Amarin stroke drug wins approval
Irish drug company Amarin has won US approval for its first drug, a treatment to help combat high levels of blood fat that can lead to stroke and heart attack.
The Food and Drug Administration last night cleared Vascepa as an adjunct to diet for a condition known as very high triglycerides, the company said in a statement.
The medication will compete with GlaxoSmithKline's Lovaza. Amarin anticipates starting sales in the first quarter of 2013, chief executive Joseph Zakrzewski said in the statement.
Vascepa may have an advantage because it doesn't raise bad cholesterol levels, a possible side effect for Lovaza, Jon Lecroy, an analyst with MKM Partners in Stamford, Connecticut, said in an interview.
Amarin's drug has the potential to reach sales of $1.25 billion in 2017, which may lead to acquisition offers for the Dublin-based company from drugmakers including AstraZeneca, Mr Lecroy said ahead of the approval.
"There will be interest from large pharmaceutical companies," Mr Lecroy said. "Any company with a large cardiovascular or diabetes sales force makes sense. That's almost any."
AstraZeneca, based in London, may be an option because of its best-selling cholesterol medication Crestor, Lecroy said. Crestor is a statin, and Amarin's drug may be used in a combination with statins. Crestor had $6.6 million in sales last year, according to data compiled by Bloomberg.
Pfizer may also be a candidate to buy Amarin to replace revenue lost from expiring patent protection for its $9.6 billion drug Lipitor, as is Abbott Laboratories, which has an existing cardiovascular franchise, said Akiva Felt, an analyst with Wedbush Securities in Los Angeles, in an interview.
Amarin is still considering an acquisition, a partnership or bringing Vascepa to market itself, Mr Zakrzewski said.
Joan Campion, a Pfizer spokeswoman, Scott Stoffel, a spokesman for Abbott, and Tony Jewell, a spokesman for AstraZeneca, said the companies did not comment on speculation.
About 40 million people in the US have elevated triglyceride levels, which are associated with an increased risk of developing coronary artery disease, according to Amarin. The company's drug is a prescription-grade omega-3 fatty acid.
Very high triglyceride levels are those considered greater than 500 milligrams per deciliter. Amarin also is studying the medication in high triglyceride levels between 200 and 500 milligrams per deciliter.
Amarin is attempting to gain "new chemical entity" status from the FDA for the drug, which the agency grants to innovative medicines or those that make significant changes in already approved products, Mr Felt said. The status makes a difference in whether Amarin has five or three years to market its treatment without generic competition.
"It's fairly unique," Mr Felt said. "Usually it's pretty clear whether a drug qualifies for NCE or not."
The FDA is expected to determine whether the therapy is a new chemical entity next months, Mr Lecroy said.