AstraZeneca's $3B push for Tagrisso gets leg up from Clovis setback

AstraZeneca's headquarters

AstraZeneca ($AZN) got a valuable gift from Clovis Oncology ($CLVS) this week. An FDA panel came down hard on Clovis' data for its lung cancer hopeful rociletinib, which would be a head-to-head rival for AstraZeneca's recently approved Tagrisso--and now, it looks likely that AstraZeneca will have that market niche all to itself until 2019.

That's a good thing for the U.K.-based drugmaker: It's looking to build Tagrisso into a $3 billion-a-year blockbuster.

Tagrisso is a first-in-class kinase inhibitor that targets tumors with a particular EGFR gene mutation, and it's a linchpin of CEO Pascal Soriot's ambitious goal of $45 billion in sales by 2023.

But the Tagrisso estimate is hefty, even for a cancer drug that's priced at $12,750 per month. All the more so with a head-to-head rival launching about the same time, as rocelitinib might have. After one FDA setback--in which the agency asked Clovis for more response data, and the rate came in lower than previously reported--the company had anticipated an approval in the first half of this year.

Not so anymore. The FDA's internal reviewers detailed some serious reservations about the data supporting rociletinib's approval app. Then, the advisory panel voted to require Clovis to finish a Phase III study before considering an approval. (As an FDA-designated breakthrough product, rociletinib might have been cleared ahead of that study's completion.)

The FDA itself doesn't always take its advisory committees' advice. But as FierceBiotech noted Tuesday, given the internal skepticism of the drug and the panelists' cold reception, the agency is likely to follow suit.

That Phase III study is due to wrap up in 2018, and with the requisite review after that, rociletinib isn't likely to hit the market until the following year.

Now, AstraZeneca has three years to ramp up Tagrisso sales, and it's already aggressively working to market the med. Its marketing team has experience in the lung cancer field. Early uptake has been strong, the company said during its fourth-quarter earnings call with analysts, with $19 million in sales between its launch in late November and December 31.

As with other targeted cancer drugs, Tagrisso patients are identified using a diagnostic test, and its marketing staffers are pushing doctors and cancer centers to make that testing a routine operation, executives said during the call.

Earlier this year, Soriot pointed to Tagrisso as a reward for fending off Pfizer's ($PFE) 2014 takeover attempt. At the time, AstraZeneca argued that a megamerger would stop R&D in its tracks for some time. Without the pain of a Pfizer integration, Tagrisso sped its way from lab to market, with a breakthrough designation and a three-months-early FDA nod. "We could not have done that in a disrupted environment," Soriot told the Financial Times in January.

- see the call transcript from The Street
- get more from FierceBiotech