Johnson & Johnson is pleased to reach an advanced stage in its discussions for a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, which is based in South Africa. The parties will continue to work toward a definitive agreement that builds on their existing manufacturing collaboration and would enable the first COVID-19 vaccine to be manufactured and sold by an African company, in Africa and for people living in Africa. Currently, COVID-19 vaccination rates are significantly lower across Africa compared to those seen in high-income countries.
"Since the earliest days of the pandemic we have been committed to supporting Africa's response to COVID-19 through our vaccine clinical development program, large-scale implementation studies, first-of-their-kind purchase agreements and COVID-19 vaccine manufacturing at Aspen," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer. "Everyone at Johnson & Johnson is very proud of our ongoing collaboration with Aspen, which unites global and national expertise in the effort to support the vaccination of populations who are most in need at this critical stage of the pandemic."
The timing of the signing of a final agreement is dependant on a number of factors. The license under discussion would enable Aspen, using COVID-19 vaccine drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa through transactions with national governments of African Union member states and certain multilateral entities serving Africa including the African Vaccine Acquisition Trust (AVAT), Gavi/COVAX and UNICEF.
"This is an important step toward vaccine manufacturing in Africa, for Africa, but a lot more needs to be done," added Dr. Stoffels. "Most critically, the global community should prioritize a clear plan to scale up investment across the African continent in the specialized vaccines manufacturing infrastructure - and skilled local workforce - that will be needed to really rise to this challenge."
The potential license would be the latest example of Johnson & Johnson sharing its intellectual property (IP) and manufacturing know-how to reliable and proven manufacturers that are well equipped to uphold the highest standards of product quality and safety.
Johnson & Johnson is delivering on its commitment to make available up to 900 million doses of its COVID-19 vaccine to the African Union (via AVAT) and the COVAX Facility, combined, through 2022. The Company is also a proud collaborator with the South African Medical Research Council (SAMRC) and others on a Phase 3b clinical study, 'Sisonke Boost,' to evaluate the safety and efficacy of booster doses (second-dose) of the Johnson & Johnson COVID-19 vaccine in South African healthcare workers.
Notice to Investors Concerning Forward-Looking Statements
This media statement contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a potential licensing agreement with Aspen SA Operations (Pty) Ltd relating to the development, manufacture and distribution of the Johnson & Johnson COVID-19 vaccine. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the ability of the parties to negotiate and consummate a licensing agreement on mutually acceptable terms, if at all; following execution of a licensing agreement, if any, the satisfaction of closing conditions for such agreement, including the receipt of any regulatory approvals for the transaction; the possibility that the transaction will not be completed in the expected time frame or at all; the potential that the expected benefits and opportunities of the licensing agreement, if completed, may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.