Allergy Therapeutics Plc (LON:AGY) Lead Medical Writer and Principal Scientist Matthew Heath caught up with DirectorsTalk for an exclusive interview to discuss the company’s background, the 93p valuation from Hardman & Co, the World Vaccine Congress and the US FDA trials
Q1: Now Matthew, Allergy Therapeutics are a speciality pharmaceutical company with a focus on allergy vaccination. Can you tell us a little bit about the background of the company, a brief overview if you will?
A1: So we develop and manufacture allergy immunotherapy vaccines and diagnostics using technology platforms that are unique compared to the rest of the products on the market. Our differentiation has been key to our growth strategy that has allowed us to build and strengthen our product base and develop pipelines further. Our recent press release highlights a key USP of our product portfolio which is the use of our adjuvants, literally the term adjuvant is from Latin and means ‘to aid’ so in allergy and in non-allergy indications, the addition of an adjuvant to a vaccine can make the difference in whether a product is actually effective or not. This has really paved the way to allow us to provide short course therapy, not possible in the absence of adjuvants for instance. So the data to be presented at the World Vaccine Congress will include the use of our patented adjuvants in infectious disease applications such as influenza and malaria so all in all, we have a growing business achieving revenue in the last financial year of £43 million, through our own sales and marketing infrastructure including distributors worldwide and our RandD investments include over £100 million in the last ten years.
Q2: Hardman and Co produced a report on Allergy Therapeutics value in shares at 93p each, the upside was based on a miss-match between the value of AGY versus your peers. What are your thoughts on this?
A2: Absolutely. There is a miss-match and we believe this is in part due to the realisation, a growing realisation, of our extensive clinical development pipeline for allergy products worldwide for which registration approval and the launch of new and existing products in emerging and existing markets is now more visible to potential investors. On top of this, I think we are exploiting our novel intellectual property outside the allergy fields so we are not only revolutionising allergy treatment but now encompassing new applications with high profile research groups such as the Jenner Institute at the University of Oxford and Public Health England. So given that our clinical protocols have been agreed and endorsed with both European and US regulators, to date our Pollinex Quattro brand has been extensively used as well, and in actual fact this has validated the registration and launch plans for the outside world.
Q3: You touched on this briefly earlier that you’ll be attending the World Vaccine Congress in Madrid in just a few days’ time, how will this benefit the company?
A3: Well this a flagship Congress for vaccine research and development. We have been very privileged to have been working alongside a leading group from the Jenner Institute, from the University of Oxford and also Public Health England. The work has been exploring the use of our patented novel adjuvant technology platform in infectious disease models so as consequence of this, this adds value to our intellectual property of which we have continued to develop and strengthen. Just to put this into more context, the allergy market is continually evolving and figures suggest in the region of 1 in 3 people now suffer from allergies and that’s really quite a significant statistic and whilst our experience in heritage is based upon our allergy, we realise the promise of our patented adjuvants in a broad spectrum of vaccine immunotherapy. We also believe that we align MCT development opportunities outside allergy with ongoing and future development ventures.
Q4: Now, I know it’s too early to be asking about the game-changer but how are the US FDA trials progressing?
A4: So we’re at a very exciting stage really of development in the US, we’re looking to build on our existing phase 3 studies to develop the best vaccines for North America and also having learned from recently completed studies in Europe, we have had a very proactive dialogue with the FDA who have agreed for us to assess and dose adaptations to maximise the likelihood of a product with the best efficacy. In addition, our planned studies using state of the art pollen chambers so this will be the biggest study using a pollen chamber, and this helps to standardise optimal dosage selection, in fact we’ve just completed a tolerability study to pave the way to initiate the chamber studies with active patient recruitment, that is currently ongoing in New Jersey and in Cincinnati.
Q5: What’s in the pipeline for the next 6-12 months for Allergy Therapeutics? What should investors be looking out for?
A5: Many significant milestones, we will have reached key stages for healthcare agency review towards our goal for market authorisation status. We have already discussed our activity in the US and we’re actively involved in product development in new territories as well and really building on the success of the last 12 months so we were published in a number of research articles of late and many are pending so you can expect to see us continuing to publish in journals of high impact, both in allergy and for wider vaccine audiences with the goal of providing the best medicines for the patients who deserve it.