalers or by utilising its comprehensive supply and distribution infrastructure.

Overall the Group expect the products to be a modest contributor of growth within Clinigen's Commercial Medicines business in the FY20E period, offsetting an expected decline from its supply as an unlicensed product from within its Unlicensed Medicines business.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"Obtaining MHRA approval for Melatonin has been driven by our dedicated team, which has shown a real determination to address this unmet medical need in the UK. This approval will ensure healthcare professionals can manage adult patients experiencing jet-lag with a licensed product, where before there was none.

"Identifying and developing products to offer licensed options to prescribers and patients is an important part of our strategy in Commercial Medicines. We are continuing to explore and invest to further strengthen and diversify the portfolio."

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About Melatonin

Melatonin is a hormone secreted by the pineal gland that regulates the sleep/wake cycle. It regulates a variety of physiological processes, including circadian, cardiovascular, reproductive, and neuroendocrine functions. Administration of melatonin facilitates sleep onset and improves the quality of sleep. Administration of melatonin can also produce phase shifts in circadian rhythms and has been used to treat the symptoms of circadian disorders.1

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific. In October 2018, the Group acquired CSM, a specialist provider of packaging, labelling, warehousing and distribution services, with sites in the US and Europe, and iQone, a specialist pharmaceutical company in Switzerland.

For more information, please visit www.clinigengroup.com 

References

1. Sadeghniiat-Haghighi K, Aminian O, Pouryaghoub G, Yazdi Z. Efficacy and hypnotic effects of melatonin in shift-work nurses: double-blind, placebo-controlled crossover trial. Journal of Circadian Rhythms. 2008;6(0):10.