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    Friday, June 14, 2024

    Drug trial success bolsters Mystic pharmaceutical firm's stock price

    Paresh N. Soni, left, senior vice president and head of development at Amarin Pharma, and John F. Thero, Chief financial officer of the company, speak Monday with U.S. Rep. Joe Courtney, D-2nd District, to discuss the development of the drug AMR-101.

    Quick now: Name the local company whose stock has increased by the highest percentage so far this year.

    Pfizer? General Dynamics? Dominion?

    Forget the big boys, and make room for tiny Amarin Corp. plc, a Mystic-based biopharmaceutical company with 18 employees whose stock price has tripled, from $1 to $3, since March. In fact, its performance has earned Amarin the distinction of being the fourth best-performing biopharmaceutical stock in the United States so far this year.

    "We've been No. 1 some weeks," the company's chief financial officer, John F. Thero, said Monday at Amarin's offices in the Packer Building on Roosevelt Avenue. "But I'll take No. 4."

    Driving the stock's price has been encouraging news about the advancement of two late-stage drug trials for Amarin's lead experimental medication, the cardiovascular treatment AMR101. The drug, an ultra-pure Omega-3 fatty acid that has been fast-tracked by the U.S. Food and Drug Administration and was heavily tested previously in Japan, lowers the triglyceride levels of patients at high risk of heart disease.

    Amarin's stock trades on the Nasdaq electronic exchange under the symbol AMRN.

    The Los Angeles-based Wedbush Securities has said in an initial research note on Amarin that it believes the company has "a better-than-average chance of the trial succeeding" and that it is also a "high priority takeover target." Rodman & Renshaw, a New York-based investment bank, said AMR101 at its peak "could be a $3 billion franchise globally" and called Amarin "a rapidly emerging turnaround story."

    The turnaround started in 2007 when the Dublin-based company faced its biggest crisis: the failure of lead compound Miraxion in a trial focusing on Huntington's disease. It was a failure that would have destroyed many small biopharmaceutical firms that count on one drug as a make-or-break option, but Amarin was lucky to have a newly named R&D chief, Declan Doogan of Stonington, who was the former chief of worldwide development for Pfizer Inc.

    Doogan, now Amarin's chief medical officer, quickly realized that the key ingredient in Miraxion had a long history of working against cardiovascular disease in Japan. So he set the company on a different path, and AMR101 was born.

    But the path to success in cardiovascular-disease drugs is lined with dollar bills, and Amarin has had to raise $130 million over the past three years to bring AMR101 to a point, within a year or two, of possibly receiving FDA approval as a new medication.

    "Nobody's going into cardiovascular disease anymore because you have to go through this very expensive process," said Jonathan Rowe, head of intellectual property and portfolio strategy for Amarin. "We're probably the only player right now that's in this market."

    Amarin executives met Monday with U.S. Rep. Joe Courtney, D-2nd District, to discuss some of their concerns, from taxes to the slow response time of the FDA. Courtney previously had gone to bat for the company, they said, when the FDA had threatened Amarin with the possibility that AMR101 would not be accepted as a new chemical entity, and therefore would not be eligible for being approved as a new drug.

    Courtney regularly visits with small companies in the region to hear their stories, he said following the hourlong meeting.

    "In the middle of the '08-'09 debacle, to hear that people were still in the game and moving forward is really inspiring," Courtney told the executives. "You guys are the heroes right now, especially for a place like Connecticut. ... It's awesome."

    Bob Henderson of Edward Jones Investments in Mystic said Amarin has been a great local story, though he worried about what would happen to the company in the future. Many small firms with one key drug sell out to larger companies such as Pfizer Inc. that have greater know-how in commercializing new medicines.

    Amarin already has indicated that it is looking for a partner to help take AMR101 to the next level. Amarin executive Doogan said the company meanwhile has slowly been transforming itself from a research organization - one that operates with computer models while outsourcing lab work - to a firm gearing up for commercialization.

    Doogan recently stepped aside as interim chief executive in favor of Colin Stewart, former president and CEO of CollaGenex Pharmaceuticals Inc. and a man with experience in the commercialization process. Amarin, still officially headquartered in Ireland, now has its major worldwide presence in Mystic and is in the process of becoming an American company.

    "We've said what we're going to do, and we've actually delivered," Doogan said. "It's a great team here in Mystic."


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