Pfizer’s primary care business unit has dropped two Phase III candidates, further reducing the drug giant’s product pipeline and raising more questions about its R&D decisions.
The firm said that that development of the compounds in question, esreboxetine for fibromyalgia and PD332334 for generalised anxiety disorder (GAD), had been abandoned after a review of existing clinical data.
Company spokeswoman Kristen Neese told in-PharmaTechnologist that the latest decision reflects both current market dynamics and the expectation that the dropped candidates would not have offered significant medical benefits over available products.
Neese went on to say that drugs currently in development for other indications would provide a better return for Pfizer’s clinical investment and added that the firm is “still on track to have between 24 and 29 candidates in Phase III development by the end of 2009.”
In a press statement Pedro Lichtinger, president of Pfizer’s primary care division, said that the unit “continually review[s] our portfolio to ensure we are developing medicines in areas of unmet need and have found significant potential opportunities to bring more value to patients and our company.”
Lichtinger cited the developmental pain drug tanezumab and Lyrica (pregabalin) among the products likely to benefit from additional resources freed up by the move, although he did not say how much extra would be spent.
Despite Pfizer’s upbeat tone, dropping the two drugs at Phase III has unavoidable negative connotations for the firm, especially given the pain it felt after halting the development of its heart disease drug torcetrapib at Phase III in December 2006.
While esreboxetine and PD332334 were abandoned for financial rather than safety reasons, and its last high profile failure Exubera was pulled after proving unpopular patients, questions are still being asked about Pfizer’s choice of candidates for late stage development.
Abandoning esreboxetine and PD332334 may indicate that decisions made by Pfizer's R&D department are being affected by the company's focus on bolstering product pipelines via acquisitions rather than through increased internal investment.
One observer to raise such concerns was Caris & Co analyst David Moskowitz who told Reuters that dropping the two drugs “is just another sign that the Pfizer's research and development operation is not as effective as it needs to be."
Moskowitz explained that: "If [Pfizer] are killing projects like this in Phase II it is understandable. If they are killing them in Phase III they need to go back and look at their decision process."