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FDA Approves First-of-Its-Kind, Adult Pneumonia Antibiotic; September Launch Planned
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The drug's features and its developer's commercial plans are discussed in an H.C. Wainwright & Co. report.

In an Aug. 20 research note, analyst Ed Arce reported that H.C. Wainwright & Co. raised its target price on Nabriva Therapeutics Plc (NBRV:NASDAQ) to $8 per share from $7 after the U.S. Food and Drug Administration (FDA) approved Nabriva's Xenleta (lefamulin) for the treatment of adults with community-acquired bacterial pneumonia (CABP). Nabriva is trading now at around $1.80 per share. The biopharma plans to launch Xenleta commercially this September.

Arce discussed Xenleta and its approval. Treatment with Xenleta can be administered intravenously at 150 milligrams (150 mg) in 60-minute infusions every 12 hours for five to seven days or orally at 600 mg every 12 hours for five days.

Xenleta is the first intravenous (IV) and oral antibiotic with a novel mechanism of action that the FDA approved for CABP in nearly 20 years. Xenleta is the first of its kind, a pleuromutilin, of a new class of antibiotics.

Arce described Nabriva's approach to positioning and selling Xenleta in the U.S. The biopharma intends to market Xenleta as a first-line monotherapy for high-risk CABP patients, ones with several co-morbidities or who are elderly. "We believe Xenleta's IV to bioequivalent oral formulation could enable physicians to seamlessly transition a patient's treatment from the inpatient setting to oral dosing that may be self-administered upon discharge," Arce commented.

For physicians, Arce wrote, Nabriva has a plan in place to make antimicrobial susceptibility testing (AST) available during Xenleta's launch. Before AST becomes available, slated for Q4/19, however, the observational bacterial evaluation program NOBEL will "provide research-use only materials to evaluate susceptibility information for over 700 hospitals," Arce explained. Subsequently, physicians can access "ASTs in disk and strip formats and automated testing platforms" when deciding if Xenleta is or is not the appropriate CABP treatment in specific cases, noted Arce.

As for Xenleta sales, "overall, Nabriva is targeting all stakeholders of the healthcare system in order to maximize Xenleta's early market traction," indicated Arce. Initially, for the first 15 months, the biopharma plans to use 60 sales representatives to cover about 900 accounts. The company already has a distribution network in place for delivery of Xenleta to hospitals along with specialty and direct-to-patient pharmacies.

Also, Nabriva intends to develop an educational and support platform for patients and healthcare providers called Rx Connect. Finally, it will initiate a co-pay assistance program.

H.C. Wainwright has a Buy rating on Nabriva Therapeutics.


1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from H.C. Wainwright & Co., Nabriva Therapeutics plc, Target Price Revision, August 20, 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 July 31, 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 or its affiliates did not receive compensation from Nabriva Therapeutics plc for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

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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