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With PGx Development Deal, DeCode, Roche Extend Cardiovascular Alliance

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Building on its history of agreements with Roche, DeCode Genetics will develop and commercialize phosphodiesterase-4 inhibitors in collaboration with the Swiss drug titan. The two companies will share the cost of drug discovery and clinical trials, with DeCode standing to gain milestone payments and royalties based on drug sales, the companies said.

DeCode will use its “structure-based drug-design capabilities” to “optimize” lead PDE4 compounds and begin development of the drugs, which are intended to prevent and treat vascular disease, including stroke, according to a statement.

DeCode is developing a series of lead compounds that the company will now “be moving through into clinical studies,” said Roche spokesperson Darien Wilson. “A lot of the work was based on some of the work they were doing in population genetics, so … we could see a link to a gene that encodes for PDE4 subtypes,” she added.

News of the collaboration pushed up shares in DeCode by 5.1 percent to $6.48 in mid-afternoon trading on Nov. 23 on the Nasdaq exchange.

Among the genes discovered through its population genomics database, DeCode has isolated genes linked to peripheral vascular disease and cerebrovascular disease.

Representatives of both companies declined to provide the number of products in development, as well as other details about the compounds. Both companies also declined to disclose specific financial terms or timelines of the agreement.

“This collaboration builds directly upon the results that have come out of our long and fruitful partnership with Roche,” Kari Stefansson, DeCode CEO, said in a statement.

Indeed, the two companies have a record of collaboration in this area that goes back nearly seven years. DeCode received milestone payments from Roche for discovering the vascular disease genes related to the current agreement. Terms of that four-year, $200 million deal, penned in 1998, also included the discovery of genes for osteoporosis, pre-eclampsia, and schizophrenia (see GenomeWeb News, 7/2/2001). Roche at the time said it planed to use these gene targets in developing new medications.

There is also a diagnostic element to accompany the new deal: The two companies signed a 5-year deal in July 2001 — valued by DeCode at $300 million — to develop DNA-based diagnostics. In another project, the company is working on developing a DNA-based cardiovascular disease risk panel to identify individuals at high-risk for heart attack, stroke, and peripheral arterial occlusive disease, according to Pharmacogenomics Reporter’s sister publication, BioArray News (see BioArray News, 8/4/2004).

Of their past alliances, perhaps the most pertinent is a 3-year deal inked in 2002 in which the Icelandic pharmacogenetics firm worked to develop therapeutics for four undisclosed diseases from among those genes discovered during the companies’ 1998 deal.

In a press release announcing the 2002 agreement, DeCode said it planned to get much more involved in downstream drug development, including high-throughput screening, clinical trials, medicinal chemistry, and development of pharmacogenomic testing.

“We’re talking about a dramatically different contribution by DeCode, covering the entire spectrum of drug development,” said Stefansson during an investors conference in 2002.

According to the American Heart Association 2004 Update, there were 4.8 million Americans who had suffered a stroke at sometime in their lives in 2001. Of that number, as many as 700,000 cases were composed of new or recurring attacks.

As many as 12 million Americans suffer from peripheral vascular disease, and people with peripheral occulusive disease face a risk of heart attack or stroke that is six to seven times higher than those without the disease, according to the American Heart Association website.

Other cardiovascular drugs in DeCode’s pipeline include DG031, which is intended to combat arterial inflammation and myocardial infarction risk, and D151746, a compound for the treatment of atherosclerosis.

DeCode is also involved in a $24 million project with the US National Institute of Allergy and Infectious Diseases, which will support research at DeCode, the University of New Mexico, and the National Center for Genome Resources into respiratory pathogen and smallpox vaccine responses, and may yield drug targets and a vaccine-response screen.

The three organizations involved in the study will link genes responsible for susceptibility and resistance to common infectious respiratory diseases, as well as genes that confer rare but serious adverse events to smallpox vaccine, said Rick Lyons, director of the University of New Mexico Health Sciences Center Infectious Disease and Inflammation Center, in an interview (see PGx Reporter, 10/14/2004).

DeCode’s Recent History

DeCode is under attack from at least six lawsuits, all of which claim that the company made several “false and misleading” statements regarding the firm’s financial situation between the end of the third quarter 2003 and Aug. 26, 2004 — the day its independent accountant, PricewaterhouseCoopers, resigned.

All of the claims also use statements made by PricewaterhouseCoopers, as well as the accounting firm’s unusual resignation from serving DeCode, as a lynchpin in their cases.

Before the accounting firm resigned, it brought to DeCode’s attention certain “reportable conditions,” including internal control deficiencies, that can affect consistency between management assertions and the handling of financial data. DeCode made public the existence of those conditions on Aug. 26, but has not yet publicly disclosed their nature.

— CW

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