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

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




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

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

Details of the presentations are as follows:

Title: Eravacycline combination therapy for severe, recurrent, or fulminant Clostridioides difficile infection

Presenter: Austin Morrison, PharmD

Abstract #: 390

Date and time: Thursday, October 20, 2022, 12:15pm – 1:30pm ET

Location: Hall B + C

Title: Eravacycline Use in Immunocompromised Patients: Multicenter Evaluation of Clinical and Safety Endpoints

Presenter: Ashlan Kunz Coyne, PharmD

Abstract #: 633

Date and time: Thursday, October 20, 2022, 12:15pm – 1:30pm ET

Location: Hall B + C

Title: Combination Eravacycline Therapy for Carbapenem-Resistant Acinetobacter baumannii Pneumonia

Presenter: Melissa Jackson, PharmD

Abstract #: 655

Date and time: Thursday, October 20, 2022, 12:15pm – 1:30pm ET

Location: Hall B + C

Title: Residual Infusion Performance Evaluation (RIPE): A Single-Center Evaluation of Residual Volume Post-Intravenous Eravacycline Infusion

Presenter: Alysa Baumann, PharmD, MBA

Abstract #: 1017

Date and time: Friday, October 21, 2022, 12:15pm – 1:30pm ET

Location: Hall B + C

Title: Susceptibility of Gram-Negative Clinical Isolates Collected from the USA in 2020 to Eravacycline and Comparators

Presenter: Stephen Hawser, PhD

Abstract #: 1679

Date and time: Friday, Saturday 22, 2022, 12:15pm – 1:30pm ET

Location: Virtual

About XERAVA

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. Prescribing information for XERAVA is available at www.xerava.com. and www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is marketed in the U.S. 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, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines, submitted an 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 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 to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy, and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy, and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed 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 adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri and anti-anabolic action, which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

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.

For additional information, please see Full 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 the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA® (angiotensin II) injection is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA® (eravacycline) for injection is approved by the FDA 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 royalties and innovative healthcare investments and assets. Its royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”), ANORO® ELLIPTA® (umeclidinium bromide/ 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 trademarks of the GSK group of companies.

Innoviva strengthened its portfolio in the hospital and infectious disease space through the acquisition of Entasis Therapeutics Holdings Inc. and La Jolla Pharmaceutical Co. Its development pipeline includes potentially first- and best-in-class medicines for the treatment of multidrug-resistant bacteria, including lead asset SUL-DUR. The Company’s commercial and marketed products 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 (cIAIs).

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

Cautionary Statement Regarding Forward Looking Statements

To the extent that 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 Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements regarding Innoviva’s completion of the offering, the anticipated principal amount of securities sold, the final terms of the offering, Innoviva’s anticipated use of proceeds, Innoviva’s ability to repurchase the 2023 Notes and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. For a further 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 in general, see the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 28, 2022, which is on file 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 also could affect Innoviva’s results. 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.

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

Contacts

Larry Edwards
President and CEO

La Jolla Pharmaceutical Company
ledwards@ljpc.com