Alnylam faces DOJ probe over Onpattro marketing
In the competitive market to sell drugs for the rare disease hereditary ATTR amyloidosis, the Justice Department thinks Alnylam may have crossed a line.
Alnylam disclosed in an SEC filing Monday that on April 9, the DOJ served the company with a subpoena related to how they marketed and promoted Onpattro, their $300 million per year drug for the genetic nerve-afflicting condition. The 3-sentence filing offered virtually no details, except that they are cooperating, preparing a response and have hired “experienced outside legal counsel” to assist.
Reached for comment, an Alnylam spokesperson declined to elaborate, except to say that they are prepared to handle the matter and that it will not affect patient access to Onpattro or their other drugs.
“Operating with integrity, honesty and transparency will always be core to our organization and are key parts of our Core Values and our Goals,” the spokesperson added in an email. “As a part of that, we believe our business conduct and in particular our interactions with healthcare providers must be held to the highest ethical standards. As always, we will support nothing less.”
Onpattro has not turned into the blockbuster some predicted, but the drug’s launch in 2018 nevertheless marked a milestone for Alnylam: the first approval for an RNA interference drug and for Alnylam, which hammered at the technology amid considerable outside skepticism for 17 years before. Since then, it has been the most significant form of revenue for the company as they try to chart a path toward profitability.
At the same time, the drug has not been free from competition. Just three months after Onpattro’s approval in 2018, Ionis won approval for their ATTR drug Tegsedi. And Pfizer followed the next year with their own pair of oral ATTR drugs Vyndaqel and Vyndamax. Both Ionis and Alnylam’s drugs have to be infused.
Pfizer’s drugs, with their easier-to-use formulation and the pharma giant’s greater commercial infrastructure, quickly emerged as the clear winner, bringing in over $1.2 billion last year. Alnylam, though, is continuing to roll out Onpattro worldwide, while running studies to potentially expand its market.