Thanks to Myovant Sciences GmbH’s potential $4.2 billion deal with Pfizer Inc. for recently approved Orgovyx (relugolix) in prostate cancer (PC), more physicians are going to be learning about [the compound] faster,” said chief commercial officer Adele Gulfo. “This is going to create huge demand.”

Basel, Switzerland-based Myovant disclosed an arrangement with Pfizer, of New York, to develop the compound in oncology and women’s health in the U.S. and Canada. The FDA gave its go-ahead to Orgovyx on Dec. 18 for adults with advanced PC – the first and only, once-daily oral GnRH antagonist for the disease. U.S. regulators are reviewing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for uterine fibroids, and have set the PDUFA date as June 1, 2021. The combo pill is in the works for endometriosis as well, with an NDA expected in the first half of 2021.

Myovant is banking $650 million up front from Pfizer. Regulatory and sales milestone payments could hike the value to $4.2 billion, including $200 million in potential regulatory rewards for FDA approvals of the relugolix combo tablet in women’s health, plus tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for PC, as well as for achievements in the combined women’s health indications. Pfizer also gets an exclusive option to commercialize relugolix in cancer outside the U.S. and Canada, excluding certain Asian countries. If that option is exercised, Myovant will take delivery of $50 million and stands to reap double-digit royalties.

The two firms will jointly develop and sell Orgovyx in PC and, if approved, the combo tablet in women’s health in the U.S. and Canada. Early next year, they will begin co-promoting Orgovyx for PC – a nice fit with Pfizer’s already available Xtandi (enzalutamide), the androgen receptor inhibitor partnered with Tokyo-based Astellas Pharma Inc. that was first green-lighted by the FDA in the summer of 2012 for late-stage, castration-resistant PC. Myovant and Pfizer will split profits and certain expenses for Orgovyx and the combo tablet, with Myovant recording revenues. Continuing to lead clinical development for the combo product, Myovant also remains responsible for regulatory interactions and drug supply.

Gulfo said during a conference call with investors that the tie-up with Pfizer “impacts how the payers think about reimbursement. Our plans remain the same in terms of when coverage will come online. Key commercial plans will probably make their coverage decisions beginning in the first quarter of 2021.” The prospect of adding Orgovyx to the mix “could only help expedite their thinking and their actual committing to bringing those plans online.” The setup “will also help us as we think about on the Medicare side, the opportunity for medical exceptions by having more physicians write [prescriptions for] the drug,” she said. As more patients are prescribed Orgovyx, more will want the treatment. “That all has a very powerful effect.”

Doctors will diagnose more than 190,000 cases of PC in the U.S. this year, estimates the American Cancer Society. Specifically, Orgovyx works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thereby knocking down testosterone. PC treatments largely have involved androgen deprivation therapy (ADT); it’s injected or placed as small implants under the skin. The reduction of clinic visits with the Myovant drug could be particularly important during the COVID-19 pandemic, officials have noted. In his Dec. 21 report, J.P. Morgan analyst Eric Joseph said his firm sees Orgovyx “becoming the preferred ADT backbone therapy in the hormone-sensitive segment over the longer term.”

Sumitomo cash still available, too

Evercore ISI analyst likes the Pfizer deal, after mulling over the terms. “While It gives up half the economics of relugolix (which we hadn’t modeled), that’s adequately offset by adding Pfizer’s commercial efforts as well as the billions of [dollars in] milestones which we think are achievable.” He reiterated is outperform rating and $55 price target for Myovant, “one of our top midcap picks.” Shares (NASDAQ:MYOV) closed at $29.58, up $6.83, or 30%.

Cowen’s Phil Nadeau is on board. “We are pleased that Myovant has found a capable partner ahead of relugolix's launches,” he wrote in a report. “By drawing on Pfizer's commercial strength in prostate cancer and women's health, relugolix will be better positioned to rapidly penetrate these competitive markets. We expect that the greater reach and frequency of interactions with physicians now possible through Pfizer's existing networks will create greater demand for relugolix in the near-term, and allow it to compete with [North Chicago-based Abbvie Inc.] more effectively over the long haul.”

Abbvie’s Orilissa (elagolix) is an orally administered GnRH antagonist for the management of moderate to severe pain associated with endometriosis. Orilissa was discovered and advanced through the clinic by Neurocrine Biosciences Inc., then co-developed from phase III to approval in partnership with Abbvie in a $575 million deal that provided Abbvie with global commercialization rights.

This summer, Myovant disclosed a $200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma Co. Ltd., bringing the firm’s total financing support for Myovant to $600 million. Myovant also said it signed a three-year commercial collaboration agreement with Sunovion Pharmaceuticals Inc., an indirect, wholly-owned subsidiary of Sumitomo, for services to support the commercialization of relugolix. Under the agreement, Sunovion provides third-party logistics, trade and retail distribution, contract operations, and market access account management services to Myovant, becoming a non-exclusive distributor of relugolix for prostate cancer and the exclusive distributor of relugolix combo tablet for fibroids and endometriosis in the U.S.

Frank Karbe, principal finance and accounting officer, said during the conference call that Myovant has “remaining financing commitments available to us under the existing financing facility [from Sumitomo], and those amounts remain available to us. Whether or not we use them is at our discretion. We'll see where we land there, but clearly, of course, our financial situation has been greatly enhanced, most notably through the $650 million up-front payment.” He added that, “given the proximity of our launches, the relationship with Sunovion here is not impacted.”

prostate_cancer_targetscape_12-28