Pfizer’s (NYSE:PFE) 25 percent profit growth with $15 billion in revenue came as a surprise to some expecting the company to still be hurting from the loss of its patent for blockbuster drug Lipitor last year.
Its streamlined approach to its research and development division implemented last year including a shift in the way it prioritized therapeutics development along with strong sales in emerging markets, particularly China, contributed to its profits. But what is the outlook for Pfizer’s potential blockbuster replacements, particularly its rheumatoid arthritis and atrial fibrillation drugs?
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Tofacitinib: The company’s rheumatoid arthritis drug is part of a new class of drugs called JAK inhibitors that block the action of proteins called janus-associated kinases, which are involved in signaling cells. It is being developed for a market projected to grow 50 percent from 2010 to 2015. Tofacitinib was met with a favorable U.S. Food and Drug Administration committee vote in May. But the FDA has since requested additional data that could delay its Aug. 21 PDUFA date. Geno Germano, president and general manager of specialty care and oncology, said in the pharmaceutical company’s conference call that the regulator’s advisory committee would have liked to have seen more of is more structured data, and said that company now has it. “It’s basically a routine analysis. It’s a very large NDA, we have five phase 3 pivotal trials, 5,000 patients and they have asked for some additional analysis.”
Eliquis: Pfizer developed this anticlotting drug with Bristol-Myers Squibb to prevent strokes in patients with atrial fibrillation. As Pharmalot points out, the drug is being lined up to compete with Johnson & Johnson and Bayer’s drug Xarelto, and Boeringer Ingelheim’s treatment Pradax — the two other new blood clot treatments meant to replace warfarin, the longstanding oral drug for the condition. The drug was dealt a setback in June with a complete response letter requesting additional data from its Aristotle trial. This comes after the FDA delayed an earlier decision on the drug to spend more time reviewing data. Pfizer pointed out in its conference call that the FDA could take another six months before coming back with a decision.
For both drugs, timing seems to be the biggest challenge. The delay in approving Eliquis, assuming it is approved, will mean Xarelto will have been in the market longer.
Still, Morningstar analyst Damien Conover is bullish on both of these drugs getting approved, and reckoned they had an 85 percent change of securing a green light from the FDA. Although he acknowledged Pfizer had more early stage drugs than later stage ones, he believes the pace of development is strong.
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“… Pfizer has the financial resources and the established research power to support the development of more new drugs. Its strength is evidenced by the 80-plus drugs in its pipeline and 90 discovery projects. Although Pfizer’s current pipeline is weighted more toward early phase drugs, we expect the company to increase its number of phase 3 drugs to more than 20 by late 2012.”
