In the race to launch the first oral allergy immunotherapy in the US Stallergenes has managed to pip its German rival ALK-Abelló to the post. By getting the green light from the FDA yesterday for grass allergy drug Oralair, Stallergenes has managed to give itself a clear run at the market for a good couple of months.
But while Stallergenes’ under-the-tongue treatment will offer the first new needle-free option for users, as ever the real winner will be the company that converts approval into strong sales. And this will not be easy for either group.
For now though Stallergenes can rest assured that it will be banking a $10m milestone payment from its US partner Greer, a fact that was among the reasons shares in the French group rose by 8% in afternoon trading to €62.50.
Once the initial euphoria of approval wears off, though, timing will be a big hindrance for Stallergenes. The grass allergy season only runs for a few months of the year, and treatments should be started ahead of each one.
In the case of Oralair the drug needs to be administered four months in advance, so ideally prescriptions would have been started to be filled in December. This means that analysts are now expecting reduced sales this year.
But this means that sales for ALK-Abelló’s Grastek, which is partnered with Merck & Co in the US, will be affected even more (Stallergenes and ALK-Abelló take a step closer to the US market, December 13, 2013).
Another potential brake on Grastek sales is that that Oralair has a shorter treatment duration – five to six months –and is effective against five grasses. Grastek has to be taken throughout the year and only covers ragweed.
The other issue that could weigh on sales of both products is the FDA’s very cautious stance over a possible allergic reaction to oral immunotherapies, which has led the regulator to recommend that an Epipen be prescribed alongside Oralair and Grastek to prevent the chance of anaphylaxis.
Additionally, the first administration of Oralair must occur in a doctor’s office and the user observed for at least 30 minutes afterwards. This is in spite of both drugs having been used in thousands of patients in Europe, and arguably having a better safety profile than their injected counterparts. Until this message gets through in the US, takeup might be slow.
This is reflected in sales expectations; Oralair, which is targeting patients who refuse allergy injections, has peak forecast revenues of around $300m. In contrast, consensus sales expectations for Grastek stand at a modest $113m in 2018.
While US approval has come as a welcome boost to Stallergenes, until Oralair and Grastek can prove their worth in other patient populations, with particular refrence to asthma, this could be a very quiet treatment revolution.