Sanofi and Regeneron take the lead in bringing new cholesterol drug to US market
Tuesday, January 27, 2015
Regeneron (REGN) Pharmaceuticals Inc. and Sanofi may get a head start on their biggest competitor in bringing a new class of cholesterol drugs to the U.S. market.
The U.S. Food and Drug Administration has until July 24 to make a decision on the companies’ application to market their jointly developed drug alirocumab, Regeneron and Sanofi said in a statement.
Amgen Inc. (AMGN) is developing a competing drug, evolocumab, that’s scheduled to get an FDA ruling by Aug. 27. The drugs belong to a class called PCSK9 inhibitors that can drastically cut levels of bad, or LDL, cholesterol associated with cardiovascular disease. Alirocumab has reduced LDL cholesterol by 40 to 60 percent in various studies.
Analysts surveyed by Bloomberg project that each drug will generate sales of more than $2 billion a year.
In their bid to leapfrog Amgen, Sanofi (SNY) and Regeneron deployed a special voucher that gives them an expedited, six-month review time for the drug.
The companies bought the voucher in July for $67.5 million from BioMarin Pharmaceutical Inc. and said they planned to use it for their cholesterol-lowering drug. Being first to market means drugmakers can get prescriptions written for patients who may be reluctant to switch later to a new drug.
Regeneron shares rose less than 1 percent to $422.60 at 10:10 a.m. in New York. Sanofi fell 1.6 percent to 82.27 euros in Paris. Amgen fell less than 1 percent to $159.17.
Cost Watchers
Although an earlier approval deadline is advantageous, it’s no guarantee of gaining approval more quickly, if at all. If they win the approval race, Regeneron, based in Tarrytown, New York, and Sanofi (SAN), based in Paris, will have the opportunity to set the first price for the new drug class, which will be closely watched by health-insurance plans looking to control costs on a wave of expensive new medicines.
Typical FDA reviews take about 10 months. The priority review vouchers are part of a 2007 law designed to reward drugmakers that develop treatments for neglected diseases, so they can sell the passes as a reward.
Initially the drugs may be used mostly by a limited population with particularly severe high cholesterol, such as patients who have a genetic disorder called familial hypercholesterolemia. Eventually, if they’re proven to prevent heart attacks in large, continuing studies, use could spread to millions of patients whose heart risk isn’t fully controlled with existing cholesterol medicines.
No Bazaar
This raises the question of how the drugs should be priced. Should they cost thousands of dollars a month, comparable to drugs for rare diseases, or should prices be closer to a few hundred dollars a month, more like standard brand-name cholesterol treatments?
Pricing “will depend on a lot of factors as we really go through the approval, what’s the label, the population and so on,” said Elias Zerhouni, head of research and development for Sanofi, in a Jan. 13 interview. “We are not in a bazaar here. Prices relate to value.”
Express Scripts Holding Co. (ESRX), the nation’s largest manager of prescription drug benefits, has indicated that keeping costs under control for PCSK9 drugs is a priority. In December, the benefit manager excluded Harvoni, an expensive hepatitis C drug from Gilead Sciences Inc., from its main list of covered drugs, in favor of a competing drug from AbbVie Inc., which had offered discounts in exchange for exclusive status.
Now, PCSK9 “is the next opportunity for us,” said Steve Miller, chief medical officer for Express Scripts, in a Jan. 22 interview. In contrast to Gilead, companies working on PCSK9 drugs “have taken a different approach,” he said. “They are working with us.”
http://www.bloomberg.com/
