Sumitovant Biopharma Highlights Strong First Fiscal Quarter of 2021 with Significant Commercial and Clinical Achievements Across its Portfolio of Companies
- Urovant,a wholly-owned subsidiary of Sumitovant, announced commercial availability of GEMTESA® (vibegron) to treat overactive bladder
- Myovant, a publicly-listed company that is majority-owned by Sumitovant, and its partner, Pfizer, announced the Food and Drug Administration (FDA) approval of MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids in premenopausal women
LONDON and NEW YORK, September 16, 2021 – Sumitovant Biopharma’s portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant Sciences (NYSE: MYOV), a publicly-listed company that is majority-owned by Sumitovant, achieved significant clinical and corporate milestones in the Company’s first quarter of fiscal year 2021.
“We were excited to see significant regulatory and clinical progress across the Sumitovant portfolio of companies during the Company’s first fiscal quarter, including both the commercial launch of GEMTESA® to treat overactive bladder and the FDA approval and commercial launch of MYFEMBREE® for women with uterine fibroids,” said Myrtle Potter, CEO of Sumitovant Biopharma. “In addition to bringing important therapies to market to address areas with high unmet patient need, we also made significant advancements in the clinical research program and scientific exchange area for rodatristat ethyl, Altavant’s lead candidate to treat pulmonary arterial hypertension (PAH).”
On April 12, 2021, Myovant Sciences and its collaboration partner, Pfizer Inc., announced the first participant was dosed in the Phase 3 SERENE study evaluating MYFEMBREE for the prevention of pregnancy. On May 18, 2021, the U.S. Food and Drug Administration (FDA) informed Myovant that they placed a partial clinical hold on the SERENE study. In July 2021, Myovant provided to the FDA an amended study protocol for the SERENE study. Following Myovant’s discussions with the FDA, Myovant expects the partial clinical hold to be lifted in August 2021.
On April 15, 2021, Urovant Sciences announced the Journal of Urology published positive safety and efficacy data from the GEMTESA® (vibegron) double-blind 40-week extension study with patient data over a total exposure of 52 weeks.
On April 26, 2021, Altavant presented results of in vitro and in vivo studies for nebulized ALTA-2530, which is in nonclinical development for treatment of bronchiolitis obliterans syndrome (BOS). These studies demonstrated ALTA-2530 achieved and maintained pharmacologically-relevant exposure levels in lung epithelial lining fluid and distributed to epithelial cells of the lung’s distal airways.
In May 2021, Altavant presented an update on the clinical development of rodatristat ethyl, the company’s lead investigational candidate for the treatment of pulmonary arterial hypertension (PAH), at the annual meeting of the American Thoracic Society (ATS). This update included findings from a dose-response model, which simulated daily administration of rodatristat ethyl to identify optimal doses for the Phase 2b clinical trial.
On April 12, 2021, Urovant announced the commercial launch of GEMTESA® (vibegron) to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
On May 26, 2021, Myovant and Pfizer announced that the FDA approved MYFEMBREE as the first and only once-daily oral treatment to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. MYFEMBREE was launched in the U.S. by Myovant and Pfizer in mid-June 2021. Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.
On July 6, 2021, Myovant submitted a supplemental New Drug Application (NDA) to the FDA for once-daily MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In April and June 2020 and January 2021, Myovant reported positive results from the two replicate Phase 3 SPIRIT studies and the SPIRIT long-term extension study.
On July 16, 2021, the European Commission approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO is the first and only long-term, once-daily oral treatment for uterine fibroids in Europe and has no limitation on its duration of use. The approval was based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study. The commercial launch of RYEQO is being executed by Gedeon Richter, Myovant’s commercialization partner for RYEQO in Europe and certain other international markets.
On April 27, 2021, Enzyvant announced the resubmission of the Biologics Licensing Application (BLA) to the FDA for RVT-802, cultured human thymus tissue. RVT-802 is a one-time tissue-based regenerative therapy for the treatment of pediatric patients with congenital athymia.
On May 3, 2021, Aceragen, Inc. announced the acquisition of Enzyvant’s RVT-801 (now ACG-801), an investigational enzyme replacement therapy for acid ceramidase deficiency presenting as Farber disease.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved product GEMTESA® for overactive bladder and has advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is the majority-shareholder of Myovant (NYSE: MYOV) whose marketed products include ORGOVYX® for advanced prostate cancer and MYFEMBREE® for uterine fibroids. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.
About Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530’s unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies.
Altavant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com.
About Enzyvant Therapeutics
Enzyvant, a wholly-owned subsidiary of Sumitovant Biopharma Ltd. is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. Enzyvant’s lead asset is the investigational tissue-based regenerative therapy, RVT-802, for congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. RVT-802 has been granted multiple regulatory designations, including the U.S. Food and Drug Administration designation as a Regenerative Medicine Advanced Therapy (RMAT). The RVT-802 Biologics Licensing Application (BLA) was resubmitted this year and the expected action date provided by the FDA under the Prescription Drug User Fee Act (PDUFA) is October 8, 2021. The European Medicines Agency (EMA) has granted Orphan Drug designations and the Advanced Therapy Medicinal Product (ATMP) designation for RVT-802. For more information about Enzyvant, visit Enzyvant.com. Follow @Enzyvant on Twitter, Facebook, and LinkedIn.
About Spirovant Sciences, Inc.
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. More information is available at https://www.spirovant.com/.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 to treat adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated to treat OAB in men with benign prostatic hyperplasia (OAB+BPH). The company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.
About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in 2021 in the U.S. as MYFEMBREE® as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, and by the European Commission as RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The therapy has also completed Phase 3 registration-enabling studies for women with endometriosis and is being assessed for the prevention of pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is a majority shareholder. For more information, please visit Myovant’s website at www.myovant.com.
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months.
MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.
For full prescribing information including Boxed Warning and patient information, please click here.
Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.
Important Safety Information
BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS
Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.
MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.
MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.
Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.
Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.
Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.
Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.
Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.
Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.
Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.
Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.
Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.
Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.
Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.
Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.
Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.
P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.
Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.
Advise women not to breastfeed while taking MYFEMBREE.
For more information with respect to Myovant Sciences, including disclosure regarding the risks and uncertainties related to any forward-looking statements, please refer to Myovant Sciences’ filings with the United States Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on July 28, 2021, as such risk factors may be amended, supplemented or superseded from time to time.
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