FDA powers boosted by Senate Bill
The US Senate has passed legislation to reinforce the authority of the Food and Drug Administration (FDA) to regulate drugs and medical devices.
Under the legislation, there will be an increase in user fees that drugs companies and makers of medical devices pay the FDA. The capital from these fees finances the agency’s operation. This was met with approval by the industry body, Pharmaceutical Research and Manufacturers of America (PhRMA), who said that it would strengthen the FDA’s ability to do its job and ’make a good system even better’.
The US Generic Pharmaceutical Association (GPhA) welcomed the bill, highlighting a specific amendment that will make it more difficult for drug companies to delay the approval of generic versions of existing drugs.
According to the GPhA, the Senate used the bill to reject the practice of companies filing ’frivolous citizen petitions merely to extend their monopolies’. Citizen petitions can be brought to the FDA by any organisation or individual, to request more rigorous safety reviews of a drug. Michael Mahaffey, a spokesperson for the US Senate committee, told Chemistry World that the amendment will make it harder to deliberately block the entry of generics onto the market. ’Specifically, it requires the FDA to rule that a citizen petition raises issues important to public health prior to allowing it to derail or delay the approval of a generic,’ he explained.
The FDA’s database of all Phase II and subsequent clinical trials will now be made freely available to the public. Currently, only clinical trials for serious and life-threatening conditions are required to be registered in the public data bank.
A proposed ban on the direct-to-consumer advertising of drugs is not included, having been stripped out during the amendment process.
AstraZeneca big on biologics
UK pharmaceuticals firm AstraZeneca says it is confident its $15.6 billion (?7.9 billion) deal to buy US biologics company MedImmune will go ahead, despite a legal challenge. A class action has been brought against MedImmune, stating company insiders will benefit from the sale ’to the exclusion of maximising stockholder value’. The deal would mean AstraZeneca instantly achieves CEO David Brennan’s target for biologics to make up a quarter of the company’s drug pipeline by 2010. In addition, the acquisition would give AstraZeneca a presence in the important vaccines sector.
Painkiller ’highly addictive’
US pharmaceutical company Purdue Pharma has pleaded guilty to misleading doctors and the public on the risk of addiction to their slow-release painkiller OxyContin. The company has agreed to pay $19.5 million to settle with the 26 complainant states plus the District of Columbia, and the company and its executives will pay a further $634.5 million in fines. Purdue Pharma had been encouraging doctors to prescribe that the drug be used at 8 hour intervals, rather than the FDA-approved 12 hours. As well as being addictive, the drug can be readily abused by crushing the pills, which circumvents the slow-release mechanism and reportedly gives a heroin-like high.
Uranium futures look bright
Trading in uranium futures launched on 7 May. Trading began as uranium prices reached unprecedented heights of $120 per pound, fuelled by rising demand as governments commit to building new nuclear power stations. Uranium prices were around $10 per pound only 5 years ago. Trading suggests the industry expects uranium prices to continue to rise; futures contracts for December 2007 were at $150 per pound. The futures contracts, which are traded on the New York Mercantile Exchange (Nymex), allow uranium buyers and sellers to protect themselves from uranium price changes by stabilising their revenues or costs.
Clariant quits customs
Clariant, the Swiss speciality chemicals company, is to sell its custom manufacturing arm to US investment company International Chemical Investors Group (ICIG). As custom chemicals sales continue to fall, Clariant will instead focus on its core business of colours, surface chemistry, and performance chemicals.
The Clariant custom chemicals business supplies intermediates and active ingredients to customers in agrochemicals, pharmaceuticals and polymers. Achim Riemann, managing director of ICIG, said the acquisition ’complement[s] our present portfolio of fine chemicals custom manufacturing assets.’ Clariant moved into custom chemicals in 2000, when expectations for the sector were high.
Fat fuel enters fast lane
A biodiesel made from animal fat could be the latest addition to the renewable fuel market, after US-based oil company ConocoPhillips and American food firm Tyson agreed a collaboration. Beef, pork and poultry fat will be processed by Tyson, then converted to a diesel-type transport fuel via a process developed by ConocoPhillips at its Whitegate refinery in Ireland.
Fuel production is expected to start in the final quarter of 2007, and eventually give up to 175 million gallons annually. The companies say the fuel will meet all US standards for ultra-low-sulfur diesel.
Renewables race
US speciality chemicals firm Huntsman is scaling up its proprietary process to convert renewable feedstock glycerine into propylene glycol. Glycerine is a by-product of the manufacture of biodiesel from vegetable oils; and as biodiesel production grows, so do glycerine surpluses. Huntsman plans to sell bio-sourced propylene glycol, which is used as an aeroplane de-icer and in building materials, from 2008. The chemical is currently made from the petrochemical feedstock propylene.
Huntsman isn’t the only speciality chemical firm to see the potential of cheap glycerine. Dow Chemical is currently commercialising its own propylene glycol production process.
J&J stent fails tests
US healthcare company Johnson & Johnson’s next generation ’CoStar’ drug-eluting stent has failed a study to demonstrate ’non-inferiority’ against a rival sold by Boston Scientific Corp. Both stents are coated with anti-tumour compound paclitaxel, but deliver the drug differently. The CoStar stent will now be discontinued in countries where it is already sold, and plans to seek US approval will be abandoned. Stents are mesh cylinders used to hold open heart arteries after surgery to remove blockages. Coating the stent with drugs can prevent scar tissue from re-blocking the artery. Until recently, drug-eluting stents were proving highly lucrative, but recent safety fears over blood clot risks have triggered a switch back to uncoated stents. Many in the industry had hoped next-generation stents like CoStar would reinvigorate the market. The CoStar stent was developed by Conor Medsystems, recently acquired by J&J for $1.4 billion.
Merck Generics fetches $6.6 bn
US-based Mylan Laboratories Inc. have agreed to buy German firm Merck’s generic drugs business for €4.9 billion (£3.4 billion).
Competition for the business from several firms, including Teva of Israel, Actavis of Iceland, and a private equity offer, drove the sale price upwards.
The generics division earned Merck €307 million in operating profit last year, based on sales of €1.8 billion. Mylan say, based on 2006 figures, the combined company would have generated $4.2 billion in revenues, with a gross profit of $1 billion.
Merck said it will use the sale to partially reduce its debts, following its €10.6 billion takeover of Swiss biotech company Serono in 2006.
Companies follow cheap gas
US firm Dow Chemical and Saudi oil company Aramco have agreed to develop a large petrochemicals plant in Saudi Arabia. Industry estimates put the costs of the venture at up to $22 billion, one of the largest deals of recent times.
Dow is the latest company seeking to exploit cheap Saudi natural gas to manufacture various chemicals and plastics. US-based Chevron, and Sumitomo Chemical of Japan have also invested in the Saudi petrochemicals industry recently.
The Dow deal closely follows news that, as US natural gas prices balloon, 25 per cent of US manufacturers are considering moving some production overseas.
The study, commissioned by the National Association of Manufacturers in late 2006, found that 62 per cent of companies expected ’substantial’ price rises in their chemicals as a result of the rising cost of natural gas.
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