Waltham, MA – February 5, 2024 – Innoviva Specialty Therapeutics, a wholly-owned subsidiary of Innoviva, Inc. (NASDAQ: INVA) focused on developing and commercializing critical care and infectious disease therapies, announced today that David Altarac, MD, has been appointed as Chief Medical Officer leading the company’s Clinical, Regulatory, Safety, and Medical Affairs teams.
“We are honored to have David join Innoviva Specialty Therapeutics at this important time in the evolution of the company. David’s experience and leadership in infectious disease combined with his historic role in the development of two of our innovative antibiotic therapies makes him the ideal person to lead our medical organization to help improve outcomes in patients with serious and life-threatening diseases,” said Matt Ronsheim, PhD, President of Innoviva Specialty Therapeutics.
Dr. Altarac is an infectious disease physician and accomplished pharmaceutical executive with more than 20-years’ experience leading clinical and regulatory functions at several leading biotechnology and pharmaceutical companies. Dr. Altarac previously served as the Chief Medical Officer of Innoviva Specialty Therapeutics following the 2023 acquisition of Entasis Therapeutics where he was Chief Medical Officer.
Among his many accomplishments and contributions, Dr. Altarac was pivotal in guiding regulatory needs for Innoviva Specialty Therapeutics through the Entasis acquisition and portfolio transition. His therapeutic-area expertise and knowledge of the U.S. regulatory environment was fundamental to the company’s success in achieving U.S. Food and Drug Administration (FDA) approval of XACDURO® (sulbactum-durlobactum for injection), and completion of the Phase III registration trial for zoliflodacin. Prior to serving as CMO of Entasis, Dr. Altarac was most notably Senior Vice President, Head, Global Regulatory Affairs, Safety, R&D Quality and Compliance organizations, at Shire Pharmaceuticals and Vice President of Regulatory Affairs Emerging Markets R&D, Worldwide Regulatory Teams and Worldwide Product Labeling at Merck & Co.
“I am extremely excited to be leading this talented team of pharmaceutical professionals, many of whom I’ve known for years and share my unwavering passion for addressing urgent and emerging health threats such as the impact of antibiotic-resistance on patient outcomes,” said David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics. “This team has proven that our focused efforts on developing innovative therapies in this space results in meaningful improvements in the lives of patients with critical illness and infectious disease. Our journey continues and I am incredibly proud to be a part of this dedicated team.
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter.
XACDURO® INDICATION & USAGE
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii- calcoaceticus complex.
Limitations of Use
XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.
Warnings and Precautions:
- Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other If an allergic reaction occurs, discontinue XACDURO.
- Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed.
- Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).
To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before administering, please see the Full Prescribing Information for XACDURO
About Innoviva Specialty Therapeutics
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., 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. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include 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 (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here.
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®, GIAPREZA®, XERAVA® and XACDURO® 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); 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”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy.
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.