Q1: Now, Allergy Therapeutics announced today that it has obtained approval to begin a Phase I clinical trial of its Acarovac MPL vaccine in Spain, what’s the product designed to do Gary?
A1: It’s essentially for the treatment of house dust mite allergy and so Acarovac MPL is an enhanced version of the company’s existing vaccine Acarovac Plus and this is currently used as a named patient product for the treatment of allergies caused by house dust mites. House dust mite allergy is a common problem in many countries, including the US and Europe, and is growing in accordance in certain Asian countries like China. House dust mite allergies typically allergic rhinitis causes year-round sneezing, runny nose, itchy eyes and so, the usual signs of allergic rhinitis, whilst these symptoms can adversely impact day to day life the bigger concern is that this allergy can progress to a more serious condition known as allergic asthma, which can be life-threatening.
So, Acarovac MPL takes the strengths of the existing Acarovac Plus product and enhances this through the addition of MPL which is the company’s vaccine adjuvant and an adjuvant is like an accelerator for immune responses. MPL improves the performance of vaccines and it is used in the company’s Pollinex Quattro range of vaccines for seasonal allergies such as hay fever caused by pollens. So, by treating allergic individuals with the Acarovac MPL the company hopes to safely and effectively induce a rapid reduction in the symptoms of house dust mite allergy and do this using many fewer injections than conventional injected vaccines for these sorts of allergies.
Q2: What does the CTA clearance mean for the product’s development?
A2: Ordinarily, there’s considerable work involved in gaining clearance from the regulators to take new products into clinical trials. So, before such a clearance is granted, companies have to demonstrate that such a product will be safe, that there are reasonable grounds to believe that it will be effective and that the product can be consistently produced according to the high standards required for pharmaceuticals so that’s GMP manufacturing.
For Allergy, this is a relatively straight forward thing because it already uses different components of these vaccines in some of its existing vaccines so allergoid from house dust mite is already included in Acarovac Plus. The other key components of this vaccine so microcrystalline tyrosine or MCT and the MPL itself are also used on a fairly regular basis in the products sold throughout Europe by Allergy Therapeutics. So, assuming successful study, the vaccine will require further trials in order to obtain the full regulatory approval for commercial sales, we believe that, with favourable results, such an approval might be possible in 2023 which seems like a long way away. In the meantime, assuming this study gets positive results, that will enable Allergy Therapeutics to launch the vaccine and sell it on a named patient basis similar to the Acarovac Plus but this would be an enhanced version.
Q3: Now, you’ve mentioned that house dust mite allergy is a relatively common allergy, so if we’re talking of a fully approved vaccine, what sort of sales do you think might be possible for Allergy Therapeutics?
A3: In our usual mode of conduct here, we’ve modelled sales for the products following a launch which we estimate could be in 2024 in the USA and Europe so there’s still roughly 6 or 7 years to go before it might complete that development for full regulatory approval. So, from that point of launch to peak sales, as we refer, we think which might occur in 2030, we believe sales could exceed roughly $500 million with $200 million of those in Europe and $300,000 in the US. Clearly, that’s a long way off but in the meantime the product would be available on a named patient basis so the company would be able to provide the product for specific patients if a doctor prescribes it.