International news
- California legalises stem cell research
- Eli Lilly pays Amylinup to US$195m to develop diabetes drug
- Genentech and Xoma clear psoriasis drug hurdle
- Genetic testing technology just got smaller
- Myriad to market "direct to public" gene test
- PPL Therapeutics to close stem cell business
- US debates discrimination law
- US FDA launches web portal
- US National Institutes of Health pledges global protein database
California legalises stem cell research
23 September - The Governor of California, Gray Davis, has signed legislation to allow embryonic stem cells research in the state. The legislation, which directly contradicts recent (non-legislative) federally imposed limits on such research, has been cleared by Governor Davis in the interests of medical research. The Bill mirrors the legislation currently pending in Australia - allowing both the donation and destruction of human embryos for the specific purpose of embryonic stem cell research. Clinics offering IVF will be required to inform women that they have the option to donate surplus embryos to research. Consent to donate embryos will be required in writing, and the sale of embryos is to be prohibited. Commentators are predicting the bill will attract more stem cell researchers to the state. The Whitehouse is yet to make any comment on the passage of the Bill, including whether the state's law would be overruled by a federal statute.
[Source: Associated Press - Jennifer Coleman]
Eli Lilly pays Amylinup to US$195m to develop diabetes drug
20 September - Drug giant Eli Lilly & Co is to take a stake in the small biotech Amylin Pharmaceuticals Inc, to give Amylin the marketing power it needs to sell its experimental diabetes drug, currently called AC2993. The drug, designed to treat Type II diabetes, works to lower blood glucose levels only when they are high. Under the agreement, Eli Lilly is to make an initial payment to Amylin of US$80m. It will also purchase US$30m of Amylin stock at a 50% premium and make additional payments of up to US$85m when certain milestones are achieved. The two companies will share the marketing of the drug in the US, with Eli Lilly to market it exclusively abroad. Amylin is sure to benefit from Eli Lilly's contribution, with its expertise and marketing history in diabetes treatments. AC2993 is currently in late-stage clinical trials, with a submission for marketing approval expected in early 2004. Shares in both companies rose in response to the announcement.
[Source: Reuters - Edward Tobin and Jed Seltzer]
Genentech and Xoma clear psoriasis drug hurdle
17 September - Genentech Inc and Xoma Ltd have announced their experimental psoriasis drug, Raptiva, has cleared a significant hurdle. Genentech has successfully demonstrated it can make the drug to the same efficacy standards as earlier batches made from materials manufactured by both firms. This latest demonstration contributes to the probability that the drug will soon be commercialised, as the study was undertaken in response to a FDA request. It required proof the drug could be duplicated at Genentech's plant without changing its chemical composition. Earlier, Genentech had admitted that Raptiva made by Genentech was qualitatively different from earlier batches. The two companies now plan to submit an application for marketing approval for the drug before the end of the year.
[Source: Reuters - Jed Seltzer]
Genetic testing technology just got smaller
13 September - A United Kingdom company, LGC Ltd, is developing the world's smallest genetic testing "laboratory" - approximately the size of a shoe box. The kit, which could provide testing in locations such as chemists or airports, aims to offer test results in half an hour. The tests will also be cheaper and less invasive than conventional testing methods. In addition to providing genetic testing, the system is designed to diagnose microbe strains responsible for infections, or to test whether a person will react adversely to prescribed medications. Examples of genetic tests that could be performed include breast cancer, or a predisposition to deep vein thrombosis (DVT) on long plane flights. LGC believes the kit should be ready in a few months, with the final version to be made available to chemists and doctors in around a year. However, the kit has sparked concern with watchdogs and regulators, who are concerned about tests made available directly to the public. The UK's Human Genetics Commission is currently deciding whether any restrictions on "over-the-counter" genetic tests are needed. A company representative claims the device has been designed for use with health professionals and not consumers, with the aim of bringing testing closer to the point of care between a health professional and a patient.
[Source: BBC News Online - Helen Briggs]
Myriad to market "direct to public" gene test
12 September - In a world-first, Myriad Genetics has launched a US campaign to market its predictive genetic test for breast cancer, BRACAnalysis®, direct to consumers. The five-month campaign aims to raise awareness of cancer prevention options among women who have a family history of breast or ovarian cancer. In two US states, the campaign will use television, radio and print media to carry a message of "hope and help" to those at high risk of cancer. Myriad research suggests that of the target market, around 85% would be likely to contact their doctor for testing in response to the campaign. The rationale behind the new campaign is that to date, the company has focussed upon cancer care professionals, who only treat patients already diagnosed with the disease. The company now wishes to reach an audience where prevention may be warranted.
[Source: Company Announcement]
PPL Therapeutics to close stem cell business
16 September - PPL Therapeutics, the company behind the birth of Dolly the sheep, is to shut down its stem cell operations. Unable to find a buyer, PPL has decided to cease the business altogether, and is to adjust its focus to more profitable fields such as developing protein treatments for cystic fibrosis. The company also hopes to sell its xenotransplantation unit - which recently generated headlines with the birth of genetically altered pigs with organs that could soon be used in pig-human transplants. PPL chief executive Geoff Cook stated that protein treatments offer a greater return for shareholders at the current time. Although PPL's cloning and xenotransplantation projects have made significant scientific advances, these applications are still some years away from market. The company expects its first protein-based product, a sealant for use in surgical procedures, to be available within three years.
[Source: BBC News]
US debates discrimination law
13 September - A US House subcommittee is hearing alternative views as to whether legislation, currently stalled, to ban genetic discrimination by insurers and employers is necessary. Several witnesses to the subcommittee have argued against legislation, claiming it will introduce undue complexity. Some reasons offered by detractors of legislation include the existence of differing yet overlapping classes of genetic information, such as predictive compared to diagnostic results. Additionally, legislation could effectively bar insurers from collecting information which could help patients to stay healthy; or people could use their genetic information to manipulate the insurance market. Others have further argued that there is no evidence that pre-symptomatic genetic information will be used in medical underwriting. Yet others have asserted a need for such legislation to fill "gaps" in existing protections of individuals' rights. Those in favour of the legislation point to the significant public fear about misuse of genetic information, even if discrimination is not actually currently occurring. Importantly, this fear of discrimination and potential loss of benefits is causing people to withdraw from looking after their own health. The hearing is continuing.
[Source: Reuters]
US FDA launches web portal
23 September - The US Food and Drug Administration has launched a new Portal Page to offer information for industries that fall under its regulation. The portal will assist companies to locate information about a variety of agency regulations, including links to industry guidance, import information and inspection references. The portal also covers warning letters and other enforcement activities, and has interactive features to allow submission of comments on pending regulations.
[Source: FDA News digest]
US National Institutes of Health pledges global protein database
12 September - Nature reports that the US National Institutes of Health is to give US$15m to European and US institutions, to establish a global database of information on protein sequence and function. The database, to be known as the United Protein Database (or UniProt) will incorporate existing databases, such as Swiss-Prot and Trembl, together with the Protein Information Resource based in Washington. UniProt marks the first time that money from a large NIH infrastructure grant has gone outside the US. The database is to contain quality editorial and functional information, in addition to links to other genomic and bioinformatic databases. For researchers, the new database will help ensure the availability of a sustainable and reliable data source about protein sequences and functions in an environment of rapidly expanding data.
[Source: Nature]
