Latest news with #ParatekPharmaceuticals
Yahoo
22-05-2025
- Business
- Yahoo
Paratek expands commercial portfolio with Optinose
Paratek Pharmaceuticals has completed the acquisition of Optinose, valued at almost $330m, broadening its commercial product offerings. The companies signed a definitive merger agreement in March 2025. The portfolio of Paratek now includes its lead antibiotic, Nuzyra (omadacycline), and Optinose's Xhance (fluticasone propionate). The acquisition encompasses all outstanding shares of Optinose, including debt assumption and full payment of contingent value rights (CVRs). Optinose shareholders approved the merger on 16 May. The transaction was supported by capital from Paratek, Novo Holdings and B-FLEXION Life Sciences, and debt financing from Oaktree Capital Management funds. The shareholders received $9 per share in cash and CVRs for up to $5 per share, contingent upon Xhance reaching certain net revenue milestones. Paratek has agreed to pay $1 per share on Xhance's achievement of $150m in net sales in any calendar year before 31 December 2028, and an additional $4 per share if they reach $225m before 31 December 2029. Nuzyra is designed to combat tetracycline resistance and functions against a broad range of bacteria, including drug-resistant strains. It is available in both oral and intravenous formulations for treating community-acquired bacterial pneumonia and acute bacterial skin infections. Xhance, a drug-device combination product, utilises the exhalation delivery system, which delivers the topical steroid to the deep nasal cavity areas. Paratek Pharmaceuticals CEO Evan Loh stated: "Adding Xhance to our portfolio is a pivotal first step in achieving our long-term vision to become a multi-product speciality therapeutics company, focused on addressing significant unmet medical needs. "This transaction establishes a strong platform for us to continue to leverage these capabilities as we move forward to explore opportunities to expand our portfolio through future product acquisitions." Lazard and Skadden, Arps, Slate and Meagher & Flom provided exclusive financial and legal advisory services to Paratek. Evercore and Hogan Lovells US provided exclusive financial and legal advisory services to Optinose. "Paratek expands commercial portfolio with Optinose" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.


Associated Press
10-04-2025
- Health
- Associated Press
Paratek Pharmaceuticals to Present New Data on NUZYRA® (omadacycline) at ESCMID Global 2025
BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company developing specialty therapies for community care and public health challenges, today announced that data from several new studies of NUZYRA® (omadacycline) will be presented at ESCMID Global 2025, the Congress of the European Society of Clinical Microbiology and Infectious Diseases, taking place in Vienna, Austria, April 11-15. 'We continue to invest in science as part of our commitment to furthering the medical community's understanding of NUZYRA,' said Randy Brenner, Chief Development and Regulatory Officer of Paratek. 'This week's ESCMID presentations will include data from non-clinical efficacy studies for the treatment and post-exposure prophylaxis of inhalation anthrax and pneumonic plague, supporting NUZYRA's potential use in biodefense. In addition, researchers will share data on skin and soft tissue infections, enterococcal infections, and activity against Acinetobacter baumannii-calcoaceticus complex isolates.' NUZYRA Presentation Details Presentation Title: Omadacycline for skin and soft tissue infections: a multicentre retrospective analysis of efficacy and safety in real-world clinical practice Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D Abstract #: 04456 Session Title: 02f. Community-acquired skin, soft tissue, bone & joint infections (incl epidemiology, clinical, imaging, treatment & prevention, excl prostheses) Poster #: P1095 Presentation Title: Clinical efficacy and safety of omadacycline in the treatment of enterococcal infections Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D Abstract #: 03861 Session Title: 02f. Community-acquired skin, soft tissue, bone & joint infections (incl epidemiology, clinical, imaging, treatment & prevention, excl prostheses) Poster #: P1092 Presentation Title: Omadacycline demonstrated efficacy as both therapeutic treatment and post-exposure prophylaxis against inhalation anthrax and pneumonic plague in cynomolgus macaques Time/Location: April 13, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D Abstract #: 01058 Session Title: 11. Public health & vaccines Poster #: P3784 (The anthrax-related project has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) (The Pneumonic Plague-related project has been funded by the Rapid Acquisition and Investigation of Drugs for Repurposing program within the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense's (JPEO-CBRND) Joint Project Manager for CBRN Medical.) Presentation Title: Activity of omadacycline against multidrug-resistant and molecularly characterised Acinetobacter baumannii-calcoaceticus complex clinical isolates from United States hospitals, 2020–2023 Time/Location: April 14, noon CEST (7:00 a.m. U.S. EST) in poster area in Hall D Abstract #: 02641 Session Title: 03b. Resistance surveillance & epidemiology: Healthcare-associated bacteria Poster #: P1314 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for community care providers and specialists, addressing important medical and public health threats. Paratek's lead product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. 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. For more information, visit 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. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONS Mortality imbalance was observed in the CABP clinical trial, with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.