Ipsen shares gained 7% to trade near record highs on news last week that the European Medicines Agency recommended approval for febuxostat, a treatment for gout.
The ruling was a positive surprise, given that many analysts believed there was a high chance of a delay in approval, or even a knock-back. The decision is also good news for Teijin, the Japanese drug maker which discovered the drug, out-licensed it, and is now set to receive royalties.
Progress is also expected in the US, where the product is being developed and commercialised by TAP Pharmaceutical, the Abbott Laboratories/Takeda joint venture. Abbott said in October that approval would be sought in the first quarter of this year, and with two approvable letters already under its belt, the group will be hoping to have got it right this time.
Gout, a particularly painful type of arthritis occurring most frequently in men, is caused by elevated levels of uric acid, or hyperuricaemia. Febuxostat, an oral, once-daily medication, has been shown to lower and maintain uric acid levels more effectively than allopurinol, the current standard of care treatment.
Considering there have not been any new treatments launched for gout for 40 years, other than newer anti-inflammatories, analysts are expecting a successful launch. Consensus sales forecasts for 2012 in Europe sit at $220m, and $383m in the US, according to EvaluatePharma.
Ipsen plans to promote the drug itself in France, and will seek partners elsewhere in Europe, news on which should soon be forthcoming.
Hard to treat niche
While gout itself is a fairly niche indication, there are a subset of patients which develop extreme symptoms such as deposits on the joints (tophi) and swellings, and do not respond to current treatments. Also, allopurinol cannot be given in large doses and some people cannot tolerate it.
Savient Pharmaceuticals' Puricase should fit this refractory, hard-to-treat population. The drug is very effective at ridding the body of uric acid, and studies have suggested it can reduce tophi and painful gout flares. The US company has completed phase III trials, and meets the FDA to discuss a filing on April 17.
Concerns about anaphylaxis means approval straight off is viewed as uncertain, but given the unmet medical need and the potential for a speedy review, analysts believe the drug could be launched next year. Consensus for 2012 sales sits at $391m.
Because they address different stages of the disease, febuxostat and Puricase are not likely to compete directly.
But with a handful of other drugs in trials, the area could start to become more competitive a bit further down the line.
Regeneron Pharmaceuticals' IL-1 Trap and Ardea Biosciences RDEA806 are both in phase II trials, and Pfizer is about to start a phase III trial of its COX-II inhibitor Celebrex, which will run to the end of 2009.