AnnJi Pharmaceutical, an emerging biotech company listed on Taiwan’s over-the-counter market, announced on the evening of the 17th that it has received a ruling from the International Chamber of Commerce (ICC) International Court of Arbitration regarding the emergency injunction filed by U.S.-based Avenue Therapeutics Inc. The court ruled that Avenue’s request for an emergency injunction was groundless and dismissed the petition, awarding the victory to AnnJi.

Following the receipt of the ruling, AnnJi will proceed with the mAR analysis on muscle biopsy samples collected from its Phase 1b/2a clinical trial of its novel drug AJ201. In addition, the arbitration costs will be borne by Avenue.

AJ201 is AnnJi’s innovative drug developed for the treatment of Kennedy’s Disease, a rare neuromuscular disorder. In March 2023, AnnJi licensed AJ201 to Avenue Therapeutics Inc., a NASDAQ-listed pharmaceutical company in the U.S. At the time, AnnJi announced that the total deal value, including upfront payments and milestone payments, could reach up to USD 250 million.

However, on March 4 this year, AnnJi was informed that Avenue had filed for an emergency injunction with the ICC International Court of Arbitration. The dispute stemmed from AnnJi’s completion of the Phase 1b/2a clinical trial and unblinding of AJ201, actions which triggered Avenue’s contractual obligation to pay milestone fees, procure clinical trial materials, and proceed with the Phase 2b/3 clinical trials and further product development. Despite these obligations, Avenue repeatedly and unreasonably delayed the unblinding process and failed to fulfill its contractual duty to make commercially reasonable efforts to advance the program.

Avenue escalated the dispute by filing an emergency injunction with the ICC Court of Arbitration, seeking to prevent AnnJi from conducting further analyses on the AJ201 Phase 1b/2a trial samples. AnnJi was notified on March 4 that the emergency arbitrator had officially accepted the case.

Now, there is a significant development in the arbitration proceedings between AnnJi and Avenue. On the evening of the 17th, AnnJi stated that it had received the ICC’s official ruling, which rejected Avenue’s petition for an emergency injunction on the grounds of lack of merit, marking a clear victory for AnnJi.

With this ruling in hand, AnnJi will move forward with its planned mAR analysis of muscle biopsy samples from the AJ201 Phase 1b/2a clinical trial. Avenue will be responsible for covering all arbitration costs associated with the case.

Additionally, following AnnJi’s notice of intent to terminate the licensing agreement with Avenue, Avenue has requested high-level negotiations and mediation with AnnJi’s senior management. AnnJi confirmed it will engage in discussions with Avenue at an appropriate time.

Resource: 安基生技與美國授權對象Avenue公司仲裁結果 獲得勝訴