Sumitovant Biopharma Ltd. | October 03, 2022
Sumitovant Biopharma Ltd. in conjunction with parent company Sumitomo Pharma Co., Ltd. announced it has submitted a non-binding proposal to the Audit Committee of the Board of Directors of Myovant Sciences Ltd. offering to acquire all outstanding shares of Myovant not already owned by Sumitovant for $22.75 per share in cash. The proposed transaction, if completed, would result in Myovant being delisted from the New York Stock Exchange.
The proposed acquisition consideration represents an equity value for Myovant of $2.4 billion and an enterprise value of $2.5 billion. The proposed per share consideration represents a premium of approximately 27% to Myovant's closing share price on September 30, 2022, and a premium of approximately 31% to the 60-day volume weighted average price of Myovant's shares through September 30, 2022.
The Proposal is a natural step in the well-established relationship between Sumitovant and Myovant, and represents an unprecedented opportunity to combine expertise, platforms, and resources to deliver innovative therapies addressing unmet patient needs in women's health and prostate cancer. Sumitovant and Sumitomo Pharma have been impressed with the culture and significant accomplishments of Myovant's employees. If a transaction is completed, we will continue to provide support and resources to Myovant to enable achievement of its mission to redefine care for the patients they so passionately serve.
Since the investment in Myovant in December 2019, both Sumitovant and Sumitomo Pharma have enjoyed a collaborative and successful relationship with Myovant that has facilitated the continued development and commercialization of Orgovyx® and Myfembree® in prostate cancer and women's health in and outside of the U.S. Further, Sumitovant and Sumitomo Pharma believe that the Proposal is financially compelling and will create significant and immediate value for Myovant's shareholders.
The Proposal provides that the proposed transaction will be subject to the approval of the shareholders of Myovant holding a majority of the shares not owned by Sumitovant.
In addition, Sumitovant and Sumitomo Pharma informed the Audit Committee in the Proposal that, in Sumitovant's capacity as a majority shareholder in Myovant, Sumitovant and Sumitomo Pharma are interested only in acquiring the shares of Myovant not already owned by Sumitovant and that in such capacity, Sumitovant has no interest in selling any of the Myovant shares it owns, nor would Sumitovant support any alternative sale, merger, or similar transaction involving Myovant.
The Proposal does not create any binding legal obligation between Sumitovant or Sumitomo Pharma and Myovant. Neither Sumitovant, Sumitomo Pharma nor Myovant will have any obligation or liability to the other with respect to a transaction unless and until definitive transaction documents are executed and delivered by the parties.
About Sumitovant Biopharma Ltd.
Sumitovant is a technology-driven biopharmaceutical company accelerating development and commercialization of new potential therapies for patients with rare conditions and other diseases. Through our proprietary computing and data platforms, scientific expertise and diverse company portfolio, Sumitovant has supported development of multiple FDA-approved products and a robust pipeline of early- through late-stage investigational assets addressing unmet patient needs in pediatrics, urology, oncology, women's health, specialty respiratory and infectious diseases. Sumitovant is a wholly owned subsidiary of Sumitomo Pharma.
About Sumitomo Pharma Co., Ltd.
Sumitomo 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 with about 7,000 employees worldwide. Sumitomo Pharma defines its corporate mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide."
Vetsource | November 17, 2022
Vetsource®, a pet health company designed to provide innovative pharmacy, technology and business services to those who care for pets, launched a new brand identity to signal the official start of three brands coming together as a single, unified portfolio of solutions for the veterinary industry.
Already established as a leading provider of innovative prescription management and home delivery services for veterinary practices and pet owners since 2008, Vetsource announced the acquisitions of VetSuccess, a data and analytics provider, and Vet2Pet, a client engagement system, in 2018 and 2019, respectively. Since the acquisitions, the three companies have largely worked together under Vetsource corporate, while still maintaining their separate identities, to allow time to formalize and ease the transition for customers.
Information about Vetsource's client engagement, and data and insights services can be found on Vetsource's new website at Vetsource.com, which received a complete redesign to reflect the company's rebrand and comprehensive solutions. The Vet2Pet and VetSuccess websites will be automatically redirected to Vetsource.com and will support access to customer logins.
"Adding client engagement, and data and insights, to the Vetsource portfolio allows us to leverage their combined strength to add greater value for the industry. Our goal is to foster strong relationships and positive experiences so veterinarians can focus on what they do best – caring for pets."
Kurt Green, Vetsource CEO
The product sign-in URLs will remain the same for all three products. The Vet2Pet name will be retained as a product name under Vetsource's client engagement services.
"There will be no disruption of service for any of our customers. They will receive the same support and access to services they always have," said Green. "When the companies joined, so too did the same innovative and talented team of people their customers know and trust. We're lucky to now count them as part of the Vetsource family."
VMX attendees can find Vetsource at booth #1230 exhibiting its prescription management, client engagement and data and insights solutions for the first time as one united brand.
Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and those who care for them. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement.
AbbVie | September 19, 2022
AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
"We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission. With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition."
Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie
AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study).1,2 Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.1,2,5-10 This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies.1,8,9 Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study.2,10 Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.1,2,8-13
"Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision."
Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.3,4 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.14,15
About the ADVANCE and MOTIVATE Inductions
Studies, and the FORTIFY Maintenance Study1,2,8-10
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of risankizumab 600 mg and 1200 mg as induction therapy, and risankizumab 180 mg and 360 mg as maintenance therapy in subjects with moderately to severely active Crohn's disease. Topline results of the ADVANCE and MOTIVATE induction studies were announced in January 2021 and topline results of the FORTIFY maintenance study were announced in June 2021.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.11,16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.11,16 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg prefilled syringe injections or one 150 mg prefilled pen or prefilled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.11 The use of risankizumab in Crohn's disease is not approved in the European Union and its safety remains under review with the global regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.12,13,17
EU Indications and Important Safety Information about SKYRIZI® (risankizumab)11
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.
SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.