AbbVie edges closer to Imbruvica deal payoff with another FDA filing

AbbVie ($ABBV) and Johnson & Johnson ($JNJ) are one step closer to a new use for Imbruvica. The companies went to the FDA with an application for first-line use in chronic lymphocytic leukemia (CLL), in a march toward a set of new indications the companies will need to hit their ambitious goals for the med.

The app is based on data in seniors who haven't yet been treated for CLL, comparing Imbruvica to traditional chemo. The drug did a better job of halting the disease, and delivered "significant improvements" in several secondary trial goals, including response rate and overall survival.

Given that the number of newly diagnosed CLL patients is much larger than those who've already failed on a previous treatment, an expansion could give Imbruvica a significant boost.

But to get to the multibillion-dollar sales the two pharma giants need from Imbruvica, they'll need a series of new indications after this one. That means a laundry list of ongoing clinical trials, including one in previously untreated CLL patients younger than 65, to round out the first-line CLL approval.

AbbVie CEO Richard Gonzalez

Imbruvica's success is particularly important for AbbVie, which bought J&J development partner Pharmacyclics earlier this year for $21 billion. CEO Richard Gonzalez talked up the deal with projections for $7 billion in peak revenue from Imbruvica--and given that AbbVie will share the wealth with J&J, that translates into about $11.5 billion to $12 billion in total sales at peak, analysts say.

Gonzalez has totted up potential new uses in other blood cancers, such as multiple myeloma. AbbVie figures that about one-fourth of Imbruvica's growth will come from its previously approved uses in mantle cell lymphoma, CLL and Waldenström's macroglobulinemia. A bigger chunk--about one-third--will come from new first-line uses, including CLL. And other new indications would account for the rest.

Plus, AbbVie sees a sales boost for Imbruvica used alongside its own drug candidate, ABT-199. The two meds could be used together, or in sequence, the company figures, in a variety of blood cancers.

- see the release from J&J

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