{"id":794970,"date":"2024-12-16T07:04:40","date_gmt":"2024-12-16T12:04:40","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-signs-exclusive-distribution-and-licensing-agreement-to-acquire-u-s-marketing-rights-for-zevtera-ceftobiprole\/"},"modified":"2024-12-16T07:04:40","modified_gmt":"2024-12-16T12:04:40","slug":"innoviva-specialty-therapeutics-signs-exclusive-distribution-and-licensing-agreement-to-acquire-u-s-marketing-rights-for-zevtera-ceftobiprole","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-signs-exclusive-distribution-and-licensing-agreement-to-acquire-u-s-marketing-rights-for-zevtera-ceftobiprole\/","title":{"rendered":"Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera\u00ae (ceftobiprole)"},"content":{"rendered":"

<\/p>\n

Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera\u00ae<\/sup> (ceftobiprole)<\/b><\/p>\n

BURLINGAME, Calif.–(BUSINESS WIRE<\/a>)–
\nInnoviva Specialty Therapeutics, Inc., (\u201cIST\u201d) a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), for the commercialization of Zevtera\u00ae <\/sup>(ceftobiprole), an advanced-generation cephalosporin antibiotic, in the United States.<\/p>\n

\n“The licensing of Zevtera expands IST\u2019s diverse yet complementary portfolio of differentiated treatments that address substantial unmet medical needs,\u201d said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. \u201cWe are excited to leverage our operating platform to deliver this important drug to patients. The transaction reinforces the significant opportunity for growth we see in our therapeutics business, building on the momentum and success we have had with our existing marketed products.\u201d<\/p>\n

\nIn April 2024, the U.S. Food and Drug Administration (FDA) approved Zevtera for three specific treatment indications, and it is the only FDA-approved methicillin-resistant Staphylococcus aureus <\/i>(MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus<\/i> bloodstream infections (bacteremia) (SAB) and endocarditis. Zevtera is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).1<\/sup><\/p>\n

\n“Zevtera strengthens our role as a provider of essential therapeutics for infectious diseases and critical care within our primary customer base,” stated David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics, Inc. \u201cDrug-resistant pathogens, like MRSA, pose significant challenges for patients in hospitals and other healthcare facilities with a high mortality rate and huge cost burden. Zevtera will enable physicians to treat this important pathogen more effectively, as it is the only approved cephalosporin specifically for MRSA bloodstream infections.\u201d<\/p>\n

\nUnder the terms of the agreement, Innoviva, Inc., will be granted exclusive marketing rights to Zevtera in the U.S. Basilea will receive a $4 million upfront payment in addition to tiered royalties and milestones on net sales in the U.S. Innoviva Specialty Therapeutics anticipates commercializing Zevtera in mid-year 2025.<\/p>\n

Reference<\/b><\/p>\n

    \n
  1. \nFull US prescribing information: https:\/\/www.basilea.com\/ZEVTERA_US_prescribing_information_46b9y4wk<\/a><\/li>\n<\/ol>\n

    About Zevtera\u00ae<\/sup> (ceftobiprole medocaril sodium for injection)
    \n
    <\/b>Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus<\/i>,including methicillin-resistant strains (MRSA), and Gram-negative bacteria.1<\/sup> Outside the U.S., the brand is currently approved and marketed in several countries in Europe and beyond as Zevtera\u00ae<\/sup> and Mabelio\u00ae<\/sup> for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries.<\/p>\n

    Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for injection)<\/b><\/p>\n

    Contraindications<\/b><\/p>\n

    \nZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class.<\/p>\n

    Warnings and precautions<\/b><\/p>\n