Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



Pozen Hedges Its Bets

As promised, Pozen (Nasdaq: POZN  ) and partner GlaxoSmithKline (NYSE: GSK  ) announced yesterday that the pair had submitted a response to their approvable letter, but it was the second half of the press release that should have peaked investors' interest.

Back in August, the companies received a second approvable letter for Trexima, because the FDA was worried about a pre-clinical assay that showed the drug combination caused DNA damage. The companies think they can convince the FDA that the DNA damage is an artifact that wouldn't occur in humans -- thus the response to the approvable letter.  Still, just to be on the safe side, the companies are launching a clinical trial to show that the drug doesn't cause DNA damage in humans. It doesn't sound like the companies are too convinced that the response will be enough, does it?

The artifact argument revolves around the differences between the cells used in the pre-clinical DNA damage assay, which are derived from ovaries of Chinese hamsters (CHO), as well as human cells. Essentially, the CHO cells are more susceptible to DNA damage and therefore not a good indication of the likelihood that Trexima will cause cancer.

While I think this argument is sound, and I'd agree it's the most likely explanation for the result -- given that two other assays showed no DNA damage -- I'm just not sure the FDA is going to agree. The agency's main concern, especially after Merck's (NYSE: MRK  ) Vioxx issue, is the safety of the drug. And what better way is there to test the hypothesis that it won't hurt humans than to do a clinical trial?

The good news is the safety trial should be relatively quick, with patients being dosed and having a blood draw to look for DNA damage in their white blood cells in about 10 days. The bad news is that the analysis of the DNA damage is very labor-intensive and the data won't be ready until about the end of February. The FDA could take up to six months to make a decision about the response, so the companies might be able to amend their response with the new trial data without having to extend the review any further.

As I said in my previous article, I think Pozen is making the right move by submitting the response arguing that it's an artifact -- especially given the time constraints. But I think it's more likely that the FDA will want to see the safety trial data before approving the drug, and that makes the announcement of a safety trial an even better move.

Read/Post Comments (0) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 538590, ~/Articles/ArticleHandler.aspx, 10/22/2016 5:39:52 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 20 hours ago Sponsored by:
DOW 18,145.71 -16.64 -0.09%
S&P 500 2,141.16 -0.18 -0.01%
NASD 5,257.40 15.57 0.30%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/21/2016 4:00 PM
ARLZ $4.93 Down -0.04 -0.80%
Aralez Pharmaceuti… CAPS Rating: **
GSK $41.13 Down -0.30 -0.72%
GlaxoSmithKline CAPS Rating: ***
MRK $61.20 Down -0.72 -1.16%
Merck and Co. CAPS Rating: ****