February 2008



Thecommercialchemist

In this week’s Chemistry World business news round-up, we cover new ventures in biofuels and catalysis, the first successful human clinical trial of a gene-silencing drug, and the accidental escape of some GM corn seeds.

Chemical Industry

Bayer Results:
Bayer‘s 2007 sales grew to €32.4 billion (£24.7 billion), a 11.8 per cent rise on 2006, with company CEO Werner Wenning describing 2007 as the company’s best year ever. The company’s net earnings also rose, to €4.7 billion. Bayer says it expects sales to grow by 5 per cent during 2008.

Biofuels grant:
Netherlands-based DSM has won a US Department of Energy grant to lead a consortium to develop enzymes for bioproduct and biofuel formation. The grant, the size of which has not yet been disclosed, will fund research into biorefineries based on cellulosic feedstocks. US research labs at Los Alamos and Sandia will also participate in the project.

Smaller chips:
Computing giant IBM has announced it will partner with US speciality chemicals firm Rohm and Haas to develop technologies for 32nm and smaller circuitry. The partners will investigate chemical mechanical planarisation and ion implantation.

IBM chip

Playing tag:
German chemical companies BASF and Evonik are among a consotrium of firms who have joined a German government-backed project to develop printable RFID tags. Developing printed electronic technoogy is expected to reduce the cost of the tags, which work like a radio frequency bar code, to a price level at which they could be incorporated into cheaper consumer goods.

Lanxess rubber expansion:
German speciality chemicals group Lanxess are to build a 100,000 tonne-per-year butyl rubber plant in Singapore, to be commissioned in 2011. The €400 million plant, the largest in the company’s history, will be directly connected to a neighbouring Shell refinery, which will supply raw materials.

Catalysis centre opens:
A research centre intended to develop new catalytic processes has been opened in Aachen, Germany. The Catalysis Center Aachen will be the home of a research collaboration between local university RWTH Aachen and chemicals giant Bayer, the latter having invested over €7 million in the project.

Pharmaceuticals

RNAi human proof of concept
Cambridge, Massachusetts-based Alnylam Pharmaceuticals say they have completed the world’s first human trial to demonstrate an effective therapeutic based on RNA interference. During the Phase II trial, 88 volunteers were deliberately exposed to a respiratory virus, and half were then given an RNAi nasal spray designed to silence one of the virus’s genes. 67 per cent of the participants given the drug contracted the virus, compared to 88 per cent who received a placebo. The virus is rarely fatal in healthy young adults, although it causes 17,000 deaths in the elderly each year in the US.

Novartis trial success:
Novartis has stopped its Phase III clinical trial for experimental kidney cancer drug everolimus early, after an independent committee found the drug successfully prevents the cancer from progressing. Those patients receiving placebo during the trail will now be switched to the active drug. Novartis plans to file for regulatory approval for the drug in the second half of 2008. Analysts predict the drug, one of a new generation of target cancer therapies, could become a blockbuster if Novartis are able to show the drug also works in more widespread cancers such as lung or breast.

FDA heparin inspection:
The US FDA have completed their inspections of the Chinese plant that supplied most of the active ingredients for US-based Baxter’s now withdrawn blood thinner heparin. While the regulator noted lapses in the manufacturer’s quality-control, the reason for the bad reactions to the drug experienced by patients haven’t been discovered – which may be unrelated to the ingredient supplier.

Second lung cancer trial halted:
Anglo-Swedish pharmaceutical firm AstraZeneca has stopped clinical trials for lung cancer drug Recetin – just a week after Bayer and Onyx stopped their own lung cancer trial for Nexavar. In AZ’s case, the drug appeared to have clinical activity, but the trial was stopped due to toxicity problems. Analysts have said the toxicity issues may be overcome by changing dosage, and AZ say they remain comitted to developing the drug for lung cancer.

Avastin approval:
Genentech have won FDA approval for their breast cancer drug Avastin – despite the FDA’s own advisory panel’s recommendation in December that the drug be rejected. The panel had narrowly voted not to recommend the drug because data provided by Genentech had not shown that the drug’s benefits outweighed its toxicity risks. Avastin is already a blockbuster colon and lung cancer drug.

HRT verdict:
In a trial in Arkansas, US, jurors have found that an local woman’s breast cancer was caused by a combination of Provera (made by Pharmacia, which is now owned by Pfizer) and Wyeth‘s Premarin. The two companies have been ordered to pay $2.75 million (£1.39 million) in damages. Wyeth currently faces over 5,000 similar cases, and has lost four of the seven trials that have come to court so far.

Agrochemicals

Dow AgroSciences has informed the US EPA and FDA that during 2006 and 2007 it sold a corn seed mix inadvertently contaminated with unregistered genetically modified corn seeds. The EPA has established that the proteins produced by the GM seed are identical to those produced by a registered seed, which already has food safety clearance. In 2005, Switzerland’s Syngenta was fined $375,000 for accidentally mis-labeling and then selling an unapproved seed.

Energy

BP green investment:
BP is to spend $1.5 billion on its Alternative Energy business this year, which encompasses wind power, solar and biofuels. The company says the investment is an acceleration of its long term, $8 billion plan for the company, and that it is looking to grow the business primarily for its equity. However, BP says it has no immediate plans to sell the business.

Fuel cell commercialisation:
Australia’s Cermaic Fuel Cells has won a 50,000 order for its domestic combined heat and power (CHP) units from Dutch energy company Nuon. Ceramic Fuel intends to build a €12.4 million manufacturing plant in German, with capacity to build 160,000 units per year, to meet demand.

Fuel Cell

Biofuel value added:
China Biodiesel has announced an increase in production of higher-value plastics feedstocks, as profit margins on biodiesel shrink due to the rising costs of feedstock and the Chinese government’s regulation of fuel prices.

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Applications for Chemistry World’s annual internship have just opened. That means you could work as a science writer for us during the summer, spending six weeks on Chemistry World and two weeks on Education in Chemistry. It’ll give you a hands-on introduction to the complete editorial process, from writing and editing to page layout and printing.

We even pay you (a bit). The internship is supported by a bursary of £1750, provided by the Marriott Bequest Trust. Many of our previous interns – mostly final-year undergrads or PhD students in chemistry – have used this experience as a springboard to become full-time science journalists.

Find out more here: http://www.rsc.org/AboutUs/rscwork/Sciencewriter2008.asp
Closing date = Friday 25 April

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The latest idea for making an alternative to petrol is butanol(n?). This is to made from starch/sugars by fermentation with Clostridium acetobutylicium. It mentions a process used in WW1 to make acetone (by Chaim Wiseman). The interesting thing about this is that his choice of starting material. He found that sugar/starch were in short supply and realised that there was cheap readily available source of starch, the Horse Chestnut. He and the government arranged a collection system using youth organisations, which solved the acetone crisis. We have plenty of conkers, why not use them?

From Norman Nicholson

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I am retired, statin damaged by simvastatin , and can stand as a living example, along with other sufferers, of the damage statins can do to one’s mitochondria. I have no medical background and no financial motivation. My background is in economics and project management, but I have become well versed in the field of Statin side effects. They DO cause harm!

From John Brooks

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Virgin Atlantic have flown a Boeing 747 jumbo jet from Amsterdam to London, powered – in part – by biofuel. Just one of the plane’s four engines was powered by a biofuel mixture derived from coconuts and babassau nuts, the other three engines running on conventional fuel.

coconuts

Virgin boss Richard Branson announced back in January that the flight would take place some time this month – as reported in Chemistry World – but had not previously revealed what the biofuel would be. The fuel turned out to be a mixture of coconut and babassau oil – the later collected from palm trees that grow wild in the Amazon rainforest.

Branson admitted that the babassau nut was unlikely to provide a viable source of commercial biofuel – although he stressed that the fuel wasn’t derived from a food crop and so wouldn’t compete with food supplies. The billionaire instead highlighted biofuels produced by algae, which Virgin partners Boeing and GE Aviation are known to be exploring, as a more likely genuine replacement for conventional jet fuel.

However, the flight comes as scientists and governments increasingly recognise the potential for biofuels to do more harm than good, both environmentally and socially. Many studies now suggest that producing many biofuels releases more carbon dioxide than simply burning fossil fuels.

Just last week, UK Transport Minister Ruth Kelly announced a review into the indirect impacts of biofuel production, saying that the UK would not mandate any further increases in biofuel use until it can demonstrated as sustainable. The announcement follows the Royal Society’s detailed report highlighting the potential dangers in indiscriminately increasing biofuel use. The EU has already said it will review its 2020 10 per cent biofuels target, following concerns over the potential impact on food prices and rainforest destruction.

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Thecommercialchemist

In this week’s Chemistry World business news round-up, we cover the latest chemical financial results, the heparin storm, and GM corn deals.

Chemical Industry

BASF bounty:
German chemicals firm BASF has reported 2007 sales of almost €58 billion , up 10 per cent on 2006 – and a 5 per cent jump in annual profits to over €7.6 billion. However, the world’s biggest chemical company by sales reported a drop in fourth quarter income of over 3 per cent. The company primarily attributed the fall to over-running maintenance shutdowns, and predicts business will ‘develop positively’ in 2008.

Polymer acquisition:
Paris, France-based speciality chemicals group Eliokem is to buy the polymer business of India’s Apar Industries for 1.11 billion Indian rupees (£14 million). Eliokem, majority-owned by AXA Private Equity, says its post-acquisition global revenues will reach €200 million, and the purchase will allow the company to reinforce its position in Asia, a region experiencing growth.

Apar plant

Pharmaceuticals

Heparin reaction:

Following 350 adverse reactions and 4 fatalities amongst patients given the blood thinner heparin during medical procedures, the FDA’s inspection procedure for foreign manufacturers supplying drug ingredients to the US market has fallen under increasing scrutiny. US-based Baxter, who made the heparin in question, was supplied by a Chinese plant which had not been FDA-inspected – possibly due to an administrative error by the regulator. US congress members have suggested that the drug Baxter is supplying could therefore be unapproved – they are currently awaiting FDA clarification on the point, according to the Wall Street Journal. The exact cause of the adverse reactions to heparin, which is made from pig intestines, remains unknown, and Baxter, which previously supplied 50 per cent of the US heparin market, has temporarily withdrawn its product.

heparin pig guts

AstraZeneca appeal:
UK-based pharma firm AstraZeneca has been fined $215 million by the state of Alabama for overcharging the Medicaid programme for its drugs. AZ says it plans to appeal the decision. The company was one of 73 drugmakers, including GSK and Novartis, accused by the state in 2005 of overstating the average wholesale price of their medicines. The other trials are scheduled for April.

Regulator backing for GSK vaccines:
The FDA’s panel of vaccine experts has recommended that the US regulator approve GSK‘s infant rotavirus vaccine, Rotarix. The virus can cause gastrointestinal illness, and in the US causes up to 70,000 children under five to be hospitalised each year. US drugmaker Merck’s rival product, RotaTeq, launched in 2006, made $525 million in sales for the company in 2007. Meanwhile, GSK‘s flu vaccine, intended to give protection against the H5N1 ‘bird-flu’ virus, has received preliminary approval from the European Medicines Agency (EMEA). GSK says it plans to submit Prepandrix, which is designed to be used before an outbreak occurs, for FDA approval before the end of the year.

Pfizer pipeline purchase:
US pharmaceuticals maker Pfizer has agreed to by Encysive Pharmaceuticals for $195 million (£99 million). The deal sees Pfizer acquire the rights to Encysive’s pulmonary arterial hypertention drug Thelin, which has gained regulatory approval in the EU but has failed to win approval from the FDA. Pfizer, facing a dearth of new drugs in its own pipeline, says it plans to conduct a further Phase III trial to support US registration.

Lung cancer trial halted:
Germany’s Bayer and US-based Onyx, who co-market cancer drug Nexavar, have announced they have halted a clinical trial of the drug for lung cancer, because of an increase rate of death in patients taking the drug. The medicine is already approved for liver cancer, but the companies were hoping to expand the drug’s approval across other tumour types, including for the larger lung cancer market.

Abbott approval:
US drug firm Abbott has received FDA approval for its combination cholesterol drug Simcor. The drug raises levels of HDL – good cholesterol – but lowers levels of LDL and triglycerides. However, trials to establish whether these effects actually reduce heart attacks and death more than basic statins – which recently tripped up Merck and Schering-Plough‘s Vytorin – will not be completed until 2011, Abbott says.

Direct detector:
Kent, UK-based diagnostics company Vivacta has raised £6 million in second-stage funding to run the clinical trials needed to bring its blood test device to market. The company say their device will provide instant, lab-quality blood analysis within doctor’s surgeries.

FDA off-label drug use proposal:
The FDA has proposed that pharmaceutical companies be allowed to provide doctors with information on prescribing their drugs for unapproved uses. Under the proposal, companies would be allowed to provide doctors with relevant peer-reviewed journal articles. Companies are currently not allowed to promote such ‘off-label’ uses since a law allowing certain articles to be distributed by the firms lapsed in 2006, and can receive multi-million dollar fines for doing so – although doctors are allowed to prescribe drugs for any condition, and off-label prescriptions make up an estimated 21 per cent of the market. The FDA is currently inviting public comment on the proposal.

Agrochemicals

Syngenta DuPont licensing deal:
Switzerland-based agrochemicals company Syngenta has agreed to license its MIR162 insect control corn gene sequences to DuPont. The US firm will include the trait in their GM corn stains. MIR162, introduced from Bacillus bacteria which naturally produce insecticidal proteins, can control above-ground lepidopteran pests such as corn ear worms and borers. Financial details of the deal were not disclosed.

DuPont cornfield

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Researchers at the Wellcome Turst Sanger Institute have come up with a new screen that can identify weak, short-lived protein-protein interactions. The technique could be useful for spotting potential drug targets, the scientists say.
Most drugs that are currently on the market target cell surface proteins, often changing the way they interact with other proteins. But these interactions tend to be quite weak – if cell surface proteins cells interacted more strongly, cells would end up sticking to each other – not good for a blood cell or for a developing nerve cell.
The two techniques that are commonly used at the moment – Yeast 2 hybrid and biochemical purification methods – btoh have drawbacks. Yeast 2 hybrid relies on being able to produce the protein inside a yeast cell, where many of these extracellular proteins won’t fold properly (disulfide bonds may not form properly for example) while biochemical methods often only work if the proteins bind to each other strongly.
Screen
The new method neatly overcomes both problems. The proteins are produced in mammalian cells – so they fold properly and have all the right post-translational modifications like attached sugars. And to overcome the weakness of the interactions, one of the cell surface proteins is attached to a ‘coiled coil’ protein that is known to form a complex with four other ‘coiled coil’ proteins. When the coiled coil proteins bind to each other, they also bring with them the cell surface protein to which they’re attached. That means the cell surface proteins are clustered together, and that increases the strength of the interaction with its partner.
So far, the researchers have only tried out the screen with cell surface proteins from zebra fish but they hope to start looking at human proteins soon.

The article by K M Bushel et al is published in Genome Research today (DOI:10.1101/gr.7187808)

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A study in the Lancet highlights the problem of illegal skin-lightening creams – which are packed full of nasty substances, such as steroids. The problem came to light after a 28-year old woman saw doctors at Hammersmith Hospital in London after she was unable to conceive for 18 months. She had also gained 12kg of weight over three years and had stripes on her arms, back, abdomen and legs. Initially, the doctors diagnosed Cushing’s syndrome – a condition that results from excess levels of steroid hormones.
But later the patient admitted to using a skin-lightening cream (found to contain the potent steroid clobetasol) from a local shop unauthorsied to stock it. The problem is believed to be widespread, as the creams are used in the Americas, the Middle East, Africa and parts of Asia.
Stripes due to use of illegeal skin-lightening creams

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Fitting catalytic converters to cars in the UK may have helped to cut suicide rates in young men and women to its lowest level since the 1970s. Legislation to cut exhaust fumes was introduced in 1993 and since then, there’s been a marked reduction in gas poisoning. Other factors include falling levels of unemployment and changes to the way antidepressants are prescribed.
In the second of two studies published in the BMJ, the researchers found that recent restrictions on antidepressant prescribing to children and adolescents in the UK have had no effect on suicide rates
‘These findings are important because they suggest that reduced access to antidepressants in young people appears not to have had an adverse impact on suicide deaths,’ said Richard Martin, co-author of the paper.

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Thecommercialchemist

In this week’s Chemistry World business news round-up, we cover exploding sugar dust, Fujifilm snapping up a pharma firm, and legal wrangling between stent manufacturers.

Chemical Industry

Company carbon footprint:
German chemicals giant BASF has released a carbon emissions balance sheet – and says its products enable its customers to save three times as much CO2 as is released in making, and ultimately disposing of, the company’s products. The calculations include the input of raw materials and precursors. The company claims to be the first in the world to release such data – and says it plans to improve its carbon balance further.

Exploding dust:
An explosion and fire at a sugar refinery in Georgia, US, on 7 February, that killed six workers and injured dozens more, has been attributed to combustible sugar dust. The U.S. Chemical Safety Board has deployed a team of investigators to the site, and note that finely powdered sugar dust has been responsible for a number of previous refinery blasts.

Imperial Sugar explosion

DSM looks to its margins:
Dutch chemicals company DSM plans to sell its low-margin base chemicals business during 2008, and boost its life science and performance materials business through acquisition. The company is looking to continue restructuring, focusing on higher margin sectors away from base chemicals.

Medical and Pharmaceuticals

Picture this:
Japanese photography company Fujifilm is planning to buy pharmaceuticals firm Toyama for up to 155 billion yen (£730 million). Fujifilm have already moved into medical equipment such as endoscopes, as sales of photographic consumables have fallen with the move to digital photography. Announcing the move, Fujifilm management highlighted Toyama’s experimental bird flu drug, expected to be launched in 2009.

Thai drug decision:
Thailand’s new government says it may start paying for certain cancer drugs, reversing the decision of the former administration to disregard international patent law and make generic versions of the medicines. The new Health Minister has said he fears the current policy could put the country at risk of triggering sanctions by the US.

Sanofi antibody:
French pharmaceuticals company sanofi-aventis has agreed to pay up to $500 million (£254 million) for the rights to an experimental anti-tumour drug developed by US biotech Dyax. In pre-clinical animal testing, the monoclonal antibody-based treatment has been shown to successfully target the blood supply of solid tumours.

Generic pay-off:
The US Federal Trade Commission has filed a lawsuit against Cephalon, alleging that the pharmaceutical company protected sales of its best-selling drug by paying four generic drug makers to delay introducing their own copies of the drug. Cephalon’s narcolepsy drug Provigil currently makes the company $800 million in annual sales, and Cephalon is accused of paying a total of $200 million to generic manufacturers Teva, Barr, Ranbaxy and Mylan to delay market entry until 2012.

Provigil

Stent suits:
US medical equipment firm Boston Scientific have been found guilty of a patent breach in their drug-eluting heart stents. A New Jersey radiologist has won $431.9 million after claiming that Boston Scientific had infringed his 1997 patent for a thin film-based drug delivery system. Fellow stent-maker Johnson & Johnson is currently involved in a similar suit. In addition, the four major stent manufacturers – Boston Scientific, J&J, Abbott and Medtronic – are currently all suing each other for patent infringements, a situation likely to take years to resolve.

AZ biotech spin-out:
UK-based pharma firm AstraZeneca has spun off part of its gastrointestinal (GI) R&D to form a new biotech company called Albireo, based in Gothenburg, Sweden. AstraZeneca will remain a minority shareholder, but the new company will be financed by a group of private equity firms who have invested an initial $27 million. Albireo takes one clinical and a number of pre-clinical GI programmes from AstraZeneca, leaving the parent company to focus its GI research on gastroesophageal reflux disease (GERD), and its current GERD treatment Nexium.

Agrochemicals

DuPont ups acreage:
DuPont has announced a new GM corn seed that combines multiple insect control traits with herbicide tolerance. The US firm hopes to gain EPA approval to reduce the land farmers must set aside as pest refuges when using the seed, thereby boosting overall yield. Refuge areas of non-GM seed are intended to delay the onset of insect resistance to the GM crop’s pest controls.

BASF seeks herbicide approval:
Germany’s BASF have announced a new herbicide, recently submitted for regulatory approval in North America and Australia, with other regions to follow. Saflufenacil, which will trade under the name Kixor, is a new member of the trifluoromethyl uracil family of herbicides, which are PPO inhibitors, blocking chlorophyll biosynthesis in weeds. BASF say the herbicide has blockbuster potential.

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