Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) Stocks Rise On High Cholesterol Drug Report

Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) has risen after a US regulatory staff mentioned about a plan to tackle the risks of a company’s drug.

Aegerion has gained 9.40% to $17.46 in Monday’s session. This was after the declaration of the staff report from Food and Drug Administration. An advisory panel is supposed to meet on 17^th October on the medicine lomitapide. It is the lead product candidate of Aegerion based in Massachusetts. FDA is supposed to make a final decision on this by the end of December.

The pill is supposed to be taken everyday and it aims at treating a hereditary condition known as familial hypercholesterolemia about abnormalities in liver cells responsible for clearing LDL (low density lipoprotein) particles from blood. The ailment can result in heart attack or death at a early age, as per the National Institutes of Health. The consultative panel will consider a similar drug from Isis Pharmaceuticals and Sanofi on 18^th October.

The risk plan would support suitable use of lomitapide, allowing it to be permitted for use in the projected patient population with life threatening illness and limited therapeutic choices.

The FDA may need risk evaluation and mitigation strategies that go beyond drug labeling to make sure the benefits of a medication compensate the risks.

An analyst at Think Equity Partners in San Francisco said in a telephone interview that it does not believe that larger studies will be required given the REMs. The FDA has recommended the REMs agenda to better evaluate the drug safety.

Out of 19 patients in a clinical test, 17% has experienced the presence of an amplified enzyme in their blood that shows signs of liver damage. The FDA suggests Aegerion’ risk management plan include educating prescribers about liver risks and the need for checking patients with blood tests. 

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Tow Big gainers: Yongye International (NASDAQ:YONG) & Aegerion Pharmaceuticals (NASDAQ:AEGR)

Zishen Wu, the CEO of China based Yongye International Inc(NASDAQ:YONG), a company that produces crop nutrient products, has made a buyout offer that values the company at $334 million. The offer is at $6.6 a share, 38 percent higher than Friday’s closing price of $4.79 on the Nasdaq. Full Alliance International Ltd, MSPEA Agriculture Holding Ltd and Abax Global Capital Ltd are also parties to the offer. This buyout would take the company private. Shares of YONG rose 17.35% to $5.62.

Meanwhile, a U.S. regulatory report says that the Food and Drug Administration has drawn out a risk plan to support the use of Aegerion Pharmaceuticals, Inc.(NASDAQ:AEGR)’s drug in adults with life threatening high cholesterol levels.

The release of this report saw Aegerion shares moving higher 11.25 percent to $17.76 and made a new 52-week high of $18.15 after the release, but cooled down later. The FDA will take a final decision by the end of December.

The report said that the risk plan “would support appropriate use of lomitapide, allowing it to be approved for use in the targeted patient population, a patient population with life threatening illness and limited therapeutic options.”

The FDA panel will also consider similar drugs from Isis Pharmaceuticals and Sanofi.

The medicine, lomitapide, to be taken once daily, aims at treating a genetic condition called familial hypercholesterolemia that causes abnormality in liver cells, leading to heart attack or death at an early age. People with this condition don’t respond to the standard cholesterol lowering drugs.

 Bristol-Myers Squibb Co., who had originally developed this compound, abandoned it after many patients walked out of a trial because of gastrointestinal side effects of the medicine. Aegerion has also said that 3 of the 29 patients enrolled for the drug’s clinical trial had left because of the side effects.

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