Imbruvica cocktail stalls CLL in new trial, raising hopes for bigger market

After agreeing to shell out a pretty penny for Imbruvica-maker Pharmacyclics ($PCYC) earlier this month, AbbVie ($ABBV) chief Richard Gonzalez assured investors that the drug had plenty of market growth ahead--and that much of that growth would come from moving into earlier lines of treatment in its approved indications, including CLL. Now, new Phase III results suggest the med is on the right track in that department.

Pharmacyclics partner Johnson & Johnson ($JNJ) announced Monday that it had halted an Imbruvica study after the drug hit its goal for staving off cancer progression. In a three-drug cocktail with bendamustine and Roche's ($RHHBY) Rituxan, Imbruvica met its primary endpoint in patients with relapsed or refractory forms of CLL, posting a statistically significant improvement in progression-free survival.

And while "expectations were reasonably high," J&J--and future Pharmacyclics owner AbbVie--have reason to celebrate, Evercore ISI analyst Mark Schoenebaum wrote in a note to investors. The bendamustine-Rituxan combo already is used as a first-line therapy, Schoenebaum points out. The fact that adding Imbruvica to the mix didn't cause a major increase in side effects "is very encouraging as Imbruvica attempts to move up into earlier lines of therapy," he said.

AbbVie CEO Richard Gonzalez

The way Gonzalez sees it, doing just that will account for a key chunk of Imbruvica's future growth--around 30%, to put a number on it, he told investors on a March conference call. Earlier lines of treatment boast larger groups of patients who stay on treatments for longer periods of time. And as Gonzalez told shareholders, snagging that first-line nod for Imbruvica in CLL "has "a very high probability of success based on the data that we've seen."

If Imbruvica can work its way up the CLL ranks, that might silence some of the critics who labeled AbbVie's $21 billion Pharmacyclics price tag "lofty," "staggering" and even "astronomical." The Illinois pharma predicts Imbruvica can rake in about $7 billion in peak sales for itself--a number Schoenebaum figures means about $11.5 billion to $12 billion in end-user sales between AbbVie and J&J.

- read J&J's release

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