Anglo-Swedish drug maker AstraZeneca Plc. (AZN, AZN.L) announced Tuesday that based on the totality of results from OSKIRA Phase III programme, including the data previously reported from OSKIRA-1, the company has decided not to proceed with regulatory filings for fostamatinib.
The company stated that it will return the rights to the compound to Rigel Pharmaceuticals which will decide whether it will continue the ongoing studies and pursue regulatory filings.
As a result of this decision, the company will incur a pre-tax impairment charge of approximately $140 million to R&D expense in the second quarter of 2013 for the intangible assets relating to fostamatinib.
Since intangible asset impairments, except for IS-related intangibles, are excluded from the company's Core financial measures, this impairment will have no impact on the company's financial guidance for 2013, which is provided on a Core financial measures basis, the company said.
The company announced top-line results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase III clinical trials investigating fostamatinib, the first oral spleen tyrosine kinase or SYK inhibitor in development as an oral treatment for rheumatoid arthritis or RA.
According to the company, In the OSKIRA-2 study of patients inadequately responding to disease modifying anti-rheumatic drugs or DMARDs, fostamatinib in combination with DMARDs showed statistically significant improvements in ACR20 response rates at 24 weeks in both the 100mg twice daily group and the group receiving 100mg twice daily for four weeks followed by 150mg once daily (39.6%, p<0.001 both="" arms)="" compared="" to="" placebo="">
In the OSKIRA-3 study of patients inadequately responding to methotrexate or MTX and a single TNF-alpha antagonist, fostamatinib in combination with MTX showed statistically significant improvements in ACR20 response rates at 24 weeks in the 100mg twice daily group (36.2%, p=0.004) but not in the group given 100mg twice daily for four weeks followed by 150mg once daily (27.8%, p=0.168) compared to placebo (21.1%).
The company stated that the safety and tolerability findings for fostamatinib observed in the OSKIRA Phase III programme were generally consistent with those previously reported in earlier studies. The most commonly reported adverse events in the OSKIRA programme include hypertension, diarrhoea, nausea, headache and nasopharyngitis.
The company announced an exclusive worldwide license agreement with Rigel Pharmaceuticals in February 2010 for the global development and commercialisation of fostamatinib.
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