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Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera® (ceftobiprole)

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Innoviva Specialty Therapeutics (IST), a subsidiary of Innoviva (NASDAQ: INVA), has secured exclusive U.S. distribution and licensing rights for Zevtera® (ceftobiprole) from Basilea Pharmaceutica. The FDA-approved advanced-generation cephalosporin antibiotic is notably the only MRSA cephalosporin antibiotic approved for treating adult patients with Staphylococcus aureus bloodstream infections and endocarditis.

The agreement involves a $4 million upfront payment plus tiered royalties and sales milestones. IST plans to launch Zevtera commercially in mid-2025. The drug received FDA approval in April 2024 for three indications: SAB including right-sided infective endocarditis, ABSSSI in adults, and CABP in both adults and pediatric patients.

Innoviva Specialty Therapeutics (IST), una sussidiaria di Innoviva (NASDAQ: INVA), ha ottenuto i diritti esclusivi di distribuzione e di licenza negli Stati Uniti per Zevtera® (ceftobiprole) da Basilea Pharmaceutica. Questo antibiotico cefalosporinico di nuova generazione, approvato dalla FDA, è l'unico antibiotico cefalosporinico contro il MRSA approvato per il trattamento di pazienti adulti con infezioni del sangue da Staphylococcus aureus e endocardite.

L'accordo prevede un pagamento iniziale di 4 milioni di dollari, oltre a royalties scalari e traguardi di vendita. IST prevede di lanciare Zevtera commercialmente a metà del 2025. Il farmaco ha ricevuto l'approvazione della FDA nell'aprile 2024 per tre indicazioni: SAB, compresa l'endocardite infettiva del lato destro, ABSSSI negli adulti e CABP sia negli adulti che nei pazienti pediatrici.

Innoviva Specialty Therapeutics (IST), una filial de Innoviva (NASDAQ: INVA), ha obtenido los derechos exclusivos de distribución y licencia en EE. UU. para Zevtera® (ceftobiprole) de Basilea Pharmaceutica. Este antibiótico cefalosporínico de última generación, aprobado por la FDA, es notablemente el único antibiótico cefalosporínico contra el MRSA aprobado para tratar a pacientes adultos con infecciones en el torrente sanguíneo por Staphylococcus aureus y endocarditis.

El acuerdo implica un pago inicial de 4 millones de dólares además de royalties escalonados y hitos de ventas. La IST planea lanzar Zevtera comercialmente a mediados de 2025. El medicamento recibió la aprobación de la FDA en abril de 2024 para tres indicaciones: SAB, incluida la endocarditis infecciosa de lado derecho, ABSSSI en adultos y CABP en adultos y pacientes pediátricos.

Innoviva Specialty Therapeutics (IST), Innoviva (NASDAQ: INVA)의 자회사,는 Basilea Pharmaceutica로부터 Zevtera® (ceftobiprole)의 미국 독점 배급 및 라이센스 권리를 확보했습니다. FDA 승인을 받은 이 고급 세대의 세팔로스포린 항생제는 성인 환자의 Staphylococcus aureus 혈류 감염 및 심내막염 치료를 위해 승인된 유일한 MRSA 세팔로스포린 항생제입니다.

이 계약은 400만 달러의 선급금 외에도 단계적인 로열티 및 판매 이정표를 포함합니다. IST는 2025년 중반에 Zevtera를 상업적으로 출시할 계획입니다. 이 약물은 2024년 4월 FDA의 승인을 받아 세 가지 적응증에 대해 승인되었습니다: 우측 감염성 심내막염을 포함한 SAB, 성인에서의 ABSSSI, 및 성인과 소아 환자에서의 CABP.

Innoviva Specialty Therapeutics (IST), une filiale de Innoviva (NASDAQ: INVA), a obtenu les droits exclusifs de distribution et de licence aux États-Unis pour Zevtera® (ceftobiprole) de Basilea Pharmaceutica. Cet antibiotique céphalosporine de nouvelle génération, approuvé par la FDA, est le seul antibiotique céphalosporine contre le MRSA approuvé pour traiter les patients adultes atteints d'infections sanguines par Staphylococcus aureus et d'endocardite.

Le contrat prévoit un paiement initial de 4 millions de dollars plus des redevances échelonnées et des étapes de vente. IST prévoit de lancer Zevtera commercialement à la mi-2025. Le médicament a reçu l'approbation de la FDA en avril 2024 pour trois indications : SAB, y compris l'endocardite infectieuse du côté droit, ABSSSI chez les adultes, et CABP chez les adultes et les patients pédiatriques.

Innoviva Specialty Therapeutics (IST), eine Tochtergesellschaft von Innoviva (NASDAQ: INVA), hat die exklusiven Vertriebs- und Lizenzrechte für Zevtera® (ceftobiprole) von Basilea Pharmaceutica in den USA gesichert. Das von der FDA zugelassene fortschrittliche Cepahlosporin-Antibiotikum ist das einzige MRSA-Cefalosporin-Antibiotikum, das für die Behandlung von Erwachsenen mit Staphylococcus aureus Blutstrominfektionen und Endokarditis zugelassen ist.

Die Vereinbarung beinhaltet eine Vorauszahlung von 4 Millionen Dollar sowie gestaffelte Lizenzgebühren und Verkaufsmeilensteine. IST plant, Zevtera kommerziell Mitte 2025 einzuführen. Das Medikament erhielt im April 2024 von der FDA die Zulassung für drei Indikationen: SAB einschließlich rechtsseitiger infektiöser Endokarditis, ABSSSI bei Erwachsenen und CABP sowohl bei Erwachsenen als auch bei pädiatrischen Patienten.

Positive
  • Exclusive U.S. marketing rights for an FDA-approved antibiotic
  • Only FDA-approved MRSA cephalosporin for bloodstream infections
  • Expands portfolio in infectious diseases market
  • Relatively modest upfront payment of $4 million
Negative
  • Commercial launch delayed until mid-2025
  • Additional milestone payments and royalties will increase costs
  • Entering competitive antibiotics market

Insights

This licensing deal represents a strategic expansion for Innoviva in the infectious disease market. The $4 million upfront payment plus tiered royalties structure is relatively modest for a FDA-approved drug, suggesting favorable deal terms for INVA. With MRSA infections being a significant healthcare burden, Zevtera's unique position as the only FDA-approved MRSA cephalosporin for bloodstream infections could translate into meaningful revenue potential. The mid-2025 commercialization timeline allows adequate preparation for market entry, though it means no immediate revenue impact. The deal aligns with Innoviva's strategy to build a diversified specialty therapeutics portfolio while leveraging existing infrastructure, potentially improving operational efficiency and margins.

Zevtera's triple FDA approval for SAB (including endocarditis), ABSSSI and CABP represents significant clinical value, particularly in treating resistant infections. Its unique position as the only approved MRSA cephalosporin for bloodstream infections addresses a critical medical need, as MRSA infections have high mortality rates and treatment options. The drug's broad age range approval (from 3 months old) and multiple indications enhance its market potential. The timing is opportune given increasing concerns about antibiotic resistance in healthcare settings. This acquisition strengthens Innoviva's infectious disease portfolio with a differentiated product that could become a preferred choice for complicated bacterial infections.

BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, Inc., (“IST”) 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® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the United States.

"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 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 (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).1

"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 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.

Reference

  1. Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk

About Zevtera® (ceftobiprole medocaril sodium for injection)
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.1 Outside the U.S., 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.

Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for injection)

Contraindications

ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class.

Warnings and precautions

  • Increased Mortality with Unapproved use in Ventilator-Associated Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved.
  • Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment.
  • Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs.

Adverse reactions

  • SAB (adult patients): The most common adverse reactions occurring in ≥ 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia and pyrexia.
  • ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia.
  • CABP (adult and pediatric patients 3 months to less than 18 years of age):
    • Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension and dizziness.
    • Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia.

For full US prescribing information, please visit here: www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk

About Staphylococcus aureus bacteremia (SAB)

Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.

About acute bacterial skin and skin structure infections (ABSSSI)

Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.

About community-acquired bacterial pneumonia (CABP)

Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.

For full prescribing information go to https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk

About Innoviva
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.

ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies.

Investors and Media:

Innoviva, Inc.

David Patti

Corporate Communications

(908) 421-5971

david.patti@inva.com

Argot Partners

(212) 600-1902

innoviva@argotpartners.com

Source: Innoviva, Inc.

FAQ

When will Innoviva (INVA) launch Zevtera in the US market?

Innoviva Specialty Therapeutics plans to commercially launch Zevtera in mid-year 2025.

What are the financial terms of INVA's Zevtera licensing agreement?

Innoviva will pay $4 million upfront, plus tiered royalties and milestones on net sales in the U.S.

What are the FDA-approved indications for Zevtera under INVA's license?

Zevtera is approved for Staphylococcus aureus bloodstream infections, acute bacterial skin infections in adults, and community-acquired bacterial pneumonia in both adults and children.

How does the Zevtera acquisition align with INVA's business strategy?

The acquisition expands IST's portfolio of differentiated treatments and strengthens its position as a provider of essential therapeutics for infectious diseases and critical care.

What makes Zevtera unique in INVA's antibiotic portfolio?

Zevtera is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating bloodstream infections and endocarditis.

Innoviva, Inc.

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