Top Irish heart drug group Amarin slumps 70% over patent suit loss
Shares of Irish heart drug company Amirin plunged more than 70 percent last night as the company lost an important court case in Nevada over its patent for a cardiovascular drug.
The decision by Judge Miranda Doo in Nevada's district court is a potentially fatal blow to the company, which had spent years proving to regulators that its highly purified fish oil capsule is an effective for patients at risk of heart attack or stroke There was treatment.
The court ruled in favor of the two generic drug companies that Amrin pursued for alleged patent infringement on Whatsapp, which works by lowering harmful blood fat levels called triglycerides in patients at risk of heart attack or stroke that previously Is on statins only. Of high cholesterol.
This allows generic rivals to enter the market to reduce Amarin drug. The company that regulates drugs in the US, two companies that specialize in making cheap-lot versions of medicines, have filed applications with the US Food and Drug Administration (FDA) for generic versions of Vascepa.
The court found that the generic firms’ marketing applications would infringe on the “asserted claims” of the Amarin patent but added that the asserted claims “are invalid as obvious”. She ruled that six patents on the drug, which all expire in 2030, are invalid.
The shares fell partially to $ 4.50, before falling to $ 13.58 from $ 13.58, down from $ 13.58 soon after the verdict after hours of trading in the US on Monday. The shares were trading above $ 24 as recently as December but as a result of the Kovid-19 pandemic became a general hit in the region.
Speaking after the judgment, Amarin chief executive John Thero said the company “strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision”.
He said the pharma group would seek a prohibition on any generic that approved the FDA's launch of a competitive drug pending that appeal.Mr Thero said the company had a strong balance sheet and was confident that the company could secure an injunction against a generic competition by posting bonds that would "secure the generics' lost profits in the event that Generics prevail on appeal.
Amrin said last night that no new drug application for a competitor drug had yet been approved by the FDA, so it does not believe that there is any imminent competition due to the market.
Amreen reported revenue of $ 429.8 million last year - almost all from Wasepa's sales in the US market - and analysts estimated the drug could achieve blockbuster status by registering sales of more than $ 1 billion by next year.
This is now in doubt, as is the future of the company which has no other product on the market.
After we determine the outcome of our effort to prevent a generic launch (of an abbreviated new drug application approval is obtained), we expect to provide an update on how we would adjust certain promotional activities for Vascepa in the United States, the company said.
Shares of Irish heart drug company Amirin plunged more than 70 percent last night as the company lost an important court case in Nevada over its patent for a cardiovascular drug.
The decision by Judge Miranda Doo in Nevada's district court is a potentially fatal blow to the company, which had spent years proving to regulators that its highly purified fish oil capsule is an effective for patients at risk of heart attack or stroke There was treatment.
The court ruled in favor of the two generic drug companies that Amrin pursued for alleged patent infringement on Whatsapp, which works by lowering harmful blood fat levels called triglycerides in patients at risk of heart attack or stroke that previously Is on statins only. Of high cholesterol.
This allows generic rivals to enter the market to reduce Amarin drug. The company that regulates drugs in the US, two companies that specialize in making cheap-lot versions of medicines, have filed applications with the US Food and Drug Administration (FDA) for generic versions of Vascepa.
The court found that the generic firms’ marketing applications would infringe on the “asserted claims” of the Amarin patent but added that the asserted claims “are invalid as obvious”. She ruled that six patents on the drug, which all expire in 2030, are invalid.
The shares fell partially to $ 4.50, before falling to $ 13.58 from $ 13.58, down from $ 13.58 soon after the verdict after hours of trading in the US on Monday. The shares were trading above $ 24 as recently as December but as a result of the Kovid-19 pandemic became a general hit in the region.
Speaking after the judgment, Amarin chief executive John Thero said the company “strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision”.
He said the pharma group would seek a prohibition on any generic that approved the FDA's launch of a competitive drug pending that appeal.Mr Thero said the company had a strong balance sheet and was confident that the company could secure an injunction against a generic competition by posting bonds that would "secure the generics' lost profits in the event that Generics prevail on appeal.
Amrin said last night that no new drug application for a competitor drug had yet been approved by the FDA, so it does not believe that there is any imminent competition due to the market.
Amreen reported revenue of $ 429.8 million last year - almost all from Wasepa's sales in the US market - and analysts estimated the drug could achieve blockbuster status by registering sales of more than $ 1 billion by next year.
This is now in doubt, as is the future of the company which has no other product on the market.
After we determine the outcome of our effort to prevent a generic launch (of an abbreviated new drug application approval is obtained), we expect to provide an update on how we would adjust certain promotional activities for Vascepa in the United States, the company said.
