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Alcohol dependence drug shows promise in Phase III – Evonik sells colourants – And the ECHA highlights SVHC products
PHARMACEUTICAL – The US Food and Drug Administration (FDA) has warned a US company marketing a ‘caffeine inhaler’ for making false or misleading statements about the product. The company, Breathable Foods, says its ‘AeroShot’ device is designed to provide: ‘breathable energy’. But it also says that the product should be consumed through swallowing – and these two claims contradict each other. ‘A product cannot be intended for both inhalation and ingestion,’ says the FDA. ‘Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,’ it adds.
PHARMACEUTICAL – Phase III trials of Selincro (nalmefene) show that it out performs placebo when used to help patients with alcohol dependence to reduce their alcohol consumption. The developer of the candidate, Danish drug maker Lundbeck, ran three trials looking at the number of heavy drinking days (HDD) per month and the total alcohol consumption (TAC) per day. In one (Esense 1) patients taking Selincro reduced their mean number of HDDs from 19 to 7 days per month and their mean TAC from 84 to 30g per day over the first six months. Patients taking placebo also substantially reduced their alcohol consumption but to a lesser extent. They reduced their mean number of HDDs from 20 to 10 days per month and their mean TAC from 85 to 43g per day over the first six months. Selincro is an opioid system modulator. Lundbeck bought rights to it from Finnish biotech Biotie in a deal worth up to €84 million in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product.
CHEMICAL – German chemical company Evonik has sold its colourants business to a US investment firm, Arsenal Capital Partners. The companies have not disclosed financial details of the deal. In 2011, the Evonik colourants business generated sales of €130 million and employed 300 people at sites in the US, Canada, Brazil, Australia, China, Malaysia and the Netherlands.
CHEMICAL – A food scare relating to salt is developing in Europe, according to news reports. Specifically, Polish authorities have launched legal action against three companies that allegedly sold salt for de-icing winter roads as salt for human consumption. The Polish inspectorate has taken 555 samples for testing from a range of foods including: bread and other bakery products; sauerkraut; pickled onions; wide variety of spices; beetroot; horseradish pickles; and pickled cucumbers.
CHEMICAL – For the first time, the European Chemicals Agency (ECHA) has published a list of real products on the EU market that contain at least one substance of very high concern (SVHC) as defined by the Reach (registration, evaluation, authorisation and restriction of chemicals) regulation. It based the list on data gathered from notification and registration dossiers submitted by chemical companies. Under the Reach regulation, companies must notify the ECHA before December 2012 if they intend to sell a product that contains an SVHC. The majority of notifications submitted so far relate to phthalates, typically found in plastic products, and HBCDD, a brominated flame retardant found in many construction products.