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The next wave in biotech
The FDA gives makers of targeted drugs a boost with new guidelines.
March 29, 2005: 3:40 PM EST
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - Big drugmakers look poised to reap the benefits of the FDA's recent guidelines encouraging the biotech industry to develop "targeted" drugs.

The Food and Drug Administration published guidelines last week calling for drugmakers to make products targeted at specific populations. This combination of pharmaceutical manufacturing and genetics is known in the industry as pharmacogenomics.

The idea is to create and prescribe drugs with a patient's genetic profile in mind, skipping the standard "hit-or-miss" approach.

"ImClone, Genentech, Novartis: They have more experience and they have more resources to spend on technologies and products like this," said Sena Lund, analyst for Cathay Financial.

The FDA's recognition of this relatively new science is a also potential boon to smaller drug development companies like Celera Genomics (Research), which mapped the human genome, and deCode (down $0.33 to $5.71, Research), which genetically mapped the Icelandic population, according to industry officials and analysts.

"The publication of the guideline is very helpful to us because it focuses attention to this area of pharmaceuticals and it defines the path for registration of these new products," said Celera CEO Kathy Ordonez.

"[The FDA guideline] is a clear sign to the medical community, the financial community and the industrial community that this is an accepted way now," said Kari Stefansson, CEO of deCode.

But it may be a while before small drug companies and biotechs can reap profits from targeted drug development. Spokesmen for Celera and deCode said their companies have pharmacogenomic drugs in the pipeline, but they could be years away from entering the market.

Meanwhile, some drugmakers are already making money off targeted drugs and they have additional products in the test phase.

In its guideline, the FDA said the new science has already led to several major drugs, including Herceptin, a breast cancer treatment made by Genentech (down $0.26 to $56.64, Research), Erbitux for colorectal cancer by ImClone Systems Inc. (down $0.48 to $34.85, Research) and Gleevec for leukemia by Novartis AG (down $0.25 to $46.80, Research).

Herceptin was Genentech's third biggest-selling drug last year, bringing in $483 million. Erbitux, ImClone's only drug, went on sale last year and generated about $261 million in sales. And Gleevec is one of Novartis' blockbusters, with sales of $1.6 billion, out of $18.5 billion in pharmaceutical sales last year.

ImClone spokesman David Pitts said his company had five more targeted oncology drugs in the pipeline: Two are in human testing, with two more expected to enter human testing this year and a fifth to enter testing early in 2006. "If they do what they're expected to do, they could supplant the chemotherapy regimen," said Pitts.

The FDA guideline comes as welcome news to biotech companies, particularly the smaller firms, as it will help streamline their drug approval process.

The guideline will help small biotech companies that are "looking for some guidance as to how they might develop these novel treatments," said Geoff Porges, an analyst for Bernstein & Co. "They're likely to benefit by having a clearer path to market, lower development costs and a potentially more accelerated development time."

Biotechs also stand to benefit from the FDA's new stance of approving drugs for limited populations, said Winton Gibbons, analyst for William Blair & Co. Gibbons said this was the case with Genentech's development of Herceptin, tailored towards specific types of breast cancer.

"[The FDA will] give you a broad approval even if it only works in a sub-group," said Gibbons.

Celera spokesman David Speechly said the genetic testing will make a customer "more inclined to pay money for a drug that they know is going to work" and allow them to skip sometimes unpleasant or harmful drug therapies.

Gibbons at William Blair owns 120 shares of Genentech. The other analysts interviewed do not own shares in the companies discussed and their firms do not conduct banking with these companies.  Top of page

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