KBP's Contest of Injunction Obtained by Novo Nordisk Continues in Arbitration
SINGAPORE, Aug. 13, 2025 /PRNewswire/ -- KBP Biosciences Pte. Ltd. (the "Company") today issued a statement addressing a further decision by the Singapore International Commercial Court (the "Court") to maintain the temporary injunction against the Company and its founder, Dr. Huang Zhenhua ("Dr. Huang"), in support of arbitration proceedings respectively commenced by the Company and by Novo Nordisk A/S ("Novo Nordisk").
Following the Court's judgment today, the validity of the injunction application sought by Novo Nordisk will be determined via the arbitral process, which the Company commenced before Novo Nordisk. More importantly, in the course of judgment, the Court examined a range of issues central to the dispute, including the conduct of clinical trials and the adequacy of due diligence. The findings of the Court are subject to further scrutiny by the arbitral tribunal, which will have more time and the benefit of hearing live testimony, unlike the Court.
1. Independent Testimony by Steering Committee Members
The judgment cites to the independent statements from steering committee members comprising Dr. Bertram Pitt and Dr. Janet Wittes, who are highly distinguished and well respected in the field. These evidence include an open letter by Dr. Pitt and Dr. Wittes on December 18, 2024, stating that "neither [Novo] nor KBP has provided any convincing evidence that the results from [the Bulgaria site] are fraudulent". That open letter was unavailable to the Court in the previous ex parte hearing.
Further, if the Bulgaria site were indeed tainted by serious irregularities and fraud, the "FDA and EME would have responded. However, they have not responded, and Novo did not disclose this" in the previous ex parte hearing.
2. Statistical Errors and the Futility Determination
Eight months after it acquired Ocedurenone, Novo Nordisk terminated the clinical trials for Ocedurenone because it thought they were futile. However, Parexel International (IRL) Ltd ("Parexel") later "informed Novo that statistical errors had been made in compiling the data". The judgment also states that:
"The defendants submit that Novo failed to disclose errors in the Futility Determination. After the Futility Determination was made, Parexel had informed Novo that statistical errors had been made in compiling the data. After correcting for the errors, Ocedurenone satisfied only one of two futility criteria (namely, it satisfied the SBP futility criteria but not the p-value futility criteria), such that the 'anticipated hypothesis' is that 'treatment effect is significant but not substantial', and Ocedurenone was still worth 'continuing current development plans' and not 'worthless' […]".
3. Failure to Disclose Information and Documents Provided
The judgment highlights that Novo Nordisk had access to "a full electronic data room with documents from KBP", which would have allowed Novo Nordisk to conduct its own analysis. These documents included "data on the vital signs of every patient enrolled in Phase 2, identifying the site they were from as well as their [systolic blood pressure ("SBP")]". The judgment further states that:
"The defendants allege that Novo failed to disclose the material fact that during due diligence, KBP supplied Novo with raw data in the form of the Vital Signs Data Listing and the CTA Package. Novo did not open these documents, much less request a different format for the data."
Every pharmaceutical company has a corporate social responsibility to care for patients and address unmet medical needs.
"KBP believes that Novo Nordisk erred in stopping the development of Ocedurenone because it could help patients. KBP intends to make this proof to the tribunal," said Dr. Huang Zhenhua, founder and chairman of the Company.
KBP has expended significant time and resources into the development of Ocedurenone, and it remains committed to its cause. As such, the Company and Dr. Huang will strive to engage the new management to find a way forward for Ocedurenone, whilst vigorously pursuing their rights in all legal proceedings commenced, including a possible appeal from the decision of the Singapore Court.
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About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Singapore, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet medical needs.
SOURCE KBP Biosciences
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