Allogeneic processed Thymus Tissue

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. 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 more than 6,000 employees worldwide. Sumitomo Pharma defines its 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." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. 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Enzyvant Therapeutics (Enzyvant) and Altavant Sciences (Altavant) have announced a merger to form a biopharmaceutical company focused on accelerating the development of therapies for patients with rare diseases. The combined company, which retains the name Enzyvant, will have a full range of capabilities required to advance 'bold science' for rare diseases in immunology and cardiopulmonology. This includes the development of an in-house regenerative medicine manufacturing facility to serve the company’s commercial and clinical research needs for regenerative medicines. Financial terms of the deal have not yet been disclosed. Myrtle Potter, chief executive officer of Sumitovant Biopharma, of which both individual companies are wholly owned subsidiaries of, said: “There is an immense human need for rare disease therapies, but innovation in this field is complex. Enzyvant has a proven track record of bringing unique expertise to tackle some of the greatest unmet needs in the space. “We believe the combined company will be better positioned to deliver breakthroughs in a way that wouldn’t have been possible separately.” Enzyvant received approval from the US Food and Drug Administration in October 2021 for its first commercial product, Rethymic (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in paediatric patients with congenital athymia, a disease characterised by the absence of a functioning thymus. The thymus is an organ that sits on top of the heart and helps the body produce T-cells. Children with congenital athymia can face repeated infections and may also be affected by autoimmune conditions, both of which can be fatal. Rethymic, which has been studied across ten clinical trials for over 25 years, is engineered human thymus tissue designed to regenerate the thymic function children with congenital athymia are missing and does not require donor-recipient matching. The company is also currently evaluating an investigational product, rodatristat ethyl, which is designed to address a root cause of pulmonary arterial hypertension. Also commenting on the merger, Dr Bill Symonds, current chief executive officer of both Enzyvant and Altavant, who will also lead the merged company, said: “Together, our combined team has the proven expertise to take a product from early clinical development through commercialisation, and the passion and focus to drive accelerated development of urgently needed rare disease medicines in immunology and cardiopulmonology. “Patients and families facing very serious and difficult-to-treat rare conditions are the inspiration for our work and vital partners in moving our programs forward.”