* Imminent launch of Phase III fostamatinib clinical trials
* Astra gained experience after failure of in-house products
* Drug licensed from Rigel seen as key late-stage asset
* Chasing Pfizer in race for rheumatoid arthritis pill
By Ben Hirschler
LONDON, Sept 28 (Reuters) - AstraZeneca (AZN.L) is set to start costly final-stage trials of a new pill for rheumatoid arthritis, ramping up investment in a programme that highlights its new-found pragmatism towards drug development.
The imminent launch of Phase III studies with fostamatinib, just six months after a licensing deal for the product was finalised with Rigel Pharmaceuticals (RIGL.O), underlines the group’s readiness to “externalise” the hunt for new drugs.
AstraZeneca is chasing rival Pfizer (PFE.N) in a race to develop a convenient oral alternative to costly anti-TNF injections, which have led the field for the past decade.
The Anglo-Swedish company, which badly needs new products to bolster its late-stage pipeline, had originally hoped to develop an oral arthritis drug in house — but that project hit a wall in 2009 when two experimental products failed to show efficacy.
In a quick strategic turn, however, AstraZeneca jumped horses and signed up Rigel’s product instead.
“It illustrates a departure for AstraZeneca. At the same time as we were progressing with our own two compounds in Phase IIb, we were also looking at the competitive opposition,” said Ricky Bache, head of the fostamatinib global product team.
“Within two weeks of us regrettably finding we had a negative result with our compounds, we were already talking to Rigel ... We’re pretty pleased with how fast we moved,” he said in an interview.
If all goes well, fostamatinib, also known as R788, will be submitted for U.S. and European regulatory approval in 2013 and could be launched in its first markets in 2014.
Rigel got a handsome $100 million upfront payment from AstraZeneca back in February and is entitled to up to $1.25 billion, if the drug is a success. [ID:nSGE61F054]
But speed, as well as cash, was also a big consideration when Rigel picked its partner, and the fact that AstraZeneca had already done a lot of groundwork for its failed compounds meant it could move faster than rivals in starting late-stage trials.
The move into Phase III will cost hundreds of millions of dollars, underscoring the big bet being placed on fostamatinib.
“It is an expensive area to develop drugs in by nature of the regulatory requirements, but it is a key opportunity for us,” said Lisa Anson, vice president for AstraZeneca’s emerging brands. “It is certainly one of our top Phase III priorities.”
AstraZeneca needs to find new winners to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.
Its recent product development news has been mixed, with heart drug Brilinta recommended for approval in Europe last week but its cancer drug pipeline suffering another setback on Monday. [ID:nLDE68N188]
Fostamatinib, a so-called spleen tyrosine kinase (Syk) inhibitor, is viewed as a potential blockbuster that could help transform pipeline prospects, although it is by no means perfect. Mid-stage clinical trials found it could increase blood pressure levels and one of three Phase II studies also showed a worrying lack of effectiveness.
Despite this, AstraZeneca is confident. Bache said the blood pressure issue was manageable, and the one failed trial appeared to be due to technical issues with study design.
Given as a once- or twice-daily pill, the new drug is a rival for current rheumatoid arthritis injections that include expensive biotech medicines such as Humira from Abbott Laboratories (ABT.N) and Amgen’s (AMGN.O) Enbrel.
But it also faces competition from another new class of oral medicines, led by Pfizer’s (PFE.N) JAK-3 inhibitor CP-690,550, which has been in Phase III development for more than a year and is likely to be first to market among the new wave of pills.
One differentiating factor with fostamatinib could be its faster onset of action, which is important in rheumatoid arthritis since it means earlier bone protection.
Given the variability of response among arthritis patients to different types of drugs, AstraZeneca believes there is unlikely to be a single winner among the new pills.
Within the Syk inhibitor space, Bache estimates fostamatinib is at least two or three years ahead of rivals, which include a Phase I product from unlisted U.S. firm Portola Pharmaceuticals. (Editing by Will Waterman)