Innoviva Specialty Therapeutics Signs Exclusive Distribution & Licensing Agreement

Innoviva Specialty Therapeutics, Inc. recently announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of Zevtera (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the US.

“The licensing of Zevtera expands IST’s diverse yet complementary portfolio of differentiated treatments that address substantial unmet medical needs,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc.  “We 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.”

In April 2024, the US FDA approved Zevtera for three specific treatment indications, and it is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus 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).   

“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. “Drug-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.”

Under the terms of the agreement, Innoviva, Inc., will be granted exclusive marketing rights to Zevtera in the US. Basilea will receive a $4 million upfront payment in addition to tiered royalties and milestones on net sales in the US. Innoviva Specialty Therapeutics anticipates commercializing Zevtera in mid-year 2025.

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, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the US, the brand is currently approved and marketed in several countries in Europe and beyond as Zevtera and Mabelio 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.

Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (IST), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK). Innoviva is entitled to receive royalties from GSK on sales of RELVAR/BREO ELLIPTA and ANORO ELLIPTA. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections in adults.