Complicated skin and soft tissue infection

Switzerland-based Basilea Pharmaceutica has finally won U.S. FDA approval for its broad-spectrum cephalosporin intravenous antibiotic — in three indications. Ceftobiprole, branded Zevtera, is now approved in the U.S.for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients with community-acquired bacterial pneumonia (CABP). The SAB indication, which includes those with right-sided infective endocarditis, is especially notable, given the current lack of treatments. These bloodstream infections arecaused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA. The approvals are a long-fought win for Zevtera, which will now have 10 years of market exclusivity in the U.S. after a regulatory journey that has lasted more than a decade. Ceftobiprole was first approved in Canada in 2008 for the treatment of complicated skin and soft tissue infections. It has since notched approvals throughout Europe for patients with hospital-acquired bacterial pneumonia (HABP) and CABP. Basilea says it has license and distribution agreements for the drug covering more than 80 countries. But the U.S. story has been different. In 2008, the FDA handed Basilea and then copartner, J&J, a CRL for ceftobiprole for the treatment of complicated skin and skin structure infections. The agency recommended additional site audits be conducted. A year later, the partners were handed a second CRL for the same indication, with the FDA then recommending the partners conduct additional clinical studies. In 2014, Basilea attempted to get approval for ceftobiprole for the treatment of pneumonia, but were shot down after the FDA said U.S. approval would require additional phase 3 data. Now, with an FDA approval finally in hand,Basilea is looking for a U.S. partner. "Whilst our initial goal was to have announced a commercial partnership by the time of approval of Zevtera in the US, in order to explore fully all potential partnering opportunities, we now expect to complete the process around mid-year," said Adesh Kaul, Basilea CFO.

FOSTER CITY, Calif., Sept. 22, 2023 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation under the Generating Antibiotic Incentives Now (GAIN) Act for contezolid (MRX-I) tablet and contezolid acefosamil (MRX-4) tablet and intravenous as novel new oxazolidinone antibiotics for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis. Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI. QIDP designation provides both products with a five-year extension of data exclusivity provisions and eligibility for Priority Review of its New Drug Application (NDA) for DFI once submitted. Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Continue Reading MicuRx Pharmaceuticals The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII – Generating Antibiotic Incentives Now (GAIN) Act, to encourage development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. "We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. About half of ulcers become infected and can lead to significant morbidity and mortality. When under- or untreated, severe DFI infections can progress to osteomyelitis (infection of the bone), significant tissue and bone damage, and result in amputation of the infected limb in 17% of cases of diabetic ulcers.[1] Prevalence of DFI is increasing as the prevalence of diabetes increases worldwide. With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA). Staphylococcus sp. are the most common bacteria causing DFI, and the rate of methicillin resistance in S. aureus remains at high levels ranging from 25-65% with wide regional variation in the USA. Given the difficulty and significance of diabetic foot infections, patients are treated for 2-6 weeks or longer. Many products effective against MRSA are often available only in IV formulations and can cause significant toxicities. "Contezolid and contezolid acefosamil have shown an excellent safety profile, particularly for reduced potential for hematological toxicities, in our clinical studies and after two years of real-world data on the market in China", said Dr Regis Vilchez, Chief Medical Officer at MicuRx. "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations." For more information, contact [email protected]. About MicuRx Pharmaceuticals, Inc. MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness, we are committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007, MicuRx has adhered to the principle of "Better therapy through superior medicine", focusing on the increasingly serious problem of global antimicrobial resistance. For more information, please visit the official website of MicuRx Pharmaceuticals at . About Contezolid and Contezolid Acefosamil Contezolid tablets and MRX-4 are innovative antimicrobial drugs with global intellectual property rights developed by MicuRx Pharmaceuticals. Contezolid tablets was approved by the National Medical Products Administration (NMPA) on June 1, 2021 in China, for the treatment of complicated skin and soft tissue infections, marking the first global approval of this drug. MRX-4, developed based on Contezolid tablets, serves as a prodrug of Contezolid. About Diabetic Foot Infections Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. Neurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, with up to 20% of these requiring hospitalization. Between 15-20% of moderate-to-severe infections lead to lower extremity amputations. [1] Every year, more than 1 million people with diabetes lose at least a part of their leg as a consequence of the complications of diabetes. This translates into the estimate that every 20 seconds a lower limb is lost to diabetes somewhere in the world.[2] The direct costs of treating diabetic foot ulcers in the USA are estimated to be $9 billion to $13 billion annually. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation.[1] [1] Armstrong et al, JAMA 2023. Diabetic Foot Ulcers - A Review. JAMA. 2023;330(1):62-75. doi:10.1001/jama.2023.10578 [2] Bakker et al, Diabetes Metabolism Research Review 2015. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. SOURCE MicuRx Pharmaceuticals

MELVILLE, N.Y., March 30, 2023 /PRNewswire/ -- American Regent, Inc. announces the launch of sulfite-free Epinephrine Injection, USP.1 Epinephrine Injection, USP, is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. "With the approval of this generic alternative we continue to show our commitment to ensuring both patients and providers have access to quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: See the following Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. Reference: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc.; 2022. Epinephrine Injection, USP For intramuscular, subcutaneous, and intravenous use. Do not inject into buttock, digits, hands, or feet. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION DOSAGE AND ADMINISTRATION: See Full Prescribing Information for instructions on dilution and administration of the injection. CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. May aggravate angina pectoris or produce ventricular arrhythmias. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis have been reported. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially patients suffering from coronary artery disease, or cardiomyopathy. Allergic Reactions Associated with Sulfite—This product does not contain sodium bisulfite. ADVERSE REACTIONS: Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy Risk Summary: May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation Risk Summary: There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE: Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent, Inc. at 1.800.734.9236 or to the FDA by visiting or calling 1.800.FDA.1088. REF-0848 5/2022 You are encouraged to report adverse drug events (ADEs) to American Regent: T 1.800.734.9236; E pv@americanregent.com; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) For medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years, we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications, they need. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: .