Nabriva Therapeutics PLC (NBRVF)

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NABRIVA'S XENLETA(TM) (LEFAMULIN) FOR THE TREATMENT OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) NOW AVAILABLE IN THE U.S.
First IV and oral antibiotic with novel mechanism of action approved by the FDA in nearly two decades, targets the most common CABP pathogens and supports antibiotic stewardship
DUBLIN, Ireland, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the oral and intravenous (IV) formulations of XENLETA™ (lefamulin) are now available in the U.S. through major specialty distributors. XENLETA was approved by the U.S. Food and Drug Administration (FDA) on August 19, 2019 for the treatment of adults with community-acquired bacterial pneumonia (CABP).

“The lack of innovative treatment options for CABP over the past two decades has resulted in increasing resistance in the most common bacteria causing CABP to multiple classes of antibiotics,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “These drug-resistant pathogens are undermining clinicians’ ability to fight CABP and we are delighted to announce that XENLETA is now available as a short course, empiric monotherapy treatment option for adults with CABP."

XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics. XENLETA has in vitro activity and demonstrated clinical efficacy against the most common pathogens that cause CABP. XENLETA has a novel mechanism of action that targets a binding site on bacterial cells that is different from existing antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with antibiotic classes commonly used for the treatment of CABP.

“XENLETA is now available to healthcare providers for the treatment of CABP patients in the hospital, during transition from the hospital to home, and for patients in the ambulatory care setting,” said Francesco Maria Lavino, Nabriva’s Chief Commercial Officer. “We are well-prepared for the launch of XENLETA with an experienced sales team that is fully trained and deployed to help make XENLETA available to physicians and their patients in need. Leveraging our thorough account profiling and preparation, our 60 Territory Business Managers will be focusing on those institutions with the greatest unmet need and highest level of readiness to prescribe XENLETA.”

Nabriva has efficiently expanded its commercialization, medical affairs, and supply chain infrastructure to help ensure that clinicians are informed of XENLETA’s availability and patients have easy access. The company also plans to kick-off a targeted outreach program in the ambulatory care setting, where there is a significant unmet medical need for the treatment of CABP. The program is scheduled to commence in November 2019 in advance of the upcoming 2019-2020 respiratory tract infection season and will focus on educating community-based healthcare professionals on the attributes and availability of XENLETA.

XENLETA is available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5-to-7-day course of therapy. Clinicians can initiate patients on IV or oral therapy, allowing for potential avoidance of hospitalization, or can transition from IV to oral therapy, which may expedite discharge from the hospital. The opportunity to avoid a hospital admission or to discharge a patient earlier on oral therapy may benefit patients and could result in significant savings to the health system.

In addition, Nabriva has partnered with International Health Management Associates, Inc. (IHMA) to offer Nabriva’s Observational Bacterial Evaluation Program (NOBEL). The NOBEL program will provide microbiology laboratories and clinicians access to Research Use Only (RUO) lefamulin disks and MIC gradient test strips for non-diagnostic, in vitro susceptibility testing purposes. For more information about this program or help with enrollment, please contact IHMA, Inc. at 1-800-738-3344 or email [e-mail].

XENLETA is available through the major U.S. specialty distributors: McKesson Plasma and Biologics, ASD Healthcare and, by the middle of the week, Cardinal SD. In addition, XENLETA oral tablets are available through Specialty Pharmacy Networks, including Walgreens Community Specialty Pharmacy and Option Care Health.

Wholesalers

XENLETA (lefamulin) tablets, 600 mg XENLETA (lefamulin) Injection, 150 mg XENLETA diluent,
250 ml
Wholesaler
Telephone, Fax and Web Ordering Information Item Order Number Item Order Number Item Order Number
ASD Healthcare
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.asdhealthcare.com 55560 55561 55559
Cardinal Health
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.cardinalhealth.com 5564711 5564703 5564695
McKesson Plasma and Biologics
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: connect.mckesson.com 3980885 3980877 3980893
About XENLETA

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.