A new mission for Pfizer
Pfizer Inc. scientist Rich Hutchins still vividly remembers the afternoon U.S. regulators gave the thumbs-up to lung cancer treatment Xalkori, one of three company-developed medicines that have received approval this year after being put through their paces at the pharmaceutical giant's Groton laboratories.
"You mean 4:44 Aug. 26?" he said with a smile in his voice during a phone interview. "We were all getting ready for (tropical storm) Irene."
Any day that New York-based Pfizer wins Food and Drug Administration approval for a new drug is certainly a time to celebrate. But in an age when the number of novel medicines is on the wane - and as Pfizer prepares next month for the loss of patent exclusivity for $11 billion blockbuster cholesterol treatment Lipitor - gaining an FDA victory takes on a new sense of urgency.
And Pfizer, despite announced research cutbacks locally over the next year, is banking on its 4,000 or so scientists in Groton to be the engine that drives new drugs to market quicker than ever before.
The discovery-science groups that introduced such blockbuster medicines as antibiotic Zithromax and painkiller Lyrica once made southeastern Connecticut the center of Pfizer's research universe. Now with two research groups moving to Cambridge, Mass., and a third pulling up stakes for new headquarters in Shanghai, China, Groton has transitioned into Pfizer's worldwide development hub, given the task of taking medicines from concept stage to final product.
By sometime next year, Groton's labs won't be as involved as they had been in discovering new molecular pathways to fight disease, but it will be doing nearly all of the leg work to determine whether the dream of a new medicine becomes reality. Groton will be Pfizer's key site for running clinical trials, figuring out delivery systems - formulations that might include capsules, pills or injectables - and producing the new chemical entities needed for testing on human patients.
"Timing is critical," said Jim Spavins, senior vice president for Pfizer's PharmaTherapeutics research division.
The speed with which drugs can be brought out of the labs and into patients' hands is important to the success of the company, since cutting research time can allow Pfizer's products more years of patent protection before generic competition slashes into sales. It's also critical to patients awaiting the latest life-saving medications to ease their pain or perhaps cure their cancer, Pfizer scientists say.
"You never need to motivate anyone on the team," said Hutchins, senior director of pharmaceutical services for Pfizer, who works out of the Groton labs. "Everyone knows someone who has cancer."
Cancer drugs are a staple of Pfizer's pipeline, with about 20 new treatments in testing, but the company is having successes in other areas as well, having received FDA approval earlier this year for Oxecta, an immediate-release oxycodone pain reliever designed to prevent drug abuse. In addition to Xalkori, which treats late-stage, non-small cell lung cancer patients with a specific genetic abnormality, Pfizer also received approval earlier this year to use its established cancer drug Sutent on a specific type of pancreatic tumor.
Xalkori, which in the testing phase had been known as crizotinib, came to Groton after being discovered in 2007 by Pfizer's team in LaJolla, Calif., the center for the company's cancer research.
"Most of the development and pharmaceutical services took place in Groton," Hutchins said.
The fact that the drug went from discovery phase to the bedsides of patients in only four years - compared with the typical eight to 10 years of most FDA-approved treatments - demonstrates what Pfizer hopes Groton will accomplish in the coming years as its Center for Discovery and Development Sciences.
Hutchins said two main factors account for the speed of his team: the ability to determine the best formulation for a given drug and the capacity to quickly deliver large quantities of these novel and sometimes difficult-to-produce compounds to patients in clinical studies.
"Groton took a process that usually takes nine to 12 months ... and compressed it to three months," Spavins said. "Because of the stories coming in from the clinics, there was an urgency to deliver as quickly as possible."
Reports of dramatic, positive results in the clinics, Hutchins said, pushed Groton to produce 3.1 million doses of Xalkori in response to more than 180 compassionate patient requests from about 25 countries.
"Their site has really put forth a heroic effort," Spavins said.
Spavins said any new product Pfizer hopes to bring to market will go through Groton, making the Connecticut research site perhaps more important than ever to the company's success.
"Groton is set up to bring in development work and progress it," Spavins said. "Groton is a great place to get a team of experts together to run these programs."
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