Pfizer (NYSE:PFE) may have been preoccupied by the damage that Lipitor’s lost patent protection wreaked on its third-quarter sales, but now the company and several other pharmaceutical manufacturers have turned their attention to the next generation of cholesterol-lowering medications.
The New York Times reported that these new treatments could provide an alternative for patients who do not respond to drugs currently on the market. However, the new class of drugs, PCSK9 inhibitors, will not be available for sale until 2015 at the earliest.
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On Monday, Amgen (NASDAQ:AMGN) and Pfizer presented positive mid-stage trial data for their respective treatments at the American Heart Association meeting in Los Angeles.
With its purchase of Rinat Neuroscience in 2006, Pfizer acquired a drug known as RN316. As an inhibitor of the gene PCSK9, which codes for a protein that regulates cholesterol, the drug belongs to a class of biotech medicines that pharmaceutical companies are racing to bring to the market. Because PCSK9 inhibitor drugs could be the most important advancement in the treatment of LDL cholesterol since Lipitor, RBC Capital Markets analyst Adnan Butt told Bloomberg that these types of drugs could generate at least $10 billion in sales
The twelve-week trial of 130 patients showed that Pfizer’s PCSK9 cut LDL cholesterol by 56 percent at the highest dose of 6 milligrams/kilogram of body weight. In comparison, the 3 mg/kg dose lowered cholesterol levels by 46 percent. All patients involved in the study were already taking high doses of cholesterol-lowering statin drugs like Lipitor. Statins lower cholesterol levels by inhibiting the an enzyme that plays a crucial role in the production of cholesterol in the liver.
Amgen’s rival PCSK9 drug is further ahead in its clinical trials. After its twelve-week Phase II trials, the company reported that the drug, AMG-145, reduced LDL cholesterol in 51 percent of patients intolerant to statin medicines. The figure rose to 63 percent when taken in conjunction with Merck’s (NYSE:MRK) cholesterol-lowering drug Zetia.
While Pfizer and Amgen reported positive results for their mid-stage trials, regulatory approval is still a long way off. The France-based pharmaceutical company Sanofi (NYSE:SNY) is much closer.
Having reached the third round of trials for the drug SAR236553/REGN727, Sanofi and its partner Regeneron Pharmaceuticals (NASDAQ:REGN) are one step away from filing for approval from the Food and Drug Administration. The mid-stage trial results, published recently in the New England Journal of Medicine, showed that patients who took the drug in conjunction with a high dose of atorvastatin, the generic version of Lipitor, experienced a 73 percent decrease in LDL cholesterol.
However while clinical trials from these pharmaceutical companies have indicated that PCSK9 inhibitors lower bad cholesterol, studies have not proven them to reduce the risk of heart attacks, strokes, or other cardiovascular problems.