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EMYRIA LIMITED — Capital/Financing Update 2020
Sep 29, 2020
64844_rns_2020-09-29_cd17119d-c3fc-4e29-8710-b25ec0e0d530.pdf
Capital/Financing Update
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ASX/Media Release
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30/09/2020
Emyria Signs Real-World Data Agreement for Insomnia Drug Zenivol™ with Zelira Therapeutics
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Emyria will monitor the safety and efficacy of Zenivol™ treatment in patients diagnosed with chronic insomnia to inform Zelira’s path to further development and product registration
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Leverages Emyria’s clinical and data expertise to monitor the safety and efficacy of Zenivol™ treatment in patients diagnosed with chronic insomnia
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Zenivol recently received TGA approval for prescription to patients through its Special Access Scheme
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Partnership reinforces Emyria’s model of commercialising high-quality, real-world evidence
Emyria Limited (ASX: EMD) (Emyria or the Company) (Formerly Emerald Clinics) , a company that develops and commercialises real world evidence assets by leveraging its unique clinical services and data expertise, is pleased to announce it has signed an agreement with Zelira Therapeutics (“Zelira”) to collect data from patient’s treated with Zenivol™ through Emyria’s specialist clinical services.
Zelira (ASX: ASX:ZLD) (OTCQB:ZLDAF) is Perth-based company specialising in the development of cannabinoid-based medicines for the treatment of a variety of medical conditions including insomnia, autism and chronic non-cancer pain.
Under the partnership, Emyria will collect longitudinal data on patients prescribed Zenivol™ for the treatment of insomnia and related conditions. Emyria will provide real-world data that will complement the existing clinical data-pack for Zenivol and be used to inform further clinical development and, ultimately, the path to product registration.
Zelira will pay Emyria up to $100,000 comprising an upfront fee of $50,000 along with a subscription fee for each patient enrolled in the study, up to a maximum of 100 participants. The initial term of the agreement is for 12 months, with Zelira having an option to extend the term to capture the required minimum of data for each patient.
Emyria Managing Director Dr Michael Winlo said: “We’re delighted to be working with Zelira Therapeutics, to realise the potential for a real-world evidence asset that will help to progress the commercialisation and regulatory acceptance of its medicinal cannabis products. Partnering with clinically-focused companies, such as Zelira, further supports our model of generating high-quality patient data to accelerate development of unregistered medicines for patients.”
Zelira Managing Director Dr Richard Hopkins said: “Australia’s commitment to developing a highly regulated market for prescription cannabis medicines, means this country is a global leader in collection of high-quality real-world data relating to patients treated with medicinal cannabis. We believe Emyria’s approach to collection and curation of patient data, underpinned by its clinical services, is best-in-class.
Being able to access real-world data, in real-time, from patients treated with Zenivol™ will have immediate benefit to our go-to-market strategy. This information will also inform the design of future clinical trials, reduce the risks and costs of development and accelerate the path to regulatory approval.”
This announcement has been approved and authorised for release by the board of Emyria Limited.
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For further information:
Dr Michael Winlo Matt Wright CEO Media/investor relations (08) 6559 2800 +61 (0) 451 896 420 [email protected] [email protected]
About Emyria (www.emyria.com)
Emyria Limited is a Real-World Evidence data company using its network of specialist clinical services and purpose-built, remote patient monitoring technologies and data platforms to accelerate the development and registration of new treatments and facilitate the implementation of valuable new care models. Emyria’s model provides high quality care for patients with unmet needs while also generating high quality and ethically sourced clinical data. Emyria’s evidence is used by Emyria’a customers to pay for insights, conduct clinical trials and accelerate medical innovation.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a results of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forwardlooking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.