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Athenex Announces Additional Licensing Agreements for Tirbanibulin

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Athenex expands its international commercial partnerships for tirbanibulin in Australia, New Zealand and Canada

BUFFALO, N.Y., July 26, 2021 (GLOBE NEWSWIRE) -- 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, announced today 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.

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.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.

About Seqirus Pty Ltd

In Australia and New Zealand, Seqirus is a fully integrated pharmaceutical company operating with expertise in specialty and primary care pharmaceuticals and vaccines. Globally, Seqirus is the world’s largest influenza vaccine manufacturer. With extensive research and production expertise and manufacturing plants in the US, UK and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention of control of influenza globally. Seqirus has a workforce of over 3000 employees and a presence in 20 countries.

About AVIR Pharma Inc.

Avir Pharma Inc. is a wholly-owned, privately-held Canadian pharmaceutical company whose mission is to enhance the lives of Canadians through the acquisition, in-licensing and co-development of innovative, specialty pharmaceutical products. AVIR specializes in anti-infectives, gastroenterology, dermatology and pain management. Located in Blainville, Quebec, Avir Pharma Inc. is an affiliate of the Laboratoire Riva Group, an established company with over 40 years of experience in manufacturing, distributing and promoting pharmaceutical products in the Canadian marketplace. For more information, please visit the company’s web site at www.avirpharma.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to optimally design a new clinical study for oral paclitaxel in consultation with the FDA that is capital efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Athenex Contacts

Investors:

Daniel Lang, MD
Athenex, Inc.
Email: danlang@athenex.com

Tim McCarthy
LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com

References

[1] Lucas R, McMichael T, Smith W, Armstrong B. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006.

[2] Schmitt JV, Miot HA. Actinic keratosis: a clinical and epidemiological revision. An Bras Dermatol. 2012;87(3): 425-434.