Federal prosecutors launch Alnylam marketing probe, demanding Onpattro documents

Busy launching several new drugs, RNA biotech Alnylam posted a big revenue increase in 2020—and it expects more growth in 2021, partly thanks to its top-selling Onpattro drug. But now the U.S. Department of Justice is investigating its marketing practices for that very product. 

The U.S. Department of Justice subpoenaed the biotech last week, demanding documents that detail its Onpattro marketing in the U.S., Alnylam said in a Monday SEC filing.  

“The company is preparing a response to the subpoena and cooperating with the government,” Alnylam said in the filing. The biotech has retained “experienced outside legal counsel” to help handle the probe. 

The company “takes matters like this very seriously, and we are cooperating fully with the government,” a spokeswoman said. … “Operating with integrity, honesty and transparency will always be core to our organization and are key parts of our core values and our goals. As a part of that, we believe our business conduct and in particular our interactions with healthcare providers must he held to the highest ethical standards.” 

Onpattro, approved in August 2018 to treat polyneuropathy caused by hereditary transthyretin-mediated amyloidosis, generated more than $300 million last year. 

The medicine was Alnylam’s first marketed drug, but now the biotech has a growing suite of RNA medicines on the market.

Alnylam scored FDA approval in November 2019 for Givlari to treat acute hepatic porphyria. And in November 2020, the FDA granted a green light to Oxlumo, which treats primary hyperoxaluria type 1, or PH1, a severe rare disease that causes patients to suffer from recurrent kidney stones and often forces patients into organ transplants. 

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In all last year, Alnylam generated more than $361 million from the three drugs, more than double the $166 million haul it posted in 2019. Onpattro contributed the lion’s share with more than $306 million in 2020. For 2021, Alnylam expects between $610 million and $660 million for the three drugs. 

When the company released its 2021 guidance, Cantor Fitzgerald analyst Alethia Young wrote that the number “looks conservative.” Her team projects $687 million in sales for the company this year. 

Aside from those three offerings, Alnylam’s partner Novartis late last year scored an approval in Europe for Leqvio to treat hypercholesterolemia. Alnylam picked up a $15 million milestone payment for the regulatory win. Alnylam discovered the drug and licensed it to The Medicines Company before that drugmaker’s buyout by Novartis. 

Alnylam seeks to join the top 5 biotechs by market cap by 2025, CEO John Maraganore said earlier this year. To get there, the company will need six or more products and half a million patients on its therapies, plus aggressive revenue growth.