January 14, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Pfizer Inc. , which is in a race with Amgen and a partnership between Regeneron Pharmaceuticals, Inc. and Sanofi SA, to develop and commercialize a new class of cholesterol drugs that target the PCSK9 protein, is developing an oral pill and vaccine that target the LDL cholesterol protein, the company told Reuters Tuesday. Amgen and Regeneron are in the headlines Wednesday for their PCSK9 drugs, after a major benefits provider said it would pressure the cost of the class.
Mikael Dolsten, the company’s research and development chief, told the news service at the J.P. Morgan Healthcare conference in San Francisco that Pfizer will begin human trials for its version of the drugs this year. Pfizer hopes to condense the treatment to a single shot dose, he said.
“We view this as a franchise approach,” Dolsten, estimating that the PCSK9 vaccine would enter human clinical trials in 2016. “Imagine going to your doctor to get a shot for cholesterol,” he said, and then told Reuters the vaccine could become an annual injection. For comparison, bococizumab is an injection given every two weeks.
Amgen, Pfizer, Regeneron and Sanofi are all developing PCSK9 inhibitors, which work differently than statins, the current standard treatment for high cholesterol. While statins inhibit the liver’s production of LDL cholesterol (or “bad” cholesterol), this new class of drugs blocks the protein PCSK9 that regulates how much cholesterol the liver can clean out of the body.
Human trials that test a small molecule pill that targets PCSK9 are expected to begin this year, Dolsten told Reuters. Animal tests, thus far, have shown a “substantial reduction” in cholesterol due to this treatment.
In 2014, Pfizer announced that its injectable large molecule monoclonal antibody, bococizumab, also a member of the PCSK9 inhibitor family, was shown to lower cholesterol by approximately 60 percent in human trials.
“I am hopeful that bococizumab, as a member of the PCSK9 class, will play an important role in understanding and addressing the unmet need for patients at high risk for cardiovascular events,” Christie Ballantyne, chief of the section of cardiology and cardiolvascular research from Baylor College of Medicine, said in a statement at the time of Pfizer’s announcement.
Amgen is currently in the lead to commercialize PCSK9 inhibitors, having filed a New Drug Application for its drug evolocumab with the U.S. Food and Drug Administration in August 2014.
“If these drugs succeed in reducing heart attacks and mortality rates caused by statins, they can be expected to generate billions of dollars,” reported Bidness Etc. Wall Street analysts have also forecast that each of the three entities in the running to commercialize this class of drugs could reach peak annual sales near $2 billion.
