Medytox became the largest shareholder of Evolus, a U.S. pharmaceutical company specializing in botulinum toxin (BTX), raising the possibility of the Korean company marketing its products through the new U.S. partner, a local analyst said Friday.
Lee Dong-gun, an analyst at Shinhan Investment Corp., predicted in a report that Medytox has established the requirement to use Evolus in its plans to advance into the U.S. market.
According to Lee, Alphaeon, the previous largest shareholder of Evolus, reduced its stake to 11.1 percent by selling a portion of its shares on Tuesday. As a result, Lee said that Medytox, which has a 13.7 percent stake in Evolus, has become the largest shareholder of Evolus.
Lee stressed that the increase in stakes might help Medytox market MT10109L, a BTX candidate that it recently reacquired rights from AbbVie on Wednesday.
"Medytox announced that its partner AbbVie had decided to return the rights to the liquid BTX MT10109L and terminate all existing contracts," Lee said. "As a result, Medytox will not return the $65 million in down payment and $35 million in milestones that it has already received, will retain all rights related to the phase 3 clinical trial data of MT10109L, which ended in January 2021, and related to future development, licensing, and commercialization."
MT10109L is a liquid BTX transferred to Allergan for a down payment of $65 million and a milestone of up to $297 million in September 2013. Medytox had expected that AbbVie would submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) within this year after completing the phase 3 trial.
"Although Medytox did not provide a clear explanation as to why AbbVie returned the rights of the substance, if there are no problems with the results of phase 3 clinical trial, I expect Medytox to submit a BLA in the first half of 2022 after a Pre-BLA meeting with the FDA and launch the product by 2023," Lee said.
Lee noted that if Medytox receives approval for MT10109L, the company will focus on securing a partner in charge of local distribution, which he expects to become Evolus or a third-party distributor.
"As Medytox has become the largest shareholder, I believe that sales of MT10109L will be highly possible through Evolus, which already has a distribution network in the U.S.," Lee said.
Lee stressed that his brokerage maintained its "buy" opinion for Medytox's shares but decreased the target price to 250,000 won ($214).
As of noon on Friday, Medytox's share prices stood at 154,900 won, up 0.52 percent from the previous trading day.
However, obstacles remain for Medytox to market its BTX through Evolus.
Some market watchers pointed out that Evolus cannot sell products that compete with Daewoong Pharmaceutical's BTX product Nabota in the U.S. under a previous contract with Daewoong.
As MT10109L is a drug that can compete with Nabota if this contract remains intact, they noted that Medytox could not sell the MT10109L through Evolus. Daewoong is the third-largest shareholder of Evolus and may block Medytox from marketing its BTX product through Evolus.