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Ligand Announces That Janssen Has Received Approval From U.S FDA For Tecvayli For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma; Under The Terms OmniAb Is Eligible To Receive A $25M Milestone Payment Upon The First Commercial Sale

Ligand Announces That Janssen Has Received Approval From U.S FDA For Tecvayli For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma; Under The Terms OmniAb Is Eligible To Receive A $25M Milestone Payment Upon The First Commercial Sale

Ligand公司宣布,Janssen已获得美国FDA批准将Tecvayli用于治疗复发性或难治性多发性骨髓瘤患者;根据条款,OmniAb有资格在第一次商业销售时获得2500万澳元的里程碑付款
Benzinga Real-time News ·  2022/10/26 09:08

First FDA approval of a bispecific antibody discovered using OmniAb technology

FDA首次批准使用OmniAb技术发现的双特异性抗体

OmniAb, Inc. is eligible to receive a $25 million milestone upon first commercial sale in the United States

OmniAb,Inc.有资格在美国首次商业销售时获得2500万美元的里程碑

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced that Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI (teclistamab) for the treatment of patients with relapsed or refractory (R/R) multiple myeloma. Teclistamab is a T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 discovered and developed by Janssen scientists using OmniAb's OmniRat antibody discovery technology.

兰德制药有限公司(纳斯达克代码:LGND)宣布,Janssen Biotech,Inc.(Janssen)已获得美国食品和药物管理局(FDA)对TECVAYLI(Teclistamab)的批准,用于治疗复发或难治性(R/R)多发性骨髓瘤患者。Teclistamab是一种针对B细胞成熟抗原(BCMA)和CD3的T细胞重定向双特异性抗体,由Janssen科学家使用OmniAb的Omni大鼠抗体发现技术发现和开发。

Under the terms of the licensing agreement with an affiliate of Janssen, OmniAb is eligible to receive a $25 million milestone payment upon the first commercial sale of teclistamab in the United States.

根据与Janssen附属公司的许可协议条款,OmniAb有资格在美国首次商业销售tecistamab时获得2500万美元的里程碑式付款。

"We are delighted Janssen's TECVAYLI has been approved by the FDA, which follows its approval by the European Commission. This first FDA approval of an OmniAb-derived antibody is a major milestone for OmniAb as we continue to build momentum in the business," said Matt Foehr, President and COO of Ligand and planned CEO of OmniAb, Inc. following spin-off from Ligand. "Our strategic partners and collaborators have now received regulatory approvals for three different OmniAb-derived antibodies in three major geographies that include the U.S., Europe and China. We continue to see use of our platform increase for a variety of novel modalities, and are proud of the role we play within the industry and the contribution our technologies and team make to the discovery of therapeutics to improve human health on a global level."

Ligand公司首席运营官马特·福尔、总裁和计划从Ligand公司剥离出来的OmniAb公司首席执行官马特·福尔说:“我们很高兴扬森公司的TECVAYLI在获得欧盟委员会批准后获得了FDA的批准。FDA首次批准OmniAb衍生抗体是OmniAb公司的一个重要里程碑,因为我们将继续在这一业务中建立势头。”我们的战略合作伙伴和合作伙伴现在已经在包括美国、欧洲和中国在内的三个主要地区获得了三种不同的OmniAb衍生抗体的监管批准。我们继续看到我们的平台在各种新模式中的使用增加,并为我们在行业中所发挥的作用以及我们的技术和团队为发现治疗方法在全球范围内改善人类健康做出的贡献而感到自豪。“

The spin-off of OmniAb from Ligand remains on track with an expected closing on November 1, 2022, subject to the satisfaction or waiver of closing conditions for the business combination (Business Combination) of Avista Public Acquisition Corp. II (APAC) (NASDAQ:AHPA) and OmniAb. The record date for the dividend of shares of common stock of OmniAb to be distributed to Ligand shareholders (Distribution) is October 26, 2022, and the Distribution is expected to be made on November 1, 2022 immediately prior to the Business Combination, subject to the satisfaction or waiver of closing conditions. Following the closing of the Business Combination, OmniAb will begin trading on the Nasdaq Global Market under the stock ticker symbol "OABI." Under the terms of the separation and distribution agreement between Ligand and OmniAb, the milestone payments related to the first commercial sale of TECVAYLI will remain with OmniAb regardless of timing and achievement of the milestone and the timing of the closing of the Business Combination. The license agreement with an affiliate of Janssen does not include royalty payments, and OmniAb will not receive royalties on sales of TECVAYLI.

从Ligand剥离OmniAb的工作仍在进行中,预计将于2022年11月1日完成,这取决于Avista Public Acquisition Corp.II(纳斯达克代码:AHPA)和OmniAb的业务合并(业务合并)的完成条件是否得到满足或放弃。将分配给Ligand股东(分配)的OmniAb普通股股息的记录日期为2022年10月26日,预计分配将在紧接业务合并之前的2022年11月1日进行,条件是满足或放弃结束条件。业务合并结束后,OmniAb将在纳斯达克全球市场开始交易,股票代码为“OABI”。根据Ligand和OmniAb之间的分离和分销协议的条款,与首次商业出售TECVAYLI有关的里程碑式付款将保留在OmniAB手中,无论里程碑的时间和实现以及业务合并的结束时间。与Janssen附属公司的许可协议不包括特许权使用费支付,OmniAb将不会从TECVAYLI的销售中获得特许权使用费。

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