FDA Approval of Antibiotic for Bacterial Pneumonia Expected in Late Summer17th May 2019
By The Life Science Report
Source: Streetwise Reports 05/15/2019
An update on this biopharma’s two lead drug candidate programs was provided in an H.C. Wainwright report.
In a May 13 research note, H.C. Wainwright & Co. analyst Ed Arce reported that for Nabriva Therapeutics Plc (NBRV:NASDAQ), “all eyes [are] on [its] Aug. 19, 2019 lefamulin PDUFA date,” around which time the U.S. Food and Drug Administration (FDA) is expected to approve the antibiotic for the treatment of community-acquired bacterial pneumonia.
Approval will be based on positive Phase 3 data from the LEAP 1 and LEAP 2 trials and the FDA not requiring an advisory committee (Ad Com) meeting, Arce pointed out. Additionally, the fact that lefamulin can be delivered in an outpatient setting, orally or intravenous-to-orally, is significantly advantageous in that it eliminates the need for hospitalization of these pneumonia patients, which can cost about $2,500 a day. Also, the FDA accepted Nabriva’s new drug applications for lefamulin in both formulations based on a six-month priority review target.
Were the FDA to approve lefamulin, Nabriva likely would launch U.S. sales soon after and reach domestic peak sales of an estimated $460 million by 2026, highlighted Arce.
With respect to the commercialization of lefamulin in Europe, Nabriva submitted in early May amarketing authorization application to the European Medicines Agency for approval, Arce noted. If approval is secured, which H.C. Wainwright expects, the antibiotic would likely hit the European Union market in about mid-2020.
Regarding another Nabriva asset, Contepo (fosfomycin), an injected treatment for complicated urinary tract infections, Arce indicated the company most likely will request a Type A meeting with the FDA to address the complete response letter it issued regarding the company’s market application for approval.
If the meeting is granted, the FDA would likely “discuss concerns and potential remedies of the manufacturing deficiencies” and decide whether to categorize Contepo’s new drug application resubmission as a Class 1, which has a two-month target review time frame, or as a Class 2, with a six-month window, Arce explained. It’s expected that Nabriva, at the meeting, would address all of the FDA’s concerns to resume the regulatory approval process of Contepo.
Finally, Arce reported that Nabriva ended Q1/19 with $91.3 million in cash and cash equivalents, enough to cover operations through Q2/20, according to management. Also, during the first quarter, the company generated $9.7 million in net proceeds from the sale of common shares.
H.C. Wainwright has a Buy rating and a $7 per share price target on Nabriva, whose stock is currently trading at around $2.76 per share.
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Disclosures from H.C. Wainwright & Co., Nabriva Therapeutics plc, Earnings Update, May 13, 2019
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Ed Arce and Thomas Yip, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Nabriva Therapeutics plc (including, without limitation, any option, right, warrant, future, long or short position).
As of April 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Nabriva Therapeutics plc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm does not make a market in Nabriva Therapeutics plc as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.
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