Latest news with #TsutomuNakagawa
Yahoo
5 days ago
- Business
- Yahoo
Knight Therapeutics and Sumitomo Pharma enter into Exclusive Licensing Agreements to commercialize Sumitomo's Canadian Portfolio
MONTREAL and MARLBOROUGH, Mass., June 05, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, and Sumitomo Pharma America Inc. ('SMPA') announced today that Knight and SMPA's affiliates have entered into exclusive license and supply agreements to commercialize MYFEMBREE® (relugolix/estradiol/norethindrone acetate), ORGOVYX® (relugolix) and vibegron in Canada, as well as an asset purchase agreement under which Knight will acquire certain mature products (the 'Mature Products', together with MYFEMBREE®, ORGOVYX® and vibegron, the 'Products'). For the year ended March 2025, the Products generated C$11.2 million in revenue. Under the terms of the agreements, Knight will have the exclusive rights to distribute, promote, market and sell the Products in Canada. Knight will begin commercial activities following a transition period from Sumitomo Pharma Canada. The consideration for the transaction includes an upfront amount of C$25.4 million and Knight may pay future contingent payments of up to C$15.75 million upon achieving certain sales milestones. In addition, Knight is expected to pay an estimated C$7 million for inventory to be acquired over the next eight months. 'We are pleased that Knight will continue to bring this suite of products to patients and health care providers throughout Canada,' said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. 'This divestiture is aligned with our long-term strategy to focus on and grow our core brands in the U.S. and to accelerate commercialization of our pipeline assets for oncology, regenerative medicine and cell therapy.' 'This transaction is another great example of our continued execution on our growth strategy of building a portfolio of innovative products,' said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc. 'MYFEMBREE®, ORGOVYX® and vibegron are highly synergistic with our current Canadian business in women's health with IMVEXXY® and BIJUVA®, as well as in urology and prostate cancer with TRELSTAR®. We look forward to expanding access to these innovative therapies to patients and healthcare providers.'Conference Call Notice Knight will host a conference call and audio webcast to discuss the acquisition on Thursday, June 5, 2025, at 8:30 am ET. Knight cordially invites all interested parties to participate in this call. Date: Thursday, June 5, 2025Time: 8:30 a.m. ETTelephone: Toll Free 1-888-699-1199 or International 1-416-945-7677Webcast: or WebcastThis is a listen-only audio webcast. Media Player is required to listen to the broadcast. Replay: An archived replay will be available for 30 days at About MYFEMBREE® MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg tablets) was approved by Health Canada in September 2023 making it the first oral prescription treatment for both the management of heavy menstrual bleeding associated with uterine fibroids and for the management of moderate to severe pain associated with endometriosis in pre-menopausal women. According to IQVIA, sales of MYFEMBREE® in Canada were approximately C$2.9 million in 2024. About ORGOVYX® (relugolix) ORGOVYX® (relugolix 120mg tablets) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by Health Canada in October 2023 for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX® blocks the pituitary GnRH receptor, thereby reducing the release of the luteinizing and follicle-stimulating hormones, and consequently reducing the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. According to IQVIA, sales of ORGOVYX® in Canada were approximately C$1.2 million in 2024. About Vibegron In the U.S., vibegron 75mg tablets (tradename GEMTESA®) has been indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. Vibegron works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase bladder capacity. About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at or Forward-Looking Statement This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. About Sumitomo Pharma Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA, MYFEMBREE and ORGOVYX are trademarks of Sumitomo Pharma Switzerland GmbH. For more information:Investor Contact for Knight Therapeutics Inc.: Knight Therapeutics Inc. Samira Sakhia Arvind Utchanah President & Chief Executive Officer Chief Financial Officer T: 514.484.4483 T. +598.2626.2344 F: 514.481.4116 Email: IR@ Email: IR@ Website: Website: For SMPA Thomas HillVice President, Head of Corporate Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
29-04-2025
- Health
- Associated Press
Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting
– Data include results from COURAGE Phase 3 and COMPOSUR Phase 4 studies of vibegron (GEMTESA®) – MARLBOROUGH, Mass., April 29, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) presented new, positive data from the COURAGE Phase 3 open-label extension study of vibegron (GEMTESA®) in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH). Data presented from the Phase 3 COURAGE trial (URO-901-3006) included a total of 276 men with OAB symptoms receiving pharmacological therapy for BPH who participated in the open-label extension study. The primary outcome was to evaluate the long-term safety of vibegron 75 mg, which was well tolerated for up to 52 weeks in men with symptoms of OAB who were receiving pharmacological treatment for BPH. The data reveal that the efficacy results of treatment with vibegron 75 mg a day were sustained among those receiving vibegron for 52 weeks and improved after 28 weeks of vibegron treatment for those who received placebo during the first 12 weeks of a double-blind placebo-controlled study (URO-901-3005). Sustained efficacy results in all secondary outcomes were observed, including mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-Storage and volume voided per micturition. Vibegron demonstrated favorable long-term safety and efficacy, with no new safety signals compared to prior OAB studies. At the conference SMPA also shared findings from the Phase 4 COMPOSUR, real-world study of vibegron in patients with OAB, which continue to support that it was generally safe and well-tolerated, with the majority of patients satisfied with treatment and remaining on vibegron after 12 months. Most common adverse events were urinary tract infection (4.0%), headache (2.7%), dizziness (2.2%) and diarrhea (2.0%). 'SMPA remains committed to advancing scientific innovation that helps the lives of the millions of patients suffering from OAB and receiving pharmacological therapy for BPH,' said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. 'These data continue to reaffirm vibegron's safety and tolerability.' Vibegron is approved for OAB with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and in December 2024, became the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. INDICATIONS AND USAGE GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of: Please click here for full Prescribing Information. About GEMTESA® (vibegron) In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA was approved on December 18, 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).7 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.1 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.4, 5 Even when the obstruction is alleviated by BPH treatment, unresolved symptoms of OAB may persist. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).4, 5 LUTS can be divided into storage, voiding, and postmicturition symptoms.8 More than half of men with LUTS report storage symptoms, and about a quarter report voiding symptoms.5 This suggests that many men with a diagnosis of BPH may have overactive bladder.5 About Sumitomo Pharma Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. The Sumitomo corporate symbol mark is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. ©2025 Sumitomo Pharma America, Inc. All rights reserved. References View original content to download multimedia: SOURCE Sumitomo Pharma America
Zawya
11-04-2025
- Politics
- Zawya
African Union Commission (AUC) Chairperson received H.E. Mr. Tsutomu Nakagawa, Ambassador of Japan to the African Union
The Chairperson of the AU Commission received H.E. Mr. Tsutomu Nakagawa, Ambassador of Japan to the African Union, for a productive exchange on strengthening AU–Japan relations. They discussed deepening bilateral cooperation, Japan's continued support to AU, including peace and security efforts, and preparations for the upcoming TICAD Summit. They agreed to establish a high-level policy dialogue mechanism to align Japan's support with the AU's strategic priorities and to identify concrete areas for enhanced collaboration. The Chairperson expressed appreciation for Japan's commitment to multilateralism, its direct support to AU-led initiatives, and longstanding trade and development partnerships with AU Member States. Ambassador Nakagawa conveyed an official invitation from the Government of Japan for the Chairperson to undertake a visit to Japan to further advance the strategic partnership. Distributed by APO Group on behalf of African Union (AU).
