Wednesday, May 19, 2021

 Johnson & Johnson donates Ebola vaccine amid new outbreak; Ji Xing promises more than $127M for Milestone's nasal spray for rapid heart rate

Nicole DeFeudis

Associate Editor

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

Officials in Guinea officially declared a new Ebola outbreak back in February, after the country recorded its first cases since the end of the 2014 to 2016 outbreak. It appears the new outbreak was caused by the same strain, and officials say it was likely introduced by a survivor. There have been at least 12 deaths, J&J announced.

“Johnson & Johnson’s vision is to help prevent Ebola outbreaks before they start,” CSO Paul Stoffels said in a statement. “WHO Prequalification of our vaccine regimen and the deployment to West Africa are important steps forward in reaching this goal and an important milestone for epidemic preparedness.”

Ji Xing promises more than $127M for Milestone’s nasal spray for rapid heart rate

Milestone Pharma hit a major snag last March when its nasal spray for episodes of rapid heart rate missed the primary endpoint. Now, more than a year later, it’s touting new data on its secondary endpoints and a partnership with Ji Xing Pharmaceuticals to develop the candidate in China.

ng $15 million upfront and making a $5 million equity investment for the rights to develop and commercialize etripamil, a fast-acting calcium channel blocker, in Greater China, the companies said on Monday. If all goes well, Milestone stands to receive up to $107.5 in milestones and royalties.

At ACC 2021, Milestone said etripamil had higher scores than placebo related to relief of specific symptoms associated with paroxysmal supraventricular tachycardia (PSVT), including rapid pulse (p=0.002), palpitations (p<0.001), shortness of breath (p=0.008), dizziness (p=0.012), and anxiety (p=0.006), Milestone said at ACC 2021.

But last year, the drug failed on the primary endpoint in a Phase III study: a comparison of the nasal therapy with placebo over 5 hours in turning SVT to sinus rhythm. It fell far short of the mark on statistical significance with a value of 0.12. It also fell short on reducing trips for emergency care, with the same p-value.

“Etripamil holds the potential to enable patients to treat their episodes in the at-home setting and ultimately take control of their condition. We remain focused on the execution of our ongoing Phase 3 program and our vision to help patients suffering from episodes of SVT,” CEO Joseph Oliveto said in a statement.


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