4th May 2006 07:00
AstraZeneca PLC04 May 2006 AstraZeneca Discontinues Development of GALIDA(TM) (tesaglitazar) AstraZeneca today announced the discontinuation of the GALIDA developmentprogramme. GALIDA is a dual PPAR alpha and gamma agonist and was in phase IIIdevelopment for the treatment of the glucose and lipid abnormalities associatedwith type 2 diabetes. Following analysis and interpretation of recently obtained results from thefirst four of eight Phase III clinical trials (GALLANT 6,7,8 and 9) and onePhase II trial (ARMOR), which were reviewed in consultation with externalexperts, the company considers that the overall benefit / risk profile isunlikely to offer patients significant advantage over currently availabletherapy. Central to the decision is data showing elevations in serum creatinine and anassociated decrease in Glomerular Filtration Rate (GFR). The magnitude of theserum creatinine elevation was greater than anticipated based on earlierclinical studies. Such elevations reversed towards baseline upon stoppingtreatment with the drug and have not been associated with kidney toxicity. There is no immediate safety concern for patients and all primary efficacyendpoints were met in the Phase III trials. Patients are advised to speak withtheir physician before stopping their treatment. All ongoing GALIDA clinicalstudies will now be brought to a close and physicians will be advised to switchpatients to the alternative available therapies at their next scheduled visit.There are currently 2,245 patients taking GALIDA within clinical trials. David Brennan, Chief Executive Officer, AstraZeneca PLC, commented: "We haveacknowledged that GALIDA was in a class with a high degree of uncertainty andthe decision to discontinue is disappointing. We remain committed to furtherstrengthening AstraZeneca's pipeline of new medicines both from our own researchefforts and through the continued pursuit of external opportunities to enhanceour business." Further analysis of data from the GALIDA development programme is ongoing andthe company will make the data available as appropriate through scientificpresentation, publication and via the company's Clinical Trials Website oncecompleted. AstraZeneca has other PPAR agonist programmes in development and learning fromthe GALIDA programme will be applied to these once final analysis of the data isconcluded. -Ends- 4th May 2006 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Jorgen Winroth, Tel +1 (212) 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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