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Another look at Avastin
The ongoing US evaluation of Avastin (bevacizumab) as a breast cancer treatment has been extended by three months. US biotech Genentech, a subsidiary of Roche, is now expecting a decision on its drug from the US Food and Drug Administration (FDA) by 17 December.
In February 2008, the FDA granted Avastin – then already on the market for the treatment of bowel cancer – accelerated approval for the treatment of breast cancer, a designation intended to bring to market sooner drugs for the treatment of serious illnesses, such as cancer, or illnesses for which there are limited treatment options.
But in July, in the light of the most-recent trial data, an advisory committee voted 12-1 to recommend that the FDA dissolve this approval.
Avastin is approved in Europe for the treatment of a range of cancers. But in August, the UK National Institute for Health and Clinical Excellence (Nice) said that the high cost of Avastin means ‘it is not a cost-effective use of NHS resources for the treatment of metastatic colorectal cancer’.
FDA probes Actos
The FDA has launched a safety review of the diabetes drug Actos (pioglitazone), following preliminary results from an ongoing study that show an increased risk of bladder cancer.
This adds an interesting new angle to the Takeda-Orexigen marketing deal involving the yet-to-be-FDA-approved naltrexone-bupropion combination Contrave, which would be used to combat obesity.
Actos is a massive part of the Takeda portfolio. The penetration into the US the company has achieved has been in no small part due to huge sales of the drug – ¥385 billion (£2.9 billion) in 2009.
The company is expecting generic versions to hit the market in August 2012. But if safety concerns knock sales before then, it could end up with a large US sales force sitting around with nothing to do. Indeed safety could have been on the minds of the Takeda bosses for a while thanks to the troubled time Avandia (rosiglitazone) has been having recently – the two drugs are both peroxisome proliferator-activated receptor agonists.
The solution? Take a gamble on an obesity drug that could – if everything works out extremely well – slip into the hole vacated by Actos. The obesity and diabetes markets are in many ways similar, so few changes would be needed.
This, for the uninitiated, is what the analysts call ‘portfolio fit’.
Pradaxa gets US recommendation
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German pharmaceutical company Boehringer Ingelheim has received a thumbs-up from the FDA advisory committee, which voted 9-0 to recommend Pradaxa (dabigatran) for preventing stroke in patients with atrial fibrillation.
The result makes it highly likely that the FDA will give the drug market approval.
Atrial fibrillation (AF) affects 4.5 million people in Europe and 2.2 million in the US. Patients with AF are five times more likely to suffer a stroke. Warfarin is the first-line treatment for reducing stroke in patients with AF, but although It often works extremely well, it comes with significant limitations.
Bristol-Myers Squibb and Bayer are both trying to bring drugs to this attractive market. The Bristol-Myers Squibb candidate, apixaban, recently demonstrated better performance compared with aspirin in Phase III trials.
Waste-to-fuel on its way
TMO Renewables, a UK greentech company, has signed up with US company Fiberight to design and build waste-to-ethanol plants in the US through a 20-year contract.
The 15 planned plants will convert municipal solid waste (MSW) – household rubbish, including food, packaging and discarded consumer goods – into ethanol. Construction of the first plant will begin next year, with delivery of the rest expected within five years.
Fiberight uses digestion and fractionation to sort non-recyclable MSW into a ‘clean fibre’ stream. The company says that 102 million tonnes of non-recyclable MSW is generated each year in the US. It adds that its process does not need energy or water to be added. The clean fibre material will feed into the TMO process, which uses bacteria to produce ethanol. TMO says it has achieved yields of over 340 litres per tonne of waste at the pilot-scale.
DWC moves into wine
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Dow Wolff Cellulosics (DWC), a subsidiary of US chemical major Dow, has launched a wine additive designed to prevent the formation of tartaric acid crystals.
Tartaric acid occurs naturally in grapes and plays an important role in wine. During production, it lowers pH, discouraging bacteria that might otherwise spoil the wine. After fermentation, it acts as a preservative. And when you finally get round to drinking some of the stuff, it provides some of the tartness of the wine.
But tartaric acid can lead to the formation of crystals of potassium bitartrate, sometimes called wine diamonds. Therefore, winemakers routinely use temperature stabilisation and other techniques to precipitate out some of the tartaric acid before it is bottled.
DWC says its ‘Clear+Stable for Wine’ is cheaper, provides better long-term stability, is more environmentally friendly – through reduced energy use – and is allergen free. In addition, it is quicker than cold stabilisation.
The ‘plant-derived’ substance does not change the taste or smell of the wine, the company adds.