International news
- Amgen awarded US$150m in drug licence battle
- Dolly creator turns to humans
- European Union fails to agree on biotech rules
- FDA to rethink disclosure rules
- Generics debate heats up in US
- Genentech doubles third quarter income
- Gene therapy urged to continue
- Nobel Prize in chemistry goes to protein researchers
- UK's Medical Research Council to establish mouse gene spin-off
Amgen awarded US$150m in drug licence battle
18 October - Biotech giant Amgen is to be paid US$150m by Johnson & Johnson in a drug licensing stoush. However, the arbitrator in the case declined to accede to Amgen's bid to have the licence revoked, and also refused to meet a damages claim by Amgen for US$1.2bn. The disputed licence, for the popular anaemia drug erythropoetin, was granted in 1985. Amgen had claimed that J&J breached the agreement by improperly selling the drug into Amgen's exclusive kidney dialysis market. It was found that J&J had generated sales in markets where Amgen possessed exclusive rights, yet that this did not warrant a termination of the contract. In the absence of a clear winner in the case, both companies are to seek a costs award.
[Source: Reuters - Deena Beasley]
Dolly creator turns to humans
13 October - Professor Ian Wilmut, the scientist who directed the project which produced Dolly the cloned sheep, is now planning to clone human embryos. Professor Wilmut, head of the Roslin Institute in Scotland, is to become the first to lodge an application to carry out such research under the UK's liberal laws. If approved by his institute and external regulators, Wilmut plans to investigate the same nuclear transfer technique that was used in Dolly, to examine how well it can translate to early human embryos. Professor Wilmut was careful, however, to stress he has no intention to create cloned human beings from his research. Rather, he aims to create stem cell lines which may aid in the treatment of several human diseases, with a particular focus on heart disease and Parkinson's Disease. If approval progresses as planned, research is slated to commence within six months.
[Source: The Observer ]
European Union fails to agree on biotech rules
10 October - The European Union has failed to reach agreement on biotechnology rules over genetically modified crops. Because of this delay, the Union cannot take any steps to remove its four-year long moratorium on genetically modified crops. The Union may also face an inquiry by the World Trade Organisation, at the urging of the US. US officials are demanding a lift on the GM-freeze, claiming it costs corn growers alone some US$200m per year in lost export earnings. Despite a recommendation by the EU's executive body that the ban be lifted, six countries have refused to support the move. Indeed, disagreements among member countries are so severe that no agreement was reached even on smaller issues, such as traceability and labelling of GM organisms.
[Source: Associated Press - Paul Geitner]
FDA to rethink disclosure rules
15 October - The US Food and Drug Administration, after losing several court challenges, is to rethink its regulations controlling what pharmaceutical, food and cosmetic manufacturers can claim about their products. In several recent court battles, the FDA has been found to be in violation of the First Amendment's guarantee of freedom of speech. In response, the organisation is now to reassess its "gatekeeper" stance on the balance between a company's right to connect with its customers and the FDA's obligation to protect the public. Reforms are likely to be wide-ranging, affecting practices such as how a sales representative can discuss a particular product with a doctor, or the kinds of health claims a food company can make. The practice of allowing drug advertising only with a full account of side effects and conditions will also be re-examined.
[Source: New York Times - Gina Kolata]
Generics debate heats up in US
13 October - The generic drug industry continues its stoush with branded pharmaceutical companies, with a US Senate Sub-Committee hearing considering arguments over changes to legislation governing the market. The House Energy and Commerce Subcommittee on Health is hearing arguments over changes to the Hatch-Waxman Act, which have been passed by the senate and are soon to be considered by the House of Representatives. These amendments follow a recent report by the US Federal Trade Commission into competition in the industry.
According to branded pharmaceutical companies, the Greater Access to Affordable Pharmaceuticals Act 2002 takes the recommendations of the FTC report to an extreme. However, acting US Food and Drug Administration Commissioner Lester Crawford has endorsed the conclusions of the FTC study, in particular the response to delaying tactics by big pharmas against generic competition. Yet the FDA remains opposed to the Act, claiming it will harm innovation in new medicines. They also claim it will lead to greater litigation over the approval of new drugs and the filing of patents, and that it will also ironically delay the availability of generic drugs.
[Source: Legal Media Group]
Genentech doubles third quarter income
9 October - Biotech giant Genentech has announced that its third quarter net income has doubled that of the previous year, largely attributable to a 21% increase in revenues. The company's net income for the quarter was US$89.3m, compared with US$42.7m a year earlier. Revenue rose to US$675.2m, largely attributable to sales of cancer products. The result is particularly good, given the US$12.5m in costs the company incurred in its royalties stoush with the City of Hope National Medical Centre (the result of which is being appealed by Genentech) and US$38.9m in recurring charges from the 1999 redemption of company stock by majority owner Roche Holding AG.
[Source: Associated Press]
Gene therapy urged to continue
11 October - Despite a French child contracting symptoms consistent with leukaemia from an experimental gene therapy, a US Advisory Committee has urged the US Food and Drug Administration to reverse its recent suspension of such trials, albeit with new restrictions and protections. The FDA's Biological Response Modifiers Advisory Committee advises that it is aware of the potentially dangerous implications of the technology. The Committee justifies its decision by referring to the treatment's otherwise blemish-free track record, with several children being "cured". They argue that one adverse event, although serious, is not enough to justify placing all such programs on hold. Under these particular gene therapy programs, engineered retroviruses are infused to deliver "healthy" genes to children suffering life-threatening immune diseases. One of the restrictions the Committee has recommended is that all new patients recruited into trials be informed of this added risk. Additionally, blood specimens from trial participants should also be screened periodically to monitor any evidence of cancer.
[Source: Washington Post]
Nobel Prize in chemistry goes to protein researchers
9 October - The Nobel Prize in chemistry has been awarded to Japanese, Swiss and American scientists who invented techniques now commonly used in the identification and analysis of proteins - a technique which has forever altered how new medicines are discovered and which can also aid in the detection and diagnosis of some cancers. American John B Fenn of Virginia Commonwealth University will share the honour with Kurt Wuethrich, from the Swiss Federal Institute of Technology, and Japanese researcher Koichi Tanaka of Tokyo-based Shimadzu Corp. Among the techniques developed by the researchers is the transformation of mass spectrometry, a mechanism to rapidly identify what proteins a sample contains. Fenn and Tanaka were able to expand the reach of this technology to much larger proteins than had previously been possible. Wuethrich was honoured for improving the way in which three-dimensional images of protein molecules in solution are produced - a technique called nuclear magnetic resonance.
[Source: Associated Press - Kim Gamel]
UK's Medical Research Council to establish mouse gene spin-off
9 October - The United Kingdom's Medical Research Council has provided £3m for the establishment of a new transgenic mouse company. The centre, which will genetically engineer mice to model human diseases, has been set up by two researchers who previously worked with the Council. Etiologics Ltd is a spinoff from the MRC Mammalian Genetics Unit, which conducts groundbreaking research into the genetic causes of disease. The Oxford-based Unit has developed significant technologies to generate and screen new mouse strains on a commercial scale. Etiologics will be able to provide mice which model conditions such as heart disease, kidney failure, diabetes, abnormal cholesterol levels and Alzheimer's disease. The company hopes to contribute to the identification of new therapeutic targets in light of ever-increasing genomic knowledge.
[Source: Press Association - John von Radowitz]
