After spending 50 years building its allergy business in Europe, Stallergenes is waiting to learn whether it will shortly be taking its first step into the US market. The French company’s sublingual immunotherapy Oralair will be discussed by an FDA advisory committee tomorrow, before the regulator makes its decision early next year.
The company is hoping that the under-the-tongue tablet, designed to supress reactions to grass pollen, will persuade more allergy sufferers to try an immunotherapy; the injectable options currently available put off a lot of people. But as Oralair itself requires patients to take tablets for up to six months, there remains room for improvement. Two deals were signed this year over novel delivery techniques, and Stallergenes is following other small companies working on innovations in the space that might lead to further collaborations, chief executive Roberto Gradnik tells EP Vantage.
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Earlier this month Stallergenes announced it would be working with ActoGeniX to develop its mucosal delivery technology into oral allergy drugs, a deal that followed a respiratory allergy R&D collaboration with DBV Technologies, which has a skin patch technology.
Although it is unlikely a sustainable immune response can elicited by a very short course of treatment, Mr Gradnik says the hope is that higher efficacy with a lower dose can be achieved, with obvious implications for side effects and convenience.
“To re-educate an immune system is rarely a short term effort. But we are investing in the next generation. One of our strategies is innovation through co-operations, and there a lot of small biotechs that are bringing innovations into immunotherapy,” he says.
Circassia’s progress with its T-cell approach to allergy immunity, that promises to generate responses after only four or five injections, is being closely watched (EP Vantage Interview - Circassia gets $100m injection for allergy trials, April 19, 2011).
“Whether they will be successful is an interesting scientific question. Normally to do immunotherapy you need proteins, and they use very small peptides. But we are talking with them and other companies that use the same approach, it’s something we are following,” he says.
All of these approaches certainly represent a step forward from the under-the-tongue drops that still form the base of Stallergenes’ business. Available to treat around 60 different allergies, its Staloral allergen extract solution generates sales of more than €200m ($276m) a year, and are prescribed on a named-patient basis. With the aim of gradually desensitising a patient to whatever causes the reaction, it can take three to five years to rid or substantially lessen a person’s allergy.
The hope for Oralair – which contains the allergen extracts from five grass types common to Northern regions of Europe and the US – is that a relatively simpler, off-the-shelf product will attract new patients and prescribers. It requires the same lengthy duration of treatment as traditional droplet or injected allergy immunotherapies but comes with clinical evidence of efficacy that has not been available for named-patient products; this should help persuade those sceptical of the immunotherapy approach, Mr Gradnik believes.
In the entrenched named-patient market in the US, efforts to gain a stronghold with Oralair will be aided by the collaboration with Greer, which is the biggest supplier of the active ingredients to the specialists that compound injected treatments specifically for their patients.
“Although allergists do their own compounding in the US, and they make a lot of money out of that, it means that immunotherapy is widely used and the concept is well accepted in the US. But because it is injections, about half of patients who could benefit refuse treatment. This is our primary target with the tablet, the low hanging fruit, so we can satisfy the medical need of the patients and not go against the business model of the doctors,” Mr Gradnik says.
Piece of cake
The launch of this strategy depends on the meeting of tomorrow’s FDA advisory committee. Mr Gradnik says questions could potentially be asked about the tablet’s efficacy compared to better-known injections, and safety. Anaphylaxis is the biggest concern with injected products and these reactions were not seen in clinical trials of Oralair. A couple of severe laryngopharyngeal disorders were recorded, though, and given that approval in children is also being sought the safety data will be closely scrutinised.
The following day the panel will review an application of a similar product, Grastek, developed by ALK-Abello and being commercialised by Merck & Co. Sold as Grazax in Europe, the sublingual pill only includes allergens from one grass species.
For the time being allergy immunotherapy is set to remain an option for a small proportion of severe allergy sufferers. But Mr Gradnik believes that having a big pharma player like Merck enter this space can only be a good thing.
“Immunotherapy is not as used as it should be. Having the power of a big company like Merck will help change the market. Of course they will take market share from us, but we would prefer part of a bigger cake, rather than all of a smaller cake,” he says.