|Mikael Dolsten, Pfizer's president of worldwide R&D|
Pfizer ($PFE) made good last year on its promise to slash its R&D expenses to what it believes is a more sustainable figure, whacking about $800 million out of its research budget from the year before and settling into a sweet spot of $6.6 billion for 2013. The total for 2013 is $2.8 billion below its budget for 2010, the year before Pfizer set the pace for research shock therapy with a reorganization that realigned therapeutic priorities, shed programs, shuttered facilities and demanded a much more careful pipeline strategy.
The company expects to spend roughly the same amount in 2014, projecting total R&D costs for the year of $6.4 billion to $6.9 billion in its annual crunching of the numbers. But while the harsh financial medicine has been applied, the jury is still out over whether the pharma giant's restructuring has spawned a more focused R&D group capable of turning out blockbuster products at a time sales revenue continues to shrivel.
Pfizer won only one new FDA drug approval last year, gaining a green light for Duavee, a marginal new therapy for hot flashes related to menopause. A slate of new drugs was approved in 2012, but failed to produce the kind of revenue that the company needed. And just a day before Pfizer released its annual numbers, the company announced that two late-stage studies of dacomitinib, one of its top experimental cancer therapies, had failed to produce significant results for lung cancer.
Among its most promising therapies now is palbociclib, which is in a Phase III breast cancer study and partnered with GlaxoSmithKline ($GSK) in a combo program with trametinib. There's been some talk of an accelerated filing for the drug. ISI's Mark Schoenebaum noted after Pfizer's call with analysts today that the company doesn't know "whether they can file on ph2 data. However, they can "envision a scenario" where they file on phase 2 after discussing FINAL data with FDA."
There's also a late-stage PCSK9 program underway for bococizumab (RN316), which will try and outpace rivals at Sanofi/Regeneron and Amgen ($AMGN). The pain drug ALO-02 produced promising Phase III results recently. And there's a staphylococcus aureus vaccine the pharma giant has high hopes for, which also faces major league competition.
But Pfizer's application for the rare disease drug tafamidis for transthyretin familial amyloid polyneuropathy (TTR-FAP) was rejected in 2012. The drug is now enrolling patients for a Phase III study for transthyretin cardiomyopathy (TTR-CM) as the company tries to work out a new regulatory pathway on TTR-FAP. A late-stage SGLT2 diabetes drug--ertugliflozin, partnered with Merck ($MRK)--will face a group of competitors if it is successful. Pfizer recently partnered with Eli Lilly ($LLY) on tanezumab, inking a $1.8 billion partnership for the high-risk anti-nerve growth factor pain drug, which was put on clinical hold way back in 2010. Pfizer now says it expects to submit new data to the FDA at the end of this year.
Pfizer is definitely spending less on R&D, but there's no convincing sign that the pharma giant has figured out how to get more out of the multibillion-dollar research budget that remains.
- here's the release on the numbers
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