The Ministery of Food and Drug Safety appealed a first-instance ruling ordering it to cancel its refusal to grant marketing approval for Jointstem, a stem cell therapy for degenerative knee osteoarthritis. As a result, the legal battle over Jointstem's approval will continue at the Seoul High Court.
Nature Cell(007390) disclosed on the 31st that the Ministery of Food and Drug Safety commissioner filed an appeal on the 30th against the first-instance ruling in the lawsuit seeking to cancel the refusal to grant marketing approval for Jointstem.
The Ministery of Food and Drug Safety submitted a notice of appeal to the Seoul High Court, seeking to overturn the first-instance ruling and to dismiss the claim filed by the plaintiff, RNL BioMed (formerly RNL Bio), the Institute of Regenerative Medicine. It also argued that the plaintiff should bear the litigation expense in both the first and second instances.
The plaintiff in this case is RNL BioMed (formerly RNL Bio), the developer of Jointstem. Nature Cell holds domestic sales rights and is disclosing the progress of the lawsuit.
The Seoul Administrative Court ruled for the plaintiff on the 9th in the administrative lawsuit filed by RNL BioMed. The court ordered the Ministery of Food and Drug Safety to cancel the refusal to grant marketing approval issued in Aug. last year and to bear the litigation expense.
Jointstem is a treatment for degenerative knee osteoarthritis in which mesenchymal stem cells cultured from a patient's own adipose tissue are injected into the knee joint. After completing phase 3 trials, the developer applied for marketing approval, but the Ministery of Food and Drug Safety twice refused approval, prompting an administrative lawsuit.
The key issue at first instance was whether it was lawful for the Ministery of Food and Drug Safety to require superior efficacy over existing therapies during the marketing approval review.
The court found no explicit basis in the Pharmaceutical Affairs Act and related regulations for requiring superiority over existing treatments. It also held that if statistical significance was confirmed in phase 3 according to the approved clinical trial protocol and the pre-specified statistical analysis plan, clinical significance could be recognized.
The court also found grounds to doubt fairness in the composition and deliberation procedures of the Central Pharmaceutical Affairs Council.
With the Ministery of Food and Drug Safety appealing, the appellate court is expected to revisit whether a superiority standard can be applied during the marketing approval review and whether there were procedural flaws in the operation of the Central Pharmaceutical Affairs Council sufficient to warrant canceling the refusal.
However, this lawsuit contests the lawfulness of the refusal to grant marketing approval. The first-instance ruling merely orders cancellation of the refusal and does not mandate approval of Jointstem. Depending on the appellate outcome, it appears the Ministery of Food and Drug Safety will decide whether to re-review the application and proceed with subsequent approval steps.
Nature Cell and RNL BioMed said they will continue to respond actively in the appellate court through their legal representatives.