"Take two of these and call me in the morning," will have to remain the saying for Johnson & Johnson's (NYS: JNJ) Prezista for the time being. The pharma giant announced Tuesday that the Food and Drug Administration rejected its once-daily pill to treat HIV.
Literally. The pill itself is the only thing that got rejected.
Prezista is still on the market, and Johnson & Johnson can still market it as a once-daily treatment for HIV. The company just can't sell an 800-mg version of the drug it developed. Patients who want to take Prezista as a once-daily drug will have to continue taking two 400-mg pills.
What's wrong with the 800-mg pill? Johnson & Johnson didn't say, but did point out that it doesn't think additional clinical trials will be required to satisfy the FDA. The potential culprit could be a manufacturing issue or a problem proving that the 800-mg pill releases the same amount of drug as two 400-mg pills. Either way, it's probably not that big a deal to rectify although investors should be a little worried that it happened in the first place. Johnson & Johnson should know how to satisfy the FDA's requirements to get a new dosage approved.
In theory, the rejection could keep Johnson & Johnson from selling the 800-mg pill for six months or more. Waiting for the approval isn't the end of the world, but it certainly would be nice to have the higher-dose pill approved. For many diseases, taking two pills is fairly common. But HIV patients usually don't take just one medication. Prezista is always taken with Abbott Labs' (NYS: ABT) Norvir and in the clinical trials, patients also took Gilead Sciences' (NAS: GILD) Truvada.
That's a lot of pills compared to Atripla, which contains Truvada and Bristol-Myers Squibb's (NYS: BMY) Sustiva all in one pill, and Gilead's new once-daily Quad pill. Anything Johnson & Johnson can do to reduce the pill burden should incrementally help with sales.
First, though, the pharma has to convince the FDA that its one-pill dose is approvable, something that seems a little more elusive than it should be.
Dividends can help investors ride the waves of slow drug development times. Check out the Fool's free report "Secure Your Future With 9 Rock-Solid Dividend Stocks," where you'll find one drug developer and eight other promising companies. Just click here to get your free copy.
At the time thisarticle was published Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Johnson & Johnson and Gilead Sciences. Motley Fool newsletter services have recommended creating a diagonal call position in Johnson & Johnson. 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.
Copyright © 1995 - 2012 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.