Recently in Cholesterol Drugs Category

It's a sure bet drug developer Liponex Inc. will be feeling one of those things at the end of February when it reports do-or-die clinical results for a new treatment to raise levels of "good" cholesterol and reduce heart disease.

"This is the Holy Grail of cardiovascular R&D," claims Duncan Emerton, an analyst with British market research firm Datamonitor PLC, referring to the link between raising good cholesterol, or HDL, and melting plaque buildup in arteries that can cause heart attacks and stroke.

On the other hand, statin drugs, of which Lipitor is the best known, have created a $32-billion-a-year (U.S.) market by lowering "bad" cholesterol, or LDL. But they only halt the buildup of additional plaque. Studies have shown that a 1-per-cent drop in LDL can reduce the risk of developing heart disease by 1 per cent, but a 1-per-cent increase in HDL can reduce the risk by 3 per cent.

Pfizer Inc.'s new experimental heart drug is dead, but the dual approach the company was testing -- boosting good cholesterol while lowering the bad -- is very much alive, specialists said Monday.

A drug already on the market, Niaspan, raises good cholesterol without serious risks, and a large federal study is testing it with statin medications -- the very thing Pfizer was trying to do before being forced to abandon research on its drug, torcetrapib, over the weekend because of safety problems.

For consumers, the main fallout may be a delay in getting a new medicine that avoids Niaspan's chief side effect, a hot prickly sensation called flushing that patients hate but that can be minimized, doctors said.

Pfizer Inc. said Saturday it has cut off all clinical trials and development for a cholesterol drug that was supposed to be the star of its pipeline because of an unexpected number of deaths and cardiovascular problems in patients who used it.

The world's largest drugmaker said it was told Saturday that an independent board monitoring a study for torcetrapib, a drug that raises levels of HDL, or what's commonly known as good cholesterol, recommended that the work end because of "an imbalance of mortality and cardiovascular events."

The news is devastating to Pfizer, which had been counting on the drug to revitalize stagnant sales that have been hurt by numerous patent expirations on key products. It has said it was spending around $800 million to develop Torcetrapib.

Two pharmaceutical drug distributors pleaded guilty Thursday to taking part in a $42 million conspiracy to illegally import and sell the cholesterol reduction drug Lipitor and other medicines.

Richard K. Rounsborg, 48, of Kearney, Neb., and Albert David Nassar, 51, of New York, each pleaded guilty to conspiracy.

U.S. Attorney Bradley Schlozman said they bought Lipitor intended for distribution in South America, then illegally imported it into the U.S. to sell at a lower cost than Lipitor made for the U.S.

The Lipitor bought and sold by the conspirators was not manufactured by Pfizer, which makes Lipitor for distribution in the U.S.

source - STL Today 

Unlike the Lipitor case where Ranbaxy Laboratories Ltd has been facing severe legal hurdles, a US Court of Appeal has upheld a district court's ruling granting Ranbaxy a 180-day exclusivity on the 80 mg strength of the anti-cholesterol drug, Simvastatin (the generic form of Merck's blockbuster drug, Zocor).

"We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical companies who expend significant effort and finances to introduce affordable generic medicines to the US healthcare system,'' said Jay Deshmukh, Senior Vice-President of Global Intellectual Property, Ranbaxy.

Cholesterol lowering 'statin' drugs are cost effective in far more people than current guidelines recommend and should be considered for a wider range of people, say researchers in a study published online by the BMJ today.

Large trials have shown that lowering blood cholesterol levels with statins greatly reduces major vascular events, such as heart attacks and strokes, in people at high risk.

And research published in 2005 from the largest of those trials (the heart protection study) showed that when cheaper generic versions are used, several years of statin treatment is cost effective for a wide range of people with vascular disease or diabetes.

Moving further into the cholesterol management market, Abbott Laboratories said this morning it will buy a New Jersey drugmaker for $3.7 billion in cash, or $78 a share.

Kos Pharmaceuticals, Inc. of Cranbury, N.J. is a pharmaceutical company developing and marketing various drugs to treat 'chronic cardiovascular, metabolic and respiratory diseases,' in a growing $20 billion lipid management market, Abbott said in a statement this morning.

'Kos Pharmaceuticals is an excellent strategic fit for Abbott, both scientifically and commercially,' said Abbott chairman and chief executive Miles White. 'This acquisition expands Abbott's presence in the lipid management market and will provide several on-market and late-stage pipeline products. Kos also complements our existing commercial and research and development expertise, and increases our R&D spending capacity.'