Basilea Announces Agreement with Innoviva for US Commercialization of Zevtera

Basilea Pharmaceutica Ltd. (SIX: BSLN), a Swiss biopharmaceutical company, has entered into an agreement with Innoviva Specialty Therapeutics for the commercialization of its antibiotic Zevtera® (ceftobiprole) in the United States. This agreement is a significant milestone for Basilea, as it expands the reach of its flagship product to the world's largest pharmaceutical market. Zevtera® is a broad-spectrum antibiotic with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. The drug is currently approved and marketed in major European countries and a number of countries in Latin America, the Middle East, and North Africa (MENA) regions, as well as in Canada. The agreement with Innoviva Specialty Therapeutics will enable Basilea to tap into Innoviva's extensive commercial infrastructure and expertise in the US market, which is expected to drive significant revenue growth for the company. Basilea will initially supply Innoviva with ceftobiprole at a transfer price, and will be eligible for tiered double-digit royalties on product sales once Innoviva manufactures ceftobiprole itself. Basilea is also eligible for pre-specified sales milestone payments. This agreement is a testament to the potential of Zevtera® as a valuable addition to the US market, and a significant step forward for Basilea's commercialization strategy.



The regulatory requirements for the approval and launch of Zevtera in the US include the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA), which will be reviewed by the agency's Antimicrobial Drugs Advisory Committee. The FDA will then make a decision on the approval of the drug, which is expected to take approximately 6 to 9 months. Once approved, Innoviva will be responsible for the commercialization of Zevtera in the US, with Basilea receiving royalties on product sales. The launch of Zevtera in the US is anticipated to occur in the second half of 2021.

In conclusion, Basilea's agreement with Innoviva Specialty Therapeutics for the commercialization of Zevtera® in the US is a significant step for the company, expanding the reach of its flagship product to the world's largest pharmaceutical market. The agreement provides Basilea with access to Innoviva's established commercial infrastructure and expertise in the US market, which is expected to drive significant revenue growth for the company. The regulatory requirements for the approval and launch of Zevtera in the US include the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA), which will be reviewed by the agency's Antimicrobial Drugs Advisory Committee. The FDA will then make a decision on the approval of the drug, which is expected to take approximately 6 to 9 months. Once approved, Innoviva will be responsible for the commercialization of Zevtera in the US, with Basilea receiving royalties on product sales. The launch of Zevtera in the US is anticipated to occur in the second half of 2021.