Antibe Announces Unfavorable Decision in Arbitration With Nuance Pharma

2024-03-04

引进/卖出临床2期专利侵权

TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to target pain and inflammation, today announced that the arbitrator has found in favor of Nuance Pharma in the dispute regarding the license agreement for the commercialization of otenaproxesul in the Greater China region. The confidential ruling from the Singapore International Arbitration Centre rescinds the license agreement and requires Antibe to refund the US$20 million upfront payment and pay interest and costs of approximately US$4 million. The decision is not subject to appeal. Antibe views this unexpected result as highly unusual based on best practices for licensing deals in the biotech industry.

“We strongly disagree with this decision,” commented Dan Legault, Antibe’s CEO. “Nonetheless, we acknowledge the fact that we agreed to binding arbitration in a foreign jurisdiction. Antibe respects the confidentiality and final nature of the arbitration proceedings and will accept the decision in good faith. We continue to believe that the comprehensive data package shared with Nuance for the previous chronic pain formulation fully reflected the drug’s safety and efficacy characteristics. Although this ruling presents a significant short-term challenge, we remain committed to developing otenaproxesul -- particularly due to the strength of recent clinical results for acute pain that have significantly de-risked its final trials.”

In light of the arbitral ruling, the Company is evaluating its development and milestone plans for the balance of 2024, which may include adjusting timelines as circumstances require. The strong data from the recent PK/PD study highlight otenaproxesul’s potential and the priority remains conducting the Phase II trial as soon as possible. More information will be shared as the Company determines the best path forward for all stakeholders.

About Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.

Forward Looking Statements

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the payment of amounts due to Nuance under the arbitral award, the anticipated scope, timing, duration and completion of certain of the Company’s pre-clinical and clinical trial programs and studies and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.