Vascepa is an omega-3 drug derived from fish oil to treat severe hypertriglyceridemia patients. Acasti is advancing a similar drug called CaPre to treat the same condition (high levels of triglycerides in the blood), which is known to contribute to heart disease and strokes.
On Thursday, a US Food and Drug Administration advisory committee voted to approve a New Drug Application for Vascepa’s label extension -- which would significantly expand the size of the patient population that could use the drug. The FDA is expected to decide on the new label by December 28.
READ: Acasti Pharma says independent study highlights effectiveness of CaPre in treating hypertriglyceridemia
“If Vascepa’s NDA is eventually approved, we believe the Omega-3 market should grow enormously – Acasti’s CaPre should be able to piggyback on this,” Mackie analysts Andre Uddin and Toby Ma wrote in a note released Thursday.
The analysts noted that Acasti is conducting two Phase 3 TRILOGY trials with CaPre in patients with severe hypertriglyceridemia. Top-line results of TRILOGY-1 & 2 remain on track to be reported in December 2019 and late January 2020, respectively.
If the FDA approves the Vascepa label extension, the US omega-3 market would be open to 80 million patients (from 3 million) with hypertriglyceridemia or high triglycerides levels.
In previous trials Acasti’s CaPre demonstrated superior safety and pharmacokinetics (no food effect) compared to Amarin’s Vascepa and pharma giant GlaxoSmithKline's Lovaza, analysts noted.
“Accordingly, we believe CaPre should become the best in class – a best-in-class drug should achieve market leadership easily, regardless of its order of market entry,” they added.
The analysts also maintained a C$8.70 price target for Acastii shares, which are currently trading at US$1.99 in New York and C$2.64 in Canada.
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