PHARMACEUTICAL

HGS granted approval for Benlysta

An advisory committee of the US Food and Drug Administration (FDA) has recommended granting marketing approval for Benlysta (belimumab) for the treatment of lupus. Benlysta is a member of a new class of fully human monoclonal antibodies that inhibits B-lymphocyte stimulator (BLYS), a protein that facilitates the development of plasma B cells. In autoimmune diseases, such as lupus, plasma B cells produce antibodies that attack healthy tissue instead of unwanted antigens. The candidate is being developed by US biotech Human Genome Sciences and UK pharma major GlaxoSmithKline (GSK) under a 2006 agreement. 

Lovaza brings no benefit…

New study results have shown that, compared with placebo, Lovaza does not reduce the recurrence of symptomatic atrial fibrillation (AF). Lovaza is a prescription formulation of omega-3 fatty acids from fish oils marketed by GSK. The study was presented at a meeting of the American Heart Association and also published in the Journal of the American Medical Association. ‘In this patient population, there was clearly no benefit from Lovaza,’ said Murray Stewart, clinical vice president of cardiovascular and metabolic medicines development. Lovaza is approved for lowering triglycerides in patients with high levels.

…but rivaroxaban reduces stroke risk

Phase III trial results for rivaroxaban show that under certain parameters it performed better than warfarin, the most common treatment for patients with AF. Rivaroxaban is being jointly developed by US healthcare giant Johnson & Johnson and German company Bayer. The candidate reduced the risk of stroke and blood clots by 21 per cent in patients with AF during the Rocket trial – while they were taking rivaroxaban. Looking at all data from randomisation until study completion, the candidate was as effective as warfarin. Robert Califf, a Duke University, US, researcher who worked on the trial said: ‘There was no increase in bleeding, so we have a drug you can take once a day, without monitoring, that is at least as good as warfarin and carries no additional risk.’ Less problematic alternatives to warfarin for the treatment of AF are eagerly sought by pharma companies as this is seen as a lucrative market. Last month, the FDA approved Pradaxa (dabigatran) from Boehringer Ingelheim. 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.

CHEMICAL 

Sigma boss dies

Jai Nagarkatti, chairman, president and chief executive of fine chemicals company Sigma-Aldrich, has died suddenly and unexpectedly of an apparent heart attack. He was 63 years old. Nagarkatti started working at Sigma-Aldrich in 1976. During his time at the company he held positions in research & development, manufacturing, operations, sales and marketing. He became president and chief operating officer in 2004, chief executive in 2006 and chairman in 2009. Rakesh Sachdev has become president and chief executive and Barrett Toan chairman, effective 14 November.

New BASF site for cathodes

German chemical giant BASF has started building a production site at Elyria in Ohio, US, for cathode materials used in the lithium-ion batteries of hybrid and electric vehicles. The project will run to over $50 million (£31 million), including a $24.6 million grant from the US Department of Energy under the American Recovery and Reinvestment Act. The site is expected to be fully operational in 2012, and according to BASF when opened it will be the most advanced cathode materials production plant in North America. BASF has access to lithium-stabilised nickel-cobalt-manganese cathode materials, technology licensed from the Argonne National Laboratory.

Arkema acrylics investment

French chemical company Arkema has said it will invest $110 million over the next three years at its acrylics sites at Clear Lake and Bayport in Texas, US. The company will target acrylic acid and related esters, focusing on applications in water treatment, super absorbent polymers and enhanced oil and gas recovery – described as ‘growth opportunities’. The company seems to be in a spending mood at the moment. Earlier this month, it said it would invest €30 million (£26 million) in the production of dimethyl amino ethyl acrylate (DMAEA) at its Carling site in France. And in September, it said it was planning to build a $30 million plant in China for the production of emulsion polymers for coatings and adhesives. Can it afford the splurge? The third quarter results certainly suggest it can. Arkema made sales of €1.6 billion, an increase of 41 per cent compared with the same period last year, while operating income increased from €28 million to €173 million. The acrylics activities acquired from Dow at the start of this year put in a ‘good performance’, the company said.

Andrew Turley

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