Hugel, Benev Partner to Bring New Toxin to U.S.

Hugel Inc.’s botulinum toxin product Letybo  is coming to the U.S. via a strategic partnership with BENEV Company, Inc.

The two companies will collaborate in sales, marketing, education, and research. The goal is to capture approximately 10% of the U.S. market share within three years.

Hugel recently announced the launch of Letybo at “The Aesthetic Show in Las Vegas at the Wynn.” The initial production for the U.S. launch has been completed, with the first set of shipment scheduled for the end of July, followed by the full-scale sales.

 “We are confident that Hugel’s established track record in South Korea, coupled with BENEV’s network, will resonate well with the U.S. market,” says Ethan Min, CEO of BENEV, in a news release.  “We will prioritize quality, broaden choices for medical professionals, and provide superior experiences and accessibility to the consumers.”

FDA, EMA Accept BLA for New Stelara Biosimilar

The U.S. Food and Drug Administration accepted the Biologics License Application (BLA) for Bio-Thera Solutions Inc. BAT2206, a proposed interchangeable biosimilar to Stelara (ustekinumab).

In addition, the European Medicines Agency (EMA) accepted the marketing authorization applications (MAA) for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA).

This BLA/MAA for BAT2206 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2206 was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2206 with both the EU and US reference ustekinumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2206 with ustekinumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with moderate to severe plaque psoriasis.

BAT2206 is a proposed biosimilar to Stelara which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23. Stelara is a currently approved treatment for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s, and moderately to severely active ulcerative colitis. In pediatric patients 6 years and older Stelara is currently approved for the treatment of 1) moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy and active psoriatic arthritis (PsA).

FDA Extends Dosage Allowance for Revyve Antimicrobial Wound Gel.

The US Food and Drug Administration (FDA) has increase Dosage Allowance of revyve Antimicrobial Wound Gel.

The FDA eliminated its usage limitation on the Company’s 510(k) clearance.  Prior to the removal of this restriction, there was a 90 grams/month limit to the amount of revyve product that could be administered to patients.

This now clears the way for the introduction and extended use of Kane’s revyve Antimicrobial Wound Gel Spray which is expected to be filled in spray cans in a higher quantity making it ideal for application on large wounds.