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Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on cardiovascular medicines, announced that China’s National Medical Products Administration (NMPA) has approved etripamil nasal spray for treating paroxysmal supraventricular tachycardia (PSVT) in adults. According to the company, this marks the first regulatory approval of etripamil outside the United States.

The approval triggers a $2.0 million milestone payment to Milestone Pharmaceuticals, according to the company’s announcement. Everest Medicines holds an exclusive license to develop and commercialize etripamil nasal spray in Greater China, including Mainland China, Hong Kong, Macau and Taiwan. Under the license agreement, Milestone is eligible to receive up to $98.0 million in additional commercial and development milestones, plus tiered royalties of up to 18 percent on future sales in Greater China, the company said.

The NMPA decision was based on data from the global Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China. According to Milestone Pharmaceuticals, the JX02002 study met its primary endpoint, demonstrating that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment. The company reported a hazard ratio of 3.002 with a 95 percent confidence interval of 1.578 to 5.711 and a p-value of 0.0005. Treatment-emergent adverse events were comparable between etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across Phase 3 studies, according to the company.

Milestone Pharmaceuticals markets the drug in the United States as CARDAMYST nasal spray, which the company describes as a self-administered treatment for adults with PSVT. The company noted that an estimated three to six million people in China and two million people in the United States are currently diagnosed with PSVT, which is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute.

Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals, said the approval represents progress toward the company’s vision to help patients worldwide living with PSVT. Milestone Pharmaceuticals is also pursuing additional development programs, including Phase 2 development for PSVT treatment in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate in adults, according to the company.

The international approval expands Milestone Pharmaceuticals’ addressable market and establishes a precedent for the drug’s regulatory pathway in other regions. For investors, the approval demonstrates clinical validation of the drug outside the U.S. market and creates a revenue stream through milestone payments and royalties from a major Asian market.

Sources