The Novartis Institute For Tropical Diseases is developing new drugs for tuberculosis, dengue fever and malaria with the goal of moving a candidate into the clinic for TB as soon as year-end, Novartis' Head of Corporate Research Paul Herrling told "The Pink Sheet" DAILY in a recent interview.

"In the best case, if it does survive the next phase ... then it could be in the clinic ... toward the end of 2007," Herrling said. The Novartis exec also serves as chairman of the board of the nonprofit institute.

NITD has previously said it hopes to have "at least one novel and attractive compound on the market by 2012."

Regarding NITD's research and development in TB, Herrling said the Singapore-based institute has been able to "build on work that was already done in the company on other microobes," meaning that development of a TB candidate is more advanced than a dengue fever candidate.

"We could just use all the work that had already been done on the commercial side," Herrling said. "We just applied it and tailored it to tuberculosis, which gave us a huge advantage in terms of speed."

Developing drug candidates for dengue fever, however, has been more challenging, according to Herrling.

"We had to start from scratch and there we had to go back and do some fundamental work about the biology of the disease, the epidemiology," Herrling said. "We have a major genomics study where every patient that comes in with high fever to the hospital ... they get the genetic test to see if you find the virus in their blood. If you find the virus in their blood, you do the complete sequence of the virus, and you do the complete sequence of the host of the patient. This goes into a database."

The study is underway in Singapore, and NITD plans to expand the program to Indonesia and Vietnam, Herrling said.

"While we don't know the names of the patients, we do know which genomes correspond to which outcome and the idea is to see if we can find a correlation between the genetic properties of the host of the virus and the severity of the outcome of the disease, because dengue has a benign form, but it also has a deadly form, the hemorrhagic fever part," Herrling said. "And we have no clue why some people react by dying and others react by being sick and recovering."

Herrling said the "most promising" project in dengue, thus far, "is finding the first chemicals that seem to interfere with the entry mechanism of the virus. The virus has to somehow get into the cell of the host and then inject its genome so that it can hijack the host's cellular machinery."

"If you can prevent this fusion of the virus with the host cell membrane, they can't replicate," he said.

Founded in 2004, NITD initially decided to focus on TB and dengue fever, but later added malaria because of an increasing likelihood of strains emerging that are resistant to Novartis' Coartem (artemether-lumefantrine), and because of financial support from the London-based Wellcome Trust, "who have a long history of financing research in malaria," Herrling said.

The Wellcome Trust "came to us and said will you consider partnering with us to do half and half and set up a group for malaria. We said no because we have dengue and TB and if we allocate some of the budget to a third disease, we'd dilute everything down and then everything will be slowed down."

Six months later, Herrling said the Wellcome Trust agreed to completely finance a malaria group, "as long as we would allocate our expertise and ... take leadership of this program. At this point, we said 'yes.'"

The genesis for NITD came from Novartis' belief that it had a responsibility to "contribute in this area to the access of medicine," Herrling said.

"We are a commercial organization and our primary goal is to make a return on investment for our investors, and while there is a lot of patients in these areas, they have no money so there is no market," Herrling acknowledged.

"For many, many years, there has been no really concerted effort to make medicines for these diseases. So my proposal was why don't we create, using exactly the same technology, sciences and brains that we use in research for Alzheimer's, diabetes. ...Why don't we use exactly the same kind of modern science, which hasn't ever been applied to these diseases, and select a few of these diseases in a complementary way and try to contribute new drugs, according to modern criteria for these diseases."

Herrling said Novartis decided to establish the institute in Singapore because the company wanted to be in close proximity to patients with the diseases. In addition, Novartis wanted a place where scientists would not work in isolation, where there was infrastructure, "political stability, legal certainty, IP protection," noted Herrling.

[Yeoh Keat Chuan, director of the Singapore Economic Development Board's Biomedical Sciences Group, recently spoke with "The Pink Sheet" DAILY about the country's biotech and pharma strengths (Also see "Singapore Biomedical Sciences Group Director Yeoh Keat Chuan: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 24 January, 2007.).]

Singapore wanted to parlay its advances in basic life sciences "into medicines and create a biomedical industry, and they were extremely interested in attracting ... some of the big companies to do research here," Herrling said.

"It was a match in time that we were looking for a place to do this, and they were looking to get people like us in there."

"Usually, when you set up a research institute, you work with a multitude of government agencies because you need work permits, you need to import drugs, animal experiments. It take years," Herrling said.

"Singapore had a completely different model. They had an economic development board, whose mission was to establish these kinds of activities. ...They allocated a small team of brilliant young people that ... whenever we needed something, we called them and they knew exactly where to do it. So we got all the permissions, all the stuff in no time at all."

Novartis is also active in other areas of Asia. In July, the company plans to break ground on an integrated biomedical R&D center in Shanghai's Zhangjiang Hi-Tech park as part of a commitment to conduct research in China (Also see "Novartis Shanghai R&D Center To Focus On Diseases Prevalent In China" - Pink Sheet, 6 November, 2006.).

- Daniel Fowler

This article is reprinted from "The Pink Sheet" DAILY, Feb. 9, 2006

Novartis Institute For Tropical Diseases Could Have TB Drug In Clinic By Late 2007

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