Compounds Discovered In Asia Expected To Enter Clinic In Three Years, Pfizer Says

SINGAPORE - Pfizer expects to see drugs discovered and developed in Asia brought into the clinic in about three years, Pfizer's Pharma Therapeutics R&D Head Martin Mackay told local reporters April 7 during a press conference at the company's Clinical Research Unit at Raffles Hospital in Singapore.

Asia was "never a cost play," said Mackay, who stressed that outstanding talent and patient needs for Asians are the main reason to be in Asia. He said that etiology of disease is different in Asians and "more profound than we thought."

Collaborations in Asia have grown exponentially since 2006 when Pfizer Asia R&D Head Steve Yang came on board.

The most recent such deal was announced April 6. Pfizer formed a discovery and development deal with Shanghai-based Cumencor Pharmaceuticals and Hayward, Calif.-based MicuRx to discover novel therapeutic agents to treat multi-drug resistant tuberculosis. Cumencor is applying MicuRx's technology to discover and develop novel antibiotics for MDR-TB.

Pfizer is providing an upfront payment and funding the discovery and preclinical development of the antibiotics and payments are linked to development and commercialization milestones, as well as royalty payments on sales. Research will be conducted at the Zhang Jiang High-Tech Park in Shanghai

"This is a very unique way for us to work with local collaborators," Yang told reporters. "We have a model called Asia Research Accelerator, which works as a virtual biotech, so in this particular case our collaborator had a specific idea" and the collaboration involves "a very flexible risk-sharing structure" in which both sides bring resources and contribute insight with the collaboration executed by local resources in China, Yang said.

The teams held a teleconference earlier this week, and both bring insight and prior learning from earlier TB programs into the joint effort. Products are jointly owned, but also dependent on the resources brought by the parties.

"Multi-drug resistant TB and malaria are some of the diseases that have not found an effective cure, and we have an internal program on malaria to support [the program]," Yang said, adding, "this effort is not just a stand-alone R&D effort. It's actually very concerted with Pfizer's overall business development strategy to serve the emerging markets."

"The emerging market part of Asia is very important for Pfizer," Yang stressed. "We have a business unit dedicated to service patients in China, India, Brazil, Russia, Turkey and Mexico - countries where many of the diseases that are highly prevalent in those countries are different than the West."

Mackay said he started working in TB in1972 in Edinburgh. "Here we are in 2010 and TB is till a major killer clearly in the developing world, but also in the West," he said.

Just last month another multi-pharma collaboration was announced that aims to speed development of new combination regimens for TB. The "Critical Path to TB Drug Regimens" initiative, unveiled March 18, is a creation of the Bill & Melinda Gates Foundation, the Critical Path Institute and the TB Alliance. It is intended to make it easier for pharma companies to work together and get TB drugs approved more quickly (Also see "Big Pharmas Come Together On TB, But Effort To Accelerate Development May Hit Speedbump From Lack Of Biomarkers" - Pink Sheet, 29 Mar, 2010.).

Asia R&D At Center

Pfizer is increasingly shifting its R&D resources to Asia, Mackay said, where Shanghai is the central R&D hub. The group is increasingly engaging in creative partnerships within and outside Asia to feeds into its global portfolio. Part of that strategy is to establish credibility of Asian academics and have them work with Western scientists to gain knowledge.

The major shift now is understanding that different populations have different etiology of disease. For example, liver and gastric cancer and head and neck cancer are more prevalent n Asia, and Pfizer is forming numerous partnerships to tackle these diseases in Asia.

The company extended its partnership with Korea's state-run Korea Research Institute for Bioscience and Biotechnology to jointly develop drugs for liver and gastric cancer (PharmAsia News, May 18, 2009).

Pfizer also announced a three-way collaboration with Lilly and Merck to form a nonprofit organization called the Asia Cancer Research Group, which takes an open innovative approach to gather patient-specific data to accelerate research in addressing Asia's most-commonly diagnosed cancers. The group will gather pharmacogenomic data on Asia's most prevalent cancers, and will initially focus on identifying biomarkers for lung and gastric cancers in Asia (Also see "Pfizer, Lilly And Merck Strike Up Cancer Research Partnership In Asia" - Scrip, 24 Feb, 2010.).

Mackay said these types of collaborations highlight "how interested we are in cracking some of these diseases but also the fact that big companies like Merck, Lilly and Pfizer can actually work together to do this. Historically we would keep things very close to our chest and work in our own laboratories but more and more you're seeing partnerships in Big Pharma, mid-sized [companies] with biotechs, with academics because disease knows no bounds."

Pfizer opened its Singapore Clinical Research Unit in 2001, which conducts Phase I first-in-man studies only. Director Chong Chew Lan said the Singapore unit conducted 23 Phase I trials last year and plans to increase that number by 10 percent this year.

Pfizer runs all of its Phase I trials out of its three CRUs located in Singapore, the U.S. and Belgium. Roughly 90 Phase I trials are running across those three units now, compared to about 600 trials in all three phases globally. Roughly 80 percent of Pfizer's Phase I trials are run in house and the other 20 percent are outsourced when specialty areas are needed, but the goal is to drive all Phase I units internally, said Roisin Armstrong, Global Head - Core Clinical Sites.

She highlighted the fact that Pfizer became the first pharma company to be accredited by the U.S.-based Association for the Accreditation of Human Research Protection Programs for its Phase I Clinical Research Unit in Singapore. Its accreditation marks a double first as it is the only CRU in Southeast Asia to secure certification, and together with the company's two other CRUs globally, affords Pfizer the distinction of having the only pharmaceutical research units in the world to be accredited (Also see "Pfizer Achieves Double Firsts With AAHRPP Status For Phase I Trials In Singapore" - Scrip, 7 Oct, 2009.).

Focus On Big, Early Signals Or Death

Pfizer is betting on its ability to see "big signals early and move through the pipeline quickly," Mackay said, in order to kill projects early that don't show a big signal "because flatliners are flatliners and need to die early."

He pointed to the success the company saw with a Phase I trial that went straight to Phase III for non-small cell lung cancer agent PF-2341066, which targets the c-MET and ALK pathways.

During the Phase I study, a small cohort of patients was identified who had a genetic mutation and stood to benefit the most from this treatment. Mackay said in this particular cohort, response rates of greater than 50 percent were seen, compared to standard of care response rates in the single digits. Pfizer was able to move directly into registration trials once it was able to validate the genetic translocation via biopsy and diagnostics.

Yang said Pfizer is at the forefront in finding new talent to build up skill sets for pharmacometrics to incorporate more "adaptive trials" into its drug development programs.

"This is a new area of science and not enough is known, and there is not sufficient talent anywhere on the globe," he said, so Pfizer is developing that talent by partnering with academic institutions in Korea and Beijing to train pharmacometricians.

By cultivating local talent to conduct adaptive trials for Pfizer and the industry, it is "good for students, local industry and gives Pfizer the opportunity to engage with local regulatory agencies so they can understand new models," Yang said.

- Tamra Sami ([email protected])