0001104659-20-083753.txt : 20200715 0001104659-20-083753.hdr.sgml : 20200715 20200715163739 ACCESSION NUMBER: 0001104659-20-083753 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20200715 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200715 DATE AS OF CHANGE: 20200715 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: 201029451 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 tm2019110-5_8k.htm FORM 8-K
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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): July 15, 2020

 

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):

 

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

 

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

 

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

 

¨    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 Select 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 1.01. Entry into a Material Definitive Agreement.

 

On July 15, 2020 (the “Effective Date”), Nabriva Therapeutics Ireland Designated Activity Company (the “Company”), a wholly owned subsidiary of Nabriva Therapeutics plc (“Nabriva Therapeutics”), entered into a Sales Promotion and Distribution Agreement (the “Distribution Agreement”) with MSD International GmbH (“MSD”) and Merck Sharp & Dohme Corp. (“Supplier”), each a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Under the Distribution Agreement, upon satisfaction of certain specified conditions described below, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient (marketed and sold by Supplier and MSD prior to the Effective Date under the trademark SIVEXTRO®) for injection, intravenous use and oral use in final packaged form labeled with the Company’s National Drug Code numbers (the “Products”) in the United States of America and its territories (the “Territory”). SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms.

 

Under the Distribution Agreement and subject to fulfillment of certain conditions (including the Company having engaged sufficient sales representatives, restrictions relating to travel and physician office access in the Territory due to COVID-19 having continued to decrease in a sufficient portion of the Territory so as not to hinder the successful detailing of the Products, and other conditions specified in the Distribution Agreement), the Company is granted the right by MSD initially to promote the Products in the Territory and, upon satisfaction of additional conditions, including an increase in sales representatives, the right to exclusively distribute the Products in the Territory, including the sole right and responsibility to fill orders with respect to the Products in the Territory. The Company is granted the right by MSD to use certain trademarks applicable to the Products in connection with the promotion and distribution of the Products by the Company. MSD and, as applicable, its affiliates retain ownership of all trademarks and all patents to the Products and the marketing authorizations and rights to certain know-how relating to the Products in the Territory. Supplier will sell, and the Company agreed to purchase, the Products at specified prices in such quantities as may be specified by the Company, subject to certain limitations, in one or more purchase orders. Subject to applicable law, the Company is entitled to determine the final selling prices of the Products charged by the Company to its customers at its sole discretion, subject to an overall annual limit on price increases, and will be solely responsible for sales contracting and all market access activities, including bidding, hospital listing and reimbursement. The Company expects to fulfill all of the relevant conditions to have the Company to begin distribution of the Products as early as January 1, 2021. Neither party made an upfront payment to the other in connection with entering into the Distribution Agreement.

 

The Company is responsible for all costs related to the promotion, sale and distribution of the Products by the Company, as well as all costs required to meet the Company’s staffing obligations under the Distribution Agreement. The Company is obligated to use commercially reasonable efforts to promote and distribute the Products and to maximize the sales of the Products throughout the Territory. The Company has agreed to employ a sales force or retain the services of a contract sales organization to fulfill its obligations under the Distribution Agreement.

 

Unless earlier terminated, the Distribution Agreement will continue until December 31, 2023, and shall be automatically extended for successive additional periods of 36 months each unless either party provides written notice to the other party that it elects not to renew the Distribution Agreement at least 12 months prior to the end of the then-current period. MSD has the right to terminate the Distribution Agreement upon 30 days’ notice to the Company if the Company has not achieved specified promotion and distribution targets by specified dates (subject, in certain cases, to specified cure periods), and has the right to terminate the Distribution Agreement immediately if the Company is subject to a change in control. In addition, MSD has the right to terminate the Distribution Agreement on a stock keeping unit-by-stock keeping unit basis in the event of certain Product discontinuances. Either party may, subject to specified cure periods, terminate the Distribution Agreement in the event of the other party’s uncured material breach. Either party may also terminate the Distribution Agreement under specified circumstances relating to the other party’s insolvency or certain changes in law.

 

The Distribution Agreement contemplates that the Company will enter in ancillary arrangements with MSD, including a transition services agreement, pharmacovigilance agreement and quality agreement.

 

 

 

 

The foregoing description of certain terms of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement that the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020. 

 

Item 7.01 Regulation FD Disclosure.

 

On July 15, 2020, Nabriva Therapeutics announced the entry into the Distribution Agreement with MSD and the Supplier. The related press release is attached hereto as Exhibit 99.1 and incorporated by reference herein. 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 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.		   Description
99.1   Press Release dated July 15, 2020
104   Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

 

Forward-looking Statements

 

Any statements in this Form 8-K about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about fulfillment of conditions for granting the Company the right to exclusively distribute and promote the Products, the potential benefits under its sales promotion and distribution agreement with MSD, 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 Company’s ability to execute on it promotion and distribution plans under the Distribution Agreement, the Company’s ability to secure a sales force or a contract sales organization to fulfill its obligations under the Distribution Agreement, it reliance on third parties and such other important factors as are set forth under the caption “Risk Factors” in Nabriva Therapeutics’ annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this Form 8-K represent Nabriva Therapeutics’ views as of the date of this Form 8-K. 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 Form 8-K.

 

 

 

 

SIGNATURES

 

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

 

  NABRIVA THERAPEUTICS PLC
   
Date: July 15, 2020 By: /s/ Gary Sender
    Gary Sender
    Chief Financial Officer

 

 

 

 EX-99.1 2 tm2019110d5_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Nabriva Therapeutics Enters into Exclusive Agreement to Promote and
Distribute SIVEXTRO® (tedizolid phosphate) in the U.S.

 

-Accretive transaction creates synergies and scale that strengthen Nabriva’s community-focused commercialization organization to optimize product uptake

 

-Nabriva partners with Amplity Health to provide community-focused customer engagement and sales initiatives for SIVEXTRO and XENLETA® (lefamulin)

 

DUBLIN, Ireland and KING OF PRUSSIA, Pa., July 15, 2020 (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 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. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible Gram-positive microorganisms.

 

Ted Schroeder, Chief Executive Officer of Nabriva, commented, “We are excited to be selected by Merck & Co. Inc., Kenilworth, N.J., USA as their exclusive commercialization and distribution partner for SIVEXTRO in the U.S. This transaction is aligned with our corporate strategy to add revenue generating products to our business that benefit patients and create value for shareholders. SIVEXTRO is an excellent fit in our portfolio, with a highly complementary customer base, creating synergies and scale with our commercial team.”

 

Patrick Magri, Merck & Co. Inc., Kenilworth, N.J., USA’s Senior Vice President, Hospital & Specialty Business stated, “For more than 80 years, Merck has contributed to the discovery and development of novel medicines to combat infectious diseases, and we continue that commitment today by driving innovation in the antibacterial marketplace. We are pleased to enter into this arrangement which provides Nabriva with the rights to market, sell and distribute SIVEXTRO in the United States.”  

 

Under the terms of the agreement, Nabriva will procure SIVEXTRO from Merck & Co. Inc., Kenilworth, N.J., USA and be responsible for marketing, sales, and distribution of SIVEXTRO in the U.S. through December 31, 2023, with renewable three-year extensions.

 

Additionally, Nabriva has engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA® in the U.S.

 

“Our new partnership with Amplity Heath provides us the opportunity to build a flexible and scalable commercial infrastructure that enables us to optimize the uptake of both SIVEXTRO and XENLETA, while mitigating potential risks associated with the evolving COVID-19 pandemic. Amplity has the experience and depth to effectively educate prescribers about the appropriate use of both of these important antibiotics. We look forward to educating clinicians about the differentiating attributes of both products and bringing these important treatment options to patients,” said Mr. Schroeder.

 

 

 

 

About Acute Skin, Skin Structure and Soft Tissue Infections (ABSSSI)

 

Acute bacterial skin and skin structure infections (ABSSSIs) are common and often require antibiotic treatment. According to the U.S. Food and Drug Administration (FDA), these infections can be uncomplicated – simple abscesses, cellulitis or wound infections mainly caused by the two most common Gram-positive pathogens, Staphylococcus aureus and Streptococcus pyogenes. They can also be complicated either involving deeper soft tissue or requiring surgery – such as ulcers, burns and major abscesses or involving a significant underlying disease state. ABSSSIs are at least 75 cm2.

 

About SIVEXTRO® (tedizolid phosphate)

 

SIVEXTRO was approved by the FDA in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. MRSA has been categorized by the U.S. Centers for Disease Control and Prevention (CDC) as a serious public health threat.1 SIVEXTRO 200 mg is administered once daily orally or as an intravenous (IV) infusion over one hour for six days.

 

Selected Important Safety Information for SIVEXTRO

 

Patients with neutropenia: The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm³) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Alternative therapies should be considered when treating patients with neutropenia.

 

Clostridioides difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including SIVEXTRO. Evaluate all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

 

Development of drug-resistant bacteria: Prescribing SIVEXTRO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

 

Adverse reactions: The most common adverse reactions (≥ 2%) in adults for SIVEXTRO are nausea (7%), headache (5%), diarrhea (4%), vomiting (3%), and dizziness (2%).

 

In adult patients receiving SIVEXTRO intravenously, infusion- or injection-related adverse reactions including but not limited to: phlebitis, injection- or infusion-site pain or swelling, injection-site reaction, erythema, or induration, and infusion-related reaction occurred (4%).

 

The most common adverse reactions (>2%) in pediatric patients 12 years of age and older are phlebitis (3%) and increased hepatic transaminases (3%).

 

 

 

 

Drug interactions with BCRP substrates: SIVEXTRO (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein (BCRP) substrates and the potential for adverse reactions. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided.

 

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.

 

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 the potential benefits to Nabriva Therapeutics under its sales promotion and distribution agreement with the subsidiaries of Merck & Co. Inc., the potential benefits to patients of SIVEXTRO and XENLETA, the market opportunity for SIVEXTRO and XENLETA, the sufficiency of its 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 satisfy the conditions under the distribution agreement to obtain the right to exclusively distribute and promote SIVEXTRO, including its ability to establish or secure a commercial infrastructure sufficient to promote and distribute SIVEXTRO, 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 SEC. 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 may 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

 

Please see Prescribing Information for SIVEXTRO® (tedizolid phosphate) at
https://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro pi.pdf

 

 

1 CDC’s Antibiotic Resistance Threats in the United States (2019 AR Threats Report) accessed 6/2/2020 https://www.cdc.gov/drugresistance/biggest-threats.html#mrsa

 

 

 

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