0001104659-19-046525.txt : 20190819 0001104659-19-046525.hdr.sgml : 20190819 20190819162555 ACCESSION NUMBER: 0001104659-19-046525 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 38 CONFORMED PERIOD OF REPORT: 20190816 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190819 DATE AS OF CHANGE: 20190819 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Nabriva Therapeutics plc CENTRAL INDEX KEY: 0001641640 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L2 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37558 FILM NUMBER: 191036739 BUSINESS ADDRESS: STREET 1: 56 FITZWILLIAM SQUARE CITY: DUBLIN STATE: L2 ZIP: 2 BUSINESS PHONE: (610) 816-6640 MAIL ADDRESS: STREET 1: 1000 CONTINENTAL DRIVE STREET 2: SUITE 600 CITY: KING OF PRUSSIA STATE: PA ZIP: 19406 FORMER COMPANY: FORMER CONFORMED NAME: Nabriva Therapeutics AG DATE OF NAME CHANGE: 20150507 8-K 1 a19-17297_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of Earliest Event Reported):  August 16, 2019

 

NABRIVA THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-37558

 

Not Applicable

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
No.)

 

25-28 North Wall Quay,
IFSC, Dublin 1, Ireland

 


Not Applicable

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (610) 816-6640

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which
registered

Ordinary Shares, nominal value $0.01 per share

 

NBRV

 

The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 


 

Item 7.01.  Regulation FD Disclosure.

 

On August 19, 2019, Nabriva Therapeutics plc (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) approved the oral and intravenous formulations of XENLETATM (lefamulin) for the treatment of community-acquired bacterial pneumonia in adults.

 

The Company will host a conference call to discuss the FDA approval of XENLETATM on Monday, August 19, 2019 at 4:30 PM Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company’s website.

 

The slide presentation to be used by the Company during the call is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01.  Other Events.

 

XENLETATM (lefamulin) Announcement

 

The press release announcing the FDA approval of XENLETATM is attached hereto as Exhibit 99.2 and incorporated herein by reference.

 

CONTEPO™ (fosfomycin) Announcement

 

In addition, on August 16, 2019, the Company announced its plans to resubmit its new drug application for marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis. The related press release is attached hereto as Exhibit 99.3 and incorporated herein by reference.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d)  Exhibits.

 

Exhibit
No.

 

Description

99.1

 

XENLETATM Presentation dated August 19, 2019.

99.2

 

Press release issued by Nabriva Therapeutics plc, dated August 19, 2019.

99.3

 

Press release issued by Nabriva Therapeutics plc, dated August 16, 2019.

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

NABRIVA THERAPEUTICS PLC

 

 

Date: August 19, 2019

By:

/s/ Gary Sender

 

 

Gary Sender
Chief Financial Officer

 

3


EX-99.1 2 a19-17297_1ex99d1.htm EX-99.1

Exhibit 99.1

XenletaTM (lefamulin) FDA Approval Investor Call August 19, 2019

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Safe Harbor and Disclaimer This presentation contains forward-looking statements about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about launch and commercialization of XENLETA for the treatment of CABP, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring XENLETA and CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, plans for distributing and timing of the availability of XENLETA, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA 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 successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force and prepare for commercial launch of XENLETA on the timeline expected, or at all, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ reliance on third-party manufacturers for the commercial supply of XENLETA and third-party distributors to make XENLETA available to hospitals and the medical community and the ability of such third parties to comply with regulatory requirements, 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 availability or commercial potential of CONTEPO for the treatment of cUTI or of XENLETA for the treatment of CABP, the ability to retain and hire key personnel, 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 presentation represent Nabriva Therapeutics’ views as of the date of this presentation. 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 presentation. 2

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XENLETA Approval Introductory Comments Ted Schroeder Chief Executive Officer

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XENLETA Receives U.S. FDA Approval XENLETA (lefamulin) injection and XENLETA (lefamulin) tablets received U.S. FDA approval for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms XENLETA is the first IV and oral pleuromutilin antibiotic and the first novel antibacterial class to be approved for the treatment of CABP in nearly two decades Provides medical community with an important empiric monotherapy treatment option to address increasing resistance and safety concerns with currently approved agents Expected to Be Available for Patients and Physicians in Mid-September 2019 Key Highlights 4

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XENLETA Prescribing Information Highlights Jennifer Schranz, MD Chief Medical Officer

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Pneumonia A Leading Cause of Morbidity, Mortality and Healthcare Cost 6 #3 Cause of hospital readmission2 ~5MM Cases Annually8 1: el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA. 2018;319(12):1248–1260. doi:10.1001/jama.2018.2089 2: Fingar K, Washington R. Trends in hospital readmissions for four high-volume conditions, 2009-2013: Statistical Brief #196. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality; November 2015. http//www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.pdf. Accessed February 23, 2016. 3: HCUP Fast Stats - Most Common Diagnoses for Inpatient Stays – 2015 https://www.hcup-us.ahrq.gov/faststats/NationalDiagnosesServlet 4: 2017 CHARTBOOK STATIC ANALYSES - Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation - Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017 5: Joya-Montosa Critical Care 2015 19(Suppl 1):P19. 6: AlOtair Journal of Taibah University Medical Sciences Volume 10, Issue 3, Sept. 2015, Pages 293-299. 7: File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122:130–41. 8: National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 - 2010. https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed June 21, 2019). #5 Cause of total hospitalizations3 #1 Cause of infectious death1 Mortality rate ~$17B ~15% in hospital4 ~25 – 30% in ICU5,6 Direct costs of pneumonia7

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New Treatment Options For CABP Are Needed Resistance, Safety & Convenience Concerns Related to First-Line Treatment Options1 7 Mid Atlantic 38.5% East North Central 44.3% West North Central 51.7% East South Central 50.5% West South Central 57.2% Mountain 33.2% Pacific 29.1% New England 38.6% Mid Atlantic 38.5% South Atlantic 43.7% CONCERNS WITH FIRST-LINE AGENTS THREAT OF ANTIMICROBIAL RESISTANCE Distribution of Azithromycin Resistance for S. pneumoniae Across the U.S. (2015-2018)2 FDA and EMA have issued class safety alerts for fluoroquinolone, including boxed warnings β-lactams limited by hypersensitivity and lack of IV-to-oral conversion (ceftriaxone) 1First-line treatment options per consensus guidelines are macrolides, fluoroquinolones, and/or β-lactams 2:Criteria as published by CLSI (2019) Dataset provided by JMI Laboratories and the SENTRY Antimicrobial Surveillance Program; available at sentry-mvp.jmilabs.com 7

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XENLETA, USPI, August 2019 Paukner S; Riedl R. Cold Spring Harbor perspectives in medicine;2017:2157-1422 Waites KB, et al. Antimicrob Agents Chemother. 2017;61:pii: e02008-16. 8 P site A site PTC of the 23S rRNA of the large 50s ribosomal subunit XENLETA inhibits bacterial protein synthesis through multiple interactions with peptidyl transferase center (PTC) of the 50S ribosomal subunit No cross-resistance with β-lactams, fluoroquinolones, macrolides, and tetracyclines Low risk of resistance development due to multiple binding sites on the bacterial ribosome XENLETA Novel Mechanism of Action

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CLINICAL TRIAL EXPERIENCE INDICATION 9 XENLETA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms XENLETA was approved based on two global, Phase 3 clinical trials (LEAP 1 & 2) that enrolled 1289 adult patients with PORT scores II to V CABP 1: Adjunctive linezolid in patients with known or suspected MRSA. XENLETA First Approved IV and Oral Pleuromutilin DOSAGE AND ADMINISTRATION Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* 5 to 7 days 600 mg orally every 12 hours 5 days *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course

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XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval 10 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents Embryo-Fetal Toxicity: Based on findings from animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception Clostridium difficile-associated Diarrhea (CDAD): Class labeling XENLETA Favorable Safety Profile in Adult Patients with CABP ADVERSE REACTIONS OCCURRING IN >2% OF PATIENTS RECEIVING XENLETA XENLETA injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache XENLETA tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation

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1806 KOLs engaged and profiled; scientific exchange with 2815 HCPs Over 1,300 KOL clinical insights captured to better understand the unmet need in cUTI and CABP 13 Advisory Boards to gain insights from HCPs (ID, ED, PharmD, Chest) in 2018/19 Health Economics and Outcomes Research (HEOR) Value determination, demonstration & communication Scientific Publications Lefamulin PK/PD Supplement LEAP 1 & LEAP 2 Scientific reach from 2010 116 abstracts/posters 25 manuscripts Medical Education Live symposia Web based and enduring materials Medical Information Call Center/Pharmacovigilance Standard response letters AMCP dossier Experienced Medical Science Liaisons: Profiling and Engaging Key Option Leaders (KOLs) 11 Nabriva’s Comprehensive Approach to Medical Affairs Scientific Leader Engagement, Data Dissemination and Medical Education HCPs: Healthcare Physicians Customer Insights What do HCPs value? What drives decision making? Scientific Communication Publication Plan Clinical Evidence Value of Antimicrobial Treatment Evidence Generation Registrational Trials Life Cycle Global Value Team

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XENLETA In Vitro Antimicrobial Susceptibility Testing Will Be Available at Launch Research Use Only (RUO) materials for non-diagnostic, in vitro purposes available for up to 700 hospitals Disks (Mast) MIC test strips (Liofilchem) Automated device testing (Vitek-2, Sensititre); disks (BD, Thermofisher, Liofilchem) Nabriva Observational Bacterial EvaLuation program (NOBEL) 1-800-738-3344 or email: nobel-ruo@ihma.com August 2019 1Q20 4Q19 1H20 12

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XENLETA Commercial Opportunity Francesco Maria Lavino Chief Commercial Officer

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Pneumonia A Leading Cause of Morbidity, Mortality and Healthcare Cost 14 #3 Cause of hospital readmission2 ~5MM Cases Annually8 1: el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA. 2018;319(12):1248–1260. doi:10.1001/jama.2018.2089 2: Fingar K, Washington R. Trends in hospital readmissions for four high-volume conditions, 2009-2013: Statistical Brief #196. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality; November 2015. http//www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.pdf. Accessed February 23, 2016. 3: HCUP Fast Stats - Most Common Diagnoses for Inpatient Stays – 2015 https://www.hcup-us.ahrq.gov/faststats/NationalDiagnosesServlet 4: 2017 CHARTBOOK STATIC ANALYSES - Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation - Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017 5: Joya-Montosa Critical Care 2015 19(Suppl 1):P19. 6: AlOtair Journal of Taibah University Medical Sciences Volume 10, Issue 3, Sept. 2015, Pages 293-299. 7: File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122:130–41. 8: National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 - 2010. https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed June 21, 2019). #5 Cause of total hospitalizations3 #1 Cause of infectious death1 Mortality rate ~$17B ~15% in hospital4 ~25 – 30% in ICU5,6 Direct costs of pneumonia7

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Outpatients Transition of Care In-Patients Prioritized Accounts Community Hospital Point of Care: Initial Nabriva Focus 1 2 3 A: Healthcare Cost and Utilization Project (HCUP) 2013, Age 18+ (projected to 2029) B: Community Data (CDC 2009-2010), Age 18+ (projected to 2029) C: Company Sponsored Market Research, Medical Marketing Economics, July 2016, (N=122) ED Treatments & Discharge ~ 0.9MM PatientsA,C Hospital Discharge ~ 2.4MM PatientsA,C Hospital In Patient ~ 3.8MM PatientsA,C Office Based ~ 2.3MM PatientsB Patients numbers approximately six years after launch & continue to grow until LOE, following the CABP epidemiology growth**~3.0MM Hospital Initiated Outpatients and ~0.9MM of ED Outpatients. 15 3 Distinct and Significant Opportunities in the Treatment of CABP Targeted Commercial Strategy to Accelerate Adoption and Market Uptake

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IPSOS Research, March 2018 (funded by Nabriva) First Line Empiric Therapy Of CABP Ceftriaxone, Macrolides And Fluoroquinolones Are The Main Choices For All Adult Patients with CABP 16 Macrolides Fluoroquinolones Cephalosporins PCN/BLI Tetracyclines Vancomycin Oxazolidinones TMP/SMZ 0% 10% 20% 30% 40% EMERGENCY DEPARTMENT 0% 20% 40% 60% FLOOR 0% 20% 40% 60% ICU 0% 10% 20% 30% 40% COMMUNITY

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Safety Issues: Box Warnings, FDA Ad Com Recommendations High Risk for C. difficile Infections Off target activity: Collateral Damage Pressure to reduce use Ceftriaxone IV only Admission required Need to change antibiotic for discharge (no Oral available) Macrolide resistance to S. pneumoniae and M. pneumoniae High Risk for C. difficile Infections with β-Lactams No MRSA coverage Ceftriaxone plus Macrolide Fluoroquinolones Current First-Line Treatment Options for CABP Have Limitations 17 30% of patients treated for CABP are receiving 2nd/3rd line Therapy A Hospitals on average lose money when using generics due to extended length of stay and readmission B A Company sponsored market research, Medical Marketing Economics, July 2016, (N=122) B Company sponsored market research, Avalere 2016 Analysis of CABP 2015 MedPAR data

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Emerging Fluoroquinolone Safety Concerns FDA web site: Fluoroquinolone antimicrobial drugs information. EMA website: https://www.ema.europa.eu/en/news/fluoroquinolone-quinolone-antibiotics-prac-recommends-new-restrictions-use-following-review Communications Issued by FDA and EMA 18 2008 2011 2013 2015 2016 2018 July 2008 FDA Tendinitis and tendon rupture; “consider risk/benefit in individuals” Feb 2011 FDA Worsening symptoms in patients with myasthenia gravis Aug 2013 FDA Risk of peripheral neuropathy Nov 2015 FDA Advisory Committee meeting July 2018 FDA: Distinction between warning for mental health and CNS effects; include risk of coma with hypoglycemia July 2016 FDA “Serious side effects associated with FQs generally outweighs the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated UTI” Reserved for those without alternative treatment options. Adverse effects include tendons, muscles, joints, nerves, CNS May 2018 EMA: Recommendation to restrict the use of fluoroquinolone following a review of disabling and potentially long-lasting side effects Dec 2018 FDA: “fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta” Oct 2018 EMA: New warning regarding risk of aortic aneurysm and dissection associated with fluoroquinolones for systemic and inhalation use

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Fluoroquinolones Use Clear Trend of Reduced Use in the Hospital and Community 19 Source: IQVIA, NSP Audit Extended Units, All-Outlet (Hospital & Retail) Extended units are the number of tablets, capsules, milliliters, ounces, etc. of a product shipped in each unit. This number is calculated by multiplying the number of units by the product size. Increased fluoroquinolone restrictions, including specific limitations for CABP at some hospitals, are leading to a reduced use Fluoroquinolones remain the most commonly prescribed antibiotics in the hospital FQ Usage in the Hospital & Retail Combined has Declined in Recent Years 0 500,000,000 1,000,000,000 1,500,000,000 2,000,000,000 2,500,000,000 3,000,000,000 3,500,000,000 4,000,000,000 4,500,000,000 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Extended Units Fluoroquinolones Volume Trends (Units)

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The most important unmet needs in CABP New Drugs with Base: All Respondents: Total (n=291) across ID/ED/PCP/ICU/Pharm D/Hospitalists Responses on a 1-7 Scale: 1-2 is Lowest Need and 6-7 is Highest Need IPSOS Research, March 2018 (funded by Nabriva) The majority of respondents believe there is a high need for new CABP treatments Activity against multi-resistant pathogens Low propensity to develop resistance Easy IV to Oral conversion Good safety & tolerability profile 20 HCPs Believe There is An Extremely High Need For New CABP Treatment Options Differentiated Treatments Needed Both in the Hospital and Community Setting

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Addressing Antimicrobial Resistance: MSDRG: certain diagnosis related group codes (ICD-10) that include an antimicrobial resistance (MDRO) will be designated as a complication or comorbidity, which generally results in assignment to a higher payment for inpatient stays. Increased DRG payments will begin on October 1st 2019 New NTAP Policy CMS has finalized an alternative and simplified New Technology Add-on Payment (NTAP) pathway for Antimicrobial Products designated by FDA as Qualified Infectious Disease Products (QIDPs) CMS is increasing the payment for QIDP antimicrobials granted NTAP from 50% to 75% The final rule will update Medicare Payment Policies for hospitals for fiscal year (FY) 2020 which begins on October 1st 2019 New NTAP applications will be filed by early October 2019 and, if granted, will be effective in October 2020 CMS Inpatient Prospective Payment System (IPPS), August 2, 2019 21 Healthcare Policy Reform Pathways for Increased Reimbursement for New Innovative Antibiotics Are Becoming a Reality

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Complete Spectrum of Coverage of Main CABP Pathogens Monotherapy with appropriate spectrum for CABP aligned with principles of antimicrobial stewardship; Low risk of C. difficile infection Generally Well Tolerated Profile Low rates of discontinuations due to adverse events in Phase 3 clinical trials New Class for IV and Oral Use New Mechanism of Action Overcomes existing mechanism of resistance in vitro; Low propensity for development of bacterial resistance Convenient for Patients in Hospital, Transition of Care and the Community IV and bioequivalent oral formulations approved; Short course of monotherapy Excellent PK-PD Profile No loading dose; no dose adjustment for renal insufficiency; mild food interaction potential 22 XENLETA A Promising Treatment Option for CABP

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The Right Spectrum, Right from the Start 23 1st Line Empiric Therapy for CABP Patients in the Emergency Department that can Avoid Hospitalization 1st Line Empiric Therapy for CABP Patients admitted to the Hospital with Co-Morbidities and limited options 1st Line Empiric Therapy for CABP Patients admitted to the Hospital then Transitioned to Oral and Discharged XENLETA Target Patient Population

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Critical Success Factors for an Antibiotic Launch Preparation, Preparation, Preparation! 24

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Focus on Transition of Care (Outpatients) Market Development identified accounts with: High macrolide or β-Lactams resistance Higher than average: C. difficile rate CABP mortality rate CABP readmission rate Reimbursement penalties for CABP Fluoroquinolone restrictions for CABP Higher incentive ($) to deflect admissions or to accelerate patients discharge on oral therapy XENLETA Hospital Initiated Business Opportunity(1) ~1,600 Accounts Represents >80% CABP Patients Symphony Data: Antibiotic Spend in US Hospitals, 2016 As of August 10, 2019 Priority Accounts >600 Accounts Profiled to Date(2) Nabriva’s Comprehensive Approach to Pre-Commercial Activities Focus on Identification of Priority Accounts and Maximization of Patients Access 25 Engagement with Key Payers (2) Meetings with Key Payer Accounts ~95% of the Targeted Lives Corporate Overview and Disease State Overview Clinical Review of LEAP 1 & 2 Topline Data (by Medical Affairs) Contracting Process initiated with the majority of Key Payers and contracts finalized with large, integrated health systems

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XENLETA Initial Focus in the Hospital & Transition of Care XENLETA Commercialization Plan Focus on Executing a Successful Launch in the US Exploring creative ways to access the community opportunity in 2019 leveraging the existing infrastructure XENLETA Business Opportunity(1) ~1600 Accounts represent >80% Opportunity (1) Pharma Intelligence Consulting Primary Research Prescribing Physicians, September 2016 26 Expected to Launch with 60 Reps to cover ~900 Target Accounts in 2019-2020 Community

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XENLETA Distribution Plan Specialty Distribution Model and Specialty Pharmacies Network to Support Transition of Care 27 Specialty Distributors McKesson Plasma and Biologics ASD Healthcare Cardinal SD 3PL Hospital Specialty Pharmacies (Supporting Transition of Care) Hospital Hospital Our Goal: XENLETA is available to clinicians in mid-September 2019

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Nabriva Specialty Pharmacy Network Partners Removing Barriers to Ensure Patient Access to Oral XENLETA Focus on IV to Oral Transition and Aligned to Key Hospital Targets Direct-to-Patient Services, Meds to Beds and Home Fulfilment Consistent with XENLETA Dosing Schedule Expected to be available at: ~300 Specialty Retail IDN, Community and Medical Office Building Sites Bedside delivery at discharge, same day pick up and mail to home Facilities in 46 States, serving patients across 50 States 96% of US population covered 76 nationwide care management centers & 90 ambulatory Infusion Suites (IV) Home care infusion services (IV) and Mail to home service (Oral) Outpatient Hospital Pharmacies and Specialty Pharmacy Network will ensure continuity of care Cleveland Clinic* UPMC* Highmark* Kaiser* Geisinger* Local Outpatient Hospital Pharmacies * Listed Institutions are just examples of Hospitals that do have their own Outpatients Pharmacies to support Transition of Care 28

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Nabriva Hub Services Removing Barriers to Ensure Patient Access to Oral XENLETA In Partnership with RX Cross-Road Multiple services available for providers and patients to ensure a smooth transition from Hospital to Home Available for eligible patients with commercial insurance Limited out-of-pocket to secure adherence No eligible patient will pay more than $50 / prescription 29

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Closing Remarks Ted Schroeder Chief Executive Officer

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XENLETA Receives U.S. FDA Approval Well-Positioned for a Successful Launch Key Drivers of Success 31 Product XENLETA has a novel mechanism of action with a complete spectrum of activity for the main CABP pathogens with a low risk of resistance Demonstrated efficacy as an empiric monotherapy with activity against multi-resistant pathogens Generally well-tolerated safety profile XENLETA offers short course IV or oral dosing flexibility People Highly experienced and talented HQ and field-based team Preparation Diverse and thorough preparation over the past two years focusing on: Medical education Profiling the right hospitals for launch Creating an innovative distribution network Optimizing payor coverage to help with patient access

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Questions?

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EX-99.2 3 a19-17297_1ex99d2.htm EX-99.2

Exhibit 99.2

 

 

Nabriva Therapeutics Receives U.S. FDA Approval of Xenleta™ (lefamulin) to Treat Community-Acquired Bacteria Pneumonia (CABP)

 

First New IV and Oral Antibiotic with a Novel Mechanism of Action Approved in Nearly Two Decades Provides Critically Needed Treatment Option for Adult Patients with CABP

 

XENLETA Expected to be Available mid-September 2019

 

Conference call and webcast today at 4:30 p.m. EDT

 

DUBLIN, Ireland, August 19, 2019 — 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 U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. As the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades, XENLETA represents an important new empiric monotherapy treatment option for adults with CABP.

 

“Today’s approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” said Ted Schroeder, chief executive officer of Nabriva Therapeutics. “We are especially proud of this approval because XENLETA was discovered in our labs over a decade ago and the entire development program was designed and executed by our dedicated and passionate team. We are indebted to the patients and researchers who collaborated with us and are excited to bring to patients and healthcare providers a novel, short course, empiric monotherapy treatment option for CABP. XENLETA has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes. XENLETA has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship.”

 

“The gravity of antimicrobial resistance cannot be overstated, particularly in the context of treating pneumonia,” said Julio Ramirez, MD, FACP, Professor of Medicine, and Chief within the Division of Infectious Diseases, University of Louisville School of Medicine. “As an infectious disease specialist who treats CABP patients in the hospital setting, I am grateful to have both a new IV and oral option that gives me confidence that my patients will continue to receive appropriate therapy once they are discharged from the hospital.”

 

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. Currently, the median length of stay for patients with pneumonia is 3-to-4 days, resulting in approximately $17 billion in hospital costs per year in the United States. The opportunity to avoid a hospital admission or to discharge a patient earlier on oral therapy benefits patients and may result in significant savings to the health system.

 

Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA. The FDA approval was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of IV and oral XENLETA compared to moxifloxacin in the treatment of adults with CABP. LEAP 1 was designed to evaluate 5-to-7 days of IV/oral therapy of XENLETA versus 7-days of IV/oral moxifloxacin, with or without linezolid, with both treatment groups having the option to switch from IV to oral administration after 3-days. LEAP 2 evaluated 5-days of oral XENLETA versus 7-days of oral moxifloxacin. LEAP 1 showed comparable efficacy with moxifloxacin, with or without linezolid, while LEAP 2 showed comparable efficacy with moxifloxacin, with two fewer days of therapy. XENLETA was generally well tolerated in both LEAP 1 and LEAP 2.

 

“Emergency departments across the country treat hundreds of thousands of patients with CABP each year. Many of these patients, especially elderly patients with comorbidities, are admitted solely because of the lack of an effective and well-tolerated oral treatment option” said Philip Giordano, MD, Vice Chairman of Emergency Medicine at the Orlando Regional Medical Center. “With a new oral antibiotic option that has been shown to be as effective as a respiratory fluoroquinolone, possessing a favorable side effect profile, we can consider sending more patients home directly from the emergency department and avoid costly hospitalizations, which is good for both patient care and the health system.”

 

Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to recent data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide resistant. In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option, however fluoroquinolones carry boxed warnings for several significant safety concerns.

 

Nabriva expects XENLETA will be available through major U.S. specialty distributors in mid-September 2019. XENLETA will have a wholesale acquisition (WAC) price of $205 per IV patient treatment day and $275 per oral patient treatment day.

 

“Offering clinicians and patients a new treatment option for CABP that addresses the urgent and growing threat of antimicrobial resistance is our top priority. With that in mind, our team has been working hard to make XENLETA available in the weeks ahead to ensure that patients with CABP who can benefit from this new treatment option can access it,” said Schroeder.

 

Conference Call and Webcast

 

Nabriva Therapeutics will host a conference call and webcast today, August 19, 2019, at 4:30 p.m. EDT. 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 (866) 811-8671 (U.S./Canada) or (409) 981-0874 (international) and providing the passcode 8787189.

 

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. Based on results from its two global, Phase 3 clinical trials, Nabriva Therapeutics believes XENLETA is well-positioned for use as a first-line monotherapy for the treatment of CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile. Nabriva Therapeutics believes XENLETA represents a potentially important new treatment option for the approximately five million adults in the United States diagnosed with pneumonia each year.

 

In LEAP 1 and LEAP 2 (pooled), the median age of patients treated with XENLETA was 61 (range 19-97) years; 42% of patients were 65 years or older and 18% of patients were 75 years or older. In both trials, approximately half of XENLETA-treated patients had impaired renal function and the most common other comorbidities included hypertension, asthma/COPD and diabetes mellitus. These baseline characteristics were broadly representative of the adult patient population with CABP.

 

In LEAP 1, XENLETA demonstrated non-inferiority compared to moxifloxacin, with or without linezolid, for the FDA primary endpoint of early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population (ECR rate = 87.3% for XENLETA and 90.2% for moxifloxacin, with or without linezolid; treatment difference -2.9 [95% confidence interval (CI) -8.5, 2.8]). In LEAP 2, 5-days of oral XENLETA also demonstrated non-inferiority to 7-days of oral moxifloxacin for the ECR endpoint in the ITT population (ECR rate = 90.8% for XENLETA and 90.8% moxifloxacin; treatment difference 0.1 [95% confidence interval (CI) -4.4, 4.5]). Importantly, high-risk patients 65 years and older achieved a similar ECR rate as those less than 65 years of age. The most common adverse reactions in patients receiving XENLETA in LEAP 1 (IV and oral) were administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache in LEAP 1, and in LEAP 2 (oral only) diarrhea, nausea, vomiting and hepatic enzyme elevation. Few discontinuations due to adverse reactions were reported (3.3% in both treatment arms) and the 28-day mortality was low and balanced between treatment groups [8 patients (1.2%)] and [7 patients (1.1%)] for XENLETA and comparator, respectively from pooled data for LEAP 1 and LEAP 2.

 

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), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing ContepoTM (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit https://www.nabriva.com.

 


 

INDICATION AND IMPORTANT SAFETY INFORMATION

 

INDICATION

 

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

 

USAGE

 

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

IMPORTANT SAFETY INFORMATION

 

CONTRAINDICATIONS

 

XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

 

XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

 

WARNINGS AND PRECAUTIONS

 

XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

 

Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

 

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

 

ADVERSE REACTIONS

 

The most common adverse reactions (>2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

 

USE IN SPECIFIC POPULATIONS

 

In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

 

Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

 

Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

 

Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

 


 

XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

 

To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see Full Prescribing Information for XENLETA.

 

Forward-Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about launch and commercialization of XENLETA for the treatment of CABP, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring XENLETA and CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA 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 successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force and prepare for commercial launch of XENLETA on the timeline expected, or at all, 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 availability or commercial potential of CONTEPO for the treatment of cUTI or of XENLETA for the treatment of CABP, the ability to retain and hire key personnel, 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.

 


 

CONTACTS:

 

For Investors

Gary Sender

Nabriva Therapeutics plc

ir@nabriva.com

 

For Media

Mike Beyer

Sam Brown Inc.

mikebeyer@sambrown.com

312-961-2502

 


EX-99.3 4 a19-17297_1ex99d3.htm EX-99.3

Exhibit 99.3

 

 

Nabriva Therapeutics Provides Update on the Planned Resubmission of the New Drug Application for Intravenous CONTEPO™ (fosfomycin) for Injection

 

NDA resubmission anticipated early in the fourth quarter 2019 –

 

DUBLIN, Ireland, August 16, 2019 — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that following its receipt of final Type A Meeting minutes from the U.S. Food and Drug Administration (FDA) it anticipates resubmitting its New Drug Application (NDA) seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis early in the fourth quarter of 2019.

 

The Type A meeting was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in April 2019 in response to the NDA and related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers. Nabriva Therapeutics, along with one of its contract manufacturers, are collaborating to address the issues raised in the CRL based on the feedback from the FDA at the Type A meeting and the meeting minutes. We believe that sufficient corrective actions will be implemented to allow for a resubmission of the NDA.

 

The FDA has not requested any new clinical or non-clinical data, and they did not raise any concerns with regard to the safety or efficacy of CONTEPO at the Type A meeting or in the FDA meeting minutes. Additionally, according to the FDA meeting minutes, the resubmission will be designated as “Class 2,” requiring the FDA to review the resubmission within 6 months of the receipt date.  CONTEPO’s exclusivity is based on the combination of Hatch-Waxman and Qualified Infectious Disease Product (QIDP) designation which begins upon approval by the FDA and continues for eight years in total.

 

“I am pleased that we had the opportunity to clarify the information needed to address the observations in the CRL. With the official minutes from the FDA in hand, we have identified a path forward for resubmission of the CONTEPO NDA in the near future. We look forward to the opportunity to bring this important treatment to patients as quickly as possible and providing clinicians an urgently needed early and appropriate therapeutic option to manage patients at risk of resistant infections with limited available treatment options for cUTIs” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.

 

About CONTEPO

 

CONTEPO (fosfomycin) for injection, (previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva

 


 

Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as an early appropriate treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. An estimated 40 percent of cUTIs are suspected to be caused by MDR bacteria and limited treatment options are available in the U.S. for these patients.

 

About Nabriva Therapeutics plc

 

Nabriva Therapeutics is a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). For more information, please visit https://www.nabriva.com.

 

Forward-Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about Nabriva Therapeutics’ plans for further interactions with the FDA; plans for and timing of working with its third-party contract manufacturer to correct deficiencies at the manufacturer; the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings, 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 potential benefits under its license agreement with Sinovant Sciences, 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, its ability to achieve any of the specified regulatory or performance milestones under its loan agreement with Hercules Capital, 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 resolve the matters set forth in the Complete Response Letter it received from the FDA in connection with its NDA for CONTEPO (fosfomycin) for injection; Nabriva Therapeutics’ reliance on third-party manufacturers to manufacture the clinical and commercial supply of its product candidates and the ability of such third parties to comply with applicable regulatory requirements; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of its acquisition of Zavante Therapeutics, 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 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 CABP and CONTEPO for the treatment of cUTI, the ability to

 


 

retain and hire key personnel, 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.

 

CONTACTS:

 

For Investors

Gary Sender

Nabriva Therapeutics plc

IR@Nabriva.com

 

For Media

Mike Beyer

Sam Brown Inc.

mikebeyer@sambrown.com

312-961-2502

 


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