Pfizer manufacturing plant in question after torcetrapib blow
could prove to be a waste after the potential blockbuster it was
designed to make has been canned.
Pfizer announced that it will stop the development of its cholesterol drug torcetrapib after clinical trial results showed an increased risk of death in patients.
Since 2003 Pfizer has been undertaking a $90m (€68m) investment and expansion at an existing Irish manufacturing site in Loughbeg, Cork, so that it could make the new drug, a combination of torcetrapib - a cholesteryl ester transfer protein (CETP) inhibitor - and Pfizer's current blockbuster Lipitor (atorvastatin).
The company was touting the combination as a "major new cardiovascular treatment" and finished construction of the new extension in the middle of 2005, which included the design and installation of a fluid bed drier and granulation system over three floors, along with solids handling and management systems, specifically for the production of the new drug.
Pfizer had also developed at the site a new dosage form technology called Spray-Dried Dispersion (SDD) to manufacture the SDD component that is combined with Lipitor to formulate the torcetrapib/atorvastatin combination used in the drug.
In addition, the Loughbeg facility was equipped with the latest in process analytical technology (PAT), online sensing instruments, a wide range of novel manufacturing technologies, as well as a range of new refrigeration equipment and production tracking technologies, said the firm.
The plant extension had been used to make clinical trial quantities of the new Lipitor combination, which until last week was in Phase III, and was being groomed for the commercial manufacturing of the drug, which was expected to be on the market by 2008, following successful trials.
However, successful clinical trials did not follow.
Last week Pfizer cut short the drug's development, following an independent monitoring body recommendation to halt the study because of an imbalance of mortality and cardiovascular events.
This decision now raises questions over the consequences for the future of Pfizer's brand new expansion, which would now appear redundant.
A Pfizer spokesperson refused to speculate on the potential repercussions the blow will have on the Loughbeg facility, but said that only four people were currently working on the manufacturing of the compound and that they were already existing staff.
"The $90m investment was a capital commitment, not a resources commitment," the spokesperson told In-Pharmatechnologist.com.
She added that not all of the $90m earmarked for the project had already been spent by Pfizer, but wouldn't comment on a figure.
Nor would she comment on the company's future plans for the site and its extra manufacturing capacity.
Either way, the wasted investment at this plant will only add to what is already expected to be a huge loss for Pfizer, as not only was torcetrapib one of the biggest drugs in the giant's pipeline, but Pfizer has already spent $800m developing torcetrapib for over a decade.
The giant had undertaken the largest and most comprehensive clinical trial development programme ever, which involved 25,000 patients at hundreds of medical centres worldwide.
What is more, torcetrapib was seen by many as a potential blockbuster and intended to be a successor to Lipitor - which generates $12bn in annual sales - before that drug's patent expires in 2010, a looming date that is making Pfizer extremely nervous in the face of generic competition.
