Pfizer unveiled its new pipeline of research drugs for the first time since closing its $68 billion acquisition of rival Wyeth last October. The world’s largest drug company needs new drugs to replace older ones like its top-seller, Lipitor, which generates $11 billion in annual sales but will face competition in the U.S. next year.
The combined company is now working on 500 different drug programs, including those not yet in human trials. That is 17% fewer than had been running under Pfizer and Wyeth individually. Even more pruning is likely going forward, as data comes in on drugs currently under development. Eight new medicines are today moving into the last stage of clinical trials before approval, including a new estrogen formulation for menopause, several new cancer drugs, and a treatment for an ultra-rare disease. The Pfizer pipeline includes 30 experimental drugs aimed at cancer, 20 aimed at pain, 10 targeted at Alzheimer’s disease and five vaccines.[All but one of the vaccines and most of the AD treatments, with Dimebon a notable exception, came from Wyeth.]
Martin Mackay, one of two Pfizer senior vice presidents charged with running the research operation, says that right now he and his partner, Mikael Dolsten, have culled the most obvious candidates. “The portfolio will get smaller, for sure, but it will be based on data, not just early decisions,” Mackay says.
Thanks to its sheer size and acquisitions of smaller companies like Pharmacia and Warner-Lambert, Pfizer has always had more drugs in development than anybody else. The problem is that the last decade has delivered few hits, launching only a single blockbuster, Lyrica, in the span of a decade.[Chantix for smoking cessation was once expected to be a blockbuster, but that now seems highly unlikely.]
Mackay and Dolsten now have to prove a research enterprise structured very differently than other drug company labs. Mackay handles mass-market drugs, with Dolsten taking command of protein medicines and vaccines. Once any compound has passed a proof-of-concept test, later stage trials are run by one of Pfizer’s business units, with the idea that this will result in more commercially viable products.
In the near term, new uses of existing drugs will provide part of the boost. Lyrica, used for treating a host of pain disorders, remains a big success. It brings in $2.8 billion annually. Pfizer is withdrawing its application with the Food and Drug Administration to sell Lyrica as an anxiety drug, but it is still developing the medicine for five other new uses, including epilepsy and several types of pain.
Prevnar, a vaccine against pneumococcal bacteria that cause brain and bloodstream infections, is expected to be Pfizer’s biggest product after Lipitor sales wane. It was acquired from Wyeth. A new version, Prevnar-13, is awaiting FDA approval for infants; Pfizer is also applying for use in adults. It could be a $5 billion franchise by 2013.
Pfizer is testing more cancer drugs than any other company, and twice as many as two years ago. One medicine, an inhibitor of two different cancer proteins, proved so effective in a group of patients with a particular genetic mutation that it leaped from the earliest stage of clinical trials to the last stage before approval in patients with lung cancer. Three other cancer drugs also advanced.
Dolstein expressed optimism about the compounds Pfizer is testing in pain. One, a blocker of nerve growth factors, could be the first protein drug targeted against the sensation of pain. Another could add on to immune-system modifying drugs like Enbrel for rheumatoid arthritis, which Pfizer sells with Amgen.
The vaccines, though fewer in number, tend to have a better chance of success. One exciting entrant is a vaccine against Staphylococcus aureus, an often drug-resistant bacterium that is a scourge in hospitals. Merck has a similar vaccine that is further ahead in trials, but Pfizer hopes its entrant will work on a broader range of strains. Some of the same researchers who developed the Merck product are now working on the Pfizer one. Dolsten called the S. aureus vaccine “a really important unmet medical need.”‹
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