GlobeNewswire

Novavax Confirms Accelerated Approval Pathway Available for Licensure of NanoFlu™

Share
  • Pivotal Phase 3 clinical trial expected to initiate in the fall of 2019
  • Top-line clinical data expected in the first quarter of 2020

GAITHERSBURG, Md., June 27, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will utilize the accelerated approval pathway for licensure for NanoFlu™, its nanoparticle seasonal influenza vaccine candidate. The U.S. Food and Drug Administration (FDA) acknowledged in a recent letter that the accelerated approval pathway is available to Novavax for its NanoFlu vaccine. Novavax expects to initiate its pivotal Phase 3 clinical trial by the fall of 2019 with top-line clinical data expected in the first quarter of 2020. These immunogenicity data are expected to support a U.S. biologics license application (BLA).

Novavax will conduct an End-of-Phase 2 meeting with the FDA in the third quarter of 2019 to discuss the proposed Phase 3 clinical trial design and other topics that will support the future BLA. The accelerated approval pathway enables Novavax to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.

“NanoFlu’s encouraging results observed in prior clinical trials, which demonstrated improved immune responses against licensed comparators, provide us confidence in the future success of the Phase 3 clinical trial,” said Gregory M. Glenn, M.D., President of Research and Development of Novavax. “The accelerated approval pathway allows us to potentially obtain U.S. licensure more expeditiously, and ideally, deliver a greatly needed improved flu vaccine, which could reduce the tremendous medical and economic burden of influenza.”

“The accelerated approval pathway, combined with the strategic partnership we announced today with Catalent Biologics, allow us to efficiently and cost effectively complete the clinical development of NanoFlu through BLA and licensure,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “The Catalent deal provides an $18 million cash infusion and flexible manufacturing capacity, supported by the experienced professionals transferred from Novavax to Catalent.”

Previously Reported Phase 2 Clinical Trial Results with NanoFlu

Earlier this year, Novavax released positive top-line results of its Phase 2 clinical trial of NanoFlu in older adults. The data showed NanoFlu induced improved immune responses when compared to the best-selling flu vaccine in the older adult market. The Phase 2 clinical trial compared the safety and immunogenicity of various quadrivalent formulations of NanoFlu with or without our Matrix-M adjuvant with two licensed influenza vaccines in 1,375 healthy older adults. All formulations of NanoFlu were well tolerated and elicited vigorous immune responses to the four strains included in the vaccine. NanoFlu also demonstrated significantly improved hemagglutinin inhibition (HAI) antibody responses against wild-type H3N2 viruses, including drifted strains when compared to Fluzone High-Dose, the leading flu vaccine in older adults.

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.

About NanoFlu™ and Matrix-M™

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which 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.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection which is the second leading cause of death in children under one year of age worldwide. Novavax is also advancing NanoFlu™, its quadrivalent influenza nanoparticle vaccine, to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

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

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, 2018, and Quarterly Report on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the 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 give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Trahan
Senior Manager, Investor & Public Relations
ir@novavax.com
240-268-2000

Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Brandzone/Speak Life Science
Amy Speak
amy@speaklifescience.com
617-420-2461

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

EVS Broadcast Equipment reports update of share buyback program22.7.2019 17:45:00 CESTPress release

Publication on July 22, 2019, 5.45pm CET Regulated information – reporting share buyback EVS Broadcast Equipment S.A.: Euronext Brussels (EVS.BR), Bloomberg (EVS BB), Reuters (EVSB.BR) EVS reports update of share buyback program EVS Broadcast Equipment reports that the following transactions, conducted within the framework of the share buyback program announced on October 24, 2018, took place between July 15, 2019 and July 17, 2019. Date Number of shares acquired Average price (EUR) Total (EUR) 15/07/2019 1,856 20.3713 37,809 16/07/2019 1,760 20.0932 35,364 17/07/2019 378 20.9000 7,900 As of July 22, 2019, and since the start of the buyback program, EVS has bought 255,028 shares at an average price of EUR 20.8174, representing in total EUR 5,309,024. After aforementioned transactions the total number of own shares amounts now to 333,676 shares as of July 22, 2019 (including 93,144 shares already held by the company before the start of the share buyback program and taking into account t

Change in Amer Sports Corporation’s financial reporting schedule22.7.2019 17:15:00 CESTPress release

Amer Sports Corporation STOCK EXCHANGE RELEASE July 22, 2019 at 6:15 p.m. Change in Amer Sports Corporation’s financial reporting schedule Amer Sports changes the publication date of its half-year financial report 2019. The updated schedule for the half-year report is 30 September, 2019 at approximately 1:00 p.m. Finnish time. The previously announced publication date was July 25, 2019. The change is related to the recent ownership change in the company. ANTA Sports Products Limited consolidates Amer Sports as an associated company in its half-year financial report which will be published on 26 August, 2019. On the same day, Amer Sports will publish a stock exchange release disclosing its financial information included in ANTA Sports’ half-year financial report. On March 28, 2019, Mascot Bidco Oy completed a voluntary recommended public cash tender offer for all the issued and outstanding shares in Amer Sports Corporation and on April 1, 2019 announced that it will exercise its redempt

Changes in Huhtamaki’s Global Executive team22.7.2019 17:00:00 CESTPress release

HUHTAMÄKI OYJ STOCK EXCHANGE RELEASE 22.7.2019 AT 18:00 Changes in Huhtamaki’s Global Executive team Michael Orye, Executive Vice President, Fiber Packaging and a member of Huhtamaki Global Executive Team has decided to leave Huhtamaki to pursue other career opportunities. Eric Le Lay, Executive Vice President Foodservice EAO will assume the leadership and take full responsibility of Fiber Packaging in addition to his current role. This change is effective as of 22.7.2019. “I want to thank Michael for his contribution to Huhtamaki and wish him all success in his future endeavors” says Charles Héaulmé, President and CEO of Huhtamaki. Following the aforementioned change, the members of the Global Executive Team are: Charles Héaulmé (chairman), President and CEO Thomas Geust, Chief Financial Officer; Leena Lie, Senior Vice President, Marketing and Communications; Sami Pauni, Senior Vice President, Corporate Affairs and Legal, Group General Counsel; Teija Sarajärvi, Senior Vice President,

Metso establishes a new business services center in Vilnius22.7.2019 14:00:00 CESTPress release

Metso establishes a new business services center in Vilnius Metso Corporation’s press release on July 22, 2019 at 15:00 EEST Metso has decided to establish a new Metso Business Services (MBS) center in Vilnius, the capital of Lithuania. The investment supports the company’s profitable growth strategy by improving operational excellence and scalability of business services. The Vilnius MBS center will initially offer services for Metso’s finance operations, later followed by logistics. The objective is to centralize the related services to the new center and thus gain benefits from process harmonization, standardization and digitalization. Initially, the center will employ some tens of experts, but the number of personnel is expected to grow in the coming years. As part of the initiative, employee negotiations have been held at Metso Minerals in Tampere, Finland, to review the possible employee arrangements and implications. Metso has decided to transfer its Financial Services operation

Radisson Hospitality AB’s Q2 Financial Report & Webcast on 26 July 201922.7.2019 12:00:00 CESTPress release

Radisson Hospitality AB (publ) will release its Financial Report Q2-2019 on Friday 26 July 2019 at 7:30am CEST. Federico J. González-Tejera, President & CEO, and Sergio Amodeo, CFO, will also host an audio webcast on the same day, at 10:00am CEST. To access the telephone conference, please dial one of the following numbers: LOCATION PHONE NUMBER Belgium National free phone 0800 48740 Belgium +32 (0)2 400 9874 France National free phone 0805 103 028 France +33 (0)1 76 70 07 94 Norway National free phone 800 51874 Norway +47 2396 0264 Sweden National free phone 0200 125 581 Sweden +46 (0)8 5069 2180 Spain National free phone 800 098826 Spain +34 914 146 280 United Kingdom National free phone 0800 376 7922 United Kingdom +44 (0)844 571 8892 USA National free phone 1 866 966 1396 USA +1 631 510 7495 Standard international dial-in +44 (0)207 192 8000 Confirmation Code: 4689049 To follow the webcast, please visit: https://www.radissonhospitalityab.com/investors/financial-information For furt