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."
Jacobio Pharma | October 13, 2022
Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®.
This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.
"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck,"
Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio
JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.
ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells.
ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.
Astellas Pharma Inc. | September 30, 2022
Astellas Pharma Inc. announced the European Medicines Agency has accepted for regulatory review the company's marketing authorization application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2
"More than half of women 40 to 64 years of age experience hot flashes during menopause, with limited nonhormonal treatment options. The EMA's acceptance of our MAA for fezolinetant brings us one step closer to advancing a potential first-in-class nonhormonal treatment option for women in Europe who experience VMS associated with menopause, similar to the FDA acceptance of our NDA for women in the U.S."
Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas
The MAA is supported by results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across Europe, the U.S. and Canada. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant. Within the MAA, Astellas proposes a 45 mg daily dose, which is subject to the EMA's review.
Fezolinetant is an investigational nonhormonal selective neurokinin 3 receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.
This acceptance will have no impact on Astellas' financial forecasts of the current fiscal year ending March 31, 2023.
About the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.
About VMS Associated with Menopause
VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.1
Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.