Pfizer Pulls Two Late-stage Drugs from Development

Pfizer, on Tuesday, announced that it would end development of two drugs currently in Phase III programs. 

The drugs were shelved as part of a larger plan to optimize the company’s overall portfolio by focusing its attention on compounds that either meet new critical needs or that serve a purpose beyond what’s currently available on the market.

“This is a clear example that we are putting our money where our mouth is,” Pfizer spokesperson Ray Kerins told Pharm Exec on Wednesday. “When it comes to R&D, resources are not finite-we have to take what we have available to us, in this environment, and put it towards areas of unmet medical need.”

The two treatments on the chopping block were esreboxetine for fibromyalgia and PD 332,334 for generalized anxiety disorder. Both investigational compounds were found to have no “meaningful benefit beyond the current standard of care.” In esreboxetine’s case, Pfizer already has a strong fibromyalgia drug in Lyrica, which it will continue to test for expanded indications.

Pfizer made it clear that neither drug was pulled because of safety reasons, however patients in trial settings will have to discontinue use of the drugs.

“ Both of those products didn’t demonstrate data that would have made them more attractive to Lyrica,” Deutsche Bank analyst Barbara Ryan said. “In the current environment, if you don’t have a follow-on that is going to be significantly better in safety or efficacy it’s like throwing good money after bad.”

Why Now?
The most surprising aspect of Pfizer’s decision to pull the drugs is the timing. By the time a drug makes it to a Phase III programs it’s usually expected to make it to FDA.

Kerins said that this is all part of Pfizer’s new business plan, which didn’t officially come into being until January 1, 2009.

In early 2008, Pfizer unveiled a plan to restructure its drug development program into business units, allowing the development teams to make decisions about what compounds to focus their resources on.

“In the old days you would have R&D make the decisions and hand them off to the commercial teams,” Kerins said. “We’ve seen enough examples in the last decade when a drugs come to market, it’s not necessarily what the market was looking for. Either it didn’t improve upon the existing medicines or it just wasn’t something that doctors or patients really wanted.”

The business units were tasked with determining which compounds are the most promising and ending any floundering trials. Within six weeks of launch, these two programs were discovered.

While no specifics were revealed, Pfizer said that all drugs would be reviewed and more drugs could be shelved in the future.

“There has been this overall strategy in the industry of “shots on goal”-the idea that the more compounds you have in your pipeline-the more likelihood something is going to come out the other end,” Kerins said. “This is the complete opposite of that strategy. We need to focus our resources on where we feel we will have the best opportunity--whether that’s based on our expertise and science or market conditions.”

Kerins noted that it is boosting resources for its investigational pain drug tanezumab and would consider licensing esreboxetine or PD 332,334 down the line to another company.

Pfizer currently has 26 compounds in Phase III trials.