On May 21, 2020 Sumitovant Biopharma, Inc. reported that members of its family of five healthcare companies achieved multiple clinical and corporate milestones in the company’s first quarter of operation (Press release, Sumitovant Biopharma, MAY 21, 2020, View Source [SID1234558402]).

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"The Sumitovant family of companies continue to advance our pipeline with positive clinical trial results, multiple regulatory submissions, publication of data in major medical journals, an acquisition and a global commercialization agreement," said Myrtle Potter, CEO of Sumitovant Biopharma. "As a new company, we are pleased that our first quarter of operation has yielded progress on so many potential therapies for patients."

Clinical Highlights
On February 4th, Urovant Sciences announced the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder (OAB) from two double-blind, placebo-controlled randomized Phase 1 trials. The first trial was conducted with instillation therapy and the second trial with direct injections into the bladder wall under local anesthesia. The peer-reviewed publication was published online in Neurology and Urodynamics.

On February 10th, Myovant Sciences announced that the Phase 3 LIBERTY open-label extension study of once-daily, oral relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) demonstrated an 87.7% response rate at one year while maintaining bone mineral density.

On March 2nd, Urovant Sciences announced the publication of the efficacy and safety results of vibegron in patients with overactive bladder (OAB) from the international Phase 3 EMPOWUR trial. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the August issue of Journal of Urology.

On March 5th, Urovant Sciences announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

On March 9th, Myovant Sciences announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with moderate to severe symptoms associated with uterine fibroids. The two most common symptoms associated with uterine fibroids are heavy menstrual bleeding and pain.

Corporate Highlights
On January 8th, Altavant Sciences announced it had entered into a definitive agreement to acquire Onspira Therapeutics, a private drug development company similarly focused on therapeutics for rare pulmonary diseases. This acquisition expands Altavant’s pipeline to include OSP-101, a novel inhaled interleukin-1 receptor antagonist (IL-1Ra) with orphan drug designation from the U.S. Food and Drug Administration. OSP-101 is in preclinical development for the treatment of bronchiolitis obliterans syndrome (BOS), the leading non-infectious complication following lung transplantation and a major cause of death in these patients.

On March 31st, Myovant Sciences and Gedeon Richter Plc., a major pharmaceutical company in Central Eastern Europe focused on women’s health, announced that they have entered into an exclusive license agreement for Gedeon Richter to commercialize relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the agreement, Myovant will receive an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones and $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S., as well as rights to relugolix in other therapeutic areas outside of women’s health.