Ibrutinib, Pharmacyclics and Johnson & Johnson

The drug: Ibrutinib
The disease: Cancer
The developers: Pharmacyclics, Johnson & Johnson
Peak sales potential: Goldman Sachs initiated coverage of Pharmacyclics by projecting peak sales of this cancer drug at $6 billion. And a number of other analysts aren't far off that market, including some who have been significantly upping the ante here over the past 12 months. The number may not bear up in the market, but at half that amount this is still a top prospect.

The scoop: Cancer drug development is in a category all by itself these days. Turn in the right data on a targeted drug with an adequate safety profile and there's generally not a lot of mystery about the FDA's take. The BTK drug ibrutinib helps illustrate how that works, adding a few key business markers that help set the odds in its favor.

The therapy blocks a key enzyme involved in the growth of cancer and helped control the cases of 68% of 116 patients--with a relatively improved safety profile among treatment-resistant patients. The data have driven Pharmacyclics' ($PCYC) shares to new heights, making CEO Robert Duggan a paper billionaire in the process.

J&J ($JNJ) stepped in in late 2011, providing a rich $975 million deal to collaborate on development and marketing. And the FDA cooperated by handing out a "breakthrough drug" designation, indicating that cancer drug czar Richard Pazdur is completely comfortable with the clinical progress he's been seeing.

The big question now about this drug is not whether it will be approved--the NDA was filed back in July--but when. Look for a near-term launch as Pharmacyclics scrambles to prove it can hold up its end of the blockbuster deal.

For more:
Special Reports: Top 20 orphan drugs by 2018 - Ibrutinib | Fierce's 10 top biotech billionaires - Robert Duggan
J&J hands over $75M payout as FDA countdown begins for ibrutinib
'Breakthrough' ibrutinib NDA makes rapid arrival at FDA
Pharmacyclics bounces higher as J&J wins third 'breakthrough' cancer drug coup
J&J, Pharmacyclics score 'breakthrough' coup with blockbuster hopeful ibrutinib

Ibrutinib, Pharmacyclics and Johnson & Johnson
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