Innovative drug blockbuster! Arvinas (ARVN.US) collaborates with Pfizer Inc. (PFE.US) to advance the third-party commercialization of "breast cancer ER degrader."
Arvinas and Pfizer will transfer the commercialization rights of the anticancer asset vepdegestrant.
The American biotechnology newcomer Arvinas (ARVN.US) and its partner pharmaceutical giant Pfizer Inc. (PFE.US) have decided to out-license the commercialization rights of the blockbuster innovative drug vepdegestrant - that is, they have decided to out-license the commercialization rights of the drug to a third party, which is an investigational estrogen receptor protein degrader (ER degrader) for breast cancer. Its approval application was submitted to the U.S. Food and Drug Administration (FDA) in June.
Arvinas stated in a press release that outsourcing the commercialization to a third party is "the best path forward to unlock the full value of vepdegestrant and ensure timely market supply upon regulatory approval."
Arvinas and Pfizer Inc. jointly announced that they have decided to grant a third party (licensee) the rights to develop, manufacture, market/commercialize their product, technology, or intellectual property, with the other party driving and paying upfront, milestone payments, royalties, and other returns as agreed. This practice is common in the global pharmaceutical industry, such as out-licensing the commercialization rights of a drug in specific regions or globally.
Arvinas mentioned that due to significant changes in the vepdegestrant project, the company will reduce its workforce by 15%, seek larger strategic business development opportunities, and identify more efficiency improvement spaces.
According to available information, the company has three important candidate drugs in Phase I clinical trials: ARV-102 (mainly for progressive supranuclear palsy and Parkinson's disease); ARV-393 (for non-Hodgkin lymphoma); and ARV-806 (for solid tumor malignancies).
What is the background of the biotechnology newcomer Arvinas? What is the buzz surrounding vepdegestrant?
Based in the United States, the clinical-stage biotechnology company Arvinas with the Nasdaq code ARVN focuses on targeted protein degradation (TPD) and uses its proprietary PROTAC platform to create a "new class" of drugs, advancing pipelines in areas like oncology, collaborating on development and commercialization - such as the partnership with Pfizer Inc. on a breast cancer project, with the innovative drug vepdegestrant being Arvinas' flagship innovative drug project and primary value driver at present.
Vepdegestrant (ARV-471) is an oral estrogen receptor (ER) degrader PROTAC used for ER+/HER2- locally advanced or metastatic breast cancer; one end of the molecule binds to ER while the other recruits an E3 ubiquitin ligase (such as cereblon), inducing ER ubiquitination and degradation by the proteasome.
The latest information shows that vepdegestrant has received FDA fast track designation; the NDA (New Drug Application) was submitted and accepted by the FDA for review by 2025, entering the review stage in August - it is the closest project for Arvinas to market, currently still under review; Arvinas/Pfizer Inc. recently decided to out-license its commercialization rights. Vepdegestrant is an oral PROTAC (targeted protein degradation) estrogen receptor degrader that tags ER for degradation through binding E3 ligase and clearing it by the proteasome, which is fundamentally different from traditional SERDs/antagonists that "merely block the receptor," representing a breakthrough in innovative drug types.
Related Articles

Guangdong Taienkang Pharmaceutical (301263.SZ): The application for the registration and listing approval of sulfamethoxazole tablets has been accepted.

SoftBank (SFTBY.US) and OpenAI's Japan AI joint venture plan has been reported to be delayed, with new developments expected to be announced in November.

Guotai Haitong: Initiates "buy" rating on BEST PACIFIC (02111) with a target price of HK$4.42.
Guangdong Taienkang Pharmaceutical (301263.SZ): The application for the registration and listing approval of sulfamethoxazole tablets has been accepted.

SoftBank (SFTBY.US) and OpenAI's Japan AI joint venture plan has been reported to be delayed, with new developments expected to be announced in November.

Guotai Haitong: Initiates "buy" rating on BEST PACIFIC (02111) with a target price of HK$4.42.
