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Futura collaboration with Menarini to commercialise erectile dysfunction treatment

Posted on March 23, 2022March 23, 2022 by Kiran

LONDON: Futura Medical plc has entered into a licensing agreement with A. Menarini Korea Limited, a wholly owned subsidiary of Menarini Group, for the exclusive rights to commercialise the Company’s topical, gel-based Erectile Dysfunction treatment MED3000 in South Korea.

Commercial Highlights:

· Futura is eligible to receive an initial upfront payment

· Menarini Korea to pay an agreed price to Futura for the manufacture and supply of MED3000 by Futura’s Contract Manufacturing Organisation (“CMO”)

· Menarini Korea is responsible for all local MED3000 development, regulatory approvals, product launch and marketing.

Menarini Korea, a wholly owned subsidiary of A. Menarini Asia-Pacific Holdings PL based in Seoul Korea, is part of the world’s largest Italian biopharmaceutical company with a heritage of over 135 years and over 17,500 employees in more than 140 countries. Menarini Korea possesses the capability to successfully register, launch and commercialise brands in the market, with key strengths in therapeutic areas such as Cardiovascular, Hemato-Oncology/Pain, Men’s Health, Consumer Health, and Specialty/Orphan diseases.

Under the terms of the agreement, Futura will support Menarini to gain marketing authorisation and in commercialising MED3000 as a clinically proven treatment for erectile dysfunction (ED) in South Korea.

Menarini will be responsible for all costs related to the regulatory approval and marketing of the product in the region, including a clinical bridging study if necessary. Futura will provide reasonable technical support for product development and commercialisation and will receive an upfront payment and provide manufactured product from Futura’s contract manufacturing organisation.

James Barder, Chief Executive of Futura commented: “We are delighted to have reached an agreement with a prestigious company that operates in a key Asian market such as South Korea. Menarini is a trusted partner in the region that is perfectly situated to market retail products, with local teams that have deep understanding and experience of the South Korean market as well as significant expertise and a track record in rapidly registering and launching new products. We look forward to collaborating closely with the team at Menarini.

“Futura is continuing to build a strong and specialist distribution network for MED3000 across the globe and we are particularly focused on covering the key, top 15 markets for Erectile Dysfunction (ED) especially where the product already has been granted regulatory approval. We look forward to providing further updates on commercialisation as soon as possible.”

Hyeyoung Park, General Manager of A. Menarini Korea commented: “The commercialisation agreement to license-in Futura’s MED3000 is a significant milestone for enhancing Menarini’s Men’s Health portfolio in South Korea. According to the Korean Urological Association’s report1 on Erectile Dysfunction patients in South Korea, there are approximately 2.3 million men suffering from ED in the region, including patients with underlying etiology. MED3000 has been clinically studied for its onset speed and safety profile and has the potential to be a meaningful treatment option for Korean ED patients. Based on our extensive reach to physicians, multi-channel marketing capabilities, strong core values, and established track record in product launch, we are confident in generating significant value and long-term sustainable growth for both Futura and Menarini.

“The global Erectile Dysfunction (ED) treatment market is estimated to be in excess of US$3 billion1 amongst the leading 15 markets with volumes growing in the past year by 8. The USA ranked 1st and Korea ranked 9th in terms of value and measured by volume, Brazil is ranked 1st, USA 2nd, and Korea 6th. The UK is ranked 9th and 14th measured by value and volume, respectively.”

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