AstraZeneca and Ranbaxy Laboratories have been unable to wiggle out of a pay-for-delay case that said they colluded to keep generics of AstraZeneca's blockbuster heart medicine off the market until its patent expired in May 2014. The drug is still not on the market but at this point it is not because of backroom deals but because of FDA oversight and Ranbaxy's drug testing mess ups.
Will they or won't they? That question seems to be on quite a few minds these days as the oddsmakers assess the chances of another Pfizer megamerger bid for AstraZeneca after the U.K.'s cooling off period ends on Wednesday.
Bristol-Myers Squibb announced a new project in Ireland earlier this month, followed by Amgen's completion of a continuous processing facility in Singapore. Now AstraZeneca says it needs more biologics capacity and will spend in excess of $200 million to build out a facility in Maryland.
AstraZeneca has been touting its pipeline full of promising products as a reason it will return to growth by 2017 and has no need to hook up with Pfizer. As if to put an exclamation point on that declaration, the company says it will kick off a U.S. expansion that will add 300 jobs so it can realize that potential.
Thanks in part to its all-hands approach to immuno-oncology, AstraZeneca's pipeline is now nearly 50% biologics, leading the company to lay out $200 million to build the capacity it will need to follow through on those in-development projects.
Shares of Clovis Oncology slid 10% on Wednesday as investors and analysts juggled a new data set on its closely watched lung cancer drug rociletinib (CO-1686). Even though the updated Phase II results were promising, the numbers slipped a bit from its last snapshot delivered last summer at ASCO. And slipping now looks a lot like falling behind in its race with AstraZeneca's rival AZD9291, frequently touted as one of the pharma giant's top R&D comeback programs.
When Pfizer and Merck KGaA announced their big immuno-oncology deal Monday, market watchers immediately started extrapolating. The tie-up means Pfizer won't come back for another try at AstraZeneca, some say. But others figure that there's still a solid chance of Pfizer, round two.
Rounding out year two of CEO Pascal Soriot's turnaround mission at AstraZeneca, the U.K. drugmaker believes it has the pipeline assets to fuel double-digit submissions and approvals by 2017, reaffirming its promise to pump up sales by 75% as former suitor Pfizer creeps back into the frame.
AstraZeneca has detailed the data from two of three studies of its late-stage combination program for lesinurad, a new drug for gout obtained in their $1.26 billion buyout of Ardea, which showed that the treatment hit the desired biomarker for blood levels of uric acid as promised--but added today that it failed to actually reduce the rate of painful flare-ups of the disease for patients in the study.
With Pfizer's eligibility to bid again for AstraZeneca nearing, the drug giant seems unlikely to make another run at its one-time target, industry-watchers say. But that doesn't mean it isn't prepping a run at someone else.