DOJ Subpoenas Documents from Alnylam Over Marketing of Onpattro

Federal prosecutors launch Alnylam marketing probe, demanding Onpattro documents
April 13, 2021 Eric Sagonowsky

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.

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.

DOJ Subpoenas Documents from Alnylam Over Marketing of Onpattro - Global Genes

 

The dish best served cold.

 

And the above post says it all - an ex-employee (we all know who you are) is the reason for this - they will find nothing because there is nothing to find.

 

They'll find plenty- where there's smoke, there's fire.

 

No, not true. Dream on !

 

They already have enough, you will see soon.

 

Its obvious that you have no idea of the processes involved in a DOJ investigation. These phony "nothing to see here" details may once have worked on the upper level glass walled office dwellers (many of whom are no longer here), but they don't work on this bunch.

But by all means, keep posting.

 

Shut up since you don't work here anymore - we are doing just fine without you. Personally - I'm very excited about Tolga doubling the ON team - so fun!!!!!!!

 

Yoga the Pfizer reject

 

Guess we just have to see. I believe we have very questionable practices, but whether or not it a full violation the DOJ will have to figure it out. The rats leaving the ship is definitely curious.

 

People are leaving because Tolga is an asshole and every knows it.

 

I am sure that they have the Excel spreadsheet TM makes us complete for him.

 

Jury awards former AstraZeneca sales manager $2.4M in whistleblower retaliation case
by Fraiser Kansteiner |
Jun 23, 2021 10:05am

A jury found AstraZeneca didn't discriminate against its former sales manager because of her age.

AstraZeneca and a former sales manager have each scored partial wins in the case of Suzanne Ivie, who alleged the company fired her after she raised concerns of off-label marketing.

While a federal jury in Oregon found that AstraZeneca violated whistleblower statute by firing Ivie after she made a "good faith" report of alleged marketing misconduct, jurors rejected allegations of age discrimination, Oregonlive reports. The jury didn't hold the drugmaker liable under the False Claims Act for marketing violations, either, according to the publication.

After a trial that started in mid-June, jurors reached their conclusion Tuesday and awarded Ivie $2.4 million.

Ivie is in line to receive $1.87 million in damages plus another $510,423 for wages lost. She lost her job in 2019 after 19 years with the company.

During her career, Ivie worked in AZ's respiratory division. After a new director took over in 2018, the director allegedly pushed the team to promote certain AstraZeneca drugs for uses that weren't approved by the FDA. When Ivie refused to play ball and complained to the company, a pattern of retaliation emerged, she claimed.

After raising concerns, Ivie said she was removed from leadership roles, had her bonus slashed and more.

Meanwhile, AstraZeneca's lawyer claims Ivie was fired for failing to do the work expected of her as a district sales manager, Oregonlive reports. The company's compliance unit also determined that Ivie's claims of potential off-label marketing were "unsubstantiated," the lawyer said.

With regards to age discrimination, AZ's legal team pointed out that Ivie's supervisor was just four years younger than her at 47, Oregonlive reports. Meanwhile, the sales team included other staffers aged 50, 49, 45, 40 and 39.

 

So I guess most of the info on this thread is no longer in question now that so many people have been fired over our practices? Only question I have is how the hell has Jim M been able to keep his job? He started the cardiology sales tactics as SE RSD and took them to his TLL role. Has DOJ looked at how much he targeted cardiologists in this role?

 

Jim should have been fired long ago right next to Nathan and Lisa- Come on Dan - hurry up already.

 

Same with CG?

 

People are starting to receive subpoenas. Did you really think the departures of Andy / McGee / Leena would be enough to satisfy the government? PLEAZZZZZZZ.

 

How many of us have received a knock on their door?

 

At least, nine former / current reps have been subpoenaed. Not sure if Alnylam's second set of lawyers will cover the former employees since one of them could be the whistleblower.

 

This really didn’t age well.

https://www.fiercepharma.com/pharma/judge-overturns-2-4m-whistleblower-retaliation-verdict-against-astrazeneca

Looks like Ivie has no money, no job, and no future in pharma. Maybe she can change her name?