Futura Strikes Deal With Menarini To Commercialize MED3000 ED Gel In South Korea
Executive Summary
South Korean erectile dysfunction sufferers may soon be able to acess Futura Medical's drug-free MED3000 treatment thanks to a deal with Menarini Korea Limited, a wholly owned subsidiary of Italy’s Menarini Group, for exclusive commercialization rights in the country.
Menarini Korea Limited, a wholly owned subsidiary of Italy’s Menarini Group, has struck a deal with UK R&D specialist Futura Medical plc for the exclusive rights to commercialize the latter’s topical, gel-based erectile dysfunction treatment MED3000 in South Korea.
Under the terms of the agreement, Menarini will be responsible for all local MED3000 development, regulatory approvals, product launch and marketing, including a clinical bridging study if necessary.
In return, Futura will provide reasonable technical support for product development and commercialization and will receive an upfront payment. It will also provide manufactured product from Futura’s contract manufacturing organisation.
“We are delighted to have reached an agreement with a prestigious company that operates in a key Asian market such as South Korea,” commented Futura CEO James Barder.
“Menarini is a trusted partner in the region that is perfectly situated to market retail products,” he continued, “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.”
Menarini Korea general manager Hyeyoung Park added that the commercialization agreement to license-in Futura’s MED3000 is a “significant milestone for enhancing Menarini’s Men’s Health portfolio in South Korea.”
According to a 2016 Korean Urological Association report, there are over two million men suffering from ED in South Korea, he said. “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,” he said.
Global Strategy
South Korea is the latest in a string of deals taking MED3000 to new markets.
In September last year, Futura agreed a deal for Labatec Pharma to commercialize the gel – which works via a mixture of volatile and non-volatile ingredients applied directly to the tip of the penis – in Jordan, Lebanon, Iraq and the GCC region of Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Oman and Bahrain. (Also see "Futura Strikes Deal To Commercialize Erectile Dysfunction Gel In Middle East" - HBW Insight, 28 Sep, 2021.)
Around the same time, Futura announced a licensing agreement with Latin America specialists m8 Pharmaceuticals for the commercialization of MED3000 in Brazil and Mexico. (Also see "Futura Takes Drug-Free Erectile Dysfunction Gel To Latin America" - HBW Insight, 6 Sep, 2021.)
Futura is also getting ready to launch MED3000 in Europe, where it has a CE Mark under the EU Medical Devices Regulation (2017/745) as a Class II(b) medical device. (Also see "Futura Gains EU CE Mark For Drug-Free OTC Erectile Dysfunction Treatment" - HBW Insight, 6 May, 2021.)
In the US, meanwhile, regulatory approval for MED3000 as an OTC medical device is also progressing.
In a pre-submission meeting last year, the FDA agreed that Futura can make an application for a de novo classification – a newly finalized pathway for low-risk medical products to obtain marketing authorization as class I or class II devices – for MED3000 on the condition that it completes two additional studies. (Also see "Futura’s Drug-Free Erectile Dysfunction Gel On Track For US And EU Launch" - HBW Insight, 26 Aug, 2021.)
The first of these – a short, non-clinical, human factors study – has been successfully completed, while the second, FM71 – a confirmatory clinical study designed to provide supplementary six-month efficacy data with a “least burdensome” approach and modest cost – pre-screened its first patient in September 2021. (Also see "Study Suggests Futura’s Drug-Free Erectile Dysfunction Gel Suitable For US OTC Pathway" - HBW Insight, 5 Jan, 2022.)
“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 ED especially where the product already has been granted regulatory approval,” Barder commented. “We look forward to providing further updates on commercialization as soon as possible.”