PDUFA date of December 30, 2020

BUFFALO, NY, USA I March 09, 2020 I 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 U.S. Food and Drug Administration (FDA) has completed its filing review and determined that the Company’s New Drug Application (NDA) for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment) for the treatment of actinic keratosis (AK) is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 30, 2020.  Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application.

“We are delighted by the FDA’s acceptance for filing of the NDA for tirbanibulin ointment, which was submitted in late December 2019,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “It marks an important step towards bringing this valuable treatment option to AK patients and we look forward to working with the FDA during the review process towards potential approval.”

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, also stated, “Tirbanibulin is the first compound to come out of our discovery program, and this represents a significant milestone as the first NDA filing for our company. We would like to thank our team for their hard work and dedication, especially in making the submission ahead of schedule. We are excited to continue collaborating with our partner, Almirall, to prepare for the potential commercial launch of tirbanibulin ointment for AK in the U.S.”

The tirbanibulin ointment NDA includes data from two positive pivotal Phase III studies of tirbanibulin ointment 1% in actinic keratosis. As previously reported, the studies achieved the primary endpoint of 100% clearance of the AK lesions on Day 57 within the face or scalp treatment areas. Safety results showed that tirbanibulin ointment was well tolerated, with few adverse events. 

Athenex and Almirall, S.A. entered into a license agreement in which Athenex granted Almirall an exclusive license to research, develop and commercialize tirbanibulin ointment in the U.S. and European countries, including Russia. Almirall will employ its expertise to support the development in Europe and commercialize the product in the defined territories. 

About the Phase III Clinical Program of Tirbanibulin Ointment
Two double-blind, randomized, vehicle-controlled, parallel group, multi-center studies (KX-AK-003 and KX-AK-004) were designed to support the registration of tirbanibulin ointment as field therapy for AK of the face or scalp.  The studies enrolled a total of 702 patients across 62 sites in the US. Tirbanibulin ointment 1% or vehicle (randomized 1:1) was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days.

About Actinic Keratosis
Actinic Keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly or crusty skin. Left untreated, the lesions may progress to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. AK is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans, and accounts for between 14-29% of dermatologist visits in the U.S.1

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 platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), 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.  Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit www.athenex.com.

SOURCE: Athenex