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



Approval Likely, but Details Still Important

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.

Gilead Sciences (Nasdaq: GILD  ) has already submitted its marketing application for its HIV quad pill to regulatory authorities, and the biotech has said the drug worked in two different trials.

But the devil is in the details, especially since Gilead is only trying to prove that the quad is non-inferior to Atripla -- a three-in-one pill -- or to a combination of Abbott Labs' (NYSE: ABT  ) Norvir, Bristol-Myers Squibb's (NYSE: BMY  ) Reyataz, and Gilead's Truvada.

Investors got their details this week when the data was presented at the Conference on Retroviruses and Opportunistic Infections. Safety data is most important, since the quad works just as well as -- but not markedly better than -- the other combinations.

The trial comparing the quad to Atripla is the more important of the two, since Atripla is currently the most-prescribed HIV treatment regimen in the United States. Gilead has a financial incentive to sell the quad over Atrtipla, since it has to share profits of Atripla with Bristol-Myers but owns all four components of the quad.

The quad produced lower levels of abnormal dreams, insomnia, dizziness, and rash, but caused more low-grade nausea. It looks like the quad might have won the safety battle, but the adverse events are all fairly minor issues and might not be enough to convince doctors to switch patients. The quad also induced smaller increases in cholesterol levels compared to Atripla, which might give it an edge in patients who are already struggling with high cholesterol levels.

With an approval looking pretty likely, the upcoming advisory committee will be an interesting event for investors to pay attention to. Rather than the advisory committee being a typical binary event with hints of whether the FDA will approve the drug, investors might instead learn how likely it is that key opinion leaders will prescribe the drug. In addition to competing with Atripla and the Norvir-Reyataz-Truvada combination, investors should listen for comments comparing the quad to Merck (NYSE: MRK  ) Isentress, which is an integrase inhibitor as in one of the components of the quad. Even without substantial head-to-head data, some of Isentress' market might be the easiest low-hanging fruit to steal, since the quad comes in a convenient all-in-one once-daily pill.

While you're waiting to see how the quad will compete, take a look at what Fool analysts believe is the next rule-breaking multibagger. Get the free report 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 Abbott Laboratories and Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Read/Post Comments (0) | Recommend This Article (2)

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: 1808178, ~/Articles/ArticleHandler.aspx, 10/25/2016 1:06:53 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 3 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 4:00 PM
GILD $74.15 Down -0.14 -0.19%
Gilead Sciences CAPS Rating: *****
ABT $40.41 Down -0.09 -0.22%
Abbott Laboratorie… CAPS Rating: *****
BMY $49.23 Down -0.79 -1.58%
Bristol-Myers Squi… CAPS Rating: ****
MRK $60.75 Down -0.45 -0.74%
Merck and Co. CAPS Rating: ****