April 2008



cwcoverjan2006

The discoverer of LSD, ALbert Hofmann, has died at the age of 102 at his home in Basel, Switzerland. Here’s an extract from David Nichol’s Chemistry World article on Hofmann, published in January 2006:

“On Friday 16 April 1943, in the course of recrystallising a few hundredths of a gram of LSD for analysis, Hofmann reports that he ‘was seized by a peculiar sensation of vertigo and restlessness. Objects as well as the shape of my associates in the laboratory appeared to undergo optical changes. I was unable to concentrate on my work. In a dreamlike state, I left for home, where an irresistible urge to lie down and sleep overcame me. Light was so intense as to be unpleasant. I drew the curtains and immediately fell into a peculiar state of ‘drunkenness’, characterised by an exaggerated imagination. With my eyes closed, fantastic pictures of extraordinary plasticity and intensive colour seemed to surge towards me. After two hours, this state gradually subsided and I was able to eat dinner with a good appetite.’

As he reflected on the experience, and what might have caused it, he concluded that it must have been an accidental exposure to the LSD-25 he had been preparing.

He resolved to carry out an experiment on himself with LSD-25 to determine whether it had been responsible. (more…)

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In this week’s Chemistry World business news round-up, we cover litigation over bisphenol A, the death of ICI, and the multimillion biotech deal over a drug derived from red wine.

Chemical Industry

Bottle maker sued over bisphenol A:
Just a week after Canada moved to label bisphenol A (BPA) toxic and the US National Institutes of Health concluded that the polycarbonate ingredient – used in plastic drinks bottles and food containers – may affect health, a Californian woman has sued bottle maker Nalgene. The suit accuses the firm of knowing about the risks of BPA leaching out of its reusable drinks bottles, but downplaying them. On 18 April – prior to the suit – Nalgene had announced it would phase out production of bottles using BPA ‘over the next several months’, while stating it continued to believe its BPA-containing products are safe.

ICI no more:
Netherlands-based chemicals company Akzo Nobel, who bought the UK chemicals firm ICI in January 2008 for £8 billion, has confirmed that the name ICI is to disappear. However, certain ICI brand names, including Dulux, will be retained.

Pharmaceuticals

Multimillion vaccine deal:
Cambridge, UK-based vaccine maker Acambis has won a 10 year, $425 million (£213 million) contract to supply smallpox vaccine to the US government’s Centers for Disease Control and Prevention. Acambis says that, as well as covering operating costs at the firm’s two US manufacturing plants, the deal will fund increase spending in R&D.

Drug costs cut for World Malaria Day:

Novartis has cut the price of its antimalarial drug Coartem, boosting supplies of the treatment to developing countries. Swiss pharmaceuticals firm Novartis has announced it will reduce by one fifth the price it charges governments and NGOs for artemisinin-based drug Coartem. The price cut means such bodies will now be able to supply 25 per cent more drugs with the same resources.

Crohn’s drug approved:

Belgian biotech UCB has received FDA approval for its antibody-based drug Cimzia to treat moderate to severe cases of bowel disorder Crohn’s disease. The treatment, which targets tumour necrosis factor alpha, also has potential as an arthritis treatment, and analysts suggest it has the potential to earn $1 billion a year in sales. Cimzia was originally developed by UK biotech firm Celltech, and the drug was the primary motivation for UCB’s £1.53 billion takeover of the UK firm in 2004.

GSK sees red:

GSK has agreed to buy US biotech company Sirtris Pharmaceuticals for $720 million. Sirtris’s lead compound, SRT501, is an analogue of resveratrol, a compound from red wine believed to be responsible for the drink’s associated health benefits. SRT501 is currently in Phase II trials for type 2 diabetes.

The agreement came the day before GSK revealed its financial results for the quarter, which revealed a pre-tax profit fall of 13 per cent to £1.96 billion. Sales of troubled diabetes drug Avandia continue to fall, and the company was also hit by the patent expiry of heart disease medicine Coreg.

Heparin fallout:

Ram Sasisekharan and colleagues at Massachusetts Institute of Technology have confirmed that oversulfated chondroitin sulfate is the contaminant found in tainted batches of Baxter’s blood thinning drug heparin – and have demonstrated in tests on pigs that the compound does trigger severe allergic reactions similar to those experienced by affected patients. This week the same contaminant was also found in small amounts Sanofi Aventis‘s heparin injection, Lovenox, in the UK, Sweden, Spain and Australia.

The active ingredient of the heparin involved in the US recall was supplied to Baxter by a firm in China. On 22 April the FDA was heavily criticised by the Government Accountability Office for its inspection of foreign manufacturing plants supplying drugs to the US, who said that at the current rate it would take the FDA 13 years to inspect every factory. Meanwhile, the debate has triggered dispute between US and Chinese officials over the source of the contaminant.

Bayer sues generics makers:

Germany’s Bayer has sued Watson Pharmaceuticals, and Novartis’s Sandoz arm, in a bid to stop them from selling generic copies of birth control pill Yasmin, Bayer’s biggest selling drug. The two generic drug makers had applied for FDA approval to sell copies of the drug, after Barr Pharmaceutical won a March US court ruling voiding a patent on the Bayer drug, previously set to run until 2020. The FDA may approve Barr’s application to sell a copy of the drug on the basis of the ruling – although Bayer is appealing the court’s decision.

Energy

BP’s Brazilian biofuels:
BP is to invest $560 million in a project to make ethanol from sugar cane in Brazil. The company will invest $60 million to buy a 50 per cent stake in Tropical BioEnergia, a joint venture set up by Brazilian firms Grupo Maeda and Santelisa Vale. The remaining $500 million will be invested in two new ethanol refineries.

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Chemistry in its element

In case you haven’t noticed our muted marketing campaign, our new, weekly podcast: Chemistry in its element was launched this month. There are now four five-minute podcasts for you to listen to, each featuring a leading scientist, author or broadcaster telling you the story behind the chemistry.

Look out for future contributions from Nobel prize-winners Kary Mullis and Harry Kroto, and award-winning author Philip Ball.

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RSC Publishing is in the middle of a hiring spree – there are jobs in journals editorial, informatics, ICT, sales, and marketing available. Chemistry World is also looking for a Business Editor – and applications for our annual summer internship are still welcome. Better dust off those CVs …

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In this week’s Chemistry World business news round-up, we cover the world’s strongest fiber™, ‘deliberate’ heparin contamination, and biofuels in UK petrol.

Chemical Industry

Wastewater recycling:
Japan’s Asahi Kasei Chemical has launched a water recycling business, to clean industrial wastewater so that it can be reused. The company’s first project will be in Suzhou, China – and Asahi predicts that water shortages around Asia will drive demand for the process, which is based on filtration membranes already used in water treatment plants.

BASF bioplastics:
BASF is to increase production capacity at its Ludwigshafen biodegradable plastics plant from 14,000 to 74,000 tonnes per year. The expanded plant will start producing the plastic, a petrochemical-based material called Ecoflex, in the latter part of 2010. BASF is also to increase capacity for Ecovio, a new product derived from Ecoflex but incorporating 45 per cent by weight polylactic acid, a renewable material.

Saudi joint venture:
US firm Rohm and Haas and Saudi Arabia’s Sahara Olefins Company, have agreed a joint venture to make acrylic monomers. The 250,000 tonne facility, to be built in Jubail, Saudi Arabia, will start operation in 2011, and will primarily produce feedstock for Rohm and Haas’s water-based acrylic products.

CSB: better fire protection needed:
The US Chemical Safety Board has released the final report of its investigations into the 2006 fire at the Environmental Quality Company’s hazardous waste facility in Apex, North Carolina. The fire occurred at night, when no staff were on site. The CSB is calling for a new national fire code for such facilities – current EPA requirements state such facilities must have ‘fire control equipment’, but the Apex site was only equipped with portable, manually operated extinguishers and had no fire walls or automatic fire suppression system.

DSM invests in ultrastrong fibre:
Netherlands chemicals company DSM says it will invest up to $450 million over the next two to three years increasing production capacity for its Dyneema fibre – which the company has trademarked ‘the world’s strongest fiber’. DSM says sales are up for the polyethylene fibre, which is 15 times stronger than steel, weight for weight. Dyneema is already used in a wide variety of products, from ropes to medical equipment to body armour.

Dow in India:
Dow has announced a 50:50 joint venture with India’s Gujurat Alkalies and Chemicals to build a 200 kilotonne per year chloromethane plant in Gujurat, expected to start operating in 2011. Dow’s recent history in India has been troubled, as many Indians hold the company responsible for the 1984 Bhopal methyl isocyanate leak, since Dow bought Union Carbide – the company that owned the Bhopal facility – in 2001. Construction of Dow’s proposed R&D centre in Pune, India, was halted earlier this year by a several week blockade by protestors.

Pharmaceuticals

Roche oncology acquisition:
Switzerland-based pharma firm Roche has bought UK biotech company Piramed for $160 million. Piramed is developing drugs targeting PI3-kinase, known to play a role in cancer and inflammatory disease. The company’s first oncology drug candidate is currently in Phase I trials, and Roche says it has the potential to target major cancers including breast and lung.

Generics deal:
AstraZeneca and generic drug maker Ranbaxy have struck an agreement over AZ’s blockbuster ulcer treatment Nexium. An earlier FDA patent ruling, barring Ranbaxy from selling the drug in the US, expired on 14 April. Under the new deal, Ranbaxy will start making some of AZ’s US Nexium supply from 2010, and will be allowed to sell a generic of the drug from May 2014. Both companies’ share price rose over 10 per cent on the news.

Clinical milestone:
UK biotech firm Antisoma has received a $25 million milestone payment from partner Novartis, after Antisoma’s experimental drug ASA404 entered Phase III clinical trials for non-small cell lung cancer. Antisoma’s agreement to co-develop the drug with Novartis means it could eventually receive up to $865 million more from the Swiss firm, if the drug is successfully sold for multiple indications.

Merck masked Vioxx risk:
Documents disclosed by Merck during court proceedings over withdrawn painkiller Vioxx show that Merck suppressed data showing the drug could triple the risk of death in Alzheimer’s patients, according to the Journal of the American Medical Association. Two articles in the journal also show that Merck employees wrote manuscripts on Vioxx studies, and later hired experts from academia to put their name to the findings as primary author. A JAMA editorial states that the practices aren’t limited to Merck – court records have simply made it possible to document in the Vioxx case.

Parkinson’s drug trial terminated:
Japanese drug firm Eisai has stopped Phase III trials of its Parkinson’s disease treatment Perampanel. The drug, still in clinical trials for the treatment of epilepsy and neuropathic pain, failed to reduce ‘off time’ – the time taken for symptoms of Parkinson’s disease to return after the effects of standard treatment wear off. The company had hoped to launch it as a first in class add-on therapy for patients with late-stage disease, who can often suffer extended relapses of their symptoms.

Shire moves offshore:
Shire, the UK’s third largest pharmaceutical firm, is to move offshore to reduce its tax liability. The £3 million establishment of a new holding company, based in the Republic of Ireland, will cut the company’s £4.2 million corporation tax bill.

Heparin contamination ‘deliberate’:
The contaminant in Baxter’s China-sourced blood thinner heparin was likely added deliberately for economic gain, FDA commissioner Andrew von Eschenbach has told the US Senate panel. The contaminant, hypersulfated chondroitin sulfate, is cheaper to make than heparin, FDA officials have said.

Energy

Biofuel blend:
The UK government’s Renewable Transport Fuels Obligation, which stipulates that all petrol and diesel must contain at least 2.5 per cent of biofuels, came into force on 15 April. The threshold rises to 5 per cent from 2010. Environmental groups have protested the move, citing concerns over land clearance and rising food prices.

Agrochemicals

Syngenta in China:
Swiss agrochemicals company Syngenta is to build a new biotechnology R&D centre in Beijing, China. The Basel-based firm will invest $65 million in the centre in the first five years. Starting in summer 2008, research will focus on GM and native traits for key crops, such as corn and soy, to improve drought resistance, disease control, and biomass conversion into biofuels.

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Test-tube science is a new communication experiment, showing *shock* that scientists are just lucky people who get to do interesting stuff in their job. All this is going to be turned into a film, apparently. Like it, and nice music too.

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Thecommercialchemist

In this week’s Chemistry World business news round-up, we cover greener steel from captured gases, the clinical trial failure of a cannabis-based pain-relieving drug, and synthetic jet fuel.

Chemical Industry

Display deal:
US chemicals company Rohm and Haas has bought South Korea’s Gracel Display for around $40 million (£20.3 million). The Seoul-based OLED developer and manufacturer will join the Display Technology group of Rohm and Haas. The deal follows the US firm’s June 2007 purchase of Eastman Kodak’s Light Management Films, and brings Rohm and Haas’s total investment in its display business to $270 million during the last 12 month.

oled tv

Air Liquide makes green steel:
French industrial gas maker Air Liquide has demonstrated a carbon-capture blast furnace for steel-making, which also uses less fuel than conventional plants. The 1/100-scale pilot plant uses pressure swing adsorption to separate carbon dioxide from hydrogen and carbon monoxide in the furnace waste gases; the former could then be stored underground, while the latter two gases are fed back into the furnace, reducing the amount of coke the plant needs to burn. A full-scale demonstration plant is scheduled for 2010.

Compound expansion:
Japan’s Sumitomo Chemical is to significantly expand its global production of polypropylene compounds. The company says it will expand its operations in China, as well as in Thailand and Saudi Arabia, boosting its annual production capacity to 2 million tonnes.

Shell threat over carbon credits:
Shell has told the European Parliament that it will stop investing in Europe, if the EU continues with plans to make companies buy 100 per cent of their CO2 emission quotas – currently scheduled to come into effect in 2020, under the Emissions Trading Scheme (ETS). Shell says buying the full quota would cost $250 million – the same as the company’s European profits.

Pharmaceuticals

Novartis $39 billion deal for eye-care firm:
Swiss pharmaceuticals company Novartis has agreed to buy a 25 per cent stake in Nestlé’s eye-care company Alcon. In addition to the initial $11 billion payment, Novartis has the option to buy Nestlé’s remaining 52 per cent for a further $28 billion between January 2010 and July 2011. The deal marks a shift from Novartis’s core prescription drug market; Alcon makes a variety of eye-care products, from contact lens solution to cataract surgery items.

eye

GSK Avandia violations:
The US Food and Drug Administration has written a warning letter to GSK over serious violations relating to the company’s failure to report all Avandia clinical trials, and trial results, to the US regulator between 2001 and 2007. The diabetes drug has subsequently had a black box warning imposed by the FDA after links to heart attack. GSK described the reporting failures as ‘inadvertent omissions’.

Takeda acquisition:
Japan’s Takeda Pharmaceuticals has agreed to buy US biotech firm Millennium Pharmaceuticals, following an $8.8 billion cash offer. The deal brings Takeda into the cancer treatment market – Millennium’s biggest product is blood cancer treatment Velcade, which is expected to make $345 million during 2008. The acquisition closely follows Takeda’s February deal to buy Amgen’s Japanese arm, and comes as the company faces the loss of patent protection for its blockbuster diabetes drug Actos in 2010.

Cannabis drug trial failure?:
The UK’s GW Pharmaceuticals says its cannabis-based drug Sativex has failed to show statistically significant benefits in a late-stage clinical trial to treat neuropathic pain in multiple sclerosis patients. The company ascribed the failure to an unusually large placebo response, but the company’s shares fell over 25 per cent on the news. However, shares rallied slightly as the company subsequently reported positive results from a Spanish pilot study – although this study was not placebo-controlled.

Cancer vaccine first approval:
Russia’s regulatory authority has approved Oncophage – described as ‘the world’s first cancer vaccine’. The kidney cancer vaccine, made by US biotechnology company Antigenics, has been approved despite failing a Phase III clinical trial. In the subset of patients whose cancer was least likely to recur following surgery, Oncophage did lengthen the period before which the disease recurred by 45 percent versus those in the control group – and Russian regulators have accepted this subset analysis because 70 per cent of the total trial population (of 604 patients) fell into it.

Pharma’s rush to market:
Research published in the Annals of Oncology suggests that increasing numbers of late stage clinical trials for new cancer are being halted early as the drug starts to show a benefit – and that such decisions are commercially-driven. Stopping such trials early could mask the true long-term benefit of such drugs, as well as their safety. The Association of the British Pharmaceutical Industry counters that trials are stopped early to get drugs to patients as quickly as possible.

Board to boost UK lifesciences:
The UK government has announced a new Lifesciences strategy board, whose role will be to promote the UK’s position as a global centre for biotech, pharmaceuticals and healthcare. The Lifescience Marketing Strategy Implementation Board is intended to counter increasing international competition in the sector.

Testing times:
US proteomics company Power3 Medical Products has begun a clinical validation study of its diagnostic test for Alzheimer’s and Parkinson’s disease. If successful in the trial, the test, which checks for biomarkers in the blood, would be the first diagnostic test for a neurodegenerative disease – diagnosis currently relies on doctors assessing symptoms.

Energy

Synthetic jet fuel:
South Africa’s Sasol says it has become the first company to receive international approval for its 100 per cent synthetic jet fuel – made using coal to liquids (CTL) chemistry. The company has previously supplied a blend of synthetic and crude oil-derived fuels, and now has global aviation authority approval for a completely synthetic fuel.

aeroplane takeoff

Agrochemicals

Fungicide deal:
Monsanto has announced an agreement with Bayer to use the German firm’s Vortex broad spectrum fungicide in its SmartStax GM corn, from 2010. Financial details of the deal were not disclosed.

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I love poster sessions – it’s like speed-dating for geeks. Stroll along row after row of posters, checking out the merchandise, until you see something that takes your fancy. Then tarry for as long as you like, before moving on to flirt with the next chemical idea that catches your eye. Here are a couple of this evening’s encounters …

(more…)

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Will Antigenics’ cancer vaccine prove US regulators wrong?

Will Antigenics’ cancer vaccine prove US regulators wrong?

Russia’s regulatory authority has approved Oncophage – described in reports as ‘the world’s first cancer vaccine’. (Merck’s Gardasil and GSK’s Cervarix – previously approved vaccines – target the human papilloma virus, which causes many types of cervical cancer. This is the first one to directly target tumour cells.)

Semantics aside, this particular vaccine, a kidney cancer vaccine made by US biotechnology company Antigenics, has been approved under rather unusual circumstances. It failed a late stage clinical trial, at least by the US FDA’s standards.

According to a Reuters report, a phase III trial carried out in 2006 failed to show that the vaccine delayed the recurrence of kidney cancer. But in the subset of patients whose cancer was least likely to recur following surgery, Oncophage lengthened the period before which the disease recurred by 45 percent, or an average of 1.8 years, versus those in the control group.

But this subset analysis won’t fly in the US – the FDA doesn’t consider it a valid measure of success since any sub-population could be carved out of the study retrospectively. Russian regulators have accepted it because 70 per cent of the total trial population (of 604 patients) fell into this subset.

The company is now pinning its hopes on the European market. It plans to file for conditional approval of the vaccine in Europe. If granted, this would allow Antigenics to sell the vaccine on the proviso that it carries out follow-up clinical studies at the same time. Regulators will then watch these clinical trials, and could decide to withdraw the drug at any time.

So it’s been a rather muted fanfare for a world-first.

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April 7 marked a key transition in the debate over open access publication of scientific research. The US National Institutes of Health (NIH) have mandated that, as of that date, any research it funds that is accepted for publication must be deposited into PubMed Central – the NIH’s free digital archive – within one year of publication.

As Chemistry World reported in January, some journal publishers have raised concerns about the potential impact of the mandate, and will no doubt be taking the opportunity to reiterate these during the NIH’s period of public comment, which runs from 31 March to 31 May.

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