WALTHAM, MA. – May 9, 2023 – Innoviva, Inc. (Nasdaq: INVA) (Innoviva), a diversified holding company with a portfolio of royalties and other healthcare assets, today introduced Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics integrates Entasis Therapeutics Holdings Inc. (Entasis), a pioneer in the development of novel, anti-infective therapies, and La Jolla Pharmaceutical Company (La Jolla), with proven capabilities in commercializing medicines in critical care and hospital settings. Innoviva completed the acquisitions of Entasis and La Jolla in 2022.
“We see significant unmet need and are confident we can benefit seriously ill patients and create shareholder value by delivering differentiated, novel therapies in critical care and infectious disease,” said Pavel Raifeld, Chief Executive Officer, Innoviva. “Rooted in the strengths of Entasis and La Jolla, Innoviva Specialty Therapeutics is an integrated business with excellent capabilities and significant expertise in these settings that enable us to focus on the unique challenges and needs of all stakeholders. We have a proven, growing platform with significant operating leverage, and we aspire to be a partner of choice for solutions in this critically important healthcare sector.”
Innoviva Specialty Therapeutics, including through its affiliate, La Jolla, currently markets two products:
• GIAPREZA® (angiotensin II), a vasoconstrictor that helps to increase blood pressure in adults with septic or other distributive shock, a leading cause of death in hospitalized patients
• XERAVA® (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI) caused by multidrug-resistant bacteria.
Innoviva Specialty Therapeutics also awaits the completion of the U.S. Food and Drug Administration’s (FDA’s) Priority Review of the New Drug Application (NDA), submitted by its affiliate, Entasis, for sulbactam-durlobactam. On April 17, 2023, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in support of approval based on a favorable benefit-risk assessment of sulbactam-durlobactam, the first pathogen-targeted therapy, for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The Company continues to work with the FDA as it completes its review of the NDA, prior to the Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.
In addition, Innoviva Specialty Therapeutics, through its affiliate, Entasis, retains commercial rights in major markets—in North America, Europe and Asia-Pacific—to zoliflodacin, a novel oral antibiotic being developed in partnership with the Global Antibiotic Research & Development Partnership (GARDP) for the treatment of uncomplicated gonorrhea infection, caused by Neisseria gonorrhoeae, one of the most commonly diagnosed sexually transmitted diseases in the U.S. and globally. The enrollment of the Phase III trial evaluating the safety and efficacy of zoliflodacin for the treatment of uncomplicated gonorrhea remains on track, with trial completion anticipated this year.
Innoviva Specialty Therapeutics is committed to fighting anti-microbial resistance, a growing health crisis associated with significant morbidity and mortality rates. Carbapenem-resistant Acinetobacter1 and drug-resistant Neisseria gonorrhoeae2 are characterized as urgent threats by the Centers for Disease Control and Prevention (CDC). In addition, the World Health Organization (WHO) has identified carbapenem-resistant Acinetobacter as a Priority 1 pathogen3, and drug-resistant Neisseria gonorrhoeae as a high priority4, setting a target to reduce its incidence by 90 percent by 20305.
For more information about Innoviva Specialty Therapeutics, please visit www.innovivaspecialtytherapeutics.com.
Innoviva is a diversified holding company with a portfolio of royalties and other healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva Specialty Therapeutics, a subsidiary of Innoviva, is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include 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. In addition, sulbactam-durlobactam is an investigational, targeted antibiotic in late-stage development for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), the subject of the NDA filed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here.
GIAPREZA® (angiotensin II) injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. The European Summary of Product Characteristics is available at www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by Innoviva Specialty Therapeutics, through its affiliate, La Jolla Pharmaceutical Company, and is marketed in Europe by PAION Deutschland GmbH on behalf of La Jolla Pharma, LLC.
GIAPREZA Important Safety Information
Warnings and Precautions
There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.
The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.
For additional information, please see Full Prescribing Information for the United States and the Summary of Product Characteristics for the European Union.
XERAVA® (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline-class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. U.S. Prescribing information for XERAVA is available at www.xerava.com and the EU SmPC is available at www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is marketed in the U.S. by Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc.; in Europe by PAION Deutschland GmbH; and in mainland China, among other Asia-Pacific countries, by Everest Medicines Limited (Everest). XERAVA was approved by the China National Medical Products Administration in March 2023, by the Hong Kong Department of Health in September 2022, and in Singapore by the Health Science Authority in April 2020. Everest also submitted an NDA in Taiwan, which was accepted by the Taiwan FDA in August 2022.
XERAVA Important Safety Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA.
Warnings and Precautions
Hypersensitivity Reactions: Life-threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA. Avoid use in patients with known hypersensitivity to tetracyclines.
Tooth Discoloration and Enamel Hypoplasia: The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
Inhibition of Bone Growth: The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.
Most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals, Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Concomitant use of strong CYP3A inducers decreases the exposure of eravacycline. Increase XERAVA dose with concomitant use of a strong CYP3A inducer.
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
For additional information, please see Full Prescribing Information.
Sulbactam-durlobactam is an intravenous, or IV, investigational drug that is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, being developed for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Sulbactam-durlobactam has been designated a Qualified Infectious Disease Product by the FDA, a designation that aims to spur development of new antibiotics for serious and life-threatening infections. In November 2022, the FDA accepted the New Drug Application (NDA) for sulbactam-durlobactam for Priority Review and set a Prescription Drug User Fee Act (PDUFA) target date of May 29, 2023.
Forward Looking Statements
This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Green Room Communications
1 Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat
2 Centers for Disease Control and Prevention, “Antibiotic Resistance Threats in the United States,” December 2019: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf
3 World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed
4 World Health Organization, “Globally Sexually Transmitted Infections Programme.” Diagnostics for gonococcal antimicrobial resistance: https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/stis/testing-diagnostics/diagnostics-for-gonococcal-antimicrobial-resistance
5 World Health Organization, “Multi-drug resistant gonorrhea,” August 25, 2022: https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea