Solasia Pharma: DARVIAS ® Injection 135mg (Generic Name: DARINAPARSIN /Development Code: SP-02) Approved in Japan
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) officially announced today that an organoarsenic drug “DARVIAS® Injection 135mg” (SP-02, hereinafter DARVIAS®) has been approved for relapsed or refractory Peripheral T-Cell Lymphoma (hereinafter “PTCL”) by the Ministry of Health, Labor and Welfare (MHLW). Solasia filed an NDA with the MHLW in Japan in June 2021. In October 2021, Nippon Kayaku Co., Ltd. (TSE: 4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto) secured a license agreement with DARVIAS® for marketing rights in Japan.
DARVIAS®, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. DARVIAS® is believed to exert an anticancer effect by inducing cell cycle arrest and apoptosis. This approval is based on the result of an Asian Multinational phase II study of SP-02 in patients with relapsed or refractory PTCL, Japan being the first country in the world where it was approved.
Mr. Yoshihiro Arai, President and CEO of Solasia, commented for this approval as follows:
Since its founding, we have been focusing on developing new treatment options that solve the quality of life of patients in the treatment of cancer that affects one in two Japanese people. The two products, episil® Oral Solution and Sancuso®, which have been successfully developed so far, are not for the treatment of cancer itself, but used as supportive care such as suppression of nausea / vomiting caused by chemotherapy and alleviation of pain associated with oral mucositis caused by chemotherapy and radiotherapy. DARVIAS® is our first NDA approved anticancer drug. Nippon Kayaku is our commercial partner with strengths in the field of oncology. We are very pleased to have this opportunity to deliver DARVIAS® to nationwide medical institutions providing new cancer treatment by utilizing Nippon Kayaku’s extensive experience in oncology and contribute to the treatment of patients suffering from PTCL.
About DARVIAS®
DARVIAS®, an organoarsenic drug, is a novel anticancer agent targeting mitochondria.
DARVIAS® provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. In addition to the PTCL, it has been suggested that potential target indications be other hematologic cancers (lymphoma, leukemia), and solid tumors. Regarding future expansion of indications, Solasia will explore clinical development strategies in consultation with Nippon Kayaku. DARVIAS® has been granted orphan drug designation in the US and EU.
About Solasia
Solasia is a specialty pharmaceutical company based in Asia, with a mission to provide “Better Medicine for a Brighter Tomorrow.” To address the unmet medical needs in the oncology field, Solasia develops innovative medicines to contribute to the better health and brighter future of patients. Please visit the company website at https://solasia.co.jp/en/ for more information.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220620005030/en/
Contact information
Solasia Pharma K.K.
Toyokazu Ohata, Public Relations and Investor Relations,
Tel. +81 3 5843 8045
info@solasia.co.jp
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Kinaxis Positioned Highest on Ability to Execute in the Gartner® Magic Quadrant™ for Supply Chain Planning Solutions26.4.2024 18:03:00 CEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain orchestration, today announced it has been named a Leader in the 2024 Gartner® Magic Quadrant™ for Supply Chain Planning Solutions. Of the 20 vendors evaluated, Gartner positioned Kinaxis highest on Ability to Execute, marking the company’s 10th consecutive Leaders Quadrant within the report, a complimentary copy of which can be downloaded here. Kinaxis attributes its position to its patented concurrency approach and a proven track record of delivering innovative solutions against the foundation of its leading vision through the use of advanced technology such as AI, ML, and an intuitive user experience. Bolstered by a rich ecosystem of third-party implementation partners, Kinaxis continues to demonstrate that regardless of a customer’s industry, size, or maturity level, the company can be counted on to seamlessly orchestrate supply chain networks end-to-end from strategic planning to last-mile delivery. The recognitio
Vertex Announces European Commission Approval for KALYDECO ® to Treat Infants With Cystic Fibrosis Ages 1 Month and Older26.4.2024 17:43:00 CEST | Press release
Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Commission has granted approval for the label expansion of KALYDECO® (ivacaftor) for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. “Today’s approval is an important milestone for the cystic fibrosis community. Treating CF early in life can potentially slow the progression of the disease, which is why it is so important to start treatment from a very young age,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex. As a result of existing access agreements in Austria, Czech Republic, Denmark, Ireland, Norway, Sweden, and The Netherlands, eligible patients will have access to the expanded indication of KALYDECO® (ivacaftor)
Suzano 2023 annual report on Form 20-F26.4.2024 17:22:00 CEST | Press release
Suzano S.A. (B3: SUZB3 | NYSE: SUZ) informs that its 2023 Annual Report on Form 20-F was filed today with the U.S. Securities and Exchange Commission. Holders of the Company’s equity securities can receive hard copies of the Annual Report, including its audited financial statements, without charge by request directed to: ri@suzano.com.br. This document is also available on Suzano’s website (http://ir.suzano.com.br/). For further information, please contact our Investor Relations Department: Phone: (+55 11) 3503-9330 E-mail: ri@suzano.com.br View source version on businesswire.com: https://www.businesswire.com/news/home/20240426289818/en/Contact information Hawthorn Advisors suzano@hawthornadvisors.com
Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer26.4.2024 14:30:00 CEST | Press release
Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2 “People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes. With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new
MEDIA ALERT: Wolters Kluwer expert comments on European Parliament vote to pass amendment implementing Basel III reforms26.4.2024 14:00:00 CEST | Press release
The European financial landscape saw a milestone event this week, as the EU Parliament passed the Amendment to Regulation (EU) No 575/2013, implementing the Basel III finalization within Europe. This monumental step forward comes with the adoption of the Capital Requirements Regulation (CRR3) amendments, which are part of a broader legislative package, including amendments to Directive 2013/36/EU, known as the Capital Requirements Directive or CRD. Jeroen Van Doorsselaere, Vice President of Global Product & Platform Management, Wolters Kluwer FRR, said: “The adoption of the Capital Requirements Regulation (CRR3) amendments represents a landmark change for the banking industry, designed to strengthen the framework for risk-based capital requirements and address ESG risks. “This is a major overhaul of the capital requirements framework, impacting various aspects, including credit risk, operational risk, market risk, and the capital floor. Whereas other significant jurisdictions, includin