Safety Can't Be an Afterthought

Don't let it get away!

Keep track of the stocks that matter to you.

Help yourself with the Fool's FREE and easy new watchlist service today.

The nice thing about hepatitis C drugs is that the efficacy tends to translate really well from early to late-stage trials. Companies with active phase 1 compounds just need to run the larger trials to make sure there aren't any safety issues.

And therein lies the problem. Safety can't be an afterthought.

Bristol-Myers Squibb (NYSE: BMY  ) is down 8% today after announcing that it was suspending dosing in a phase 2 clinical trial testing of one of its hepatitis C drugs BMS-986094 because of a "serious safety issue." The company didn't disclose more in the press release, but a couple of news outlets are reporting that one of the patients in the trial suffered heart failure.

One patient doesn't prove causality. It's certainly possible that the patient would have suffered heart failure even if it wasn't on the drug. But Bristol did the right thing in stopping the trial to investigate further.

Unfortunately the right thing might kill BMS-986094's prospects even if it turns out the drug wasn't the cause. In my experience, investigations into the safety of a drug can take awhile; I'd expect something closer to a year than a month or two. A year is an eternity in the hepatitis C race.

Bristol-Myers has other hepatitis C drugs, including daclatasvir that has looked good to date. But with Gilead Sciences (Nasdaq: GILD  ) not wanting to partner with Bristol-Myers, the pharma's best hope was to try a combination of daclatasvir and BMS-986094. That plan is out for now.

The safety issue is good news for Gilead, Idenix Pharmaceuticals (Nasdaq: IDIX  ) , and Vertex Pharmaceuticals (Nasdaq: VRTX  ) , which all have drugs in the same class as BMS-986094. That assumes, of course, that the issue isn't a class effect that will affect all nucleotide polymerase inhibitors.

My guess is that the problem probably won't extend to the other drugs -- it isn't even clear if there's a problem at all -- but let's wait for the safety data from a larger population before we get all excited.

Interested in new technology? Check out the Fool's new report, "The Next Trillion Dollar Revolution." Claim your free copy by clicking here.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Gilead Sciences and Vertex Pharmaceuticals. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

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: 1969946, ~/Articles/ArticleHandler.aspx, 10/25/2016 1:18:03 AM

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 4 hours ago Sponsored by:
DOW 18,223.03 77.32 0.43%
S&P 500 2,151.33 10.17 0.47%
NASD 5,309.83 52.43 1.00%

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

10/24/2016 4:01 PM
BMY $49.23 Down -0.79 -1.58%
Bristol-Myers Squi… CAPS Rating: ****
GILD $74.15 Down -0.14 -0.19%
Gilead Sciences CAPS Rating: *****
IDIX.DL $0.00 Down +0.00 +0.00%
Idenix Pharmaceuti… CAPS Rating: **
VRTX $78.73 Down -2.03 -2.51%
Vertex Pharmaceuti… CAPS Rating: ****