Medytox, a Korean botulinum toxin (BTX) maker, said it has established a U.S. subsidiary Luvantas to advance into the global market with MT10109L, its non-animal-derived liquid BTX formulation.

The company had submitted a biologics license application (BLA) for MT10109L to the FDA in late December. 

The self-developed MT10109L eliminates animal-derived ingredients throughout the entire manufacturing process, including strain cultivation and raw material production, and does not use human serum albumin (HSA) as an adjuvant, thereby fundamentally preventing the possibility of animal-derived virus infection.

Owned entirely by Medytox, Luvantas is based in Irvine, California, and will handle local sales and marketing in the U.S. and Canada for MT10109L. The company will also be responsible for the market entry of advanced products like the hyaluronic acid filler Neuramis and the dermo-cosmetic Neuraderm in the future.

The company has appointed Thomas Albright, a former Allergan executive, as the first CEO of Luvantas. Albright is known for successfully leading the global launch of Botox for cosmetic purposes and overseeing its global marketing strategy.

Medytox is optimistic that Albright's expertise in the global skin beauty treatment market will lead to the successful U.S. launch of MT10109L, which aims for FDA approval by 2025.

"The establishment of Luvantas signifies that the company, which has been preparing for a long time to leap into a global biopharmaceutical company, has finished strategic planning and entered the actual execution phase,” a Medytox official said. “We will focus all our capabilities on obtaining FDA approval for MT10109L and thoroughly prepare for a successful entry into the U.S. market."