Controlling Cholesterol through R&D | ClinLab Staffing

Drug developers are spending billions on R&D and extensive studies on treatments for high cholesterol based on genomic sequencing. According to Damian Garde of Fiercebiotech, Amgen is the current leader and may be the first to launch a new drug; the company is completing Phase III studies with evolocumab. Sanofi has partnered with Regenero and is in late-stage studies with alirocumab. Bocozizumab by Pfizer has entered Phase III studies.

Approximately 71 million Americans suffer from high cholesterol and the new drugs, which can be used in addition to or in place of the current popular statins, are expected to create a $10 million market. The drugs use an antibody to reduce LDL levels. LDL levels are controlled by a gene called PCSK9 that regulates LDL receptors and patients with high LDL possess overactive copies of the gene. The new drugs block that gene.

Many pharma and biotech companies are conducting R&D on PCSK9 and include Roche, Bristol-Myers Squibb and Alnylam in addition to Amgen, Sanofi, Regenero and Pfizer. Amgen’s evolocumab was tested with 4,000 patients and reduced cholesterol by 57 percent compared to a placebo. Combined with statin therapy, that statistic rose to 75 percent. Sanofi and Regeneron showed similar results in initial Phase III trials of alirocumab. These companies plan to issue late-stage trials in 2014 with data from 6,000 patients. Pfizer’s bococizumab is in late-stage testing with 22,000 patients.

However, a reduction in LDL does not necessary mean improved quality of life, and there is a concern that long-term data may be required before the new, more expensive drugs are accepted by doctors. Therefore, leading companies have also committed to R&D efforts to improve rates of heart attack and stroke. Pfizer should have results of longitudinal trials with more than 20,000 patients in 2017 and Amgen, Sanofi, and Regeneron should have long-term data by 2018. A concern for investors is neurocognitive impairments that might be associated with the new drugs. Sanofi and Amgen have both revealed that the FDA has requested that the companies monitor any neurocognitive impairment issues through their 12-study Phase III program. To date, no such issues have been reported. Once the drugs hit the market, company valuations may increase but it will be at least three years before drugs such as evolocumab, alirocumab and bococizumab can be celebrated in the world of cardiology.

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