On July 26, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company has entered into licensing agreements and strategic partnerships with Seqirus Pty Ltd ("Seqirus"), a subsidiary of CSL Limited, and AVIR Pharma Inc. ("AVIR") for tirbanibulin (Press release, Athenex, JUL 26, 2021, View Source [SID1234585172]).

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Under the terms of the agreements, Seqirus will have an exclusive license to commercialize tirbanibulin in Australia and New Zealand, and AVIR will have an exclusive license to commercialize tirbanibulin in Canada.

The addition of these territories enhances the global coverage of the marketing and sales of Klisyri (tirbanibulin ointment) for the treatment of actinic keratosis (AK). Athenex currently has strategic partnerships for tirbanibulin in the U.S., Europe, China, Taiwan, Japan and now also Australia, New Zealand and Canada, among several other territories. In addition to upfront payments and milestone payments, the royalty/transfer prices generally range from 15% to 30% of annual sales across different territories.

"These new partnerships with Seqirus and AVIR will expand tirbanibulin access to more patients around the world," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Tirbanibulin, or Klisyri, is approved and launched in the United States for the treatment of actinic keratosis of the face or scalp, and is a significant step forward because of its short treatment protocol, proven efficacy, and favorable safety profile. Klisyri has recently also received approval for marketing by the European Commission. The expansion of our international partnerships represents an important step in Athenex’s strategy to optimize the potential value of this important drug and create value for our stakeholders."

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action. Athenex received approval from the U.S. Food and Drug Administration for the commercialization of tirbanibulin, under the brand name Klisyri, for the topical treatment of AK of the face or scalp. Klisyri was launched in the U.S. in February 2021, led by the Company’s partner, Almirall. In July, Almirall received European Commission approval of Klisyri (tirbanibulin) for the topical treatment of AK of the face or scalp, which followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in May.

"We are delighted to collaborate with Athenex to commercialize KlisyriTM in Australia and New Zealand," said Dani Dowell, Seqirus Head of Commercial Australia and New Zealand. "This is an exciting opportunity, building on Seqirus’ strong presence as a successful in-license partner in Australia and New Zealand. The addition of Klisyri will broaden our portfolio and is another example of our work to deliver innovative offerings to meet unmet patient need."

Actinic keratosis is one of the most common diagnoses in dermatology practices.[1] Australia has one of the highest prevalence of AK, with an estimated prevalence of 40-50% in the Australian Caucasian population over 40 years of age.[2] Treatment is a critical aspect in the management of the disease as it may progress to invasive skin squamous cell carcinoma.