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Rigel Pharmaceuticals, Inc.

Partner : AstraZeneca

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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"In the second quarter of 2013, we expect our partner AstraZeneca to report topline results from the two remaining Phase 3 studies of fostamatinib in rheumatoid arthritis, OSKIRA2 and OSKIRA3," said James M. Gower, chairman and chief executive officer of Rigel Pharmaceuticals. "Results from two other Phase 2 studies with R343 in allergic asthma and R333 in discoid lupus will follow later this year."
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Source: press release, 5/07/13. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1816201...

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As of March 2012, Rigel has eight novel small molecule programs in clinical or preclinical development, including Rigel's partner, AZ's Phase 3 clinical trial program (OSKIRA) with fostamatinib in patients with RA. AZ has recently announced that it expects to file for a new drug application for fostamatinib with the U.S. Food and Drug Administration in the second half of 2013.
Source: press release, 3/06/12. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1669348...

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James M. Gower, Chairman of the Board and CEO, commented on the Fostamatinib program for RA. He stated, "The furthest ahead is a program in phase III which is our oral Syk kinase inhibitor for RA. AstraZeneca is finishing up phase III trials this year. They have anounced they have projected to file next year."
Source: 32nd Annual Cowen and Company Health Care Conference, 3/05/12.

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Fostamatinib Update

AZ recently reported that their Phase 3 clinical development program (OSKIRA) to investigate fostamatinib as a treatment for rheumatoid arthritis is progressing well. AZ expects the first set of data in the second half of 2012 and expects to remain on track to meet the planned US and European new drug application (NDA) filing dates in 2013. AZ also announced that in the first quarter of 2011 they had commenced a Phase 2b clinical trial (OSKIRA 4) that explores fostamatinib as a monotherapy in rheumatoid arthritis. This trial will provide important information on the profile of fostamatinib without concomitant treatment with a disease-modifying anti-rheumatic drug (DMARD).
Source: press release, 8/02/11. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1591684...

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Raul R. Rodriguez, President and COO, responded to a question regarding data flow for Fostamatinib. He stated, "No additional data review is planned for those ongoing studies between now and the showing of the data. So, we are not planning on having any interim looks, there isn't any interim look planned or safety looks that are planned. So, we are not likely to see that until we see the actual read-outs of the clinical trials. We do not have a specific date of when we will have or AZ does not have a specific date as to when they will issue the data on the phase III program but given that they are planning a NDA filing in 2013 you can back up from there and have some idea yourselves in terms of when that might come along. As we get closer to some of these dates we'll have a better more fine estimate of what quarter or what half year things will occur as we get a little bit closer. As things progress, I think we will have a little bit better handle on it. As things progress in terms of enrollment too, I think they will be able to give better guidance in terms of when we can expect the data."
Source: Wells Fargo Securities Healthcare Conference, 6/23/11.

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SOUTH SAN FRANCISCO, Calif., Sept 29, 2010 /PRNewswire via COMTEX/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today. The second milestone marks the completion of the transfer of the fostamatinib long-term open label extension study from Rigel to AstraZeneca.
Source: press release, 9/29/10. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1475814...

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OSKIRA-2 - A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs
Estimated Enrollment: 900
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01197534?term=Fostamatinib&rank=8

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Fostamatinib disodium, (R788) (3) RARheumatologyRheumatoid Arthritis (RA)Syk kinase inhibitorSyk kinase

Mechanism of action: R788, a SM-inhibitor, disrupts IgG receptor signaling in macrophages and B-cells that is known to promote swelling and the inflammatory response via syk kinase inhibition.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-05-08 - 2013-06-30

Results:

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AstraZeneca announces top-line results from Phase III OSKIRA Trials of FOSTAMATINIB and decision not to proceed with regulatory filings

Tuesday, 4 June 2013

AstraZeneca today 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 (SYK) inhibitor in development as an oral treatment for rheumatoid arthritis (RA).

In the OSKIRA-2 study of patients inadequately responding to disease modifying anti-rheumatic drugs (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 (24.5%).

In the OSKIRA-3 study of patients inadequately responding to methotrexate (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 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 (common cold).

Based on the totality of results from the OSKIRA Phase III programme, including the data previously reported from OSKIRA-1, AstraZeneca has decided not to proceed with regulatory filings for fostamatinib. AstraZeneca will return the rights to the compound to Rigel Pharmaceuticals which will decide whether it will continue the ongoing studies and pursue regulatory filings.

Briggs Morrison, MD, Executive Vice President of Global Medicines Development and Chief Medical Officer, said: “The results of the late stage trials did not measure up to the promising results we saw earlier in development. We remain committed to the search for new treatments for patients with rheumatic and inflammatory diseases with Phase II compounds in rheumatoid arthritis and lupus and Phase III compounds in gout and psoriasis.”

As a result of this decision, AstraZeneca 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. As AstraZeneca will continue to incur some Core R&D costs associated with the completion of ongoing studies for fostamatinib, there is no change to the company’s guidance that it expects to hold Core operating costs for 2013 (combined Core SG&A and Core R&D) to a slight increase compared with 2012 on a constant currency basis.

AstraZeneca announced an exclusive worldwide license agreement with Rigel Pharmaceuticals in February 2010 for the global development and commercialisation of fostamatinib. AstraZeneca intends to publish a more detailed analysis of the OSKIRA clinical programme in due course.
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Source: press release, 6/04/13. http://www.astrazeneca.com/Media/Press-releases/Article/20130504-astraze...

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