Replies to post #4694 on Antares Pharma, Inc. (ATRS)

[hyperopia]

Yes good news, but the major revenues will be a few years away. At the Jefferies Conference in London, Antares provided a little color on the new partnership, and they believe there is huge potential for this product. There are well established P2Y12 blockbuster products like Plavix and Brillinta already on the market for cronic use but Idorsia’s Selatogrel will be used in an emergency, acute setting at the onset of heart attack symptoms. Although terms haven’t been disclosed, Antares will supply a fully assembled product at cost plus margin, and said the royalty will be similar to their arrangements with their other partnerships which are a single to double-digit royalty on end sales. From a royalty standpoint, it could be very meaningful since the product will address a large, global population. They plan to start a phase 2 crossover (bridging) trial, and if successful, will prepare to supply a very large, global, Phase III study in early 2021. If the product is eventually approved, from a marketing standpoint, it will be the largest product for Antares to date.


This article, makes it sound like the bridging studies may have actually started back in September.

Phase 2 data of selatogrel, Idorsia’s highly-selective P2Y12 receptor antagonist, presented at ESC 2019
September 03, 2019
https://www.globenewswire.com/news-release/2019/09/03/1910237/0/en/Phase-2-data-of-selatogrel-Idorsia-s-highly-selective-P2Y12-receptor-antagonist-presented-at-ESC-2019.html

Guy Braunstein, MD and Head of Idorsia Global Clinical Development, added:
“The Phase 2 data demonstrate that subcutaneous administration of selatogrel 16mg in patients with stable CAD and patients with AMI has a rapid onset of action, within 15 minutes, with the effect extending over 4-8 hours. Based on the speed at which selatogrel takes effect, the duration of that effect, and the safety and tolerability profile, self-administration of selatogrel at the very onset of symptoms of a suspected AMI has potential as a highly innovative approach to AMI management.”
In consultation with health authorities, Idorsia is preparing a large, international, multi-center, Phase 3 study to investigate the efficacy and safety of subcutaneous self-administration of selatogrel for the treatment of a suspected AMI in patients with an history of AMI. Participating patients will be trained on when to inject and instructed on how to self-administer treatment. An integrated drug delivery device is being developed through usability and reliability studies to ensure functional efficacy can be demonstrated ahead of the Phase 3 study.