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ECHA looks at chromium VI in leather products – Sanofi buys blood vessel blocking gel – And generic Lexapro arrives
CHEMICAL – How should we regulate chromium VI? The European Chemicals Agency (ECHA) has launched a six month public consultation on this topic – with specific reference to leather products. Chromium VI is not used deliberately used in leather production, but it can form by oxidation of chromium III. The move has been prompted by Danish authorities, who are worried about the levels of chromium VI in leather products that come into contact with skin such as shoes. The metal species can cause severe dermatitis through prolonged or repetitive contact of this kind. Therefore, the Danes have proposed a legal limit on the amount of chromium VI that can be carried on finished leather products put on the market – a limit of 3mg per kilogram, which would rule out 30% of products currently on the market.
PHARMACEUTICAL – Sanofi has told workers that it plans to close its manufacturing plant site at Fawdon in the UK resulting in the loss of 450 jobs, according to the BBC. Sanofi has begun a consultation with the Fawdon employees. The site will close in 2015.
PHARMACEUTICAL – Meanwhile, Sanofi has bought Pluromed, a US medical device company that makes a polymer product for temporarily blocking blood vessels during surgery. The ‘LeGoo’ mixture, is liquid at room temperature, but rapidly forms a gel when warmed by the body, creating a firm plug and halting blood flow. It was approved in the US in October 2011. The key ingredient is a poloxamer, a polymer comprising three distinct ‘blocks’ of repeating monomers, a hydrophobic block of polypropyleneglycol sandwiched between two hydrophilic blocks of polyethyleneglycol. In addition to LeGoo, Pluromed makes Backstop, a product designed to prevent kidney stones slipping in the wrong direction during their removal. Pluromed says the market for its products is worth over $2 billion (£1.3 billion). The companies have not released financial details of the deal.
PHARMACEUTICAL – GlaxoSmithKline (GSK) has sold another chunk of its over-the-counter products portfolio. Specifically Belgian Omega Pharma has agreed to pay €470 million (£391 million) for rights to the Lactacyd, Abtei, Solpadeine, Zantac, Nytol and Beconase brands, which generated sales of £185 million for GSK in 2011. Under the terms of the deal, Omega will get the manufacturing site in Herrenberg, Germany, which employs 110 people. GSK says that it is still planning to offload weight loss brand Alli (orlistat).
PHARMACEUTICAL – US authorities have approved the first generic version of Lexapro (escitalopram) tablets for treating depression and anxiety. Lexapro tablets are marketed in the US by Forest, which developed escitalopram in partnership with Danish drug maker Lundbeck. The generic version will be marketed by Isreali generics giant Teva, which has a 180 day period of exclusivity. Escitalopram has been a controversial drug for Lundbeck and Forest owing to its similarity to another Lundbeck drug: citalopram. The underlying molecule is chiral – citalopram is a 50:50 racemic mixture. Escitalopram, which was developed years later, is the S enantiomer only. Lundbeck was granted a separate patent for the latter, but critics said this was unreasonable given the similarity and accused the company of unfairly extending a period of exclusivity for a single drug.
PHARMACEUTICAL – Shire has signed a $325 million deal to buy US biotech FerroKin BioSciences. Shire will pay $100 million upfront and make further payments totalling up to $225 million if and when prearranged drug development milestones are reached. For this will get access to FBS0701, an iron chelator in Phase II trials for treating patients with too much iron in their blood after multiple transfusions. This situation typically arises in patients with anemia and causes problems. Under normal conditions the body is very slow to clear excess iron and this means it can accumulate in organs, including the heart and the liver, where it causes damage.