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Halozyme宣布扩大与argenx的ENHANZE®全球合作和许可协议

Halozyme Announces Expansion of Global Collaboration and License Agreement with argenx for ENHANZE®

PHARMA FOCUS ASIA 等信源发布 2024-10-05 14:52

可切换为仅中文


Halozyme Therapeutics, Inc. today announced that argenx has nominated four new targets under its global collaboration and license agreement that provides argenx exclusive access to Halozyme's ENHANZE® drug delivery technology, a proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) for rapid subcutaneous drug delivery.

Halozyme Therapeutics,Inc.今天宣布,argenx已根据其全球合作和许可协议提名了四个新目标,该协议为argenx独家获得Halozyme的ENHANZE®药物输送技术,这是一种专有的重组人透明质酸酶PH20酶(rHuPH20),用于快速皮下给药。

argenx, a global immunology company, now has exclusively licensed ENHANZE® for a total of six targets, including for the neonatal Fc receptor (FcRn) target. VYVGART® Hytrulo, argenx's branded FcRn blocker, is approved by the U.S. Food and Drug Administration for chronic inflammatory demyelinating polyneuropathy and generalized myasthenia gravis, with additional approvals granted in >25 countries globally for the latter indication.Under the terms of the expanded exclusive agreement, argenx will make upfront payments of $7.5 million per target nomination for a total of $30 million to Halozyme, and potential future milestone payments related to development progress, regulatory approvals, and sales attainment of up to $85 million per nominated target.The royalty rate for all products under the agreement is a tiered mid-single digit rate based on annual net sales until expiration of Halozyme's ENHANZE® related patents, when the rate will be reduced in one or more steps.

。argenx品牌的FcRn阻滞剂VYVGART®Hytrulo已获美国食品和药物管理局批准用于慢性炎性脱髓鞘性多发性神经病和全身性重症肌无力,并在全球25个以上国家获得了后者的额外批准。根据扩展独家协议的条款,argenx将为每个目标提名支付750万美元的预付款,总计3000万美元给Halozyme,以及与开发进度、监管批准和销售业绩相关的潜在未来里程碑付款,每个提名目标最高可达8500万美元。该协议下所有产品的版税率是基于年度净销售额的分层中位数字费率,直至Halozyme的ENHANZE®相关专利到期,届时该费率将通过一个或多个步骤降低。

Royalties will be paid for the longer of 10 years from the first commercial sale or until the expiration of the last valid claim of a co-formulation patent.'We are very pleased to strengthen our relationship with argenx, an innovative leader in immunology dedicated to improving the lives of people suffering from severe autoimmune diseases.

特许权使用费将从第一次商业销售或共同配方专利的最后一次有效索赔到期之日起10年内支付。”我们很高兴加强与argenx的关系,argenx是免疫学领域的创新领导者,致力于改善患有严重自身免疫性疾病的人群的生活。

We share argenx's patient centric mission and are united in our commitment to improve the lives of patients. As the leader in rapid subcutaneous d.

我们分享argenx以患者为中心的使命,并共同致力于改善患者的生活。作为快速皮下d的领导者。