Hepatitis B vaccine(Takeda Pharmaceutical Co., Ltd.)

CAMBRIDGE, Mass.--( BUSINESS WIRE )--VBI Vaccines Inc. (VBI) is initiating a voluntary nationwide recall of all remaining PreHevbrio ® [Hepatitis B Vaccine (Recombinant); NDC 75052-001-10] (“PreHevbrio”) due to the bankruptcy of the company and termination of operations. Further distribution or use of any remaining PreHevbrio vaccine by healthcare providers or others must cease immediately. VBI Vaccines Inc. and its affiliates commenced a proceeding under Canada’s Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the “CCAA Proceeding”) on July 29, 2024, in the Superior Court of Justice (Commercial List) in Ontario, Canada. VBI Vaccines (Delaware) Inc. and certain other affiliates filed petitions and a motion under chapter 15 of the Bankruptcy Code for recognition of the Canadian Proceeding as a foreign main proceeding on July 30, 2024, in the United States Bankruptcy Court for the District of Delaware (together with the CCAA Proceeding, the “Restructuring Proceedings”). In connection with the Restructuring Proceedings, on October 25, 2024, the company issued an initial communication to healthcare providers and the FDA regarding its intent to voluntarily withdraw PreHevbrio from the U.S. market. The company is rapidly winding down all U.S. operations and has permanently ceased distribution of PreHevbrio, a vaccine indicated for the prevention of infection caused by hepatitis B virus in adults. PreHevbrio vaccine was distributed nationwide to distributors and healthcare providers. COMMUNICATION AND REQUEST FOR DESTRUCTION OF INVENTORY: VBI Vaccines is notifying its distributors, clients, and healthcare providers by direct mail and is requesting that they further notify or re-notify any potentially affected customers, consumers, and/or patients of this recall. VBI Vaccines is requesting immediate destruction of all existing vials of PreHevbrio in accordance with applicable law, and notification of product disposition to prehevbrio@vbivaccines.com . The U.S. Food and Drug Administration is aware that VBI has permanently discontinued distribution of PreHevbrio. ADVERSE EVENT REPORTING: Adverse reactions or possible side effects experienced in connection with the use of PreHevbrio may be reported to Vaccine Adverse Event Reporting System (“VAERS”) either online, by fax, or by regular mail. Complete and submit the report Online : https://vaers.hhs.gov/ Regular Mail or Fax : Download PDF form ( https://vaers.hhs.gov/ ) and fax to 1-877-721-0366, or mail the completed form to: VAERS P.O. Box 1100 Rockville, MD, 20849-1100 If you require assistance with reporting, you can contact VAERS by email at info@vaers.org or by phone at 1-800-822-7967. INTERCHANGEABILITY AND SERIES COMPLETION: For healthcare providers needing to complete a Hepatitis B vaccination series when the original vaccine administered is no longer available, please refer to the Centers for Disease Control (CDC) Hepatitis B vaccination guidelines at https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/ . HOW TO IDENTIFY PREHEVBRIO: Please visit www.prehevbrio.com for vial and carton labels as well as information about unexpired lots of PreHevbrio. ADDITIONAL QUESTIONS: Healthcare providers and distributors with questions regarding this recall can contact VBI Vaccines at prehevbrio@vbivaccines.com . Consumers who received PreHevbrio should reach out to their physicians or other qualified healthcare providers with any questions or concerns related to the use of PreHevbrio.

EMERYVILLE, Calif., Nov. 11, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that it has entered into an Accelerated Share Repurchase transaction ("ASR") under an agreement with Goldman Sachs & Co. LLC to repurchase $100 million of the Company's common stock. Dynavax executed the ASR as part of the $200 million share repurchase program authorized by its Board of Directors in November 2024. Upon completion of this ASR, Dynavax will have $100 million remaining under the program. "Today's announcement of the accelerated share repurchase program reinforces our confidence in our business and our commitment to deliver value to our shareholders through our disciplined and thoughtful approach to capital allocation. We believe that our commercial success and financial position gives us the ability to strategically deploy capital, execute on our business strategy and invest in our long-term growth," said Kelly MacDonald, Chief Financial Officer of Dynavax. "We remain committed to leveraging our $200 million share repurchase program to create value for our shareholders through our balanced capital allocation strategy." Under terms of the agreement, Dynavax will pay $100 million to Goldman Sachs & Co. LLC and will initially receive approximately 6.1 million shares, with an aggregate value representing approximately 80% of the $100 million paid to Goldman Sachs & Co. LLC based on the $13.01 closing stock price of Dynavax's common stock on November 8, 2021. The final number of shares repurchased under the ASR will be based on the volume-weighted average prices of Dynavax's common stock during the term of the ASR, and subject to adjustments related to the terms and conditions of the ASR agreement. The final settlement of the ASR is expected to be completed in the first quarter of 2025. As of November 5, 2024, Dynavax had approximately 131.5 million shares outstanding. About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our ability to execute on our strategic objectives, the anticipated benefits of our share repurchase program and the expected timing for completion of the ASR transaction. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that our share repurchase program may not provide the benefits anticipated, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended September 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED