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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公司宣佈,Janssen已獲得美國FDA批准將Tecvayli用於治療複發性或難治性多發性骨髓瘤患者;根據條款,OmniAb有資格在第一次商業銷售時獲得2500萬澳元的里程碑付款
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技術發現的雙特異性抗體

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

OmniAb,Inc.有資格在美國首次商業銷售時獲得2500萬美元的里程碑

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.

蘭德製藥有限公司(納斯達克代碼:LGND)宣佈,Janssen Biotech,Inc.(Janssen)已獲得美國食品和藥物管理局(FDA)對TECVAYLI(Teclistamab)的批准,用於治療復發或難治性(R/R)多發性骨髓瘤患者。Teclistamab是一種針對B細胞成熟抗原(BCMA)和CD3的T細胞重定向雙特異性抗體,由Janssen科學家使用OmniAb的Omni大鼠抗體發現技術發現和開發。

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.

根據與Janssen附屬公司的許可協議條款,OmniAb有資格在美國首次商業銷售tecistamab時獲得2500萬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公司首席運營官馬特·福爾、總裁和計劃從Ligand公司剝離出來的OmniAb公司首席執行官馬特·福爾説:“我們很高興揚森公司的TECVAYLI在獲得歐盟委員會批准後獲得了FDA的批准。FDA首次批准OmniAb衍生抗體是OmniAb公司的一個重要里程碑,因為我們將繼續在這一業務中建立勢頭。”我們的戰略合作伙伴和合作夥伴現在已經在包括美國、歐洲和中國在內的三個主要地區獲得了三種不同的OmniAb衍生抗體的監管批准。我們繼續看到我們的平臺在各種新模式中的使用增加,併為我們在行業中所發揮的作用以及我們的技術和團隊為發現治療方法在全球範圍內改善人類健康做出的貢獻而感到自豪。“

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.

從Ligand剝離OmniAb的工作仍在進行中,預計將於2022年11月1日完成,這取決於Avista Public Acquisition Corp.II(納斯達克代碼:AHPA)和OmniAb的業務合併(業務合併)的完成條件是否得到滿足或放棄。將分配給Ligand股東(分配)的OmniAb普通股股息的記錄日期為2022年10月26日,預計分配將在緊接業務合併之前的2022年11月1日進行,條件是滿足或放棄結束條件。業務合併結束後,OmniAb將在納斯達克全球市場開始交易,股票代碼為“OABI”。根據Ligand和OmniAb之間的分離和分銷協議的條款,與首次商業出售TECVAYLI有關的里程碑式付款將保留在OmniAB手中,無論里程碑的時間和實現以及業務合併的結束時間。與Janssen附屬公司的許可協議不包括特許權使用費支付,OmniAb將不會從TECVAYLI的銷售中獲得特許權使用費。

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