As expected, Lipitor sales are being blasted by generic competition in the U.S. And with Pfizer's ($PFE) sales numbers plunging, the pharma giant is staying focused on the fate of a trio of late-stage therapies that are desperately needed to fill a growing gap.
For the record, Lipitor sales in the U.S. dropped 71% in the first quarter. But Pfizer is betting that after years of pipeline snafus and bad deal-making strategies, it can demonstrate once and for all that it has turned the corner on a smarter, more focused development approach.
The three main characters in that story line are tofacitinib, a potential blockbuster for rheumatoid arthritis with an August PDUFA date, the anti-clotting drug Eliquis, up for a decision in June, and the high-risk Alzheimer's Phase III studies for bapineuzumab.
Some analysts have been fretting over safety issues for tofacitinib, as Dow Jones' Peter Loftus reports. But many still expect it to fare well at the FDA, which is an experienced hand at considering the risk/benefits of new RA treatments. Eliquis, meanwhile, is widely considered an odds-on favorite for an approval. The wild card is bapineuzumab, partnered with Johnson & Johnson. According to Dow Jones, Pfizer expects late-stage data in the summer. But TheStreet's Adam Feuerstein tweeted this morning that the first Phase III trial is finished but Pfizer wants to wait until the second study is completed later in the year before releasing data.
For Feuerstein, one of many Alzheimer's skeptics who have seen a series of R&D fiascos in the space, that's an ominous sign. A number of analysts note that an approval would be worth billions, but the odds of success are slim. A pair of regulatory wins ahead of the data release, though, would soften any blow from a bapi failure.
- here's the story from Dow Jones