07 October 2021
• Lawsuit alleges multiple breaches of Collaboration Agreement
Geneva, Switzerland, October 7, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that it has filed a lawsuit against NeuroRx, Inc. and its Chief Executive Officer, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100™ (aviptadil). The complaint was filed in the Supreme Court of the State of New York in Manhattan.
The complaint alleges that the defendants are in breach of numerous provisions of the Collaboration Agreement, including without limitation (i) by failing to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute respiratory failure due to COVID-19, which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement and which data and information are required for Relief to seek approval to commercialize the product in Europe, (ii) by failing to allow Relief, despite multiple requests, to conduct a forensic audit of NeuroRx's books and records to determine how the funds that Relief provided to NeuroRx were actually used, (iii) by entering into multiple agreements relating to the development of the product subject to the collaboration without Relief's consent, as required under the Collaboration Agreement, (iv) by engaging in commercialization efforts in territories outside the purview of NeuroRx's territory under the Collaboration Agreement, and (v) by developing additional COVID-19 treatments in violation of the exclusivity provisions of the Collaboration Agreement. The suit also alleges, among other matters, breaches of the covenant of good faith and fair dealing and tortious interference with prospective economic advantage. The Complaint, among other remedies, seeks damages, an order compelling defendants to comply with multiple provisions of the Collaboration Agreement, and a declaration directing NeuroRx to deliver the entire data set from the Phase 2b/3 clinical trial of intravenously-administering aviptadil to Relief.
"We are disappointed that NeuroRx has continued to refuse to ameliorate their breaches of the Collaboration Agreement," stated Jack Weinstein, Chief Financial Officer and Treasurer of Relief. "While we continue to hope to settle these matters with NeuroRx, we are compelled to bring this action to preserve our rights under the Collaboration Agreement and to allow us to continue to develop RLF-100™ (aviptadil) in a timely manner for the treatment of acute respiratory failure due to COVID-19 in our territories."
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. On October 4, 2021, Acer's NDA for ACER-001 was accepted for filing by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
RELIEF THERAPEUTICS Holding SA
Chief Financial Officer and Treasurer
Rx Communications Group
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including: (i) whether Relief's lawsuit will be successful, (ii) whether RLF-100™ (aviptadil) will ever be approved for commercialization in the United States or Europe, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.