Nabriva Therapeutics Expands XENLETA® Presence with Exclusive Agreement with Er-Kim Pharmaceuticals
DUBLIN, Ireland and FORT WASHINGTON, Pa., July 18, 2022 (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, today announced that it has entered into an exclusive Distribution Agreement with Er-Kim, a leading partner for biotech companies in international markets, for the oral and intravenous formulations of XENLETA® (lefamulin).
Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia. Er-Kim also may distribute XENLETA to an additional five countries through a Named Patient Usage (NPU) program. Nabriva will be the exclusive supplier of XENLETA to Er-Kim.
Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics, commented, “We are excited to partner with Er-Kim, whose local expertise and proven track record uniquely position them for success in making XENLETA available to patients in these territories with community acquired bacterial pneumonia (CABP). We look forward to working with Er-Kim as a valued distribution partner to broaden the availability of XENLETA outside the U.S.”
Cem Zorlular, Chief Executive Officer of Er-Kim, added, “We are thrilled to partner with Nabriva to bring XENLETA to a region where there is a significant unmet need for patients with CABP. We feel privileged to work with Nabriva, who shares our passion in addressing patients’ unmet needs in serious infections.”
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.
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 included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com.
Er-Kim broadens and accelerates global patient access to innovative treatments by offering biopharmaceutical companies of all sizes flexible, sustainable, and compelling business models to commercialize their products in international markets. Over the past forty years, more than sixty global pharmaceutical companies trusted Er-Kim as their regional partner. For more information, please visit www.er-kim.com.
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the future development and commercialization of XENLETA in the international markets or the additional five countries through the NPU program, the potential market opportunity for or acceptance of XENLETA in such territories, revenue from product sales and other benefits under the distribution agreement with Er-Kim, the development of XENLETA for additional indications, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.
Nabriva Therapeutics plc