Uh oh

UPDATE 3-Actelion faces Tracleer U.S. sales probe,shares dip



Stocks

Actelion Ltd.
ATLN.VX
CHF44.14
-1.72-3.75%
9:03am CDT

Mon Sep 20, 2010 4:57am EDT

* Actelion receives subpoena in the U.S. for papers

* Documents related to drug marketing, sales practices

* Shares down 3.4 percent, underperform sector index

(Adds analyst comment, updates share price)

By Katie Reid

ZURICH, Sept 20 (Reuters) - The United States has asked Actelion Ltd (ATLN.VX) to hand over documents related to the marketing and sales practices of its key drug Tracleer in America, the Swiss biotech company said on Monday.

The group said it received a subpoena from the Attorney's Office for the Northern District of California and that it would cooperate with the investigation.

At 0849 GMT, shares in Actelion were trading 3.4 percent lower, underperforming a near flat European healthcare sector index .SXDP.

A spokesman for the group said Actelion had no further information as to why it had received the subpoena.

Kepler Capital Markets analyst, Tero Weckroth, said requests for sales and marketing practice materials are not unique for Actelion and most pharma companies have cases ongoing.

"But what makes this different is the fact that Tracleer is the only big product in Actelion's sales split - it represented 90 percent of sales in 2009," Weckroth said.

Tracleer is a prescription medication to treat pulmonary arterial hypertension, a rare heart and lung disorder. Tracleer brings in more than $1 billion a year.

"Settlements in these kinds of cases are common, with amounts ranging from millions to hundreds of millions of dollars," Weckroth added. (Reporting by Katie Reid; Editing by Jon Loades-Carter)

 

Another version:

http://pharmalive.com/news/index.cfm?articleID=730192&categoryid=9&newsletter=1

 

Welcome to the storm...

 

it may have been tony's farewell dinner, but in light of today's news, maybe we should rename it "rob's last supper"

 

You have the right to remain silent. If you give up the right to remain silent, anything you say can and will be used against you in a court of law. You have the right to an attorney. If you desire an attorney and cannot afford one, an attorney will be obtained for you before police questioning.


Blawhahahahahahaha...Losers.

 

Hey Rob, really looking forward to this year's Christmas card from Alcatraz.

 

Finally.

 

At Actelion, MSL = Marketing Sans Label.

 

Heard the Denver Gilead rep snitched and that's why Tim is hot water. Any info?

 

It's a coup d'etat versus the faux-Mormon's ruination of Actelion.

 

The fat one?

 

Hey there are other places where snitching could occur, like Provo UT.

 

Karma's a Bitch...For all of you who watched on the sidelines as good, reputable reps went down! Can't wait to get subpoena'ed! And just because you're gone now, doesn't mean you're exempt, either.

S.J.
R.E.
T.S.
P.M.
T.U.
T.F.
I.G.
J.R.


HR- let's not forget their evil roles, too!
S.M.
M.S.- yep- he's rotten to the core.

 

Off label selling is the least of their worries. PAH counselors giving out priviledged patient information ie: initials, dob, names. Can you say HIPPA violation!!

Hey P.M. Champion of keeping patients on drug, maybe you can share a cell with R.E.,you will pay double. You have to be his bitch and listen to him non stop.

 

You are 100% spot on. The fact that Actelion has been able to house their TAP program under the same roof in the same building for as long as they have is amazing. They have all the information on every patient that's been on drug and they contact them directly at will. If the OIG doesn't come in and bust up the place then something is terribly wrong.

The best case scenario is that that Actelion is prosecuted for the breach of patient information because it was known about by Rob and Shal and they supported it. God wouldn't it be great to see those two sons of bitches go to jail!

 

Shalom, at least YOUR pipeline will be full in prison.

 

How funny, my whole team is trying to move over to UT, after the subpoena and pending news just how many will UT be willing to take.

 

go ahead and go.

 

FDA Warns Actelion Unit On Post-Marketing Drug Report Failures
By Jennifer Corbett Dooren

Published October 05, 2010
| Dow Jones Newswires
Print Email Share Comments (0) Text Size WASHINGTON -(Dow Jones)- The Food and Drug Administration said a U.S. unit of Swiss pharmaceutical company Actelion Ltd. (ATLN.VX) failed to follow the agency's post-marketing drug reporting requirements.

In a Sept. 14 warning letter, the FDA said Actelion Pharmaceuticals US Inc. failed to report about 3,500 patient deaths in connection with Tracleer and Ventavis--which are drugs approved to treat pulmonary arterial hypertension--"without an adequate basis for not reporting them." The letter was posted on the FDA's website Tuesday.

The FDA said that it wasn't concluding that the deaths were linked to the drugs, but that Actelion didn't follow proper procedures in determining if the deaths should be reported to the FDA and under which procedure.

In cases where a drug might play a role in a patient death, or in cases where companies don't have enough information to determine if a drug might have contributed, deaths must be reported to the FDA within 15 days. In other cases, deaths and side effects can be reported in annual periodic safety updates if information suggests the death is not drug-related.

"Actelion is responsible for ensuring that it has a system in place to keep FDA appropriately apprised of adverse events so that FDA can appropriately evaluate the safety of drugs in the post-market environment," the agency said.

An Actelion spokesman said the company was working with the FDA to resolve the matters raised in the letter.

(Goran Mijuk in Zurich contributed to this article.)

Copyright © 2010 Dow Jones Newswires



ROB & CO. ARE NO BETTER THAN USED CAR DEALERS; NO SERVICE AFTER THE SALE!

 

What an ethical company we have here.