blood clots

Bayer, J&J tout rivaroxaban data

Fri, 30 May 2008 06:59:58 -0400

In a head-to-head study against Sanofi's Lovenox, Bayer and J&J's oral anti-clotting drug rivaroxaban proved superior in preventing venous blood clots in patients who underwent total knee replacement surgery. Lovenox, which is the current standard of care, is given twice daily. "Only 6.9 percent of patients treated with Rivaroxaban experienced thomboembolisms, compared with 10.1 percent for the comparison group...This reflects a 31 percent decrease in relative risk," noted Dow Jones. This was the third trial to demonstrate the drug's superiority over Lovenox. An NDA is planned for the third quarter of this year. The drug is also being developed for stroke prevention in atrial fibrillation and VTE treatment.

- see the rivaroxaban release
- here's the Dow Jones brief

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

Fri, 09 May 2008 06:59:50 -0400

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Medical Association to join the fray. DTC report

> U.S. lawmakers aren't the only ones toughening up on pharma promos. In the U.K., the industry itself is strengthening its code. Report

> Sanofi-Aventis and Bristol-Myers Squibb may have squashed copycat Plavix in the U.S., but competition is now popping up in Europe. Plavix report

> We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. Public Citizen is now campaigning to have the patch taken off the market completely. Ortho-Evra report

> Researchers are touting the early results from a study of a new brain cancer vaccine that combines protein antigens extracted from a patient's tumor and matches them with white cells also drawn from the patient. Vaccine report

And Finally... The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. Report

Lilly's prasrugel stands out in comparison study

Mon, 31 Mar 2008 07:59:57 -0400

Here's one other reason for Lilly to be upbeat today. In a head-to-head study, the new antiplatelet drug prasugrel (being developed by Lilly and Daiichi Sankyo) in combination with aspirin outperformed the standard therapy, clopidogrel (Plavix) with aspirin. Analyzing the data from 12,844 patients in clinical trials, researchers concluded that the prasugrel group suffered fewer ischemic events--including stent thrombosis--than the Plavix group. Patients who have been given a stent to open up the flow of blood are at risk of blood clots, or stent thrombosis. They're given doses of antiplatelet drugs to prevent the clots from occurring.

"These data highlight the importance of aggressive antiplatelet therapy to reduce ischemic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention," the study authors concluded. "When balancing risks and benefits of strategies to prevent ischemic events, consideration should be given to patient characteristics, including risk of bleeding and ischemic events as well as stent and procedural characteristics."

- check out the release
- read the story in the Washington Post

Relate Articles:
Investors fret over Lilly's pipeline, Prasugel data. Report
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Experts to weigh in on Amgen's Nplate

Wed, 12 Mar 2008 07:59:55 -0400

Amgen is going before the FDA's Oncologic Drugs Advisory Committee (ODAC) in order to discuss its BLA for Nplate (romiplostim). The drug is a treatment for thrombocytopenia, a disorder that causes the body to attack its own blood clotting cells. The FDA is concerned about adverse reactions noted in clinical trials. These include significantly higher platelet levels, dangerous blood clots, bone marrow growth and malignant tumors in those taking the drug. The experts will advise the FDA whether Nplate's benefits outweigh the risks, and whether it should be given a limited approval.

- check out this release
- and read the AP article for more

ALSO: Here's a peek into the FDA playbook for tomorrow's advisory panel on Amgen and Johnson & Johnson's anemia drugs. According to documents posted on the agency's website, those expert advisors will be asked to consider several limitations on the meds, which have been linked to increased tumor growth and reduced survival among some cancer patients. And the options include yanking FDA approval for that use. Report

Related Article:
Amgen platelet therapy hits endpoint in Phase III. Report

MGI lands $255M buyout option in drug deal

Wed, 29 Aug 2007 06:59:57 -0400

MGI Pharma has shelled out $45 million as a down payment for a Phase II therapy for thrombocytopenia, an abnormal drop in blood cells involved in forming blood clots. MGI says the deal to commercialize AKR-501 gives it a potential blockbuster, and MGI is keeping an option to buy the developer, AkaRx, for another $255 million payment. MGI plans to launch a Phase III study of the drug in the next 18 months, which could take two years to complete. MGI also licensed AKR-201 for thyroid cancer in the deal.

"We are pleased to have obtained the rights to this advanced-stage product with significant revenue potential that is being developed for multiple indications. AKR-501 provides MGI PHARMA with a tremendous opportunity for sustained revenue growth in future years, with U.S. peak revenue potential exceeding $1 billion," said CEO Lonnie Moulder.

- see this release
- read the report from the Minneapolis Star-Tribune

Related Articles:
FDA approves Dacogen for MDS. Report
MGI therapy "approvable," but FDA wants new trial. Report
MGI sets sights on late-stage Aquavan trials. Report

Nanosphere blueprints $100 million IPO

Tue, 14 Aug 2007 06:59:57 -0400

Apparently undaunted by a sour stock market, molecular diagnostic player Nanosphere has signed up for a $100 million IPO. But at least one analyst says it all could be a bit of a ploy as the company positions itself to merge with a larger rival with deeper pockets. Nanosphere is looking to market a test to assess the way individuals metabolize warfarin as well as their risk of blood clots. Other molecular diagnostic tests are in the works. Lux Research analyst Mark Bunger tells Red Herring that the filing might prompt a giant in the field like Roche, Abbott or Becton, Dickinson to make a buyout proposal. Roche, for one, has been eager to shell out the big bucks to expand its presence in the field of personalized medicine.

- check out the report from Red Herring

Related Articles:
Nanosphere pockets $57M in VC. Report
A closer look at the biotech IPO. Report
M&A activity heats up as biotech IPOs struggle. Report
Biotech IPOs losing their attraction. Report

Boehringer anti-clotting drug performs in Phase III

Wed, 11 Jul 2007 06:59:56 -0400

The race for a new anti-clotting therapy turned even hotter today as Boehringer Ingelheim announced that a late-stage study of its once daily pill dabigatran showed that the therapy is as effective as Lovenox injections for preventing blood clots after hip surgery. Boehringer has positioned the drug against Bayer's rivaroxaban, which demonstrated superiority to Lovenox after knee surgery. The clotting development race began after AstraZeneca failed to gain an approval for Exanta in 2004.

- see the release for more

Related Articles:
Pfizer, BMS report Phase II clotting trial success. Report
TransTech inks deal with Boehringer. Report
Boehringer wins Aptivus OK. Report

Pfizer, BMS report Phase II clotting trial success

Mon, 09 Jul 2007 00:01:36 -0400

More on the clotting drug race: Bristol-Myers Squibb and Pfizer announced that their oral anti-clotting therapy--apixaban--demonstrated comparability to the current standard of care that relies on an injectable combined with a drug that includes warfarin. The experimental pill hit its endpoints in a mid-stage study for the rates of blood clots and dangerous bleeding. The researchers say that a comparable therapy would allow patients to bypass a standard approach that includes harsh side effects and regular injections. Apixaban doesn't require close monitoring or dose adjustments.

- read the report from CNNMoney

Related Article:
Pfizer partners with BMS in $1B deal. 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

SPOTLIGHT: FDA to examine drug-coated stent safety

Sun, 03 Dec 2006 19:01:33 -0500

Later this week the FDA will tackle the question of whether or not blood clots can form within drug-coated stents designed the prevent the growth of scar tissue. The most important question experts must answer is whether the benefits of drug-coated stents outweigh the small potential risks associated with the devices. Report (WSJ sub. req.)

Medical device makers to fund stent safety study

Maureen Martino — Wed, 25 Oct 2006 09:37:48 -0400

Earlier this year, medical device giants Johnson & Johnson and Boston Scientific were involved in a knock-down, drag out fight over the acquisition of Guidant. But in light of recent reports that blood clots can form within drug-coated stents, the former rivals as well as several other device makers have come together to fund a 10,000-person study of the technology. “The new study will monitor patients for blood clots for two years, a period in which…about 100 blood clots are expected to appear. Researchers will look at a variety of factors that may contribute to the clots,” reports the Boston Globe. The research is being carried out at the North Carolina-based Carolinas Heart Institute of Charlotte, and though the device makers are funding the study, researchers insist that the funding will have on influence on the outcome.

There’s no doubt that the questions surrounding stent safety and the results of this study have serious financial implications for J&J and Boston Scientific. Boston Scientific’s Taxus and J&J’s Cypher and the two best-selling stent brands, but in recent concerns over stent safety have led to a decreased use of stents and an increase in use of drugs such as Plavix for treating clogged coronary vessels. Report

SPOTLIGHT: Device makers team up on stent safety study

Tue, 24 Oct 2006 20:01:33 -0400

Study points to serious risks from Evista

Wed, 12 Jul 2006 20:01:36 -0400

A new study of Eli Lilly's blockbuster osteoporosis drug Evista demonstrated significantly higher risk of strokes and blood clots compared to women taking a placebo. Authors of the study say that patients need to compare their risk of strokes and blood clots against the protection Evista provides against osteoporosis and breast cancer. The study's authors said that patients taking Evista had a 49 percent increase in the risk of death from stroke and a 44 percent increase in the risk of blood clots. Evista is a big earner for Lilly, bringing in $1 billion last year.

- take a look at the report on Evista from The Indianapolis Star

EPIX to buy Predix in $90M merger

Sun, 02 Apr 2006 20:01:39 -0400

EPIX Pharmaceuticals has inked a deal to buy Predix Pharmaceuticals in a deal valued at $90 million. Predix shareholders will wind up with 47 percent of the company and stand to earn an additional $35 million in milestones. The combined drug developer will have several advanced programs, including PRX-00023 in Phase III for anxiety and expected to enter Phase II for depression in 2007; EP-2104R in Phase II for imaging arterial and venous blood clots; PRX-03140, which has completed Phase Ib trials and is expected to enter Phase II for Alzheimer's disease later this year and PRX-08066 in Phase Ib development for pulmonary arterial hypertension.

- here's the release for more information

New indication for Plavix wins priority review status

Tue, 17 Jan 2006 19:01:36 -0500

The FDA has given Sanofi-Aventis' Plavix priority review status for a new indication to treat arteries blocked long enough to trigger muscle damage. Already approved to prevent blood clots, Sanofi-Aventis says that one third of all heart attacks include blocked arteries. A priority review should shave four months off the time the FDA takes to decide on a drug, helping to speed it to the market.

- read this report from AFX for more

FDA issues warning for Ortho Evra patch

Thu, 10 Nov 2005 19:01:39 -0500

On Thursday the FDA issued a warning that the popular Ortho Evra birth control patch puts women at higher risk of blood clots and other serious side effects. Though Ortho McNeil's patch and the Ortho-Cyclen pill have similar levels of estrogen, women absorb about 60 percent more hormone on the patch because it is delivered directly into the bloodstream, rather than being digested first. The FDA's warning is a result of an Associated Press report that found women on the patch were three times more likely to die and suffer blood clots than women taking an oral formulation of the contraceptive. The AP report also claimed that in 2004 about a dozen women died and many more suffered strokes after using the patch. Ortho McNeil is a subsidiary of Johnson & Johnson.

- read this report from the AP

Researchers halt enrollment in ReoPro stroke trial

Thu, 27 Oct 2005 20:01:38 -0400

Citing safety concerns, Centocor and Eli Lilly have halted enrolling patients for a trial of ReoPro for acute strokes. Some patients in the trial experienced bleeding inside the skull. The trial, which was launched in October '03, looked at using ReoPro to dissolve blood clots. ReoPro is approved for reducing chest pain prior to procedures.

- read this AP article for more

Bayer inks $290M collaboration deal with Ortho-McNeil

Tue, 25 Oct 2005 20:01:38 -0400

Bayer Healthcare has struck a $290 million deal to develop a new drug for blood clots with Johnson & Johnson. Bay 59-7939 is set to begin late-stage trials in the next few weeks. J&J's Ortho-McNeil will make an upfront payment and share in the global development costs of the drug.

- read this AP article for more

Researchers halt trial of ReoPro for acute strokes

Mon, 03 Oct 2005 20:01:35 -0400

Centocor and Eli Lilly have temporarily halted a trial of ReoPro for acute strokes as a result of safety concerns. Researchers were investigating ReoPro's effectiveness in dissolving blood clots. Patients in the trial will stop receiving the drug as the researchers evaluate the benefits versus the risks involved in the trial.

- read this AP report for more