Amid all the fervor over cholesterol-fighting PCSK9 antibodies, Esperion Therapeutics is touting more positive results for a pill it hopes will play spoiler to those would-be-blockbuster injections.
A new generation of cardiovascular drugs has proved itself capable of lowering bad cholesterol across dozens of Phase III trials, but many physicians are holding out to see whether doing so can meaningfully improve patients' lives. In an early peek at some long-term data, one such injected therapy from Amgen halved the risk of major cardiovascular problems after one year of treatment, bolstering the case for the whole class of drugs.
Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.
SAN FRANCISCO-- Keeping up the rear in a three-way race to commercialize the first of a new class of anticholesterol antibodies, Pfizer is at work on a pill that attacks the same target, planning to build a franchise in what is expected to be a blockbuster new therapeutic area.
No question that the marketing people at Sanofi are excited about alirocumab, the next-generation cholesterol drug that's expected to make its debut next year. Analysts are talking about multibillion-dollar sales, and recent trial data--not just from Sanofi and its partner Regeneron--may build optimism even further.
About 1.5 million Americans suffer from familial hypercholesterolemia, an inherited disease that leads to dangerously high cholesterol, and they're likely to be the first targets for a new class of drugs that promise to bring in blockbuster sales.
Sanofi and Regeneron's alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.
In the race to commercialize a new class of potential cardiovascular blockbusters, Amgen and its team of lawyers have filed a patent suit to fend off the advance of rivals Sanofi and Regeneron. But, looking at the patents in question and the history of such challenges, one analyst figures Amgen is unlikely to succeed in keeping its competitors off the market.
Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.
Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.