New Haven-based biotech company Arvinas announced it has received U.S. Food and Drug Administration approval for its first marketed drug, a milestone for the publicly traded company as it moves from drug development toward commercialization.
The drug, VEPPANU, which Arvinas developed with Pfizer, was approved on May 1 to treat certain patients with advanced or metastatic breast cancer whose disease has progressed after prior endocrine therapy, according to the company’s first-quarter earnings release.
Arvinas also said it has entered into an agreement to license global rights to the drug to California-based Rigel Pharmaceuticals, which will assume responsibility for development, manufacturing and commercialization, pending regulatory approvals.
Arvinas Inc. CEO Randy Teel. Contributed
Founded in 2013, Arvinas is a New Haven-based publicly traded biotechnology company focused on developing treatments for cancer and other serious diseases. CEO Randy Teel, who took over earlier this year, described the approval as a significant event for the company.
Arvinas reported first-quarter revenue of $15.6 million, down from $188.8 million in the same period a year earlier, while posting a net loss of $57.6 million, compared with net income of $82.9 million in the year-ago quarter. The company said it had $614.9 million in cash, cash equivalents and marketable securities as of March 31.
The approval follows a turbulent period for the company, which has undergone leadership changes, workforce reductions and a broader strategic reset over the past year. Teel was named CEO in February, succeeding John Houston, while Arvinas last year announced layoffs and said it would seek an outside commercial partner for the breast cancer drug as part of efforts to streamline operations and sharpen its research focus.
