La Jolla Pharmaceutical, a Wholly-owned Subsidiary of Innoviva, Inc., Announces Data on XERAVA (eravacycline) to be Presented at IDWeek 2022

WALTHAM, Mass., October 14, 2022–(BUSINESS WIRE)–La Jolla Pharmaceutical Company, a wholly-owned subsidiary of Innoviva, Inc. (Nasdaq: INVA) dedicated to bringing innovative therapies to market that improve outcomes in patients with life-threatening diseases, today announced that five abstracts highlighting XERAVA (eravacycline ) have been selected for a poster presentation at ID Week 2022, the annual meeting of the Infectious Disease Society of America taking place October 19-23, 2022 in Washington, DC

The details of the presentations are as follows:

Title: Combination therapy with eravacycline for severe, recurrent, or fulminant Clostridioides difficile infection
Presenter: Austin Morrison, Doctor of Pharmacy
Summary #: 390
Date and time: Thursday, October 20, 2022, 12:15 p.m. to 1:30 p.m. ET
Location: Room B + C

Title: Use of Eravacycline in Immunocompromised Patients: Multicenter Evaluation of Clinical and Safety Parameters
Presenter: Ashlan Kunz Coyne, PharmD
Summary #: 633
Date and time: Thursday, October 20, 2022, 12:15 p.m. to 1:30 p.m. ET
Location: Room B + C

Title: Combination therapy with eravacycline for carbapenem-resistant Acinetobacter baumannii pneumonia
Presenter: Melissa Jackson, Doctor of Pharmacy
Summary #: 655
Date and time: Thursday, October 20, 2022, 12:15 p.m. to 1:30 p.m. ET
Location: Room B + C

Title: Residual Perfusion Performance Evaluation (RIPE): A Single Center Assessment of Residual Volume After Intravenous Infusion of Eravacycline
Presenter: Alysa Baumann, PharmD, MBA
Summary #: 1017
Date and time: Friday, October 21, 2022, 12:15 p.m. – 1:30 p.m. ET
Location: Room B + C

Title: Susceptibility of Gram-negative clinical isolates collected in the United States in 2020 to eravacycline and comparators
Presenter: Stephen Hawser, PhD
Summary #: 1679
Date and time: Friday, Saturday 22, 2022, 12:15 p.m. – 1:30 p.m. ET
Location: Virtual

About XERAVA

XERAVA® (eravacycline) for Injection is approved by the United States 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. XERAVA prescribing information is available at www.xerava.com. and www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is marketed in the United States by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva Inc, and is marketed in Europe by PAION Deutschland GmbH on behalf of Tetraphase Pharmaceuticals, Inc. Everest, the company’s licensee for Mainland China, Taiwan, Hong Kong, Macao, South Korea, Singapore, Malaysian Federation, Kingdom of Thailand, Republic of Indonesia, Socialist Republic of Vietnam and Republic of the Philippines, have submitted NDA in China, which was accepted by the China National Medical Products Administration (NMPA) in March 2021. XERAVA was approved in Singapore by the Health Science Authority in April 2020.

XERAVA Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial medicines, XERAVA should only be used to treat or prevent infections that are known or strongly suspected to be caused by bacteria sensitive.

XERAVA is contraindicated in patients with known hypersensitivity to eravacycline, tetracycline class antibacterial medicinal products, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

Use of XERAVA during tooth development (late half of pregnancy, infancy, and childhood up to eight years of age) may result in permanent tooth discoloration (yellow-gray-brown) and tooth hypoplasia. ‘E-mail.

Use of XERAVA during the second and third trimesters of pregnancy, infancy, and childhood up to eight years of age may result in reversible bone growth inhibition.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of almost all antibacterial agents and can range in severity from mild diarrhea to life-threatening colitis.

The most commonly observed adverse reactions in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea and vomiting.

XERAVA is structurally similar to tetracycline class antibacterial drugs and may have similar side effects. Adverse effects including photosensitivity, pseudotumor cerebri, and anti-anabolic action, which resulted in increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and liver function test abnormalities, have been reported. reported for other tetracycline class antibacterial drugs and may occur. with XERAVA. Discontinue XERAVA if any of these side effects are suspected.

We encourage you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see the complete Prescribing Information for the United States.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a wholly owned subsidiary of Innoviva, Inc., dedicated to bringing to market innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA® (angiotensin II) injection is FDA approved as a vasoconstrictor indicated to increase blood pressure in adults with septic shock or other distributive shock. XERAVA® (eravacycline) for Injection is FDA approved as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. For more information, please visit www.ljpc.com. La Jolla Pharmaceutical Company is a wholly owned subsidiary of Innoviva, Inc.

About Innoviva

Innoviva is a diversified holding company with a portfolio of royalty and innovative healthcare investments and assets. Its royalty portfolio includes respiratory actives in partnership with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, “FF/VI”), ANORO® ELLIPTA® (fluticasone bromide/vilanterol, umeclidinium/vilanterol, “UMEC /VI”) and, formerly, TRELEGY® ELLIPTA® (the combination FF/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® . ANORO®, RELVAR®, BREO®, TRELEGY® and ELLIPTA® are registered trademarks of the GSK group of companies.

Innoviva strengthened its hospital and infectious disease portfolio with the acquisition of Entasis Therapeutics Holdings Inc. and La Jolla Pharmaceutical Co. Its development pipeline includes potentially first-in-class and best-in-class drugs for the treatment of multi-resistant bacteria, in particular the main active ingredient SUL-DUR. The Company’s commercial and marketed products include GIAPREZA® (angiotensin II), approved for increasing blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections ( IAIc).

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

Caution Regarding Forward-Looking Statements

To the extent that the statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Act. Litigation Reform Act 1995, as amended. . Forward-looking statements include all statements regarding the completion of the offer by Innoviva, the expected principal amount of securities sold, the final terms of the offer, Innoviva’s intended use of proceeds, Innoviva’s ability to repurchase the 2023 tickets and any other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project” , “target”, “potential”, “will”, “would”, “could”, “should”, “continue” and other similar expressions. These forward-looking statements involve substantial risks and uncertainties that could cause the future results, performance or achievements of the Company to differ materially from those expressed or implied by the forward-looking statements. The Company assumes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be taken to represent the views of the Company as of any date subsequent to the date hereof. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business generally, see the “Risk Factors” section of the report. annual of the Company. on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 28, 2022, which is filed with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Innoviva’s other filings with the SEC, other unknown or unpredictable factors could also affect Innoviva’s results. Past performance is not necessarily indicative of future results. No forward-looking statement 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 undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law. required.

Trademark Reference: Innoviva and the Innoviva logo are either registered trademarks or trademarks of Innoviva, Inc. or its affiliates in the United States and/or other countries. All other trademarks mentioned herein are the property of their respective owners.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20221014005417/en/

contacts

Larry Edwards
President and CEO
La Jolla Pharmaceutical Company
[email protected]