– Acquisition adds Zavante’s CONTEPO™, potential first-in-class in the United States injectable antibiotic for cUTIs, to Nabriva’s late-stage anti-infective portfolio –
– Nabriva on track to file New Drug Applications for lefamulin and CONTEPO in the fourth quarter of 2018 –
– Ted Schroeder appointed as Nabriva’s CEO to continue Nabriva’s path to commercialization; Dr. Colin Broom to continue to serve on Nabriva Board of Directors –
DUBLIN, Ireland, KING OF PRUSSIA, Pa. and SAN DIEGO, July 24, 2018 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, today announced that it has acquired Zavante Therapeutics, a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, for upfront consideration of approximately 8.2 million of Nabriva Therapeutics’ ordinary shares (which includes an indemnity holdback) to Zavante Therapeutics’ former stockholders upon completion of the acquisition. In addition, Zavante Therapeutics’ former stockholders are eligible to receive up to $97.5 million upon the achievement of specified regulatory and commercial milestones, which subject to approval by Nabriva Therapeutics’ shareholders and specified limitations, may be settled in Nabriva Therapeutics’ ordinary shares.
Nabriva Therapeutics’ ordinary shares issued upon completion of the acquisition, together with shares that may be issuable upon release of an indemnity holdback, constitute approximately 19.9% of Nabriva Therapeutics’ ordinary shares outstanding as of immediately prior to completion of the acquisition.
“We believe the strategic acquisition of Zavante’s promising late-stage product candidate bolsters Nabriva’s leading position in developing new anti-infectives that address critical areas of unmet medical need, including antibiotic resistance,” said Colin Broom, M.D., former chief executive officer of Nabriva Therapeutics. “We expect that Nabriva’s expert commercial, medical affairs and supply chain infrastructure will be able to fully support CONTEPO, a novel, potential first-in-class IV treatment in the United States. We believe CONTEPO will be beneficial in the early, appropriate treatment of complicated urinary tract infections caused or suspected to be caused by multi-drug resistant (MDR) bacteria. Nabriva expects to file New Drug Applications (NDAs) with the U.S. Food and Drug Administration for both lefamulin and CONTEPO in the fourth quarter of 2018.”
CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD), is Zavante Therapeutics’ novel, potentially first-in-class in the United States, intravenous investigational antibiotic. CONTEPO is in development to treat serious infections, including those caused by multi-drug resistant Gram-negative and Gram-positive bacteria. Outside of the United States, IV fosfomycin has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections (cUTIs) and other serious bacterial infections. In recent years, IV fosfomycin has seen increasing use for treatment of serious infections caused by MDR Gram-negative bacteria. Zavante has been developing CONTEPO with the objective of establishing CONTEPO as a standard of care in the United States for hospitalized patients with serious infections caused by suspected or confirmed MDR bacteria. Zavante has completed a pivotal Phase 2/3 clinical trial (ZEUS™) with respect to CONTEPO for the treatment of cUTIs and has initiated a pediatric clinical trial. In April 2017, Zavante announced that CONTEPO met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the ZEUS™ clinical trial in patients with cUTI, including acute pyelonephritis (AP). CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration (FDA) in several indications, including cUTI. Nabriva Therapeutics expects to file a New Drug Application (NDA) utilizing the FDA’s 505(b)(2) pathway in the fourth quarter of 2018.
Lefamulin is a semi-synthetic pleuromutilin 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. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Nabriva Therapeutics has completed two pivotal Phase 3 trials evaluating the safety and efficacy of lefamulin for the treatment of adults with community-acquired bacterial pneumonia (CABP). In both studies, lefamulin met all primary and secondary endpoints and was shown to be generally well tolerated. As a result of the favorable safety and tolerability profile observed in clinical trials to date, Nabriva Therapeutics believes lefamulin represents a potentially important new treatment option for the approximately three million adults in the United States diagnosed with CABP in the hospital setting each year.
“With this acquisition, Nabriva strengthens its antibiotics leadership position with two late-stage antibiotics with novel mechanisms of action. Nabriva shares Zavante’s deep commitment to addressing the growing global problem of antibiotic resistance by providing novel treatment options to physicians and patients that combat serious and life-threatening infections,” said Ted Schroeder, former president and chief executive officer of Zavante. “With Nabriva’s scientific, clinical and commercial leadership, we believe the CONTEPO program can thrive and deliver the most value to our existing shareholders. I want to personally thank and recognize the contributions made by the entire team at Zavante. We’re proud of the company that we collectively built and are confident that our important mission and focus will continue under the guidance of the new team and our colleagues at Nabriva.”
WilmerHale LLP acted as legal advisor to Nabriva Therapeutics, and Latham & Watkins LLP acted as legal advisor to Zavante Therapeutics, in connection with the acquisition. Bank of America Merrill Lynch acted as the financial advisor to Zavante. Wedbush PacGrow acted as an advisor to Nabriva’s Board of Directors and provided a fairness opinion.
Upon closing of the acquisition, Mr. Schroeder was appointed as chief executive officer of Nabriva Therapeutics to succeed Dr. Broom, and Mr. Schroeder’s employment agreement with Nabriva Therapeutics provides that he will be appointed to Nabriva Therapeutics’ board of directors effective immediately following Nabriva Therapeutics’ 2018 Annual General Meeting of Shareholders, scheduled to be held on August 1, 2018. Dr. Broom will continue to serve on Nabriva Therapeutics’ board of directors and will work closely with Mr. Schroeder and the management team as a consultant.
“On behalf of Nabriva’s board of directors, investors and employees, we want to thank Colin for his tremendous leadership and accomplishments during his tenure as CEO,” said Dan Burgess, Nabriva’s Chairman of the Board. “Colin has led the company through many key corporate achievements, including an initial public offering, two successful Phase 3 clinical trials and the establishment of an outstanding team who are evolving Nabriva from a clinical stage to a commercial stage company with two products potentially launching in 2019.”
Prior to serving as president, CEO, founder and director of Zavante Therapeutics, Mr. Schroeder co-founded Cadence Pharmaceuticals and served as president, CEO and a member of the board of directors until the company’s acquisition by Mallinckrodt Pharmaceuticals in 2014 for $1.4 billion. He had also held several roles at Elan Pharmaceuticals including senior vice president of North American sales and marketing, and vice president and general manager of the hospital products business unit – a role he also held at Dura Pharmaceuticals before its acquisition by Elan. In this position, he was responsible for overseeing commercialization of a number of successful IV anti-infectives including Maxipime™, Azactam™ and Ablecet™. Earlier in his career, Mr. Schroeder held a number of hospital-related sales and marketing positions with Bristol-Myers Squibb. He currently serves on the board of Cidara Therapeutics, Otonomy and Collegium Pharmaceutical.
“I am honored to join this outstanding team of professionals who are committed to advancing the treatment of infectious disease and look forward to planning for and successfully executing on the launch of two novel antibiotics,” said Schroeder. “We will remain focused on helping healthcare providers and patients manage the urgent public health crisis of bacterial resistance, through innovative and meaningful therapeutic solutions.”
Promotion to President and Chief Operating Officer
Upon closing of the acquisition, Dr. Steven Gelone, Nabriva’s Chief Scientific Officer and Vice President, Business & Corporate Development, has been named President and Chief Operating Officer of Nabriva, reporting to Mr. Schroeder. Along with his current responsibilities, Dr. Gelone will oversee Nabriva’s Technical Operations and Quality organizations. Dr. Gelone joined Nabriva in December 2014.
Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than five million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately three million of these adult CABP patients are diagnosed in an in-patient hospital and/or emergency department setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.
Urinary tract infections (UTIs) are a significant health problem in both the community- and hospital-based treatment settings. It is estimated that 150 million UTIs occur yearly worldwide, accounting for $6 billion in health care expenditures, according to the American Urological Association. Patients who fail to respond to an initial course of antibiotics can go on to develop a cUTI, which occurs when the bacteria is embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. In most cases, cUTIs occur following treatment for a normal UTI because antibiotics were given too late, for too short a period or at too low of a dose course or the wrong antibiotic was used and did not provide adequate spectrum of coverage.
An estimated 3 million cases of cUTIs are treated in the hospital setting in the United States each year for Gram-negative infections. Enterobacteriaceae are the most common pathogens causing cUTIs and, currently, widespread antibiotic resistance among these pathogens limits the effective treatment options for cUTI. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality.
Conference Call and Webcast
Nabriva Therapeutics will host a conference call and webcast at 4:30 p.m. EDT today. The live webcast can be accessed under “Events and Presentations” in the Investors section of Nabriva Therapeutics’ website at www.nabriva.com and will be accessible for 90 days. The conference call can also be accessed by dialing 1-866-811-8671 (U.S./Canada) or 1-409-981-0874 (international) and providing the passcode 9465938.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. We have two product candidates that are in late stage development: lefamulin, under development to potentially be the first pleuromutilin antibiotic available for systemic administration in humans, and CONTEPO, a potential first-in-class in the United States, hospital-based intravenous, or IV, antibiotic. We are developing both IV and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia, or CABP. We are developing CONTEPO IV for complicated urinary tract infections, or cUTI. We may potentially develop lefamulin and CONTEPO for additional indications.
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the acquisition of Zavante Therapeutics Inc. and the other transactions contemplated by the acquisition and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements related to Nabriva Therapeutics’ expectations with respect to the potential financial impact and benefits of the acquisition, including Nabriva Therapeutics’ expectations with respect to milestone payments and expectations with respect to and potential advantages of CONTEPO as well as any statements with respect to the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, conduct and timelines of clinical trials, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI and plans for filing of regulatory approvals and efforts to bring lefamulin and CONTEPO to market, the market opportunity for and the potential market acceptance of lefamulin for CABP and CONTEPO for cUTI, the development of lefamulin and CONTEPO for additional indications, the development of additional formulations of lefamulin and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources 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: Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period or at all, negative effects of the announcement of the acquisition on the market price of Nabriva Therapeutics’ ordinary shares, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition, 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, whether results of Nabriva Therapeutics’ first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, whether results of ZEUS will be indicative of results for any ongoing or future clinical trials and studies of CONTEPO, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP and CONTEPO for the treatment of cUTI, whether regulatory or commercial milestones are achieved, Nabriva Therapeutics’ ability to successfully integrate Zavante Therapeutics’ business into its business, any challenges associated with Nabriva Therapeutics’ chief executive officer transition in connection with the Acquisition, Nabriva Therapeutics’ ability to retain and hire key personnel, the risk that disruption resulting from the acquisition may adversely affect Nabriva Therapeutics’ business and business relationships, including with employees and suppliers, the sufficiency of cash resources and need for additional financing 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.
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