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Global development agreement with IDORSIA Pharmaceutical LTD.

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H2R   Tuesday, 11/19/19 03:39:28 PM
Re: None
Post # of 4760 
Global development agreement with IDORSIA Pharmaceutical LTD.

Novel Drug Device Combination Product To Be Developed For The Treatment Of Suspected Acute Myocardial Infarction

Quote:
EWING, NJ, November 19, 2019 -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) 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.

[...]

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.



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