Pfizer’s fizzle helps pave way for local firm’s cholesterol drug

Published in the Ottawa Business Journal newspaper and website.
Dec. 11, 2006

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Local biopharmaceutical company Liponex Inc. says it is now well-positioned to take the lead in the good-cholesterol drug market after the fall of Pfizer’s torcetrapib drug last week.

Liponex is currently conducting its first Phase 2 trials in heart patients for its CRD5 drug, which increases high-density lipoprotein (HDL) or “good cholesterol.”

Dr. Daniel Sparks, the company’s chief scientific officer, says CRD5 had already shown the ability to increase HDL by 20 per cent in its two-week Phase 1 trials with no apparent side-effects, even before the company had come out with its latest formulation.

The drug was also shown to lower triglycerides – the storage fat in bodies which also contributes to heart disease – by about 40 per cent.

He adds that there are no other compounds in the late stages of clinical trials since Pfizer pulled the plug on torcetrapib due to high patient mortality rates, which places CRD5 at the front of the line.

“There’s tremendous value to CRD5,” says Dr. Sparks. “There are not a lot of drugs that can raise HDL above 20 per cent, and none in Phase 2 or 3 trials at the moment.”

Dr. Sparks says the company has seen the newest version of CRD5 raise HDL protein by 40 to 60 per cent with a dose that is eight times lower than the older formulation.

The most popular HDL-increasing treatment currently on the market, niacin or vitamin B12, was shown to have a more gradual effect over 20 weeks and causes patients to turn bright red and have itchy skin, he adds.

Health-care and biotech analyst Shameze Rampertab of Jennings Capital Inc. says the cholesterol and triglyceride management drug market is “in excess of US$30 billion,” and says CRD5 is one of the only HDL-raising drugs coming out with Phase 2 efficacy data.

“The market for cardiovascular disease space is the biggest of the therapeutic markets, especially for cholesterol drugs,” says Mr. Rampertab. “If the drug works, Liponex will be courted for multimillion-dollar deals by many potential licensing partners, including Pfizer.”

He adds that Pfizer is now playing catch-up because it has only completed Phase 1 trials with one of its other products.

Meanwhile, the other big drug companies are looking for a way to supplement their incomes when their low-density lipoprotein (LDL) reducing statin drugs come off patent protection.

Pfizer was hoping to protect its franchise by promoting the use of a combination of its best-selling LDL-reducing Lipitor brand and its HDL-increasing torcetrapib drug.

However, with its bombshell announcement last week, it is now struggling to compete with the likes of Merck, Astra-Zeneca and Novartis, who all have statin drugs and are looking to capitalize on the HDL-increasing market, Mr. Rampertab says.

Merck is currently in Phase 3 tests of its niacin drug, which is formulated with another drug to counter the flushed-face effect, he adds. There are two niacin drugs already on the market, bringing in $400 million in revenue in 2004 and $600 million in 2005.

“If Liponex shows better efficacy in its nine-week study (than the niacin drugs), the company has got a real drug here,” Mr. Rampertab says.

Dr. Sparks notes that the market for all cholesterol ester transfer protein (CETP) inhibitors like torcetrapib is taking a hit right now because of the mortality issue, and says Liponex was at an advantage because CRD5 was derived from phosphatidylinositol, a soybean-derived compound which occurs naturally in the body and has a low toxicity rate.

“It’s a bit sad for the world because it looked like torcetrapib was going to have significant impact on heart disease,” says Dr. Sparks, adding, however, that he has voiced “considerable concern” about CETP inhibitors. “We have lots of work to do (in the field).”

Dr. Sparks says Liponex will see the results of the first round of Phase 2 tests on CRD5 in January or February of next year.

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