With FDA Approval and Pfizer Deal in Hand, Myovant Appoints New CEO
Myovant CEO David Marek. Photo courtesy of Myovant.
After guiding Myovant to a successful FDA approval and inking a $4.2 billion deal with pharma giant Pfizer, Chief Executive Officer (CEO) Lynn Seely is bowing out to make room for the next chief, David Marek.
“Myovant is entering a critical phase of its growth where launch strategy, execution and commercial performance are essential to the overall success of the company,” Seely said in a statement.
Marek is coming to Myovant from his most recent role as Chief Commercial Officer (CCO) at Axsome. Before that, he spent over four years at Amgen where he piloted the highly successful launch of migraine drug Aimovig, including a commercialization partnership with Novartis. He also led the company’s commercial marketing for inflammation, nephrology and neuroscience.
“I am pleased to bring my years of experience to Myovant at this pivotal time as the company transitions to being a commercial-stage enterprise. Myovant has already earned a well-deserved reputation for developing therapies with the potential to redefine care for women and for men. I look forward to working with the experienced and talented Myovant team to further strengthen the company’s competitive position while driving growth and profitability,” said Marek, chief executive officer of Myovant Sciences, Inc. “I am also committed to assuring Myovant’s drug development engine continues to grow the company as we pursue purpose-driven science, empowering medicines, and transformative advocacy.”
“We just received an important approval from the FDA for ORGOVYX™ for adult patients with advanced prostate cancer and we have another important New Drug Application for relugolix combination tablet under review with the FDA for the treatment of women with uterine fibroids,” Seely said. “Seven days ago, we announced a transformational collaboration to develop and commercialize our relugolix franchise with our new partner, Pfizer. With the accomplishment of these important milestones, the board and I have decided to transition the leadership of Myovant to an executive with significant commercial expertise. I will be working closely with Dave and the rest of the Myovant board and executive team to ensure a seamless transition.”
The deal with Pfizer is huge for Myovant. Pfizer is paying Myovant an upfront payment of $650 million and $200 million in potential regulatory milestones, and tiered sales milestones after hitting specific thresholds up to $2.5 billion in net sales for prostate cancer and also for the combined women’s health indications. If Pfizer chooses to exercise the option in oncology outside the U.S. and Canada, it will pay Myovant another $50 million and double-digit sales royalties.
The FDA approved Orgovyx based on a Phase III trial that compared the drug to AbbVie’s injectable Lupron. In the trial, Myovant’s drug outperformed Abbvie’s by suppressing testosterone to castration levels in 96.7%, compared to their competitor’s 88.8%.
Also in the works is an NDA for the company's relugolix combination tablet for uterine fibroids. Target date is June 1. Couple that with the commercialization of Orgovyx and anticipation for another NDA submission for the relogolix tablet to treat endometriosis later in the year, and 2021 is already lining up to be an exciting one for Myovant.
Myrtle Potter, chairman of the board of Myovant Sciences, said “Under her [Seely’s] leadership, in less than five years, Myovant built a high-performing clinical development engine that has conducted five successful global Phase III trials, resulting in multiple NDA and other regulatory filings, with ORGOVYX earning priority review designation and approval from the FDA. Seely also led the effort that resulted in Myovant’s important strategic partnership with Pfizer.