Antares Pharma Announces Partner Idorsia Initiates the Phase 3 Study With Selatogrel for Acute Myocardial Infarction
Antares Pharma, Inc. (NASDAQ: ATRS) announced the initiation of a Phase 3 study by its partner Idorsia Ltd, evaluating the efficacy of selatogrel for suspected acute myocardial infarction (AMI) using Antares’ Quickshot® auto-injector. This international trial will enroll around 14,000 patients across 250 sites in 30 countries, focusing on deaths and non-fatal AMIs post self-administration. The FDA has granted a Special Protocol Assessment, indicating agreement on the study's design. The partnership could lead to significant market opportunities and potential royalties for Antares upon product approval.
- Initiation of Phase 3 study for selatogrel could enhance market positioning.
- FDA's Special Protocol Assessment indicates strong regulatory support.
- Potential for significant royalties on net sales from commercial product.
- None.
EWING, N.J., June 28, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that its partner Idorsia Ltd (“Idorsia”) initiated its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected acute myocardial infarction (“AMI”) utilizing Antares’ Quickshot® auto-injector.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “We are excited to play an important role in Idorsia’s development of selatogrel with our autoinjector technology. The strong collaboration between our teams has allowed Idorsia to achieve this important milestone of initiating the Phase 3 study of this novel combination product in approximately eighteen months from the signing of our development agreement. The opportunity to self-inject selatogrel at the onset of symptoms from a suspected heart attack represents a compelling proposition for patients and we believe Idorsia’s commitment to that innovation could prove revolutionary. We look forward to continuing to support Idorsia’s clinical advancement of selatogrel.”
Idorsia is initiating an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at approximately 250 sites in approximately 30 countries.
A Special Protocol Assessment has been agreed with the U.S. Food and Drug Administration (“FDA”) for Idorsia’s selatogrel. This indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application.
In December 2020, the FDA designated Idorsia’s investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a “fast-track” development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.
Idorsia selected Antares’ Quickshot® autoinjector for the development of selatogrel due to the robustness, reliability, ease-of-use and emergency-ready capabilities of our technology. Idorsia has confirmed the usability of the Quickshot® autoinjector in the clinical development program through human factor validation studies.
Antares entered into a global development agreement with Idorsia in November 2019. Under the terms of the agreement, Antares will provide clinical supply to Idorsia during clinical development in addition to fully packaged product upon FDA or foreign regulatory approval. Idorsia is responsible for the clinical development and regulatory approvals of the combination product. Idorsia will be responsible for global commercialization of the product, pending regulatory approvals, and Antares will be entitled to receive royalties on net sales of the commercial product.
About Acute Myocardial Infarction (AMI)
An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off. It is usually caused by a blood clot or blockage in one or more of the coronary vessels supplying blood to the heart muscle. An AMI requires immediate treatment and medical attention, as any delay in intervention can result in irreversible damage to the heart muscle. According to the U.S. Centers for Disease Control and Prevention, each year more than 800,000 persons living in the US will suffer a heart attack.[1]
1. Benjamin EJ, et al. Heart Disease and Stroke Statistics—2019 Update: A Report From the American Heart Association. Circulation 2019;139(10):e56-e528.
About Idorsia
Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas such as urology and endocrinology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: successful development including the timing and results of the Phase 3 trial of the drug device combination product for selatogrel with Idorsia Ltd and FDA and global regulatory approvals and future revenue from the same; the Company’s ability to achieve the 2021 full-year revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to repay the debt obligation to Hercules Capital; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
Contact:
Tram Bui
Vice President, Corporate Communications and Investor Relations
609-359-3016
tbui@antarespharma.com
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