Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) has issued a message to investors after a US District Court invalidated patents related to Amarin Corporation’s rival drug Vascepa, potentially paving the way for generic versions: Regardless of the legal result, our drug will be better.
Matinas manufactures MAT9001, an omega 3-based drug designed to lower triglycerides more effectively than Vascepa.
“We understand that there may be concern from our shareholders about the impact this decision against Amarin may have on MAT9001, our proprietary prescription-only omega-3 free fatty acid based combination of primarily eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) for the treatment of hypertriglyceridemia and cardiovascular and metabolic conditions,” CEO Jerome Jabbour said in a statement.
“Without commenting on the substance of Amarin’s legal case, we believe there are certain facts and realities which should be highlighted.”
READ: Matinas BioPharma advances its clinical stage assets MAT9001 and MAT2203 into key trials in 2020
Those realities, Jabbour explained, include the fact that the Nevada District Court ruling on Vascepa patent has no impact on MAT9001’s issued or pending patents, which extend until 2033 or potentially later.
In fact, in a previous head-to-head study against Vascepa, Matinas' MAT9001 demonstrated superiority versus Vascepa in reducing serum triglycerides, Total- and Non-HDL-Cholesterol, apolipoprotein CIII and PCSK9 levels, he said.
The company believes that MAT9001, if approved, will be eligible for five-year New Chemical Entity exclusivity and subject to the Hatch Waxman Amendments, which could prevent generic alternatives to MAT9001 for more than seven years.
“We continue to believe that MAT9001 has best in class potential regardless of the final outcome of the Vascepa patent litigation,” Jabbour added.
“Ultimately, MAT9001’s potential position as the best-in-class prescription-only omega-3 continues to be contingent on, among other things, the results of the planned ENHANCE-IT study and the outcome of our potential Phase 3 clinical program in severe hypertriglyceridemia.
“We are excited to have the opportunity to let the data speak for themselves, and we look forward to building upon the existing data for MAT9001 which demonstrates superiority to Vascepa, and therefore to any generic alternative to Vascepa.”
Due to coronavirus, though, that data may come later than initially planned.
Enrollment in Matinas’ ENHANCE-IT study, another head-to-head against Vascepa, has been temporarily paused. The company initially expected to have topline results from the study in the fourth quarter, although the company said it doesn’t know if moving that guidance will be necessary.
The company’s preparations for an End-of-Phase 2 meeting for MAT9001 with the US Food and Drug Administration have not been affected by the pandemic. The studies necessary to support a planned 505(b)(2) registration pathway have been completed and final study reports are in the process of being prepared, the group said. Matinas expects to request a meeting held in the third quarter.
Elsewhere, enrollment in the company’s EnACT study of MAT2203, a treatment for HIV patients with cryptococcal meningitis, has also been paused. That decision came when the Uganda National Drug Authority suspended any recruitment of new clinical trial participants
The Bedminster, New Jersey company said it had not experienced any supply chain issues but had put in place a work from home policy for its employees.
—A previous version of this story incorrectly listed the date to which Matinas' patents extend—
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