Medytox and Daewoong Pharmaceuticals Working to Enter U.S. Markets with Their Botox Products

South Korean pharmaceutical companies are speeding up their processes in order to enter U.S. Botox markets that are worth $1.76 billion (2 trillion KRW).

According to pharmaceutical industries on the 21st, Medytox and Daewoong Pharmaceuticals submitted license applications to FDA (Food and Drug Administration) through their partners Allergan and Alphaeon respectively. ‘Botulinum toxin’ medicine, which is usually called Botox, is a biomedicine that is used for surgical procedures and treatments of cosmetic surgeries such as improvement of wrinkles in the middle of a forehead.

Daewoong Pharmaceutical is the first South Korean pharmaceutical company to submit license application of its Botox products to the U.S. It completed three phase of clinical trials of its Botox product and is knocking on the doors of global markets. Daewoong Pharmaceutical along with its U.S. partner called Evolus submitted BLA (Biologics License Application) to FDA regarding its product called DWP-450 (product name: NABOTA) that improves wrinkles in the middle of foreheads of adults. Application process completed within just 2 months from submitting BLA on the 16th of May. It is expected that it will take about a year for Daewoong Pharmaceutical to apply for an approval and to receive a final approval from FDA. Daewoong Pharmaceutical introduced its products that are produced from its old plant in Hyangnam, which accords to KGMP (Korea Good Manufacturing Process), to three phases of clinical trials and also completed constructing a new plant for NABOTA. However it still needs to acquire cGMP (current GMP).

Daewoong Pharmaceutical is showing its confidence that it can prove equivalence of both old plant and new plant. When it receives an approval from FDA for NABOTA in 2018 at the earliest, it will be the first South Korean company to enter U.S. markets with Botox product.

Although Medytox is ahead of Daewoong Pharmaceuticals when it comes to development of Botox, it is late in going through three phases of clinical tests in the U.S. Some are worried that clinical trials for Innotox have yet to start despite being exported 3 years ago. Medytox visited the U.S. in last July and discussed with Allergan, which is its U.S. partner, regarding schedule for clinical trials of ‘Innotox (liquid product developed by Medytox)’.

Allergan, which is a multinational pharmaceutical company, purchased monopolistic copyrights within the U.S. in 2013 and currently has at least 80% of shares of botulinum toxin within the U.S. Some are wondering if Allergan is delaying clinical trials of Medytox’s products on purpose in order to maintain its monopolistic position within the U.S. “Clinical trials are being delayed because procedure of establishing production process of medicines for clinical tests that corresponds to cGMP level of advanced countries is not happening smoothly.” said President Jung Hyeon-ho of Medytox. “We are going to carry out three phases of clinical trials of Innotox by end of this year.” It is likely that it will take at least 2 years for Medytox to complete clinical trials and to receive an approval from FDA.

Hugel is also working to enter U.S. markets with its product called ‘Botulax’ and is going to go through approval process when it is finished with three phases of clinical trials. Hugel is expecting that it will receive an approval to start selling its products in U.S. markets after second-half of 2018.

Global Botox markets are worth about $4.39 billion (5 trillion KRW) and are expected to be worth up to $6.15 billion (7 trillion KRW) by 2020. U.S. Botox markets are worth about $1.58 billion (1.8 trillion KRW) while South Korean Botox markets are worth about $87.9 million (100 billion KRW).

“Because barriers for development and approval of Botox are high, only seven Botox products are currently sold globally.” said a representative of an industry. “If Medytox and Daewoong Pharmaceuticals have success in U.S. markets based on their competitive edge in price and quality of their products, they will also be able to quickly enter Chinese and European markets.”

Staff Reporter Jang, Yoonhyeong | [email protected]