Wednesday, November 20, 2019
Antares Pharma, Inc.today announced that it has entered into a global agreement with Idorsia Pharmaceuticals Ltd. (“Idorsia”) (SIX: IDIA) to develop a novel, drug-device product combining selatogrel, Idorsia’s potent, fast-acting and highly selective P2Y12 receptor antagonist under development, with the Antares subcutaneous QuickShot® auto injector. Selatogrel, a new chemical entity (NCE), is being developed for the treatment of a suspected acute myocardial infarction (AMI) in adult patients with a history of AMI. Idorsia’s Phase 2 clinical data demonstrated that subcutaneous administration of selatogrel resulted in a potent and rapid platelet inhibition effect in patients with a history of coronary artery disease and AMI. According to Idorsia, the product was safe and well tolerated. Idorsia is now preparing for a clinical bridging study to be followed by a global Phase 3 study of a self-administered QuickShot® auto injector containing selatogrel for the pre-hospital treatment of a suspected acute myocardial infarction.
“Today, we are extremely pleased to announce a new and important global development agreement with Idorsia Pharmaceuticals, one of Europe’s premier biopharmaceutical companies. Idorsia is developing a novel approach to treating patients with a suspected AMI on an emergency basis using a new chemical entity, selatogrel, with our proven QuickShot device. Idorsia hopes to improve upon outcomes for those patients experiencing a recurrent heart attack by providing a rapid and sustained platelet inhibition thus potentially providing for early treatment of AMI,” said Robert F. Apple, President and Chief Executive Officer of Antares. “This is one of the most exciting and innovative partner product opportunities we have ever worked on in the Company’s history. The development agreement between Antares and Idorsia further expands our portfolio of pipeline partnered products and represents our first opportunity to develop a combination product utilizing a partner’s NCE. We believe our track record of drug-device combination product approvals is impressive, speaks to the reliability of our device platforms and we believe is why Idorsia chose to work with Antares on this exciting product. We look forward to working closely with Idorsia throughout the development phase of this novel product and assisting them in pursuing FDA drug device and global regulatory approval assuming successful completion of their Phase 3 study.”
Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus margin. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. Antares will be entitled to receive royalties on net sales of the commercial product.
Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented, “For patients suffering an AMI, the time from onset of symptoms to first medical contact is critical to preserving muscle and heart function. Our concept of self-administration of a potent, fast-acting P2Y12 receptor antagonist at onset of symptoms could have significant potential. This potential can only be unlocked when our compound is brought together with the right device. Hence finding a safe and reliable device which is easy for patients to use under stressful conditions was a key part for the further development. I'm confident that with Antares we have found the right partner to deliver on this mission.” He added, “The team at Idorsia is also preparing a comprehensive program to train patients on when to inject and instruct them on how to self-administer treatment. It is a challenging but incredibly exciting project, and as a cardiologist, I know how important early treatment at the very onset of symptoms of an AMI is. Based on our current plans, the usability and reliability studies, and ongoing discussions with health authorities, I hope that we can initiate the Phase 3 in the first half of 2021."