AstraZeneca PLC Quietly Kills Some Programs
February 3, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Fourth-quarter earnings calls are an opportunity for companies to flout their successes and, if possible, underplay their failures. Sometimes really underplay those failures. For example, in Pfizer ’s recent annual report, the only mention that it had killed three pipeline programs was an additional tab on its clinical trials update section at the bottom of the report. It only makes sense—lead with your strengths.
AstraZeneca recently had its fourth-quarter earnings call, and news that it had canceled its combination of PD-L1 durvalumab and CTLA-4 medication tremelimumab in pancreatic ductal carcinoma was buried in the data as well.
In addition, AstraZeneca made changes in the time table for its trial of durvalumab in squamous cell head and neck cancers (HNSCC).
AstraZeneca responded to a query by Ben Adams of FierceBiotech, saying, “With recent changes in the HNSCC competitive landscape, including the approval in the U.S. for PD-1 monotherapies for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, and based on [overall survival] data in all-comer patients, we will not make a regulatory submission for accelerated approval based on the single-arm Phase II Hawk trial in PD-L1 high patients and the uncontrolled randomized or the Phase II Condor trial (In PD-L1 low/neg patients).”
Also, four new molecular entity (NME) Phase II drugs were canceled and divested. This, Adams writes, “included its out-licensing of GI candidate MEDI2070 to Allergan a few months back, with MEDI7510 also now in limbo.”
MEDI7510 had received fast track status with the U.S. Food and Drug Administration (FDA). It is a respiratory syncytial virus (RSV) sF antigen with GLA. Adams writes, it “works as a synthetic molecule licensed from Immune Design’s GLAAS discovery platform, and was being studied by MedImmune , AstraZeneca’s biologics arm.”
An AstraZeneca spokesperson told FierceBiotech, “Based on the initial efficacy results from the Phase IIb study, we decided not to proceed with the second-year safety and immunogenicity follow-up phase of the MED17510 study. We are currently conducting a full and thorough evaluation of the Phase IIb results to determine next steps.”
Otherwise, AstraZeneca reported that revenue grew for what it’s calling “New AstraZeneca,” or, in other words, its good, fresh things, primarily emerging markets, by 6 percent in 2016, and by 6 percent in the fourth quarter. Its total revenue guidance for 2017 is “low-to-mid single-digit percentage decline” and its core earnings per share (EPS) guidance for this year is “low-to-mid teens percentage decline.”
The upturn is probably a good thing. As Dividend Drive writes for Seeking Alpha, “No matter what focus you take on the figures—revenue, operating profit or free cash flow—AstraZeneca far from impresses in its progress since 2011. Powered by a bout of patent expirations in core, blockbuster drugs like Crestor and Nexium, the company has seen its financial performance decline sharply.”
And Dividend Drive writes, “Fortunately, AstraZeneca’s pipeline remains incredibly impressive. Clearly focus remains on its potential blockbuster cancer drug, Durvalumab, and its progress through additional Phase III trials. It has a lot of hoops to jump through, with a lot of potential for both boosting and bashing AstraZeneca’s results and share price.”
Dividend Drive sums it up, “AstraZeneca’s results were pretty much as expected. Revenue, operating profit and FCF (free cash flow) all came out as still weak. Yet, the longer-term story from its pipeline potential remains intact, and 2017 is set to be a critical year for understanding just how well it has here and how well the company will do in the future. A lot of pipeline news flow is expected as the year progresses (and into 2018) on which AstraZeneca’s shareholders know a lot hinges.”