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DEERFIELD, Ill., AND CAMBRIDGE, Mass ..– (BUSINESS WIRE) – Baxter International Inc. (NYSE: BAX), a world leader in the production and delivery of sterile drugs, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, announced today that they have entered into an agreement for Baxter BioPharma Solutions to provide sterile fill / finish manufacturing and supply packaging services for approximately 60-90 million doses of Modern COVID-19 vaccine in 2021. Baxter’s BioPharma Solutions business is a premier contract manufacturing organization specializing in parenteral (injectable) pharmaceuticals, including vaccines.
“We have seen a remarkable demonstration of scientific and healthcare expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, vice president of Baxter BioPharma Solutions. “Baxter is honored to bring our extensive experience in vaccine manufacturing to help partners like Moderna strengthen their vaccine supply.”
Manufacturing of the Modern COVID-19 vaccine will take place at BioPharma Solutions’ sterile fill / finish manufacturing facility located in Bloomington, Indiana. The site has capabilities and experience in parenteral delivery systems and manufacturing of clinical and commercial vaccines, including preventive and seasonal vaccines. for global markets. In addition, Bloomington offers a range of production and marketing services, including clinical development, formulation, packaging, and commercial launch capabilities. Baxter BioPharma Solutions has operated in Bloomington for approximately 20 years and employs more than 700 people on its 600,000 square foot campus.
“We welcome the opportunity to work with Baxter BioPharma Solutions in manufacturing fill / finish for Moderna COVID-19 vaccine in the US,” said Juan Andrés, Director of Technical Operations and Quality at Moderna. “This additional production will help us continue to expand our manufacturing capacity in the United States.”
No additional details of the deal were disclosed.
About Baxter’s Biopharmaceutical Solutions Business
Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their marketing goals by providing scientific expertise, sterile manufacturing solutions, parenteral administration systems, and customized support services needed to meet the unique challenges faced by products. parenteral. For more information, visit www.baxterbiopharmasolutions.com.
About Baxter
Every day millions of patients and caregivers trust Baxter’s leading portfolio of critical care, nutrition, kidney, hospital and surgical products. For more than 85 years, we have been operating at the critical intersection where life-saving and sustaining innovations meet the healthcare providers who make it possible. With products, technologies and therapies available in more than 100 countries, Baxter employees around the world are now building on the company’s rich heritage of medical advancements to advance the next generation of transformational innovations in healthcare. For more information, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
About Moderna
In the 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the promising, but yet unproven field of messenger RNA (mRNA), to a first-drug company that has treated millions of people diverse clinical portfolio of vaccines and therapies in six modalities, a broad portfolio of intellectual property in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables clinical and commercial production at scale and at unprecedented speed. precedents. Moderna maintains alliances with a wide range of national and foreign governmental and commercial partners, which has enabled the search for innovative science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advancements in the basic and applied science of mRNA, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases, diseases cardiovascular and autoimmune diseases. Currently, 24 development programs are underway in these therapeutic areas, and 13 programs have entered the clinic. Moderna has been named a Top Biopharmaceutical Company by Science for the past six years. For more information, visit www.modernatx.com.
Baxter Forward-Looking Statements
This release includes forward-looking statements regarding Baxter’s production of the Modern COVID-19 vaccine, including expectations regarding the approval of the vaccine, its availability in the United States, and the timing and volume of the vaccine. The statements are based on assumptions about many important factors, including the following, that could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other government authorities; quality, manufacturing or supply issues of the product or patient safety; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of a natural disaster, public health crisis and epidemics / pandemics, regulatory or other measures); changes in laws and regulations; and other risks identified in Baxter’s most recent filings on Forms 10-K and 10-Q and other SEC filings, all of which are available on Baxter’s website. Baxter makes no commitment to update its forward-looking statements.
Forward-Looking Statements by Moderna
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including: Moderna’s development of a novel coronavirus vaccine and an agreement under which Baxter will provide services. of sterile manufacturing for the Modern COVID-19 vaccine. In some cases, forward-looking statements may be identified by terminology such as “will”, “may”, “should”, “could”, “expect”, “intends”, “plans”, “aims”, “anticipates,” “” Believe “,” estimate “,” predict “,” potential “,” continue “or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are not promises or guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and control. . which could cause actual results to differ materially from those expressed or implied in these forward-looking statements. These risks, uncertainties and other factors include, but are not limited to: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology used by Moderna is still being developed and implemented; the safety, tolerability, and efficacy profile of Modern COVID-19 vaccine observed to date may change adversely in ongoing analyzes of trial data or post-marketing; Despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with Moderna’s regulatory approval strategies, the components of our submissions, such as clinical trial designs, conduct and the methodologies, or the sufficiency of the data presented; Moderna may encounter delays in meeting manufacturing or supply deadlines or disruptions in its Moderna COVID-19 vaccine distribution plans; if, and when, any application for a biological product license and / or application for an emergency use authorization can be submitted and finally approved by the regulatory authorities; Potential adverse impacts due to the global COVID-19 pandemic, such as regulatory review delays, clinical and manufacturing trials, supply chain disruptions, adverse effects on health systems, and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the US Securities and Exchange Commission (SEC) and in subsequent filings made. by Moderna before the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna denies any intention or responsibility to update or revise the forward-looking statements contained in this press release in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Baxter is a registered trademark and BioPharma Solutions is a trademark of Baxter International Inc.
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