Inhalation Anthrax

Oral NUZYRA Tablets Procured by BARDA were Manufactured in the United States as Part of the Company’s Onshoring InitiativeBOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, today announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death. In the study, a 100% survival rate was observed in omadacycline-treated NHPs at the end of the treatment period (30 days) and a survival rate over 90% was observed over the entirety of the 60-day observation period. All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis. Top-line data from this study triggered an additional procurement of NUZYRA under the company’s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts. “Positive top-line data from this study represents continued progress in our anthrax development program and further validates NUZYRA’s potential to effectively treat pulmonary anthrax,” said Randy Brenner, Paratek’s chief development and regulatory officer. “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil. We are grateful for BARDA’s continued commitment in our partnership to address national security threats and public health emergencies involving anthrax, and believe that these efforts further strengthen our nation’s commitment to address potential bioterrorism threats at a time when antibiotic resistance is a global concern.” A meeting with FDA will be planned for the middle of 2024 to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for Seysara® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and X.  About NUZYRA®NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. MEDIA CONTACT:Christine FanelleScient PRChristine@ScientPR.com215-595-5211

GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033. “As a part of our mission to protect and enhance lives, Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” said Paul Williams, senior vice president, products head at Emergent. “This new contract award is a testament to the importance of Emergent’s medical countermeasures portfolio, and we look forward to delivering on our commitments to the U.S. DoD.” Under the initial five-year IDIQ contract, there is a guaranteed purchase minimum of $20.1 million, with future orders estimated to be at least $20 million for each following year for a total award value up to $235.8 million. About BioThrax® (Anthrax Vaccine Adsorbed) BioThrax vaccine is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. BioThrax is approved for pre-exposure prophylaxis of disease in persons at high risk of exposure. BioThrax is approved for post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax. Please see full Prescribing Information here. About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X (formerly Twitter), and Instagram. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the development, availability, and government procurement of BioThrax® vaccine and the continued development of Emergent’s anthrax franchise, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact: Richard S. Lindahl Executive Vice President, CFO lindahlr@ebsi.com Media Contact: Assal Hellmer Vice President, Communications mediarelations@ebsi.com

The SensiTox B. anthracis Toxin Test requires the patient’s blood sample, added directly to a test cartridge, and placed onto the company’s benchtop laboratory instrument MultiPath Analyzer, which can provide test results within 20 minutes SensiTox B. anthracis Toxin Test runs on MultiPath Analyser. (Credit: Testalize.me on Unsplash) First Light Diagnostics has received the US Food and Drug Administration (FDA) approval for its SensiTox B. anthracis Toxin Test that runs on the company’s MultiPath Analyser. SensiTox is a qualitative immunofluorescence assay intended for rapid detection of lethal factors in the blood of individuals suspected of anthrax inhalation or exposure to B. anthracis. The test requires the patient’s blood sample, added directly to a test cartridge, and placed onto the company’s benchtop laboratory instrument MultiPath Analyzer. It can test up to 20 samples simultaneously, or employ random access, continuous loading of individual samples and provide test results within 20 minutes. First Light Diagnostics president and CEO Joanne Spadoro said: “We are very pleased with the results of the clinical study and the overall performance of our test. “We are confident that our test, with its demonstrated performance, and rapid time to result would have enormous public health benefit in a biothreat situation.” B.anthracis (bacillus anthracis) is a gram-positive and rod-shaped bacterium that causes anthrax and is a biodefence concern due to the high mortality associated with the inhalation of anthrax. According to First Light, the early diagnosis and treatment of patients are crucial in the course of infection, considering the severity and rapid progression of the disease. The SensiTox B. anthracis Toxin Test is designed to detect lethal factors, an early biomarker of anthrax infection and support the rapid and early diagnosis of inhalation anthrax. Its test’s performance has been validated in a US clinical study, evaluating blood specimens presumed to be negative for anthrax and in specimens with the B. anthracis lethal factor. In the clinical study, the SensiTox B. anthracis Toxin Test showed a 100% Negative (NPA) and 96.2% Positive Percent Agreement (PPA), said the diagnostics company. First Light has received funding support from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), for the development of the SensiTox B. anthracis Toxin Test and the MultiPath Analyzer. In addition to the SensiTox B. anthracis Toxin Test, First Light also secured regulatory approval to market its SensiTox C. difficile Toxin Test in the US.