Determined to prove to investors that AstraZeneca ($AZN) has a late-stage game plan that can rescue the pharma company from a lengthy losing streak, the company today spotlighted plans to speed up the Phase III development timeline on three key cancer drugs.
Without any late-stage data to put on display as the ASCO abstracts appeared, AstraZeneca coordinated its PR campaign around its Phase III plans for moxetumomab pasudotox as a treatment for unresponsive or relapsed hairy cell leukemia patients, along with olaparib and selumetinib, both of which will begin Phase III studies later this year. The first patient has been recruited for the moxetumomab Phase III.
AstraZeneca says it does have positive Phase II olaparib data to discuss in Chicago demonstrating its "potential as a maintenance treatment for platinum-sensitive relapsed ovarian cancer patients with BRCA gene mutations."
AstraZeneca, though, will not have an easy time convincing analysts that it's getting ahead of the game in oncology, which has been tapped as a top priority for the struggling pharma company. Olaparib failed a mid-stage study for ovarian cancer more than a year ago, though European regulators now appear willing to review subset analysis, which is far from ideal. Two months before the olaparib failure, AstraZeneca's selumetinib also failed a mid-stage study, falling short on the survival benefit.
Without any new late-stage deals under new CEO Pascal Soriot, though, AstraZeneca has to make do with what it has for now. Over the next three years Soriot has vowed to double the number of drugs it has in Phase III and file three marketing applications to prove its progress. And the pressure will be particularly evident in oncology as AstraZeneca reorganizes in a high-stakes effort to turn the company around after years of floundering.
"The progress we are making with olaparib and selumetinib, combined with our broader early phase portfolio across small molecules and biologics, puts us in a strong position to deliver our pipeline of targeted cancer medicines," said Mene Pangalos, AstraZeneca's head of early-stage research for small molecules.
- here's the press release