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For starters, Regeneron is one of the world’s most exciting biopharmaceutical companies. Praluent® (also known as alirocumab) is a first-in-class drug. And Loeb & Loeb came along at just the right time to help build a sampling program to assist in bringing it to market.
Arguably the biggest drug launch of 2015, Praluent is an alternative cholesterol-lowering medication for patients who have an inherited condition that causes LDL (the bad form of cholesterol) or who have had atherosclerotic heart problems and are not at goal with their statin.
Why is Praluent a game changer? It’s the first in a new class of drugs called PCSK9 inhibitors. It works by making the liver efficient at getting rid of LDL. And, according to Dr. Elliott Antman, president of the American Heart Association, it’s a “powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease.”
Regeneron, known for innovative research and development and impressive growth, tapped Loeb & Loeb’s FDA Regulatory and Compliance Practice for the design and rollout of a commercialization and sample distribution plan for Praluent. With FDA approval expected in a matter of months and unprecedented product demand on the horizon, Loeb & Loeb’s team knew they had to act fast.
We were tasked with making sure samples of Praluent were available immediately following approval.
Loeb & Loeb’s attorneys were involved from beginning to end and with everything in between. We drafted product sample distribution policies, standard operating procedures and forms for use by pharmaceutical sales reps with thousands of requesting prescribers, and within weeks operationalized a program that would normally take months to launch. Our team also handled nationwide sales force training. Remarkably, final approval for Praluent occurred on a Friday, the product was available the following Monday, and product delivery began on Tuesday.
Thanks in part to Loeb & Loeb, patients were able to access this new drug as fast as they could say “lower my LDL.”