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Isis jumps as FDA clears cholesterol treatment

Isis Pharmaceuticals Inc. rose to its highest value in four months after receiving U.S. approval for a drug to treat a rare form of high cholesterol.

Isis (Nasdaq: ISIS) climbed 9.8 percent to close Wednesday at $14.69, reaching its highest closing price since Sept. 25. The Food and Drug Administration cleared the company’s injection Kynamro for people with a disease that can lead to life-threatening cholesterol levels. Isis’s partner, Sanofi, rose less than 1 percent to 72.70 euros in Paris.

The treatment may generate $403 million in peak sales by 2020, Philippe Lanone, an analyst with Natixis Securities, said. Approval triggers a $25 million milestone payment to Carlsbad-based Isis, and the company will get 30 percent to 50 percent of Kynamro profits, according to a 2008 agreement with Paris-based Sanofi, France’s largest drugmaker.

The approval validates Isis’ antisense technology, which focuses on disabling genes linked to a disease, said Jim Birchenough, a BMO Capital Markets analyst in San Francisco, in a note to clients. The company is studying more than 20 other candidates in the same class of treatments and “we believe that upside potential extends beyond Kynamro,” he wrote.

Sanofi’s Genzyme unit is likely to put the drug on the market immediately, at a price of $125,000 to $200,000 a year, Birchenough said. For Isis, investors may now focus more on the development of similar drugs for prostate cancer, clotting and other conditions, he said.

Kynamro treats homozygous familial hypercholesterolemia, a disease that may cause heart attacks or premature deaths. The drug was approved with a warning label about its risks for liver toxicity, the FDA said Tuesday in a statement.

“FDA approval of Kynamro is great news for patients with HoFH who are in need of additional treatment options for this rare, and often underdiagnosed disease,” David Meeker, the president and chief executive officer of the Genzyme unit, said in a statement.

Aegerion Pharmaceuticals Inc. (Nasdaq: AEGR) won U.S. approval Dec. 24 for a similar medicine, Juxtapid, in pill form.

The FDA is requiring four postmarketing studies for Kynamro, including programs to monitor the safety of the drug.

Rare disease

In late-stage trials, 8 percent of patients treated with Kynamro experienced elevated levels of an enzyme that indicates liver damage. Juxtapid from Aegerion also was approved with a boxed warning about the potential for liver toxicity.

HoFH causes abnormalities in liver cells responsible for clearing LDL, or low density lipoprotein, particles from the blood. People with the disease can have cholesterol levels two to four times higher than normal, according to the National Institutes of Health.

Kynamro failed to win European Union backing in December. The medicine was rejected because it leads to flu-like symptoms and liver damage that deter patients from sticking with treatment, the European Medicines Agency said in a Dec. 13 statement. Sanofi said the companies planned to request a re- examination of the opinion.

Isis studied 261 people treated with Kynamro in three pooled late-stage trials, including those with other forms of familial hypercholesterolemia, that supported a pivotal trial of 51 HoFH patients.

Isis said the drug reduced LDL cholesterol by 25 percent in patients with HoFH in two late-stage trials, compared with 3.3 percent for those on placebo.

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