NY-VIVET/PFIZER
Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that they have entered into a manufacturing agreement, under which Pfizer will provide clinical supply for a Phase 1/2 clinical trial evaluating Vivet’s proprietary, investigational gene therapy, VTX-801, for the potential treatment of Wilson disease, a rare and potentially life-threatening liver disorder. The trial is expected to commence in early 2021. Terms of the agreement were not disclosed.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005790/en/
In March 2019, the companies announced that Pfizer had acquired a minority equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. The companies also announced that they would collaborate on the development of VTX-801, for which an Investigational New Drug (IND) application is planned to be filed with the U.S. Food and Drug Administration (FDA) in 2020.
“The manufacture of potentially transformative gene therapy technologies is an incredibly complex undertaking, and we are hopeful that this key milestone further strengthens our relationship with Pfizer while ensuring the long-term development of VTX-801,” said Jean-Philippe Combal, Co-Founder & CEO of Vivet Therapeutics.
The Phase 1/2 clinical supply for VTX-801 will be manufactured in Pfizer’s facility in Chapel Hill, North Carolina. In recent years, Pfizer has made significant investments in the company’s gene therapy manufacturing facilities in North Carolina to strengthen its ability to produce both clinical and commercial scale quantities of gene therapies for patients living with rare diseases around the world.
“We are proud of the significant progress made to date in our gene therapy manufacturing capabilities, and this milestone in our relationship with Vivet underscores the importance of our strategic investments in end-to-end gene therapy research and supply, to support the timely delivery of these important new therapies for patients,” said Seng Cheng, Chief Scientific Officer, Rare Disease Research Unit, Pfizer.
About Vivet Therapeutics
Vivet Therapeutics is an emerging biotechnology company developing novel gene therapy treatments for rare, inherited metabolic diseases.
Vivet is building a diversified gene therapy pipeline based on novel adeno-associated virus (AAV) technologies developed through its partnerships with, and exclusive licenses from, the Fundación para la Investigación Médica Aplicada (FIMA), a not-for-profit foundation at the Centro de Investigación Medica Aplicada (CIMA), University of Navarra based in Pamplona, Spain.
Vivet’s lead program, VTX-801, is a novel investigational gene therapy for Wilson disease which has been granted Orphan Drug Designation (ODD) by the Food and Drug Administration (FDA) and the European
Commission (EC). This rare genetic disorder is caused by mutations in the gene encoding the ATP7B protein, which reduces the ability of the liver and other tissues to regulate copper levels causing severe hepatic damages, neurologic symptoms and potentially death.
Vivet’s second gene therapy product, VTX-803 for PFIC3, received US and European Orphan Drug Designation in May 2020.
Vivet is supported by international life science investors including Novartis Venture Fund, Roche Venture Fund, HealthCap, Pfizer Inc., Columbus Venture Partners, Ysios Capital, Kurma Partners and Idinvest Partners.
Please visit us on www.vivet-therapeutics.com and follow us on Twitter at @Vivet_tx and LinkedIn.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Pfizer Disclosure Notice
The information contained in this release is as of September 23, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a manufacturing agreement between Pfizer and Vivet Therapeutics (Vivet), Vivet’s investigational gene therapy, VTX-801, and Pfizer’s collaboration with Vivet on the development of VTX-801, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the ability to realize the anticipated benefits of the transaction, including the possibility that the expected benefits from the transaction will not be realized or will not be realized in the expected time; the uncertainties
inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed in any jurisdiction for VTX-801; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether VTX-801 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VTX-801; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20200922005790/en/
About Business Wire
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 Announces Normal Course Issuer Bid5.11.2025 23:00:00 CET | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX: KXS) is pleased to announce that the Toronto Stock Exchange (the “TSX”) has accepted a notice (the “Notice”) filed by the Company of its intention to make a normal course issuer bid (the “NCIB”). In connection with the NCIB, the Company has entered into an automatic share purchase plan (an “ASPP”) with its designated broker to allow for purchases of its common shares (the “Shares”). The Notice provides that the Company may, during the 12-month period commencing November 12, 2025 and ending November 11, 2026, or on such earlier date as Kinaxis completes its purchases or provides notice of termination, purchase up to 1,403,042 Shares in total, representing approximately 5% of the issued and outstanding Shares as at October 31, 2025. As of the close of business on October 31, 2025, the Company had 28,060,844 Shares issued and outstanding. Except for block purchases permitted under the rules of the TSX, the number of Shares to be purchased p
Hyper® Wins Dual CES 2026 Innovation Awards® for its Breakthrough Tech Accessories5.11.2025 22:45:00 CET | Press release
Hyper’s HyperSpace™ Trackpad Pro and HyperDrive® Next USB4 M.2 PCIe Enclosure named as CES Innovation Awards® 2026 Honorees Hyper®, a leader in mobile tech accessories for creators and power users, today announced it has been honored with two CES2026 Innovation Awards® in the Consumer Peripherals and Accessories category. These awards reflect Hyper’s mission to build breakthrough solutions that help users create, connect, and go beyond the limits of their devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105297377/en/ CES Innovation Awards® 2026 Honorees: HyperSpace™ Trackpad Pro and HyperDrive® Next redefine haptics, personalization, and next-gen USB4 V2 speed. The CES Innovation Awards program is an annual competition that honors the most innovative, new products in consumer technology, recognizing top innovations across multiple categories. “For 20 years, Hyper has led the tech accessory space with industry-defin
CWAN Reports 800+ AI Agents Now Available for Deployment Across $10 Trillion in Client Assets5.11.2025 22:15:00 CET | Press release
Global institutions deploy CWAN GenAI agents that can scale to millions of daily tasks across reconciliation, reporting, and portfolio management Clearwater Analytics (NYSE: CWAN), the most comprehensive technology platform for investment management, today announced the global deployment of CWAN GenAI, a newly-launched, embedded generative AI platform that can be deployed to transform investment management, risk management, reporting and operations across more than $10 trillion in institutional assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105092732/en/ What sets CWAN GenAI apart from the experimental AI tools flooding the market is its production-ready integration. Unlike copilots or chat tools layered onto legacy systems, CWAN GenAI is fully integrated and deployed into production on CWAN’s front-to-back platform, enabling clients to work alongside AI as collaborative partners in their investment operations. Th
IonQ and Swiss Consortium Launch First Citywide Dedicated Quantum Network in Geneva5.11.2025 22:04:00 CET | Press release
Landmark public-private initiative includes CERN, Rolex SA, Swiss government and academic institutionsDelivers world-class quantum infrastructure to support research, collaboration, and quantum tech awareness IonQ (NYSE: IONQ), the world’s leading quantum company, with luminary Swiss partners, successfully deployed a citywide quantum network in Geneva, Switzerland. This consortium of world-class academic, enterprise, and public institutions will advance quantum cybersecurity and communications research, collaboration, and innovation. The new infrastructure, named the Geneva Quantum Network (GQN), is the nation’s first dedicated quantum network connecting key institutions across the region. “Our involvement in the GQN alongside globally-renowned companies such as Rolex and research leaders like CERN, underscores our IP and pioneering leadership in quantum cybersecurity and communication,” said Niccolo de Masi, Chairman and CEO of IonQ. “IonQ is leveraging existing fiber optic infrastruc
PPG sets paint stirring world record at SEMA 2025 to highlight benefits of new automated system for body shops5.11.2025 19:41:00 CET | Press release
SEMMIX’N’SHAKE system cuts time, waste in refinish industry PPG (NYSE: PPG) today announced that it achieved a GUINNESS WORLD RECORDS™ title for the largest simultaneous paint stirring challenge during a customer event at the 2025 SEMA Show in Las Vegas. More than 275 participants stirred paint together to highlight the manual effort still common in collision repair before PPG unveiled its new SEM MIX’N’SHAKE™ automated stirring solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105923792/en/ More than 275 participants simultaneously stirred paint at SEMA 2025 as PPG breaks the GUINNESS WORLD RECORDS™ title for the largest paint stirring challenge as it unveiled the SEM Mix’n’Shake™ automated stirring system. The SEM Mix’n’Shake system produces a fully homogenized car paint mix in less than 60 seconds. By automating this step, body shops can reduce rework and recover up to 6% more productive work hours annually. The
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
