AstraZeneca: Coming up from behind--fast--with top cancer programs

AstraZeneca CEO Pascal Soriot

AstraZeneca ($AZN) has the most to gain from ASCO because it has the most to prove as it tries to stare down Pfizer ($PFE). Merck ($MRK), Bristol-Myers Squibb ($BMY) and Roche ($RHHBY) had all distinguished themselves in the lead-up to the big cancer meeting. But earlier in the month AstraZeneca, the longtime poster child of R&D dysfunction, was reduced to making some bold--possibly ridiculous--sales projections on early-stage programs. Now their research teams are coming up with some hard numbers, and they look good.

The big focus at AstraZeneca is on MedImmune's MEDI4736, an immuno-oncology therapy that has been making waves as the pharma giant points to peak annual sales of $6.5 billion. Peak sales projections are often more about magical thinking than rational analysis. But with Pfizer breathing down its neck with a $106 billion offer, a little creative math is to be expected. Look to the big meeting in Chicago to find out more on this therapy. Wednesday night AstraZeneca focused on its other would-be star, the "breakthrough" lung cancer drug AZD9291.

The genetically targeted AZD9291 registered a 64% response rate in its Phase I study, with tumors shrinking in about two-thirds of patients in the drug arm who shared a common mutation among those who develop a resistance to EGFR drugs like Iressa.  

"AstraZeneca's management is right to be excited by the pipeline," noted Panmure Gordon's Savvas Neophytou, according to a report from Reuters. AstraZeneca blows right past the analysts with a projection that peak annual sales for this drug can hit $3 billion. But the company also notes that the analysts are looking at a more modest $1 billion to $2 billion range.

"With response rates of 64% reported in T790m + EGFR TKI refractory patients together with durable responses, it is no surprise that AZD9291 received BTD status," observed the analysts at Leerink. "Questions about '9291's relative safety profile vs. CLVS's [Clovis's] (OP) CO-1686 will have to await ASCO, where efficacy and safety data for an additional 41 patients will be presented."

Some investors weren't in a waiting mood, though. They pushed up Clovis's ($CLVS) shares Thursday morning after some analysts gave the much smaller Clovis an edge in this race as both companies push ahead into larger studies.

There were only 13 evaluable lung cancer patients taking MEDI4736, meanwhile, with a 23% response rate, leaving some big questions for Chicago.

"The preliminary data made available today highlight our strength across our three core areas of oncology research: immuno-oncology, our focus on the genetic drivers of cancer and acquired resistance and DNA damage repair," says Briggs Morrison, one of the three R&D chiefs at AstraZeneca. "We are looking forward to the presentation of the full data sets at ASCO."

Morrison is a bit more soft spoken than CEO Pascal Soriot, who's become a devotee of making bold pronouncements. Morrison won't buck the company line (and who in his position would?), but he's an experienced development veteran who knows when he's onto something good. 

- here's the release
- here's the story from Reuters