Polished performance from Pradaxa

The US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran), made by Boehringer Ingelheim, for the prevention of stroke and blood clots in patients with abnormal heart rhythm, known as atrial fibrillation.

The approval isn’t a huge surprise. In September, Boehringer got a unanimous 9-0 positive decision from the FDA advisory committee tasked with giving an opinion on the risk versus the benefit. But it will still be a very welcome bit of good news for Boehringer, which recently dropped development of flibanserin for the treatment of the hypoactive sexual desire disorder (HSDD) – a controversial condition characterised by low sexual desire in women.

Pradaxa is an anticoagulant that inhibits thrombin, an enzyme involved in blood clotting. In the most recent trial, called RE-LY, patients taking Pradaxa had fewer strokes than those who took warfarin. Interestingly, the drug will be available in 75mg and 150mg capsules, but RE-LY used on the 110mg and 150mg capsules.

Trials of apixaban, an oral anticoagulant developed by Bristol-Myers Squibb, have revealed good performance compared with aspirin. Results from the head-to-head study with warfarin are expected in April 2011.

Pfizer to buy into Teuto

Pfizer has said it will buy a 40 per cent stake in Brazilian generics manufacturer Laboratorio Teuto Brasileiro. It will pay BRL400 million (£150 million) upfront and commit to milestone payments, the details of which were not disclosed. Pfizer will get the option of acquiring the remaining 60 per cent of Teuto from 2014. According to the company, generics account for about 60 per cent of the value of the Brazilian retail pharma market driven by the increased purchasing power of growing middle income patients.

‘We believe this partnership will enable both companies to effectively build upon one another’s core capabilities and areas of expertise to help address the needs of more patients than ever before,’ said Jean-Michel Halfon, president of Pfizer’s emerging markets business unit.


Evonik builds for Silicas

German speciality chemical company Evonik has said it will increase its silica production capacity by 25 per cent over the next four years. To achieve this, the company says its investments will be in the ‘mid double-digit million euro range’. The expansion will be focused at existing silica sites in Asia and Europe. In May 2010, Evonik said it would expand capacity for precipitated silicas at its subsidiary Insilco in Gajraula, India.

‘Evonik is the market leader in precipitated silicas,’ said Thomas Hermann, head of inorganic materials. ‘The market is expected to grow substantially over the next few years. Through our capacity expansion, we plan to satisfy the increasing demand and to achieve further growth along with the market.’

The company said in September that it wanted to divest its carbon blacks business, which employs 1700 people and makes annual sales of about €1 billion (£888 million). The inorganic materials business at Evonik was hit hard in 2009. Sales fell 18 per cent to €1.8 billion, while earnings before interest and tax fell 49 per cent to €98 million.

Albemarle R&D construction

Albemarle has completed its research and development laboratories on its Yeosu, South Korea, manufacturing site. The new build enables production of metallocene polyolefin catalyst laboratory samples that use the Albemarle ActivCat technology. The company says that pilot plant facilities will be completed by the end of 2010 and intermediate commercial operations will begin in mid-2011, with full commercial operation in 2012. The site will eventually manufacture finished catalysts, activators, such as methylaluminoxane, and metallocene components.

Andrew Turley

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