Business Wire

Vivet Therapeutics and Pfizer Inc. Enter into Manufacturing Agreement for Vivet’s Investigational Gene Therapy for Wilson Disease

Share

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.

Contact information

Media & Investor contact:
Thomas Daniel-Robin
Business Development Director
+33 182283082
info@vivet-therapeutics.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Datasite Enters Agreement to be Acquired by CapVest19.10.2020 22:00:00 EESTPress release

Datasite® (the “Company”), has entered into an agreement to be acquired by funds managed by CapVest Partners LLP (“CapVest”), an international private equity firm. Headquartered in Minneapolis, Datasite is a leading SaaS provider for the mergers & acquisitions (M&A) industry, with more than 750 employees in 25 locations across 13 countries. Over the last five years, Datasite has built a rapidly growing customer base in over 180 countries and its award-winning products and services make it a truly global player in this market. In 2019, Datasite increased revenue by more than 30% as it facilitated close to 10,000 deals. The transaction represents an important milestone for Datasite, which empowers dealmakers around the world with the tools they need to succeed across the entire deal lifecycle, including its core due diligence application, Datasite Diligence™, its application to aid the preparation of transactions, Datasite Prepare™, its application for optimizing the early stage marketin

Successful Certification of Kalray’s Smart Storage Adapter19.10.2020 19:00:00 EESTPress release

Kalray (Paris:ALKAL) (Euronext Growth Paris: FR0010722819 – ALKAL), a pioneer in processors for new intelligent systems, today announced that its K200™ Coolidge™ based smart storage adapter solution has been certified for NVM ExpressTM over Fabrics (NVMe-oF) with TCP (NVMe™/TCP) protocol by the NVM Express organization through the University of New Hampshire InterOperability Laboratory (UNH-IOL), an independent testing provider of standard conformance solutions and multi-vendor interoperability. Data Centers are undergoing a very important revolution with rapidly evolving network architectures and technologies. This is mainly due to the explosion of usages, the surge of data to be processed and the resulting exponential growth of the number of machines to be managed to support this growth. Until now, storage has been one major bottleneck of this expansion. The introduction of flash memory-based SDD (Solid-State Drive) with hyper-fast communication protocols such as NVMe™/TCP, offers a

Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients19.10.2020 18:29:00 EESTPress release

Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ®, Octapharma’s human cell line-derived recombinant factor VIII (FVIII). NUWIQ ® is approved for the prevention and treatment of bleeding in people with haemophilia A. The updated PI includes immunogenicity data from the NuProtect study in previously untreated patients (PUPs). FVIII inhibitor development is the most serious treatment complication in previously untreated patients (PUPs) with severe haemophilia A. The development of inhibitors against exogenous FVIII can reduce the effectiveness of treatment and negatively impact a patient's long-term joint health and quality of life. Minimising the risk of inhibitor development is therefore a key consideration in treatment decisions for PUPs. The updated NUWIQ® PI includes data from the NuProtect study, which was the largest prospective study of a single FVIII product in true PUPs. Patients rec

Activist Malala Yousafzai and American Football Coach Katie Sowers Among Others to Headline PMI® Virtual Experience Series19.10.2020 16:00:00 EESTPress release

Project Management Institute (PMI), the world's leading association for the project management profession, is providing professionals around the world the opportunity to join three more groundbreaking Virtual Experience Series events on 20 October 2020, 12 November 2020, and 9 December 2020. Hosted by journalist, television host, and executive producer Tamron Hall, these online events connect attendees to hear unique perspectives and lessons-learned from inspiring thought leaders and experts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201019005488/en/ Hear Pakistani education activist and the youngest Nobel Prize laureate, Malala Yousafzai, speak about advancing female education and enabling women’s leadership globally. (Photo: Business Wire) “By bringing these topics to light and providing them a global stage, we can embolden people to embrace change and lean in to new opportunities,” said Sunil Prashara, president and

Bentley Systems announces Executive Appointments of Nicholas Cumins (Chief Product Officer), Katriona Lord-Levins (Chief Success Officer), and Chris Bradshaw (Chief Marketing Officer)19.10.2020 16:00:00 EESTPress release

Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, announced today, following the initial public offering of its stock on September 23, the company’s successful recruitment for three significant operating positions. All three new executives are presently in place. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201019005179/en/ Nicholas Cumins, Chief Product Officer, Bentley Systems (Photo: Business Wire) Greg Bentley said, “While Bentley Systems accomplished much throughout our 36 years of growth as a privately-held company, and I am proud of our executive talent depth, we obviously could not internally develop public company experience. The principal purpose of our IPO last month was to assure market liquidity for our colleagues, and especially executive shareholders, in advance of many anticipated retirements. In turn, for the executive opportunities accordingly created, our new h

FutureOn Secures Investment from the Bentley Acceleration Fund for Oil & Gas Digitalization19.10.2020 16:00:00 EESTPress release

FutureOn, the fast-growing Norwegian software company that works with an expanding portfolio of global energy companies, announced today that it has secured an investment from the Bentley Acceleration Fund and established a strategic partnership with US-based Bentley Systems to accelerate the digitalization of the oil and gas industry. FutureOn and Bentley Systems (Nasdaq: BSY), the infrastructure engineering software company, will combine FutureOn’s award-winning field design application (FieldAP) and its API-centric collaboration platform (FieldTwin) with Bentley’s iTwin platform to provide customers a next-generation digital twin solution capable of driving design methodologies in upstream project development for the next decade. Both FutureOn and Bentley platforms use open web standards to facilitate complex integration and customization, and the combined offerings are already being implemented in exploration and production workflows. “This is a significant milestone for FutureOn w

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