Pharmacyclics, Inc. (PCYC): Will This Be the Breakthrough of All Breakthrough Therapy Drugs?

Let’s not forget that drug approvals are only half of the battle. Once approved, properly pricing a drug and marketing it effectively to patients and physicians is the other half of the battle. Too many drugs are approved with plenty of promise, only to flop miserably once on pharmacy shelves. In sum, keep your emotions and expectations in check.

Which drug could be next?
On top of watching ibrutinib move through the process, yesterday’s NDA filing is only bound to increase the chatter over which drug could follow next. Although it’s unlikely to come until the first-half of next year because of ongoing late-stage trials, I feel Pfizer Inc. (NYSE:PFE)‘s palbociclib may be next.

In mid-stage metastatic breast cancer trials, when combined with Novartis AG (ADR) (NYSE:NVS)‘ Femara, palbociclib more than tripled progression-free survival to 26.1 months compared to just 7.5 months on Femara alone. If the ongoing late-stage data remains even remotely consistent to what we saw in mid-stage trials, expect an NDA filing around mid-2014.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool owns shares of, and recommends, Johnson & Johnson. It also recommends Celgene.

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