AstraZeneca PLC
04 May 2006
AstraZeneca Discontinues Development of GALIDA(TM) (tesaglitazar)
AstraZeneca today announced the discontinuation of the GALIDA development
programme. GALIDA is a dual PPAR alpha and gamma agonist and was in phase III
development for the treatment of the glucose and lipid abnormalities associated
with type 2 diabetes.
Following analysis and interpretation of recently obtained results from the
first four of eight Phase III clinical trials (GALLANT 6,7,8 and 9) and one
Phase II trial (ARMOR), which were reviewed in consultation with external
experts, the company considers that the overall benefit / risk profile is
unlikely to offer patients significant advantage over currently available
therapy.
Central to the decision is data showing elevations in serum creatinine and an
associated decrease in Glomerular Filtration Rate (GFR). The magnitude of the
serum creatinine elevation was greater than anticipated based on earlier
clinical studies. Such elevations reversed towards baseline upon stopping
treatment with the drug and have not been associated with kidney toxicity.
There is no immediate safety concern for patients and all primary efficacy
endpoints were met in the Phase III trials. Patients are advised to speak with
their physician before stopping their treatment. All ongoing GALIDA clinical
studies will now be brought to a close and physicians will be advised to switch
patients 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 have
acknowledged that GALIDA was in a class with a high degree of uncertainty and
the decision to discontinue is disappointing. We remain committed to further
strengthening AstraZeneca's pipeline of new medicines both from our own research
efforts and through the continued pursuit of external opportunities to enhance
our business.'
Further analysis of data from the GALIDA development programme is ongoing and
the company will make the data available as appropriate through scientific
presentation, publication and via the company's Clinical Trials Website once
completed.
AstraZeneca has other PPAR agonist programmes in development and learning from
the GALIDA programme will be applied to these once final analysis of the data is
concluded.
-Ends-
4th May 2006
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