Huons said Monday that it has signed a contract to export Hutox, its botulinum toxin (BTX), to Europe.

Developed by Huons Global’s in-house research institute, Hutox is an outcome of excellent fermentation productivity, high purification technology and the use of ATCC3502 strain, the company said.

Based on the MOU signed with Sesderma, a Spanish aesthetic company, in August last year, the company signed a 56.7 billion won ($53.1 million) contract to supply its BTX product for seven years after finishing its product registration in the EU recently.

Sesderma is an esthetic company that has branches in over 50 European and Latin America countries. It has a robust distribution network and leadership in cosmetics market around the globe. Under the agreement, the company will export its product to European countries such as Spain, Britain, France, Germany, Italy and Poland starting from the first half of 2021.

Before signing the contract, Sesderma and other European contract research organization (CRO) companies conducted preliminary due diligence on the production line and quality management systems for Hutox, while also confirming the required documents to receive certification from the European Medicines Agency (EMA). After the inspection, both Sesderma and European CROs showed high expectations of Hutox’s successful launch in Europe.

The company plans to cooperate with Sesderma to expand market share of Hutox in countries such as Spain, U.K., France, Germany, Italy and Poland, which occupy more than 80 percent of the whole European botulinum toxin market. Huons also expects to utilize the cooperation in its effort to expand its product to other European countries.

The company has also signed a strategic alliance to export Hutox with partners in Russia and Brazil in August last year. The company and its partners are currently undergoing negotiations for export.

To keep the production flow smoothly, Huons Global is building a second factory that complies with EU and U.S. current good manufacturing practice (cGMP) regulations to expand its global market reach. The construction of the second plant, located in North Chungcheong Province, will be complete in the first half of 2018. The new plant will expand production capacity by five times, and produce more than five million vials annually, according to the company.

“We are pleased to conclude a large-scale export contract for the first time in Europe, which has an advanced cosmetic market,” Huons CEO Um Key-an said. “'We expect to achieve excellent results in the European market as Hutox has already received global recognition as a superior product.”

The company will continue to expand its strategic alliance with leading global companies by using the European export contract as its first stepping stone to advance into the global market, Um added.

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>