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Did Novartis get $150M worth of positive PhII cardio data from Akcea?

Akcea has $150 million riding on the Phase II data it just posted for a cardio drug.

The company $AKCA, a closely held affiliate of Ionis $IONS, says that APO(a)-LRx — partnered with Novartis — proved in Phase II that it could significantly reduce high Lp(a) levels in at-risk cardio patients. That’s a key biomarker for cardio risk.

Back in early 2017 Novartis handed over $225 million in near-term payments, split between fees, an upfront and an equity stake, and promised $1.13 billion more in development and commercialization milestones for a worldwide option and collaboration pact on this drug and one other. And they included an option fee of $150 million if the drug passes muster in the upcoming end-of-Phase II meeting with the FDA, pointing them to a big Phase III program.

The bottom line on the data: 

Approximately 98% of patients in the 20mg weekly cohort and approximately 81% of patients in the 60mg every 4 week cohort achieved clinically significant reductions in Lp(a) levels bringing them below the recommended threshold of risk for CVD events (<50 mg/dL).

And the researchers say there were no safety issues of note.

The data were presented at the American Heart Association Scientific Sessions.

Akcea has had to deal with a series of setbacks over the course of the year. True, the FDA did provide a belated OK for Tegsedi, their new drug for TTR amyloidosis. But Alnylam got out first with what is widely considered a much better drug. And more rivals are in the pipeline. The FDA also recently rejected volanesorsen, their drug for regulating plasma triglyceride for patients with rare cases of familial chylomicronemia syndrome, even after an expert panel review gave the companies a thumbs up on marketing. The rejection forced the company to restructure, laying off 10% of its workforce as they plan a comeback.

Novartis has worked hard on the pipeline, but cardio has been a particularly tough field for the pharma giant. The FDA recently slapped down canakinumab for what had been billed as a blockbuster cardio market. And that followed other big setbacks in heart disease.


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