Shares of Isis Pharmaceuticals plunged 22 percent Tuesday, after a U.S. Food and Drug Administration committee released a report expressing serious safety concerns about its experimental cholesterol drug, Kynamro.
The drop erased $280 million from Isis’ market value. At the end of the trading day, Isis’ stock value had tumbled to $1.03 billion.
The FDA report said that taking Kynamro is associated with increased liver fat deposits, a risk factor for cirrhosis and death. However, the report also said the drug is potentially beneficial to its intended patient population. Those people have a disease that causes extremely high blood levels of LDL, or “bad” cholesterol. Those with the disease, homozygous familial hypercholesterolemia, have a greatly increased incidence of cardiovascular disease.
Meanwhile, shares of competitor Aegerion Pharmaceuticals rose 10 percent. On Monday, the same FDA committee released its report on a similar drug from Aegerion, called lomitapide.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review lomitapide today. On Thursday, the committee will review Kynamro.
Kynamro is the flagship drug for Carlsbad-based Isis. It was developed with Isis’ gene-blocking “antisense” technology. Generically known as mipomersen, the drug reduces blood levels of LDL. It could provide Isis entry into the multibillion-dollar market for cholesterol-fighting drugs.
Isis and its Paris-based marketing partner, Sanofi, aim to get approval first for the hypercholesterolemia drug in the homozygous form, then for a milder form. Later, the companies plan to seek approval for patients who don’t have the disease, but are also at high risk of cardiovascular illness. About 1 million Americans fit that category, Isis says.
The safety concerns described in the report could limit Kynamro’s use, said Damien Conover, an analyst with the Chicago-based research firm Morningstar.
The report may not stop the FDA from approving Kynamro for familial hypercholesterolemia, Conover said. Those patients have few other options. However, the findings make it less likely that Kynamro will be eventually approved for larger populations, Conover said.
The FDA is scheduled to decide on Kynamro by Jan. 29.
The drop erased $280 million from Isis’ market value. At the end of the trading day, Isis’ stock value had tumbled to $1.03 billion.
The FDA report said that taking Kynamro is associated with increased liver fat deposits, a risk factor for cirrhosis and death. However, the report also said the drug is potentially beneficial to its intended patient population. Those people have a disease that causes extremely high blood levels of LDL, or “bad” cholesterol. Those with the disease, homozygous familial hypercholesterolemia, have a greatly increased incidence of cardiovascular disease.
Meanwhile, shares of competitor Aegerion Pharmaceuticals rose 10 percent. On Monday, the same FDA committee released its report on a similar drug from Aegerion, called lomitapide.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review lomitapide today. On Thursday, the committee will review Kynamro.
Kynamro is the flagship drug for Carlsbad-based Isis. It was developed with Isis’ gene-blocking “antisense” technology. Generically known as mipomersen, the drug reduces blood levels of LDL. It could provide Isis entry into the multibillion-dollar market for cholesterol-fighting drugs.
Isis and its Paris-based marketing partner, Sanofi, aim to get approval first for the hypercholesterolemia drug in the homozygous form, then for a milder form. Later, the companies plan to seek approval for patients who don’t have the disease, but are also at high risk of cardiovascular illness. About 1 million Americans fit that category, Isis says.
The safety concerns described in the report could limit Kynamro’s use, said Damien Conover, an analyst with the Chicago-based research firm Morningstar.
The report may not stop the FDA from approving Kynamro for familial hypercholesterolemia, Conover said. Those patients have few other options. However, the findings make it less likely that Kynamro will be eventually approved for larger populations, Conover said.
The FDA is scheduled to decide on Kynamro by Jan. 29.