AbbVie, Roche look for blockbuster boost from $110K leukemia med

FDA

There's a new leukemia drug in town, and to hear analysts tell it, Venclexta is destined to hit the blockbuster target. Developers AbbVie and Roche say they're ready to roll it out within a week, at a price of $110,000 for the first year of treatment.

A first-to-market BCL-2 inhibitor, Venclexta won FDA approval to treat relapsed chronic lymphocytic leukemia (CLL) patients with a particular genetic mutation. That mutation, the 17p deletion, makes the disease particularly difficult to treat.

It also limits the population of eligible patients. But this is just the first approval on AbbVie and Roche's wish list. The FDA gave Venclexta, formerly known as venetoclax or ABT-199, breakthrough designations in two other uses that would cover far more patients. Analysts see $1.5 billion to $2 billion in sales by the end of the decade.

Roche ($RHHBY) and AbbVie ($ABBV) both need to build up their portfolios ahead of biosimilar competition for their biggest meds. Roche expects to face Rituxan biosims by the end of 2017 in some countries and in the U.S. after 2019, which would put $7 billion in sales at risk by themselves. Herceptin and Avastin knockoffs are also on tap.

But it's AbbVie that arguably has the more daunting task, Morningstar analysts have said, because Roche has several follow-up drugs already on the market. AbbVie's $13-billion-per-year Humira could see a major sales dropoff fairly quickly, some analysts predict, and it's been the company's top-selling med for years. AbbVie's next-best seller is actually its newly acquired blood cancer med Imbruvica, with $754 million in 2015 sales, its share after the deal closed in May.

That's why AbbVie shelled out a cool $21 billion for Pharmacyclics and its share of the blockbuster blood cancer med. AbbVie CEO Richard Gonzalez predicts its share of sales for that med to peak at $7 billion, implying $12 billion when Johnson & Johnson's ($JNJ) piece is taken into account.

And here's where Venclexta comes in. Gonzalez sees Venclexta as a growth driver not only in its own right but also as a booster engine for Imbruvica--and vice versa.

Venclexta has a completely different mechanism of action that complements Imbruvica's, AbbVie figures. It blocks BCL-2, a protein that prevents self-destruction of cancerous cells, while Imbruvica is a Bruton's tyrosine kinase inhibitor. AbbVie execs see the combo working not only in CLL but also in other blood cancers.

Conveniently, Venclexta's other breakthrough designations include one in acute myeloid leukemia (AML), the most common type, for newly diagnosed patients who can't tolerate chemotherapy. The other would bring on relapsed CLL patients without the 17p deletion, with Venclexta used alongside Roche's blood cancer drug Rituxan.

Roche and AbbVie share U.S. marketing rights to Venclexta, and AbbVie expects to eventually expand its salesforce to make sure doctors understand the new drug and its potential to complement Imbruvica use.

In the meantime, Venclexta will have plenty of competition in CLL. There's Gilead Sciences' ($GILD) Zydelig (idelalisib), a head-to-head Imbruvica competitor, as well as Imbruvica itself. The AbbVie/J&J drug has a specific approval in the U.S. in patients with a 17p deletion, while Zydelig's European label includes its use alongside Rituxan in 17p patients. Comparing the three by overall response rates in 17p patients, venetoclax could come out on top, some analysts say. But they also point out that researchers used "step-up" dosing on venetoclax to reduce the risk of tumor lysis syndrome, a serious side effect.

- see the release from the FDA

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