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Product news roundup from Datamonitor

Published on 09/05/07 at 10:51am

Additional indication for Pfizer's Fragmin

The FDA has approved a new indication for blood clot drug Fragmin to treat symptomatic venous thromboembolism in patients with cancer, according to the drug's developers Pfizer and Eisai.

Symptomatic venous thromboembolism (VTE) is the formation of a blood clot that can travel from a leg vein to the lung, with potentially fatal results. Fragmin is the first low-molecular- weight heparin approved in the US for the extended treatment of recurrent VTE in patients with cancer.

The approval is based on data from a study which showed that, during a six-month period, nearly twice as many patients treated with standard anti-coagulant treatment warfarin experienced at least one episode of DVT or PE, the two conditions described as VTE, compared to those treated with a once-daily administration of Fragmin. Mortality rates were similar between the study groups at the end of the study, while safety rates were higher for the Fragmin group.

Eisai licensed exclusive US rights to promote Fragmin from Pfizer in 2005, and has assumed responsibility for product distribution.

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Array BioPharma initiates clinical trials of cancer drug

Array BioPharma has initiated dosing cancer patients in a phase I clinical trial with ARRY-520, a targeted small molecule anti-cancer drug.

ARRY-520 is a potent kinesin spindle protein inhibitor that caused marked tumor regression in preclinical models of human cancer at tolerated doses, often leading to complete, durable responses.

The trial, which will be conducted in the US, is designed to evaluate the safety, tolerability and pharmacokinetics of ARRY-520 following intravenous administration to patients with advanced cancer. In addition, the trial will examine indicators of therapeutic activity in these patients.

Kevin Koch, president and chief scientific officer, said: "We are pleased that ARRY-520 has advanced to the stage of treated cancer patients in a phase I clinical trial. We are looking forward to continued progress on ARRY-520, as well as our other nine development programmes, during 2007."

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Trexima has demonstrated consistent pain-free results across multiple migraine attacks

With the FDA currently reviewing the response made by GlaxoSmithKline and Pozen to its approvable letter for Trexima, this new data represents an attempt to further differentiate the migraine drug from existing triptans prior to launch. However, the drug's commercial success has already been restricted by approval delays and will be limited further by the impending launch of generic sumatriptan.

New data from more than 1,100 patients presented at the American Academy of Neurology 59th Annual Meeting in Boston show that Trexima (sumatriptan/naproxen sodium) was effective at treating migraine attacks.

When taken early, Trexima produced pain-free results at two and four hours, as well as sustained pain-free response 2-24 hours, across individual patients' multiple migraine attacks, demonstrating the consistency in efficacy. Furthermore, nearly one third of all patients were free of pain at two hours.

With migraine sufferers frequently citing inconsistent effectiveness as a reason for their dissatisfaction with their medicine, these new data of Trexima demonstrating consistent pain-free results across multiple attacks adds to the anticipation of the drug's approval.

Trexima is an oral, fixed-dose combination tablet containing the popular migraine triptan therapy, sumatriptan 85mg, together with the anti-inflammatory drug, naproxen sodium 500mg. The drug is currently under review by the FDA for the acute treatment of migraines in adults, although its approval has been delayed. After issuing an approvable letter in June 2006, the FDA requested further safety information on the drug in November. However, the US regulator accepted an amended response to the approvable letter for review in March 2007, and a decision is now expected in August 2007, with a potential launch in the second half of 2007.

Following FDA approval, GSK is expected to aggressively market Trexima in the US. The combination of sumatriptan and naproxen will be marketed as a drug-line improvement and GSK will hope uptake will match this advancement. In the initial three years after launch, Datamonitor predicts Trexima will capture substantial market share from GSK's Imitrex (sumatriptan) and other triptans. However, sales growth will be significantly offset by the US launch of generic sumatriptan, expected in late 2008. As a result, Datamonitor forecasts Trexima sales to peak only two years after launch at $329 million in 2009.

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Angioblast cleared to trial stem-cell therapy for heart attack patients

Mesoblast's US subsidiary Angioblast Systems has been cleared by the FDA to commence a phase II clinical trial of its allogeneic, or 'off-the-shelf,' adult stem cells for patients with heart attacks.

The phase II clinical trial will be based at the Texas Heart Institute, and will follow a similar protocol to the one used by the same investigators in preclinical studies for the investigational new drug (IND) submission. These studies showed that implantation of the company's proprietary allogeneic stem cells by catheter into damaged heart muscle resulted in significant improvement in heart function and reduction in congestive heart failure.

This clinical trial will be the first to test an allogeneic stem cell product injected by catheter into heart muscle damaged by a recent heart attack. The trial will use the latest generation catheters provided through Angioblast's ongoing relationship with the Johnson & Johnson companies Cordis Corporation and Biosense Webster.

The company's founder and chief scientific adviser, Professor Silviu Itescu, said: "FDA clearance is a significant step towards commercialising our stem cell products in the US, the world's largest market for cardiovascular diseases. Importantly, FDA clearance was obtained within 30 days of the submission of the IND."

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Targeted Genetics initiates phase I trial for childhood blindness

US biotech firm Targeted Genetics has announced the start of clinical trials in the UK into a gene therapy treatment for a form of childhood blindness.

University College London's Institute of Ophthalmology and Moorfield's Eye Hospital, with funding from the UK Department of Health, are trialing the treatment in adults and children with a progressive deterioration in vision caused by an abnormality in the RPE65 gene.

In affected individuals, this defect prevents normal function of the retina, the light-sensitive layer of cells at the back of the eye. The therapy involves an adeno-associated virus vector manufactured by Targeted Genetics to deliver a normal copy of the RPE65 gene into the cells of the retina to help them to function normally.

Professor Robin Ali, who is leading the investigation, said: "We have been developing gene-based treatments for eye disease for almost 15 years, but until now we have been evaluating the technology only in the laboratory.

"Testing it for the first time in patients is very important and exciting and represents a significant step towards establishing gene therapy for the treatment of many different eye conditions."

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