In this week’s Commercial Chemist we cover Allergan’s fight to be allowed to market Botox for off-label indications under its rights to free speech, GSK’s continued push into the Chinese vaccine market and a study that suggests that exposure to bisphenol A in the womb can make girls aggressive.

PHARMACEUTICALS

Allergan challenges off-label ban

Allergan, the company made famous for its wrinkle remover Botox,  is challenging the policy of the US Justice Department and the Food and Drug Administration (FDA) that prevents it from educating doctors about the benefits of prescribing drugs for off-label indications - those that it hasn’t received marketing approval for.

What sets this challenge apart is that Allergan is claiming that the ban on off-label marketing violates its First Amendment rights to free speech and is inconsistent with the Federal, Food, Drug and Cosmetic Act.

According to the company, around 20 per cent of all prescriptions are for off-label indications, but advertising to this sizable market is a risky (and often illegal) business - just last month, Pfizer was hit with a $2.3 billion (£1.4 billion) fine for the off-label marketing of four drugs. But the stakes for Allergan are equally as high as it believes that therapeutic markets for Botox could rival its sales for cosmetic uses, which are more than $1 billion a year.

PET gets a look at Alzheimer’s vaccine trial

Bayer Schering Pharma is providing its positron emission tomography (PET) agent florbetaben, which is currently in Phase II development, to Swiss-biopharma company AC Immune to support a clinical trial of its Alzheimer’s vaccine candidate  ACI-24.

Check out Chemistry World next week for the full lowdown on the vaccine and the imaging agent.

GSK expands into vaccines for Chinese kids

GlaxoSmithKline (GSK) is continuing its push into the Chinese vaccine markets and is sinking more than £27 million into a joint venture with Jiangsu Walvax Biotech Company to develop and manufacture paediatric vaccines for use in China. The joint venture will produce vaccines for measles, mumps, and rubella (MMR).

‘This collaboration will allow Walvax and GSK to produce lifesaving vaccines to help meet China’s need for MMR vaccines,’ said Liu Hong-Yan, Chairman of Walvax. ‘The joint venture will strengthen our vaccine R&D efforts and build our capacity to increase children’s access to vaccines, one of the most cost-effective health interventions available.’

The deal follows its decision in July to collaborate with Shenzun Neptunus Interlong Bio-Technique to develop and manufacture a range of flu vaccines in the country.

INDUSTRY

LyondellBassell to exit bankruptcy by end of January

LyondellBassell, the world’s largest manufacturer of polyolefins, is planning to exit Chapter 11 bankruptcy in December or January, a year after it filed for protection for its US units. The company buckled under the weight of the loans it took on to buy Lyondell Chemical as the economic collapse sent demand for chemicals plummeting. It has already announced that it will reduce its headcount by 2500 (15 per cent of its workforce).

It now plans to become a publicly traded firm and will make an equity offering sometime in the new year.

More BPA woes

Researchers have found that exposure to the oestrogenic monomer bisphenol A (BPA) during early pregnancy can make girls more likely to exhibit aggressive behaviour. The compound is used to make some of the plastics that have been used to store food and water, despite suspicions since the 1930s that it was toxic. Last year the debate over whether it should be used erupted again, and Canada’s national public health agency, Health Canada, labelled it as toxic.

Publishing in the journal Environmental Health Perspectives, the researchers report that girls whose mothers were exposed to high levels of BPA during the early months of pregnancy are more likely to exhibit aggressive or hyperactive behaviour by the age of 2.

Dow unveils Powerhouse Solar Shingles

The Dow Chemical Company has unveiled a new line of photovoltaic solar panels in the form of roofing shingles that the company states ‘can be integrated into rooftops with standard asphalt shingle materials… reducing installation costs.’ The company believes the shingles could have sales of $5 billion by 2015.

AGROCHEMICALS

Mosaic’s sales down 66 per cent

Agrochemical company Mosaic has seen sales for the first quarter of fiscal 2010 fall to $1.5 billion, a decrease of $2.9 billion compared to sales from the same period last year. Despite the drop in sales, the company still managed to record an operating profit of $134 million - down from $1.5 billion for the same period last year.

The company said it had been hit by ‘a decline in market selling prices for phosphate as well as a decline in potash sales volumes and selling prices.‘

Meanwhile, its Mosaic Fertilizer subsidiary has agreed a $30 million settlement with the US Environmental Protection Agency (EPA) to resolve a number of alleged Clean Air Act violations at sulphuric acid production plants in Uncle Sam, Louisiana, and Mulberry, Florida.

Matt Wilkinson