Day: 13 December 2021

GAITHERSBURG, Md., Dec. 13, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its COVID-19 vaccine in the United Arab Emirates (UAE).

“The rapid emergence and continued spread of variants is a stark reminder that no one is safe until everyone is safe in the fight against COVID-19,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We remain committed to delivering our vaccine, which is based on a proven, well understood platform, to countries around the world as we anticipate that ongoing vaccination will be necessary over the long term to end the pandemic.”

Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.

Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, the European Union,Singapore and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

The chemistry, manufacturing and controls (CMC) data package submitted to MoHaP and other global regulatory agencies leverages Novavax’ manufacturing partnership with SII, the world’s largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.

About Matrix-M™ Adjuvant

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a 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 harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, received Emergency Use Authorization in Indonesia and the Philippines and has been submitted for regulatory authorization in multiple markets globally. NanoFlu™, the company’s quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company’s NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, timing and outcome of future regulatory filings and actions, Novavax’ plans to submit a complete package to the U.S. FDA by the end of the year, and Novavax’ plan to supplement the CMC data submitted to the MoHaP with data from the additional manufacturing sites in Novavax’ global supply chain are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, 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 www.sec.gov and www.novavax.com, 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 give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com

Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com

Media
Alison Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
media@novavax.com

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AUSTIN, Texas, Dec. 13, 2021 /PRNewswire/ — Doctors at St. David’s Medical Center recently became among the first in the U.S. to implant a new neurostimulator technology to help treat advanced heart failure. The Barostim System is the only technology approved by the Food and Drug Administration (FDA) to use the nervous system to control heart failure and improve the function of the cardiovascular system.

The system features a programmable device that is placed under the patient’s collarbone and sends electrical pulses to baroreceptors, which detect changes in pressure in the carotid artery. This triggers the baroreflex, the body’s main cardiovascular reflex, causing an autonomic, or involuntary, response to the heart.

“When the device is activated, it sends impulses through an electrode to the receptors in the carotid artery,” Dr. Jeffrey Apple, a vascular surgeon with Cardiothoracic and Vascular Surgeons who performed the procedure at St. David’s Medical Center, said. “This tricks the body into thinking that the sympathetic and parasympathetic nervous systems are working correctly. The brain then responds and sends messages to the body that the heart is working properly. This relaxes the blood vessels, slows the heart rate and reduces fluid in the body.”

The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure.

“This approach to heart failure is designed to improve patients’ quality of life, including those who remain symptomatic despite taking medications and have no other device-based therapy options,” Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., cardiac electrophysiologist and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, said. “It allows them to live their everyday lives with fewer limitations.”

Media Contact:
Matt Grilli
Elizabeth Christian Public Relations
MGrilli@EChristianPR.com
512-498-3192

HO CHI MINH CITY, Vietnam, Dec. 13, 2021 /PRNewswire/ — Masan Group Corporation (HOSE: MSN, “Masan”) today announced the signing of a USD350 million primary investment in The CrownX Corporation (the “Company”, “TCX”) by a consortium of investors, including TPG, Platinum Orchid (a wholly owned subsidiary of Abu Dhabi Investment Authority) (“ADIA”), and SeaTown Master Fund, managed by a wholly owned indirect subsidiary of Temasek Holdings (the “Transaction”). The Transaction marks the final capital raising at the TCX ecosystem, which has attracted over USD1.5 billion in investments from marquee global investors since its inception in 1H2020.

The Transaction implies a post-money valuation of USD8.2 billion for 100% of TCX’s equity, an equivalent of USD105 (c. VND2,415,000) per share, representing a 12% valuation uplift versus the previous capital raising round. Post the completion of the Transaction, Masan will own 81.4% of The CrownX. The Company intends to use the proceeds from the Transaction to invest in growth initiatives and conduct a share buyback.

The mini-mall concept, a unique integrated format off or online offering a broad array of daily, essential products and services, provides The CrownX a cost-efficient model to win consumer wallet share across multiple consumer use cases. The next game changer will be developing fin-tech solutions including buy now pay later products for the underserved, mass market consumers by leveraging its loyalty platform with Reddi at the core.

Mr. Danny Le, Chief Executive Officer (CEO) of Masan Group said: “We have outlined our Point of Life vision for over 7 years now. The partnership with TPG, ADIA and SeaTown is a validation of our ability to bring to life our Point of Life vision. This marks the end of our capital raising activities at The CrownX as we shift our entire focus to scale up our Point of Life platform nationwide both off and online. We look forward to a 2023-2024 international IPO of The CrownX with 3 simple KPIs: i) increasing our share of the consumer wallet by expanding our network, ii) digitizing our entire platform to become a consumer tech company, and iii) double-digit profit margins.”

“Powered by its rising middle class and rapid urbanization, Vietnam is well-positioned to be a significant driver of the next chapter of Asia’s consumption story,” said David Tan, Managing Director, TPG Capital Asia. “Having witnessed Masan’s turnaround of WinCommerce (WCM), we believe that The CrownX is the platform to capture this opportunity. They will develop the ecosystem further to expand their services to create value for all Vietnamese consumers. Leveraging our deep experience investing across the consumer sector and in Southeast Asia, we look forward to working with the management team at The CrownX to accelerate the company’s vision.”

Hamad Shahwan Al Dhaheri, Executive Director of the Private Equities Department at ADIA, said: “In one of the fastest growing consumer markets globally, The CrownX is a proven, best-in-class operator with a strong management team, well-positioned to build the leading integrated omni-channel consumer ecosystem in Vietnam. This is yet another illustration of our global strategy of investing alongside leading partners such as the Masan Group and the wider shareholder base of The CrownX. Further building on our increasing focus on Southeast Asia, this commitment underscores our belief in Vietnam’s strong underlying economic fundamentals.”

Steven Chua, Deputy CIO at SeaTown Master Fund, said: “We are very excited to have the opportunity to partner with The CrownX and Masan organization through this investment. We see a compelling long-term consumption growth story in Vietnam and The CrownX is well-positioned to capture this growth through the company’s transformative initiatives.”

All corporate actions mentioned are subject to customary corporate and regulatory approvals. Credit Suisse (Singapore) Limited acted as the exclusive financial advisor to Masan Group.

MASAN GROUP CORPORATION

Masan Group Corporation (“Masan” or the “Company”) believes in doing well by doing good. The Company’s mission is to provide better products and services to the 100 million people of Vietnam, so that they can pay less for their daily essentials. Masan aims to achieve this by driving productivity with technological innovations, trusted brands, and focusing on fewer but bigger opportunities that impact the most lives.

Masan Group’s member companies and associates are industry leaders in branded fast moving consumer goods, branded meat, modern retail, F&B retail, financial services, telecommunications, and value-add chemical processing, altogether representing segments of Vietnam’s economy that are experiencing the most transformational growth.

TPG

TPG is a leading global alternative asset firm founded in San Francisco in 1992 with $108 billion of assets under management and investment and operational teams in 12 offices globally. TPG invests across five multi-product platforms: Capital, Growth, Impact, Real Estate, and Market Solutions. TPG aims to build dynamic products and options for its clients while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio.

ADIA

Established in 1976, ADIA is a globally diversified investment institution that prudently invests funds on behalf of the Government of Abu Dhabi through a strategy focused on long-term value creation.

SEATOWN

SeaTown Holdings International (“SeaTown”) is a Singapore-based investment manager focused on alternative, absolute return strategies. With over US$6bn of assets under management, SeaTown manages multi-asset and public credit strategies through open-end funds as well as private investments strategies in closed-end funds. SeaTown is a wholly-owned subsidiary of Seviora Holdings, and indirectly owned by Temasek Holdings.

This press release contains forward-looking statements regarding Masan’s expectations, intentions or strategies that may involve risks and uncertainties. These forward-looking statements, including Masan’s expectations, involve known and unknown risks, uncertainties, and other factors, some of which are beyond Masan’s control, which may cause Masan’s actual results of operations, financial condition, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. You should not rely upon forward-looking statements as predictions, future events or promises of future performance.

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