Basel, Switzerland, and Corbeil-Essonnes, France, June 20, 2019 – Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announces it has signed a strategic partnership with Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) for preferred access and reserved capacity for cGMP grade viral vector production. Under this strategic collaboration, Yposkesi will provide expertise in process development, technology transfer, manufacturing scale-up, quality control and quality assurance. The ongoing prioritized access for manufacturing resources will support Axovant’s gene therapy programs as they proceed through development and commercialization, with an initial focus on the AAV-based gene therapies.
“This partnership is expected to provide Axovant with sufficient manufacturing capacity to deliver our gene therapies to patients at scale, a key component for the continued development of our gene therapy pipeline,” said Pavan Cheruvu, chief executive officer of Axovant. “Partnering with Yposkesi’s global leaders and experts in cGMP-grade vector production strengthens our commitment to building a team with unmatched experience in gene therapy development. With reserved manufacturing capacity and dedicated suite space for Axovant and planned expansions in production capacity, Yposkesi is a preferred manufacturing partner. We look forward to working closely with its team.”
Yposkesi is the largest European CDMO for gene therapy with capabilities to expand manufacturing for AAV and lentiviral vector production in its current 50,000 ft2 (approx. 5,000 m2) state-of-the-art facility, which houses multiple independent manufacturing suites. By 2021, Yposkesi plans to increase this footprint to 100,000 ft2 (approx. 10,000m2) to expand capacity with additional large-scale bioreactors (1,000 L) to further support growing demand for production. As a spin out from Genethon, a pioneer in the discovery and development of gene therapies, Yposkesi has 25 years of experience in GMP development and manufacturing and a team of over 150 scientific, industrial and technical specialists. Yposkesi’s current manufacturing processes comply with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) manufacturing requirements.
“We are excited to partner with Axovant to support the manufacture and delivery of its innovative gene therapies on a large-scale,” said Alain Lamproye, chief executive officer of Yposkesi. “Manufacturing is one of the most critical parts in the development of gene therapies, where expertise and available capacity are key factors. Leaders in gene therapy, such as Axovant, are looking for state-of-the-art facilities, robust manufacturing capacity and years of expertise in producing cGMP-grade material. We strive to deliver industrial experience, innovation and support services to accelerate development of these innovative treatments.”
About Axovant Gene Therapies
Axovant, part of the Roivant family of companies, is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurological diseases. The company’s current pipeline of gene therapy candidates targets Parkinson’s disease, GM1 gangliosidosis and GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease). Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations.
Roivant Sciences aims to improve health by rapidly delivering innovative medicines and technologies to patients. It does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives and deploying technology to drive greater efficiency in R&D and commercialization.
Yposkesi is a leading Contract Development & Manufacturing Organization (CDMO) for gene therapy vector manufacturing. Created in November 2016 in Corbeil-Essonnes (France) as a spin-off from the world-class gene therapy pioneer Genethon, Yposkesi provides integrated services covering bioprocess development (USP & DSP) from small/pilot to large-scale production, analytical development, GMP manufacturing of lentiviral and AAV vectors and regulatory support. Its current facility consists of a 50,000 ft2 (approx. 5,000 m2) building, operating multiple manufacturing suites for bulk drug substance and fill & finish. By 2021 it will increase its global footprint to 100,000 ft2 (approx. 10,000m2) with a second large-scale facility designed for EMA and FDA compliance. Capitalizing on the more than 25 years’ expertise of Genethon, Yposkesi invests significantly in innovation in bioprocessing to deliver on high-quality projects, cost-effectively.
Forward-Looking Statements and Information
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as ‘may,’ ‘will,’ ‘expect,’ ‘plan,’ ‘would,’ ‘intend,’ ‘future,’ and other similar expressions are intended to identify forward-looking statements. All forward-looking statements, including Axovant’s ability to continue to develop and commercialize its gene therapy platforms, its ability to successfully transition manufacturing and development processes to Yposkesi; and the level of manufacturing resources and capacity supporting development and commercialization of Axovant’s product candidates, are based on estimates and assumptions by Axovant’s management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. In addition, Axovant’s business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials, the timing and availability of data from clinical trials, the expectations for regulatory submissions and approvals; the potential safety concerns or profile of Axovant’s product candidates; and the availability or commercial potential of product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovant’s most recent Annual Report on Form 10-K for the period ended March 31, 2019, filed with the Securities and Exchange Commission on June 11, 2019, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.