Arvinas and Pfizer Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Vepdegestrant, an Investigational PROTAC ER degrader being developed in ER+/HER2- Breast Cancer

Designation indicates entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP)

NEW HAVEN, Conn. and NEW YORK, July 31, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that the U.K. Innovative Licensing and Access Pathway Steering Group, which consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC), has awarded an Innovation Passport to vepdegestrant (ARV-471), an investigational PROTAC ER degrader, for the treatment of patients with estrogen receptor (ER)+/ human epidermal growth factor receptor (HER)2- locally-advanced breast cancer or metastatic breast cancer.

The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP). The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the U.K. The Innovation Passport application is the first step in the ILAP process, which activates the Medicines and Healthcare products Regulatory Agency (MHRA) and its partner agencies, including the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC) and to develop a roadmap for regulatory and development milestones.

“This esteemed acknowledgment underscores our commitment to advancing medicine and delivering transformative solutions for patients,” said John Houston, Ph.D., president and chief executive officer at Arvinas. “Arvinas is hopeful our investigational PROTAC ER degrader, vepdegestrant, will have the potential to be an endocrine therapy backbone for ER+/HER2-breast cancer."

“The Innovation Passport designation opens the door for Pfizer and Arvinas to discuss access considerations for potential future indications for vepdegestrant,” said Chris Boshoff, M.D., Ph.D., chief oncology research and development officer and executive vice president at Pfizer. “We look forward to an ongoing dialogue with regulators, health technology assessment agencies and other partners, supporting a timely review as we aim to bring this potential medicine to patients as quickly as possible.”