Drug marketing case sees $500m settlement
Bristol-Myers Squibb will pay over half a billion dollars to settle allegations of illegal drug marketing and pricing. The ruling, announced by the US Department of justice in late September, related to accusations that BMS had inflated its drug prices, paid kickbacks to doctors, and promoted its anti-psychotic medication Abilify for unapproved uses. There are no criminal charges against the company, and the settlement did not involve the company admitting any wrong-doing.
Despite being unapproved for children, the DOJ said that BMS’s sales force had urged physicians to prescribe Abilify for paediatric patients. The DOJ also alleged that BMS promoted the drug to nursing homes for dementia-related psychosis, despite the drug’s ’black box’ label specifically warning that such use increases the risk of death in elderly patients.
This is just the latest case of a pharmaceutical giant paying a multimillion dollar figure to settle accusations of illegal drug marketing. Schering-Plough reached a $435 million settlement in August 2006, over accusations related to the company’s cancer drugs Temodar and Intron A. In 2004, Pfizer paid $430 million to resolve similar accusations of illegally marketing drugs for ’off-label’ uses - specifically Neurontin, made by Warner-Lambert, which Pfizer bought in 2000.
Prescribing drugs for off-label use is common, said Peter Lurie, deputy director of Public Citizen’s Health Research Group, a US-based consumer advocacy group. According to US National Institutes of Health, about half of cancer drugs are prescribed off-label, because these drugs’ mode of action typically applies to most cancers - and America’s Medicare system will pay for these off-label uses. The DOJ only steps in when there is ’strong evidence, often through a whistle-blower, of crass violations’ in the drug company’s promotion of the drug, said Lurie. ’Most doctors don’t know of these settlements, or are uninterested in them,’ Lurie added. ’Unless the fine is very heavy, the companies can write this off as a cost of doing business.’
James Mitchell Crow
Roche claim confidence
Roche CEO Franz Humer claims he is ’very confident’ that the Swiss pharmaceutical firm will win its $3 billion (?1.48 billion) hostile takeover of US medical diagnostics company Ventana. Humer claims hedge funds have already bought out leading shareholders. Ventana maintains that the $75 per share offer undervalues the company - Ventana shares were trading around $85 as Chemistry World went to press. Humer has said he has no intention of raising the offer, which closes on 1 November. Roche is looking to broaden its diagnostics business, which represents about 20 per cent of the company’s sales.
Tees Valley investment
UK development company Sonhoe have announced plans to build a ?2 billion crude oil processing facility on Teesside. The Wilton site, chosen from over 50 possible northern Europe locations, is expected to take five to seven years to develop. The company is now seeking investment for the project.
GSK seeks protection
UK pharmaceutical firm GlaxoSmithKline has become the first company to file a lawsuit against the US Patent and Trademark Office over new patent rules. The company claims the new rules, due to take effect 1 November, could damage around 100 of the company’s pending patent applications. Following a patent filing, the rule change limits a company to just two continuing applications on a particular invention; subsequent claims must show they could not have been submitted in a prior filing.
Breast cancer verdict
A US jury has awarded $134 million to three women who claimed Wyeth’s menopause drugs caused their breast cancer. The US pharmaceutical firm said it is facing 5300 lawsuits over its hormone-replacement drugs, involving 7900 plaintiffs. The trial is the seventh to reach a verdict; of the previous six, three found in favour of Wyeth, a fourth was overturned, and the remaining two are going to retrial. Wyeth said it would appeal the latest verdict.
A FDA advisory panel has recommended that the regulator approves US firm Medtronic’s drug-coated heart stent. To date, only Boston Scientific and Johnson & Johnson have products approved for the US market, predicted to be worth $2 billion in sales in 2007. Sales have fallen over 30 per cent this year amid fears of potentially fatal blood clots forming years after the stent is implanted. Medtronic’s data suggest its product may trigger less late clotting than its rivals.
Here comes the sun
UK solar cell company G24 and German chemicals giant BASF have agreed to jointly develop new ionic liquids for G24’s solar cells. The Cardiff-based firm uses ionic liquid-supported ruthenium dyes to capture energy from light, rather than the silicon used in conventional cells.
A sweeter deal
With Akzo Nobel’s shareholders set to vote on the firm’s proposed purchase of ICI on 5 November, the Dutch company has announced higher share dividends and a
BASF consolidates in US
BASF has inaugurated two new manufacturing plants at its site in Freeport, Texas. The plants replace facilities in North Carolina, Mississippi and Virginia, and make Freeport the base of BASF’s entire polyamide and polymers business in North America.
AZ patent safe
AstraZeneca’s European patent covering the manufacture of its stomach acid drug Nexium, which had $5.2 billion worldwide sales in 2006, has been upheld in amended form by the European Patent Office. The amendment had been opposed by German generics manufacturer ratiopharm. The Anglo-Swedish firm’s patent runs until 2015.
Buffet sells entire PetroChina stake
US investor Warren Buffet’s company Berkshire Hathaway has sold off swathes of stock in PetroChina, in October divesting of the last of Buffet’s shares. Other investors are yet to follow Buffet’s lead, and stocks in PetroChina have continued to rise.
Drug safety alliance
Seven pharmaceutical firms, including GSK and Pfizer, are joining forces with academic institutions and US regulators to look at the genetics behind drug safety problems. The Serious Adverse Effects Consortium will look for genetic markers that predict which individuals are at risk from serious side effects, including drug-induced liver injury. The announcement follows a series of drug safety scares, including Merck’s Vioxx, withdrawn in 2004, and GSK’s Avandia.
Swiss pharmaceutical giant Novartis has received EU approval for Galvus, its Type 2 diabetes drug. However, in the US, the FDA has asked for more clinical data before approving the drug. The firm’s once-yearly osteoporosis treatment, Aclasta, has received both EU and US approval. However, the company faces mounting problems over its non-steroidal anti-inflammatory, Prexige. The drug has now been withdrawn in Canada due to the risk of serious side effects on the liver, and has been rejected by the FDA in the US.
Carbon capture deal
German chemicals company BASF will join with compatriots RWE Power and Linde to build a pilot coal-fired power station that will capture 90 per cent of the CO2 it emits. BASF will develop scrubber solvents to capture the CO2 from the plant, which Linde will engineer and build, and RWE Power will run. The group aim to commercialise the technology by 2020.
New BP chief executive Tony Hayward has announced a company shake-up that will include big job losses. Hayward said he is looking to tackle BP’s poor performance by streamlining an organisation that had ’grown too complex’.
US biotech firm Biogen Idec are considering a sale of the company. Biogen, a leader in multiple sclerosis drugs, is valued at $23.5 billion.
Bayer has invested over
Car makers Volkswagen and Daimler are to take a minority stake in German biofuel company Choren. The car companies said they wanted to speed up the broad market launch of second generation biomass to liquid (BTL) biofuel.
In the largest environmental settlement in history, American Electric Power will spend $4.6 billion to cut pollution, $60 million on projects to mitigate past excess emissions, and pay a $15 million penalty, said the US Environmental Protection Agency.
Pharma job cuts
US-based Boston Scientific and Swiss drug firm Novartis have both announced that they will be cutting jobs in an effort to make savings. Boston Scientific will eliminate 2300 positions worldwide, while Novartis’s cuts will be limited to US sales and marketing staff.
New HIV treatment
The US Food and Drug Administration has approved Merck’s new oral HIV-1 treatment. Raltegravir, sold under the trade name Isentress, is a ’first-in-class’ HIV integrase inhibitor.