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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Employee Surveillance at the FDA | Main | Vivus and Qsymia: The Oddest Drug Approval »

July 17, 2012

Qnexa Approved? Someone Seems To Know. . .

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Posted by Derek

People are waiting to hear the fate of Qsymia (or Qnexa?), the obesity combo therapy being developed by Vivus (fixed the typoed names)!. In a weird development, an article went up on USA Today about the drug's approval by the FDA - before any such decision had been announced. (As of this writing, it still hasn't, but there's still time later in the afternoon). The article, which I didn't see before it disappeared, apparently included quotes from the company's CEO about the approval. (Note the URL of that ghostly link).

Basically, it looks like the company knows that the drug is going to be approved, as do some news outlets, but that news is under an embargo, which someone at USA Today inadvertently violated. This has made trading in the company's stock rather interesting, and has confused everyone mightily. So, how often do companies get this sort of tip-off? Your guess is as good as mine. . .

Update: more at Retraction Watch.

Comments (12) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. partial agonist on July 17, 2012 1:20 PM writes...

Isn't it possible that the USA Today expects a decision one way or another today, and has two articles pre-written, covering each outcome, and primed to be posted at a moments notice, and then someone goofed and posted one of them?

This often happens with sporting events that wrap up close to a press deadline. Both results are written up, and then the appropriate one is supposed to be posted quickly, but sometimes the wrong one is posted due to human error.

Permalink to Comment

2. MTK on July 17, 2012 1:48 PM writes...

Buy the rumor, sell the news!

Permalink to Comment

3. Anonymous on July 17, 2012 2:00 PM writes...

It's probably embargoed until the end of trading on NYSE/NASDAQ.

Permalink to Comment

4. ech on July 17, 2012 2:00 PM writes...

It's probably embargoed until the end of trading on NYSE/NASDAQ.

Permalink to Comment

5. David Formerly Known as a Chemist on July 17, 2012 2:05 PM writes...

#1 Partial Agonist, I think you nailed it. Just like obituaries of most advanced-age famous people are already written and ready to go, simply fill in the date of death!

Permalink to Comment

6. Derek Lowe on July 17, 2012 2:10 PM writes...

#1, #5: I'd think so, too, if it weren't for the quotes that the original article was said to contain quotes from the company's CEO about the approval decision, which is not the sort of thing you'd get in advance.

Permalink to Comment

7. Anon on July 17, 2012 3:01 PM writes...

CEO comments are interesting...It is strange that things started to level out but didn't correct back to the opening price by the end of the day. I wonder if the SEC will roll back the trades.

Permalink to Comment

8. Anonymous on July 17, 2012 4:13 PM writes...

I'm not sure if this is just adding to the confusion, but this was a top hit for me when I searched for Qsymia on Bing (oddly, Google is down for me at the moment).

http://www.cafepharma.com/boards/showthread.php?p=4432979

If we believe the posts, someone on the inside seemed to think it was going to be approved on 7/12/12, and then someone (correctly/incorrectly?) states Vivus heard they weren't approved yesterday.

What a strange situation.

Permalink to Comment

9. Chemjobber on July 17, 2012 6:10 PM writes...

Approved. Link in handle.

Permalink to Comment

10. BioBritSD on July 17, 2012 6:35 PM writes...

@partial agonist et al - that would be a good assumption except that the article had images provided by VVUS and direct quotes.

Don't assume that the companies don't know the result until the FDA issues a public statement, quite the opposite. If the FDA is going to approve, they will be working with the company to agree labeling in the weeks leading up to the announcement. If a company hasn't heard from the FDA prior to the PFUDA date, they know by default that they aren't getting approved.

So these press embargoes are pretty routine. What is unusual is a press outlet breaking it.

Permalink to Comment

11. Anonymous on July 17, 2012 9:48 PM writes...

So, what are the repercussions for the press after breaking an embargo?

Permalink to Comment

12. Philip on July 19, 2012 12:11 AM writes...

@1, It was not a prepared article. It had information about the name change that had not been announced. Way to much was correct to have been guessed at.

Permalink to Comment

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