Decode Genetics

DeCode restructures, sells non-core assets

Maureen Martino — Thu, 16 Oct 2008 12:07:57 -0400

Looking to get back on the right track, Iceland's deCODE Genetics announced that it will evaluate "strategic alternatives" as it looks to tighten up its business operations. Yesterday we reported that deCODE may be delisted from the NASDAQ because the company's market cap is at $32.8 million--short of the $50 million minimum needed to stay on the stock exchange. The company's stock has been declining steadily since 2006. Now the company said it's looking for buyers for some of its assets, though it didn't specify what exactly will be for sale. According to a statement, the end goal is to sharpen the focus of deCODE's business, sell non-core assets and secure strategic partnerships.

"We are in the process of creating a smaller, leaner deCODE that will devote its efforts and resources to one line of business. We have created a unique and growing portfolio of intellectual property, as well as a range of products and programs in both our drug development and diagnostics work, and are engaged in discussions with potential partners and purchasers for various programs and business units," said Kari Stefansson, CEO of deCODE.

- check out deCode's release for more

DeCode feels the sting of financial crisis

Maureen Martino — Wed, 15 Oct 2008 09:11:14 -0400

Icelandic firm DeCode Genetics will be removed from the NASDAQ if the company can't find a way to boost its share prices. DeCode's stock has plunged 54 percent since early September, and though a series of positive announcements have boosted share prices, DeCode's stock is currently trading at about 53 cents. At that price the company's market cap is at $32.8 million--short of the $50 million minimum needed to stay on the NASDAQ stock exchange.

Iceland has been hit with a serious banking crisis of its own, but CEO Kari Stefánsson said ongoing problems in the U.S. are contributing to the company's troubles. "We have been seriously influenced by the American banking crisis and not the Icelandic," he told Nature News. "But we will survive. We are working on refinancing and restructuring the company. And we are fairly optimistic today that we will succeed."

DeCode's stock has been on a steady decline since 2006, which was speeded by manufacturing problems and a failed clinical trial. In the last month, however, the company has announced new findings on schizophrenia and basal-cell carcinoma, and filed an application to begin human testing of an Alzheimer's drug. But is it too little, too late? Robin Campbell, a biotech-equities analyst at the London office of Jefferies International investment bank, says three issues will be pivotal in DeCode's survival: The company must find a partner for two stalled drugs, rapidly expand its diagnostics business, and prepare to repay $238 million in debt. The company has until October 30 to boost its market cap to the minimum level, or it will be delisted.

- read this Nature News article for more

deCODE touts heart attack prevention study

Wed, 09 Jan 2008 06:59:56 -0500

Iceland's deCODE genetics says that its heart attack prevention drug--DG051--produced convincingly positive data in a Phase IIa study, paving the way to a Phase IIb. This recent study produced data showing that DG051 reduced leukotriene B4 (LTB4), an inflammatory molecule linked to a higher risk of heart attacks. No safety issues were raised in the study. Now deCODE plans to recruit 400 patients for its next study, slated to begin this spring.

"Our gene discovery work pointed us to the branch of the leukotriene pathway producing LTB4 as a major mechanism involved in promoting inflammation in atherosclerotic plaque and thereby increasing risk of heart attack, said Kari Stefansson, CEO of deCODE. "DG051 has been shown to bring this pathway under control and with a very satisfactory safety and tolerability profile."

- here's the release for more info

Related Articles:
Promising results for DeCode's blood clot drug. Report
DeCode touts early heart data. Report
DeCode launches genetic trial. Report

Press Release: Positive Clinical Results for DG041

Maureen Martino — Mon, 25 Jun 2007 10:04:03 -0400

Positive Clinical Results for DG041 Lead Product Development Highlights at deCODE R&D Event

Recent clinical studies support the development of DG041 as an effective anti-platelet that does not increase bleeding risk

REYKJAVIK, Iceland, June 25, 2007 -- deCODE genetics today announced progress in the development of DG041, the company's Phase II developmental compound for the prevention of arterial thrombosis. The results of the Phase IIa and clinical pharmacology studies presented today build upon previous findings demonstrating DG041's profile as an anti-platelet compound that deCODE expects will make it possible to block the formation of blood clots mediated through inflammation in atherosclerotic plaques but without increasing bleeding risk. There is a large unmet medical need for a drug with these characteristics, with applicability to the prevention of heart attack, stroke and the progression of peripheral artery disease (PAD). Drugs such as Plavix(TM) and aspirin, the current mainstays of oral anti-platelet therapy, significantly increase the risk of bleeding by broadly blocking platelet activity.

Recent advances in deCODE's therapeutic and diagnostics pipeline will be discussed at the company's annual R&D event being held today in Reykjavik. The presentations will be webcast live through the investors page of the company's website at http://www.decode.com, starting at 9am GMT/5am EDT, and will be archived on the site. Among the highlights to be discussed are:

DG041 -- Arterial thrombosis.

DG041 is a novel, first in class antagonist of the EP3 receptor for prostaglandins E2. deCODE initially identified EP3 as a target by isolating variants in the gene encoding the EP3 receptor for prostaglandins E2 (PGE2) that approximately double the risk of PAD, a common and debilitating atherosclerotic condition in which the flow of blood to the legs is progressively constricted. The mechanism through which EP3 modulates platelet aggregation is distinct from those targeted by aspirin and Plavix(TM). Following deCODE's gene discovery, work by leading international scientists has demonstrated in mice that PGE2 is produced in atherosclerotic plaques, promoting the formation of clots immediately at the sites of plaque but not over normal blood vessels. The formation of these thrombi is dependent on signaling through EP3. This pathway is left largely unaffected by existing anti-platelet drugs such as aspirin and Plavix(TM).

deCODE's medicinal chemistry group discovered DG041 as a means to prevent arterial thrombosis by inhibiting the activity of EP3. In animal studies and extensive Phase I clinical testing completed in mid-2006, DG041 was shown to effectively inhibit platelet aggregation through this pathway without increasing bleeding time, and to be safe and well-tolerated at all doses tested. Late last year, deCODE began a Phase IIa randomized, placebo-controlled clinical trial of DG041 in 144 PAD patients, to examine safety and tolerability of doses of 100mg twice a day and 400mg twice a day and their effect on a range of biomarkers. Because a large proportion of patients in this trial and subsequent trials would be taking other anti-platelet compounds, the company simultaneously began work to identify a sensitive biomarker of anti-platelet activity that could discriminate between the effects of DG041 and these other agents. The vasodilator-stimulated protein (VASP), which normally holds platelets in a quiescent state when phosphorylated but causes platelets to bind when dephosphorylated upon activation of EP3, was found to provide such a biomarker. The company thus began a clinical pharmacology study to examine DG041's effectiveness in blocking VASP-mediated platelet activation.

The results of these studies presented today provide a compelling demonstration of DG041's potential as a next-generation oral anti-platelet therapy -- an effective means of preventing arterial thrombosis specifically at the sites of plaque lesions in the vasculature. In the Phase IIa study, DG041 was found to reduce several markers of inflammation -- c-reactive protein (CRP), monocyte chemotactic protein 1 (MCP1), and soluble intracellular adhesion molecule (sICAM) -- in a dose-dependent manner. Ankle- brachial index (ABI) measurements -- which gauge the strength of blood flow to the legs and are a key measurement of the severity of PAD - also showed improvement in both DG041 treatment groups. There were no drug-related serious adverse events in the study and no discernible difference in other adverse events between the DG041 and matched placebo groups.

The results of the placebo-controlled clinical pharmacology study also announced today demonstrate that in a concentration-dependent manner DG041 dramatically inhibits platelet activation mediated through VASP as well as platelet aggregation. DG041 also reduced levels of another indicator of platelet activation, p-selectin. Moreover, the desired effect on VASP appears to be achievable at doses lower than previously anticipated. deCODE is thus very encouraged that in targeting EP3, the company is advancing a potentially major new approach to anti-platelet therapy - one that acts specifically to prevent arterial thrombi, targets a pathway not addressed by existing drugs, with minimal impact on normal platelet function.

DG031 and DG051 - Heart attack

In its drug development programs targeting the leukotriene pathway for the prevention of heart attack, deCODE is advancing the reformulation of its FLAP inhibitor DG031 for re-entry into clinical trials. A lead formulation has been identified and a 3-month accelerated stability study completed. The company believes that a once-a-day dosing regimen may provide even better pharmacodynamic effect than the previous twice-a-day regimen. The company expects to be ready to restart Phase III testing near year end. DG051, an inhibitor of leukotriene A4 hydrolase (LTA4H), has successfully completed single- and multiple-dose Phase I testing. It has demonstrated potent, dose-dependent lowering of the production of leukotriene B4, the end product of the leukotriene pathway which deCODE's genetics and biology work has pinpointed as a key means of modulating risk of heart attack. DG051's pharmacokinetic profile supports its development with once-a-day dosing, with a very satisfactory safety and tolerability profile. The company plans to initiate Phase II clinical testing of DG051 later this year.

Diagnostics and gene discovery

In April deCODE launched deCODE T2(TM), the company's first DNA-based, reference laboratory test for gauging individual risk of type 2 diabetes. The company will provide an update on its marketing strategy for its diagnostic tests and will discuss the upcoming launch of its deCODE AF(TM) test, which detects a genetic variant that confers risk of atrial fibrillation, the leading cause of cardiogenic stroke. The company is also developing tests for sequence variants associated with risk of heart attack, glaucoma and several other conditions in which deCODE has recently isolated risk variants. Since the beginning of the year, deCODE has dramatically accelerated its gene discovery work, publishing major new risk variants for heart attack, breast cancer, prostate cancer, type 2 diabetes, among others. The company expects to announce many additional discoveries in the weeks and months ahead. deCODE is underscoring its position as the global leader in the identification of genetic risk factors for common diseases, building on this leadership by bringing together its human genetics resources and capabilities with the power of genome-wide SNP association chips.

About deCODE

deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of drugs and diagnostics for common diseases. deCODE is a global leader in gene discovery -- our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. deCODE is also leveraging its expertise in human genetics and integrated drug discovery and development capabilities to offer innovative products and services in DNA-based diagnostics, bioinformatics, genotyping, structural biology, drug discovery and clinical development. deCODE is delivering on the promise of the new genetics(SM). Visit us on the web at http://www.decode.com.

Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

Promising results for DeCode's blood clot drug

Mon, 25 Jun 2007 00:01:34 -0400

DeCode Genetics announced today that a mid-stage study of its arterial thrombosis treatment showed positive results in a Phase II study. The company says it expects DG041 will make it possible to block the formation of blood clots mediated through inflammation in atherosclerotic plaques but without increasing bleeding risk. With the development of DG041, DeCode is taking aim at drugs such as Plavix and aspirin, the current market leaders of oral anti-platelet therapy.

- see DeCode's release

Related Articles:
DeCode alleges ex-employees stole trade secrets. Report
DeCode IDs tablet problem, suspends pivotal trial. Report
DeCode touts early heart data. Report
DeCode launches genetic trial. Report

ALSO NOTED: Dr. Reddy's raising $260M; Alexion wins priority review; new data supports orencia; and much more...

Mon, 13 Nov 2006 19:01:30 -0500

> The generic drug maker Dr. Reddy's Laboratories plans to raise $260 million through an issue of 13.5 million American Depositary Shares. The Indian company has been on an acquisition spree, acquiring Germany's Betapharm in March as it pursued a strategy of expanding in the European market. Report

> The FDA has agreed to provide a priority review of Alexion Pharmaceuticals' anemia drug eculizumab. Report

> Bristol-Myers Squibb is touting new data that shows orencia helped improve a form of arthritis in children. Report

> Regeneron Pharmaceuticals, which is researching new therapies for cancer and eye and inflammatory diseases, plans to offer 7.6 million common shares. Release

> Roche's Tamiflu will carry new warnings about delirium. Report

> Cancer diagnostic company Zila has signed agreements for a $40 million private placement. Release

> DeCODE genetics is proposing to make an offering of 3.5% senior convertible notes due 2011. Release

> Spectrum Pharmaceuticals announced that it has settled a patent dispute with Glaxo over a generic version of Imitrex injection. Report

> Huifeng Bio-Pharmaceutical announced today that it has agreed to purchase two production lines of a Chinese corporation in exchange for 2 million newly issued shares of Huifeng restricted stock. Release

And Finally… Researchers in Sweden provided free junk food to students to test the effects of a high-fat diet. They gained weight, but their bodies swiftly adjusted to the change. Article

DeCode IDs tablet problem, suspends pivotal trial

Thu, 05 Oct 2006 20:01:38 -0400

Iceland's deCode Genetics has suspended a late-stage trial of the heart attack prevention drug veliflapon after determining that the tablets being used weren't dissolving properly. Researchers were concerned that the faulty tablets would have skewed the data on the drug. The developer announced that it had notified the FDA and was looking at alternative manufacturing sources to resolve the issue. Veliflapon is directed at two genes which contain proteins linked to an elevated risk of heart attack. Another compound with a similar target is in early trials.

- read the report on deCode from Hemscott

DeCODE alleges ex-employees stole trade secrets

Tue, 26 Sep 2006 20:01:36 -0400

Iceland's deCODE Genetics is suing five former employees for allegedly stealing research knowledge and trade secrets and using them at Children's Hospital in Philadelphia. And the biotech company says the theft was done with the knowledge of the hospital staff, an allegation the hospital denies. Hakon Hakonarson, deCODE's former vice president of business development, is named in the suit along with four others recruited by the Center for Applied Genomics, which is part of Children's Hospital. The hospital says it will defend its employees in the suit.

- read the AP report on the lawsuit

ALSO NOTED: IMPAX names new CEO; deCODE launches trial; and much more...

Mon, 14 Aug 2006 20:00:50 -0400

> Raven biotechnologies had reported positive early results of a Phase I clinical trial of RAV12, its lead therapeutic antibody in development for the treatment of adenocarcinomas. Release

> In Mexico and Guatemala, the Iomai Corporation has begun enrollment in a Phase II trial to test its vaccine patch for travelers' diarrhea. Release

> Iceland-based deCODE Genetics has begun enrolling patients in a Phase I trial of DG051, the company's follow-on developmental compound for the prevention of heart attack. Release

> Chutes & Ladders: IMPAX Laboratories has named Larry Hsu CEO. He is replacing current CEO Barry R. Edwards, who is resigning. Release

> And Finally... There are promising developments in the search for a skin test for Alzheimer's disease. Report

ALSO NOTED: Sheares leaves Merck; Siga touts early-stage smallpox trial; and much more...

Thu, 13 Jul 2006 20:00:50 -0400

> Bradley Sheares, the head of Merck's U.S. drug operations, has left the company. Sheares was once considered a contender for the CEO's job. Adam Schechter is being promoted to replace him. Report

> Siga Technologies announced that its lead smallpox candidate, SIGA-246, successfully demonstrated that it was safe and well tolerated at all dose levels in a Phase I trial. Article

> DeCode Genetics plans to raise $27.8 million through a stock sale. Report

> Roxane Laboratories has recalled a single lot of Azathioprine, a kidney transplant drug, after finding Methotrexate tablets in one bottle. Report

> Schering has decided against exercising an option for one of Predix Pharmaceuticals' imaging agents. Report

> CuraGen and TopoTarget have begun a Phase I/II trial of PXD101 for inoperable hepatocellular cancer. Report

> Nuvo Research has resubmitted its NDA for Pennsaid, a topical non-steroidal anti-inflammatory used for the treatment of osteoarthritis of the knee. Release

And Finally… Researchers say that short-legged people appear to be more prone to diabetes, which may be related to their nutrition or hormones at birth or in childhood. Report

SPOTLIGHT: DeCode launches genetic trial

Wed, 17 May 2006 20:01:33 -0400

Iceland's DeCode Genetics has launched a closely watched Phase III trial of DG031 to prevent heart attacks. The company will track the results of 3,400 African-American subjects who have a genetic variant linked to heart attacks. Report

ALSO NOTED: Medicure to raise $25M; DeCode designs Phase III; and much more...

Thu, 04 May 2006 20:00:50 -0400

> Canada's Medicure plans to raise $25 million in a private placement to fund clinical development of its two lead products. Release

> DeCode genetics has reached an agreement with the FDA on the design of a Phase III trial of DG031 to prevent heart attacks. Report

> Chutes & Ladders: Epix Pharmaceuticals has announced that interim CEO Michael Astrue is resigning and will be replaced by Michael Kauffman, CEO of Predix. Epix has a deal to acquire Predix for $90 million in stock. Report

> Emisphere Technologies has warned it may not have enough cash to fund operations through July. Report

> Ipca Laboratories has opened a new manufacturing facility in India. Report

> Hollis-Eden Pharmaceuticals has filed an INDA to start a Phase I trial of Neumune. Article

> CROs are saying that the new focus on Phase IV trials should be good for business. Article

> Mesa Labs has acquired Raven Biological Laboratories for $6.75 million in cash and stock. Release

And Finally… Warm weather-related diseases like malaria, dengue fever and West Nile virus are rapidly expanding their range as global warming heats the planet. Report

ALSO NOTED: Cytokinetics raises $33M in offering; A.P. Pharma sells royalty rights; and much more...

Tue, 17 Jan 2006 19:00:50 -0500

> Cytokinetics of South San Francisco will raise $33 million through a direct stock offering. Release

> A.P. Pharma sold the royalty rights to two skin treatments for $30 million in a move aimed at raising enough cash to avoid being de-listed from Nasdaq. Release

> More intense pricing competition in the U.S. generics market drove Ranbaxy's quarterly profits down by 56 percent. Also, Malvinder Singh will replace Brian Tempest as CEO of the Indian drug maker. Report

> Researchers say that Cox-2 inhibitors may still be the best form of treatment for a particular category of patients. Report

> Iceland's deCode Genetics is buying an Icelandic cancer research firm for $5.5 million in stock. Report

> Ireland's Azur Pharma has acquired Gastrocom, a treatment for mastocytosis. Report

And Finally... STMicroelectronics and Veredus Laboratories are preparing clinical trials of a disposable chip that could diagnose avian flu in an hour. Article

ALSO NOTED: MannKind reports positive data for inhaled insulin; FDA delays Myozyme decision; and much more...

Mon, 16 Jan 2006 19:00:50 -0500

> MannKind has released positive data from its Phase IIb study of the inhaled Technosphere Insulin. Release

> The FDA has delayed a decision on Genzyme's Myozyme for Pompe disease by 90 days. Report

> UCB has sold its Belgian contract manufacturing business to Lonza for $145 million. Report

> Australia's Clinical Cell Culture says that the FDA has asked for more data before it will approve ReCell, its spray-on skin treatment. The decision is likely to push back any approval by at least 12 months. The news sent shares of C3 down sharply. Report

> Sepracor has added $10 million of shares in Acadia Pharmaceuticals as part of their partnership agreement. They partnered on a program to develop a new therapy for CNS diseases. Report

> Genentech halted a Phase II trial of Xolair as a treatment for peanut allergy after reporting incidents of hypersensitivity. Xolair has been cleared in the U.S. and Europe as a therapy for asthma. Report

> Matritech of Newton, MA has raised $7 million in financing. Report

> Evotec has expanded its collaboration deal with Boehringer Ingelheim. Article

> A group of experts say that 2006 will see a big wave of biotech IPOs along with a continued focus on new drug development partnerships. Report

> Metrics: Global drug sales spiked 5 percent in the 12 months to November, according to IMS Health. Article

> Iceland's DeCode Genetics has found a genetic variation that could predispose up to 40 percent of the population to Type 2 diabetes. That finding is likely to lead to a genetic test as well as new treatments focused on that population. Article

> San Diego-based Arena Pharmaceuticals is offering 8.5 million shares of common stock. Report

> Seattle-based Blood Cell Storage has raised $3.6 million to develop a new way to test blood. Report

> A new study indicates that men who have had a heart attack and take Viagra and other impotence drugs face a ten-fold increase in their risk of blindness. Article

And Finally… Triangle Business Journal profiles Aldagen, which is harvesting adult stem cells to treat damaged hearts. Article