Menarini Korea plans to introduce a new gel-type erectile dysfunction treatment in Korea.
According to the industry sources on Tuesday, Futura Medical, a U.K.-based pharmaceutical company, signed an exclusive license agreement with Menarini Korea for commercializing MED3000, a gel-type erectile dysfunction drug candidate, in Korea.
Under the accord, Futura Medical will support the commercialization of MED3000 in Korea, and receives royalties for manufacturing and supplying MED3000, including a down payment.
Menarini Korea will bear all costs, including clinical trials and product approvals, of MED3000 in Korea. It will also be responsible for sales and marketing upon successful commercialization.
However, the two companies did not disclose the exact details of the agreement citing contractual reasons.
"Menarini is a trusted partner in the region that is perfectly situated to retail market products, with local teams that have deep understanding and experience of the Korean market as well as significant expertise and a track record in rapidly registering and launching new products," Futura Medical’s Chief Executive Officer James Barder said. "We look forward to collaborating closely with the team at Menarini Korea."
MED3000 is a gel-type treatment applied directly to the penis for 15 seconds.
In a clinical study, 60 percent of subjects had an erection effect within 10 minutes. In phase 3 clinical trial conducted with 1,000 people at 60 institutions in eight European countries, the company confirmed statistical significance in primary indicators such as the International Index of Erectile Function – Erectile Function (IIEF-EF), erection success rate (sexual encounter profile question 2), and erection maintenance and sex success rate (sexual encounter profile question 3)
MED3000 obtained CE mark approval as a medical device available without a doctor's prescription in Europe in April 2021.
The company is also conducting a phase 3 clinical trial in the U.S., participated by 100 subjects, which aims to compare the efficacy of MED3000 to the reference drug (tadalafil 5mg).
Futura Medical aims to complete the trial by the second quarter.