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Pharma news in brief

Northwick Park - enquiry outcome
Gilead marketing and med ed queried
Partner sought for potential orphan cancer drug
Lilly - biotech future
International pressure for cancer jab
S&N on brink of rival purchase

Northwick Park - enquiry outcome
The UK's drugs regulator should be more careful in its approval of certain clinical trials and experimental drugs should be administered to patients more cautiously, allowing time and space to observe any surprise reactions. These are some of the recommendations forged out of the official enquiry into the clinical trial held at Northwick Park, in London, when several volunteers fell dangerously ill after taking TeGenero's experimental arthritis drug, TGN1412 earlier this year. Gordon Duff, enquiry lead and professor at Sheffield University, said that deeper investigation leading to improved expertise at the National Institute for Biological Standards and Control could have mitigated the severity of the side effects experienced by the volunteers, the worst affected of whom required fingers and toes amputating.

Gilead marketing and med ed queried
Biopharma firm Gilead Sciences has received a subpoena from the US Attorney's Office, in San Fransisco, for information concerning marketing and medical education programmes for three antiretroviral products, Truvada (emtricitabine and tenofovir disoproxil fumarate), Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine). The company has said that it intends to comply with the subpoena and to cooperate in any related government investigation into its promotional practices.

Partner sought for potential orphan cancer drug
Oxford BioMedica, a small biotech company specialising in developing gene therapy-based treatments for cancer, has received a positive opinion from the Committee for Orphan Medicinal Products for its new renal cancer product, TroVax. If the firm gets the go ahead, which it anticipates achieving early in 2007, it would secure exclusive, 10-year marketing rights for the product, which entered phase III clinical trials in November. Oxford, which also plans to seek orphan drug status for TroVax in the US, is actively seeking a significant corporate partner to aid in final development and commercialisation.

Lilly - biotech future
Eli Lilly & Co has highlighted to analysts several investments that point towards a future based on the development and sale of biotechnology products, having noted that more than one-third of its current pipeline is already based on such products. Furthermore, the company's planned purchase of biotech firm, Icos, is expected to boost sales in this area in 2007. While Wall Street was not enamoured with Lilly's forecast for earnings growth next year of 5 per cent, which was below expectations, the company has assured investors that earnings from 2008 will be high single digit, or low double digit, and that it plans to be in a position to launch two new products per year from early in the next decade.

International pressure for cancer jab
Pressure is mounting on developers of cervical cancer vaccines to consider lowering the prices of their products in developing countries, where 80 per cent of deaths from the disease occur yet less than 5 per cent of women have a smear test. A group of international experts are meeting in London to discuss the case for new anti-cancer vaccines, such as GlaxoSmithKline's Cervarix and Merck & Co's recently launched Gardasil products which protect women against human papillomavirus, the cause of most cases of cervical cancer, being made available quickly and cheaply in developing countries. It is understood that solutions will be proffered whereby pharma firms can still achieve some profit while serving developing nations with the vaccines at an affordable price.

S&N on brink of rival purchase
Smith & Nephew (S&N) is understood to be on the verge of making a bid for its US rival, Biomet, in a deal worth around £5.6bn ($11bn). A combination of the two companies would create a sizeable competitor to large US medical device firms such as Johnson & Johnson and Stryker, though analysts have pointed out that other serious bidders for Biomet could scupper a tie-up with S&N. Some have speculated that, should a bid for Biomet be unsuccessful, S&N itself could become a takeover target.

30th September 2008

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