Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer
GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company’s development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.
“Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We welcome her medical perspective and intricate knowledge of the regulatory process at this extraordinary time for the company and the race against the global pandemic.”
Dr. Ukwu most recently served as Chief Regulatory Officer and Global Head of Quality and Regulatory at Otsuka Pharmaceuticals. While there, she globalized and led the regulatory and quality organizations with a focus on compliance excellence, inspection readiness, engagement with health authorities and regulatory agencies and successful outcomes. Prior to Otsuka, she held senior leadership roles at PPD as Senior Vice President and Head of Global Regulatory Affairs, where she had responsibilities for regulatory services across all PPD lines of business; Wyeth Pharmaceuticals, Inc. (Pfizer), where she was Vice President, Regulatory Affairs, with responsibility that spanned vaccines, biologics and pharmaceuticals across all regions; and at Merck & Co., Inc., as Head of Vaccine Regulatory Development, Vice President of Global Regulatory Affairs and Global Regulatory Policy. Dr. Ukwu has led approval of many products, including for Varivax®, a chickenpox varicella vaccine, and Crixivan®, (indinavir), an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.
Dr. Ukwu’s significant contributions to medicine, science and the pharmaceutical industry include developing and enriching the regulatory and quality profession, as well as serving as a mentor to others who have progressed into senior leadership positions. These contributions have been recognized with numerous prestigious awards.
Dr. Ukwu earned her medical and surgical degrees from the University of Jos School of Medicine in Nigeria. She completed her residency in internal medicine at Baptist Hospital, and a fellowship in infectious diseases at Vanderbilt University, both in Nashville, Tennessee. She is a Fellow of both the American College of Physicians (FACP) and the Regulatory Affairs Professional Society (FRAPS) and is a pioneer professor at the Graduate School of Pharmacy at Temple University in Ambler, Pennsylvania.
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
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Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should consider these risks and uncertainties.