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.
