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Emergent BioSolutions Statement on the Federal Court of Appeals’ Ruling on NARCAN® Nasal Spray Patents

GAITHERSBURG, Md., February 10, 2022 – Today, the Court of Appeals for the Federal Circuit (CAFC) issued a decision affirming the District Court’s decision in our patent litigation case with Teva.

“While Emergent is understandably disappointed by the Court of Appeals for the Federal Circuit’s decision today, we remain committed to expanding awareness, availability, and affordable access to NARCAN® Nasal Spray,” said Doug White, SVP and commercial business head at Emergent BioSolutions. “Despite the Court’s decision, we continue to believe that the invention embodied in the development of NARCAN has played a meaningful role in combatting the opioid crisis and we continue to champion innovation for public health threats, which aligns with our mission to protect and enhance lives.”

As previously stated, Emergent secured an agreement with Sandoz to distribute an authorized generic of NARCAN® (naloxone HCl) Nasal Spray 4mg, which is available to people in the U.S. via retail pharmacies and institutions, including hospitals. This agreement will allow Emergent to continue supporting the public interest sector, where communities and individuals with greatest need will still have access to the legacy opioid reversal medicine.

Since its approval in 2016, Emergent has distributed over 26 million NARCAN® Nasal Spray devices across the U.S. and has offered the medicine at a low cost to national, state, and local governmental health departments and first responders closest to at-risk populations, including public health clinics, fire departments, and police departments.

About NARCAN® Nasal Spray 4mg

NARCAN® Nasal Spray 4mg is the first FDA-approved, needle-free presentation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training. NARCAN Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through Emergent’s specialty products and contract development and manufacturing services, Emergent is dedicated to providing solutions that address public health threats. Through social responsibility, Emergent aims to build healthier and safer communities. Emergent aspires to deliver peace of mind to its patients and customers so they can focus on what’s most important in their lives. In working together, Emergent envisions protecting or enhancing 1 billion lives by 2030. For additional information, visit Emergent’s website and follow Emergent on LinkedIn, Twitter and Instagram.

Safe Harbor Statement

This company statement includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding safeguarding people who may be at risk of an opioid overdose and the success of our generic naloxone program and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. The reader is, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this company statement, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. The reader should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.