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Pharma news in brief

Our weekly round-up of news affecting the industry.

Cannabis-drug firm seeks marketing partners

GW Pharmaceuticals, manufacturer of the first approved prescription drug derived from cannabis, plans to discuss Europe-wide licensing and co-marketing deals with pharmaceutical partners for Sativex. The product has been launched on the Canadian market after regulators cleared it for treating pain in multiple sclerosis sufferers. However, the firm received a knock back from UK regulators in recent weeks when it sought to gain marketing approval for Sativex to treat spasticity, a different symptom of multiple sclerosis. UK officials have accepted the safety and quality data, but have requested more information from trials to support the efficacy claims. GW does not expect to have such data available until Spring 2006, though the firm has already struck a marketing deal with German firm Bayer for the UK and Canadian markets.

Shire lifted by TKT results

Shire Pharmaceuticals' share price jumped by around 6 per cent on the news that its much-maligned decision to buy ailing US biotech Transkaryotic Therapies (TKT) for $1.6bn may prove to be fruitful. TKT released positive final-stage trial data for its experimental human enzyme replacement therapy for an uncommon genetic disorder, Hunter Syndrome. Patients taking I2S (iduronate-2-sulfatase) showed a statistically significant improvement compared with those on placebo. ìIt hit all the main end-points and really validates the rationale for [Shire's] acquisition,î commented analyst at Collins Stewart, Navid Malik, who forecasts potential annual sales of some $200m for the drug.

AZ limits Iressa access

AstraZeneca (AZ) has placed strict limits on the number of patients given access to Iressa, its lung cancer treatment, after trial data revealed it to have no bearing at all on survival. While the US Food and Drug Administration held back from issuing a full withdrawal of the drug from the market - which was called for by US consumer group Public Citizen - AZ said that after September 15 this year, no new patients will be allowed access to the drug unless they are enrolled in clinical trials of an `experimental' nature. However, some patients on Iressa therapy have improved and the firm is currently evaluating biomarkers that could help predict a patient's responsiveness to the product. Patients in the US who are already taking the drug as part of a regime can still receive it through the company's special prescription `refill' programme.

Mylan seek marketing muscle

US generics firm Mylan Laboratories plans to sign up a significant pharmaceutical marketing partner for Nebivolol, its highly acclaimed hypertension and heart failure drug, which may be on the brink of gaining US Food and Drug Administration marketing approval. The product would form the foundation for Mylan's move into the more profitable branded drugs sector, allowing it to rely less on its traditional generics offering which is coming under increasing competition. Analysts have described Nebivolol as very promising and currently an under-valued asset, though it would need to be `marketed properly' with the help of a pharma company's large and established salesforce. Mylan investors reacted warmly to the firm's plans, boosting its share price rise by around 10 per cent.

Sanofi-aventis to orbit FDA and EMEA

French drugs group, sanofi-aventis, will seek to gain a speedier marketing approval from the Moroccan regulators, rather than the traditionally slower US Food and Drug Administration or the European Medicines Agency (EMEA), for its new malaria combination (artesunate-amodiaquine) product. The firm stated that as the principal market for the product is Africa, an appropriate regulatory body should be called upon to consider it for marketing clearance. Robert Sebbag, deputy head of the firm's Access to Medicines programme, added that a European or American approval for the drug could take much longer, as the regulators would be likely to request further clinical trial data to support the application. Sebbag said the firm would also seek authorisation through the World Health Organisation's pre-qualification scheme to verify the product's suitability for use in Africa.

30th September 2008

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