Assertio Announces Results of Rolvedon® (eflapegrastim-xnst) injection Same-Day Dosing Clinical Study

LAKE FOREST, Ill., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced yesterday results of a clinical trial investigating the utility of Rolvedon^® (eflapegrastim-xnst) injection when dosed the same day of chemotherapy for patients with early stage breast cancer (ESBC). The results were presented as part of the San Antonio Breast Cancer Symposium by the American Association of Cancer Research and the University of Texas Health Science Center at San Antonio.

In this open-label, single-arm study (NCT04187898), conducted across 13 sites in the US, individuals received Rolvedon 30 minutes post chemotherapy for ESBC. Rolvedon demonstrated 1.8 days to neutrophil count recovery and a febrile neutropenia rate of 2%. Zero patients required the need for hospitalization and/or intervention for febrile neutropenia. No new safety signals were identified.

"We are pleased with the expected, positive results from the Rolvedon same day dosing trial and the evidence supporting our belief that Rolvedon can make a meaningful difference for patients undergoing chemotherapy. This milestone further underscores our commitment to improving the lives of patients undergoing cancer treatment by providing convenient and effective treatment options," said Brendan O'Grady, CEO of Assertio Therapeutics.

"The excellent safety and efficacy profile of Rolvedon in this trial is very encouraging, providing clinical data indicating that same day dosing outcomes are safe and effective for this unique molecule," said Dr. Howard Franklin, SVP of Medical of Assertio Therapeutics. "Our goal is to enhance patient outcomes and quality of life (QoL), and these results support the potential of Rolvedon to do just that."

Details of the study and poster presentation can be found at the SABCS website, https://sabcs.org/.

About Assertio

Assertio is a commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. To learn more about Assertio, visit www.assertiotx.com.

Forward Looking Statements

Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio, including risks related to the subject matter of this communication and our ability to realize the benefits from our operating model, deliver or execute on our business strategy, including to expand or diversify our asset base and market reach and drive cash flows and growth, successfully integrate new assets, and explore new business development initiatives. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," "believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may," "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes and are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio, including the risks described in Assertio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") and in other filings Assertio makes with the SEC from time to time.

Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law.

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