The new production line, based at Pfizer's existing facility in Loughbeg, Ireland, has produced its first batch of torcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor which is being develop alongside the active ingredient in the company's multibillion cholesterol-lowering drug, Lipitor (atorvastatin).
Torcetrapib was discovered as part of a 15-year research effort to find a compound that can raise high-density lipoprotein (HDL) cholesterol, which is thought to reduce the risk of heart disease by removing cholesterol from the blood. Pfizer believes that the combination of torcetrapib with atorvastatin, which works by lowering harmful low-density lipoprotein cholesterol, will provide a potent weapon in the fight against cardiovascular disease.
That Pfizer has been prepared to invest in the dedicated production line ahead of marketing submissions and approval is a signal of the importance attached to the new product. Indeed, the company is investing some $800 million dollars in the Phase III programme for the drug, and enrolling 25,000 patients in trials, in its bid to reach the market ahead of competition.
"This is the type of major financial commitment Pfizer is willing to make on an entirely new and yet-to-be-approved medicine because it has potential to improve lives of people around the world," said Pfizer Global Manufacturing president Nat Ricciardi. "Having the operation up and running before our regulatory filings should facilitate the review process."
Pfizer has also developed a new dosage form technology called spray-dried dispersion (SDD) in collaboration with Bend Research, which is being used at Loughbeg. The plant in County Cork will use this new technology to manufacture the SDD component that ultimately is combined with Lipitor to formulate the torcetrapib/atorvastatin combination used in the clinical development program.
In addition to the SDD technology, the Loughbeg facility has the latest in process analytical technology, on-line sensing instruments, and a wide range of novel manufacturing technologies, according to Pfizer.
An official opening ceremony will be held at the facility tomorrow (24 June). When the facility expansion is fully operational, it will require 40 employees.