Allergy Therapeutics Share Discussion Threads

[dice1950] 14/7/2016 21:04

Mike Mitchell Panmure Gordon who covers Allergy Therapeutics PLC (LON:AGY)
14th July 2016
Forex headwinds could turn into tailwinds at Allergy Therapeutics Allergy Therapeutics PLC (LON:AGY) recently announced 19% growth on a constant currency basis in the year just ended

[dice1950] 14/7/2016 21:04

!YOUTUBEVIDEO:kRNhwSgEmaA:
Mike Mitchell Panmure Gordon who covers Allergy Therapeutics PLC (LON:AGY)
14th July 2016
Forex headwinds could turn into tailwinds at Allergy Therapeutics Allergy Therapeutics PLC (LON:AGY) recently announced 19% growth on a constant currency basis in the year just ended



Published on Jul 14, 2016
Manuel Llobet, chief executive at Allergy Therapeutics (LON:AGY), tells Proactive Investors revenues for the year ended June were slightly ahead of market expectations.


Welcome to Allergy Therapeutics, a European-based pharmaceutical company dedicated to continued allergy prevention.

[jimmyloser] 13/7/2016 09:22

The impact of that slippage is there now for all to see. Take that out of the equation and this IS the same EXCITING AGY.

Well done Manuel and Co. A director purchase when possible would show us all your confidence in the USA future!!

lol

impo/dyor

[audigger] 08/7/2016 13:39

As we appear to have stabilised at 18-19p I decided to add today. I thought it may pull back to about 14p but the EU business growth appears to be sustaining this at a slightly higher level. If we stay below 20p in to August I will add some more....just waiting until I have the cash!

[maddox] 08/7/2016 09:27

Excellent research results - to put this into perspective - house dust mites (HDM) are the most common cause of allergy in the world.

HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies.

That's a massive market to go after.

Regards, Maddox

[jimmyloser] 08/7/2016 07:34

BETTER NEWS:

8 July 2016

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces publication of 1-year follow up results of its mite allergoid immunotherapy Acarovac Plus(TM)

Significant decreases in symptom scores reported with Acarovac Plus

Product treatment was proven to be well tolerated and safe

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the publication of a 1-year follow-up study of patients using Acarovac Plus(TM), its unique, microcrystalline tyrosine-adsorbed, house dust mite-allergoid subcutaneous immunotherapy in the peer-review journal Immunotherapy.

A previous study in 2014, led by Dr Albert Roger, Director of the Allergy Unit at Universitari Hospital Trias I Pujol, Badalona, Spain, assessed the tolerability and safety of Acarovac Plus(TM) in patients with respiratory allergy to Dermatophagoides pteronyssinus under conditions of normal clinical practice. This 1-year follow-up investigation, with the existing patient pool and testing regimen, assessed effectiveness using a nasal provocation test and measurement of immunological markers that are indicative of immunotherapy success.

A statistically significant reduction in symptom scores was observed at both follow-up visits (four weeks and one year), with >50% reduction in symptom scores recorded after one year. Moreover, significant improvements in immunological markers were noted at the follow-up visits. Patients reported statistically significant improvements in satisfaction scores after one year in relation to overall effectiveness and convenience of the treatment.

2016 has seen a significant increase in sales of Acarovac Plus(TM) to over EUR 1 million in key markets Spain and Portugal, compared to 2015. Sales of house dust mite immunotherapy are expected to increase rapidly over the coming years with over 20% of the population in Europe experiencing an allergic reaction to house dust mites. Therefore, Allergy Therapeutics is continuing to develop Acarovac Quattro(TM), an ultra-short course therapy utilising the adjuvant monophosphoryl lipid A (MPL), which is used in the Company's successful Pollinex Quattro product range currently in late stage development in Europe and the US to complement Acarovac Plus(TM).

Commenting on the publication, Dr Albert Roger, principal investigator for the study, said: "The successful clinical results in the 1-year follow-up study clearly demonstrate the effective treatment of house dust mite allergy by Acarovac Plus(TM). We also observed significant decreases in symptom scores and improvement in nasal sensitivity immediately after the up dosing phase of one month and a high rate of patient satisfaction early in treatment."

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "This data further reinforces the benefits of Acarovac Plus(TM) in the perennial allergy vaccine market. Using maintenance injections six weeks apart, Acarovac Plus(TM) has been shown to decrease the symptoms of house dust mite allergy one year after treatment. This dosing regime has the potential to improve the adherence and compliance that is essential for a successful treatment. Acarovac Plus(TM) bolsters our portfolio of allergy immunotherapy products on the market in Europe and we look forward to continued good growth."

[audigger] 27/6/2016 18:28

Excellent JL, thanks for posting this. I am reassured by what Manuel says that there isn't any significant safety or efficacy issue. The waiting game continues!

[jimmyloser] 27/6/2016 15:44

Feedback from the company:
I wrote to Manuel earlier to-day. Here is his reply. Permission given to share this response.

Thank you very much Jim.
We would have preferred to be able to pick a dose from this study, but I think is part of the process.
In a full clinical development program (often 7 or 8 studies involved) there is always one or two inconsistent or inconclusive studies. The G204 has been one of them.
We are confident we will get a proper dose response using the CPT technique and then, we will be able to go into phase III with the best dose possible.

In the meantime, we are enjoying our progress in our European business, where we are accelerating our market penetration.

Best regards
Manuel

[audigger] 27/6/2016 12:48

Exactly mobox. Are we dealing with a trial design issue such that G204 has failed to yield appropriate data or has G204 identified an issue based on sound data? If the latter then Phase III actually happening may not be a raging certainty. Perhaps institutional investors are better informed than us mere mortals?

[mobox1] 27/6/2016 11:24

This is a paragraph from the previous release announcing the G204 trial. The last sentence is important.

"G204 is a dose-finding study using, for the first time, two mobile environmental exposure chambers based in Cincinnati and in New Jersey Shore. The chambers are inflatable laboratories that enable subjects with grass pollen allergy to be exposed to a constant concentration of pollen for periods of three hours over four consecutive days. Their great advantage is that they can be used outside of the grass pollen season for accurate dose selection studies.

This means that even if it all goes smoothly with a new dosage trial, phase III trials won't start till 2018.


Questions for me are:

1. How much money will the new trial cost and can they fun it from funds raised/current cash flow?

2. Could the reasons why the recent dosage trial failed affect whether the FDA will allow the product to progress to Phase III?

3. They state; "The next dose range finding study is planned to start in 2017". The word "planned" does not give me the impression of high conviction . What are the reasons that could prevent this happening?

Having been a holder of AGY when the FDA placed a "clinical hold" on GrassMATAMPL back in 2007, I probably won't be around by the time they eventually get this product to market.

As with jimmyloser, my basic premise has always been that as it works in Europe, all that is needed to get it into the USA is the ticking of boxes through US approved trials. If the planned launch date is now 2020/21, my patience may finally expire before I do.

[audigger] 27/6/2016 10:45

My perspective is that, by not being more open as to the reason behind this then its going to lead to speculation. I think Qackers is probably right as the RNS suggests that the issue is methodological by indicating the switch to a CPT based test for the repeat range-finder. The RNS is quite confusing with regard to the timing of the next steps as they say the repeat dose-range finder (which is presumably still part of the Phase II work)won't start until 2017 yet they indicate they will have an end of phase II meeting with FDA in 2016. Surely they need the repeat range-finder data to set doses for Phase III as well as the implication of G204 findings. Is it just me, or is that confusing!

[jimmyloser] 27/6/2016 09:56

Armageddon it ain't.
I personally take great comfort out of the fact that we know the product works and is attractive to the market as can be witnessed by another strong growth figure in Europe.
impo, this team will sort this setback and quickly.

In the eye teeth of a storm on the markets, the reaction is better than many of us anticipated

impo/dyor

[apfindley] 27/6/2016 09:16

Oh well.Time to get into Gold for safetyGWMO

[maddox] 27/6/2016 09:07

These results are going to cost time and delay to US launch of 9 to 12 months. On the positive side the 19% growth is very reassuring.

Regards Maddox

[qackers] 27/6/2016 08:33

Trying to understand the RNS
Nothing to suggest safety problem. Surely they would be asking for trouble if they tried to conceal this as it would come out eventually.
They reported successful dosage trial at lower dose.
Going to be generous and sugest that the problem was with the method used.
(novel technology of the mEEC (mobile environmental exposure chamber)

Positives from the RNS

"In Europe, our market penetration continues to accelerate, outperforming the market with 19% year-to-date revenue growth*, an increase from the 12% revenue growth* we had achieved in December 2015.

"Elsewhere in the pipeline, we successfully completed a Phase IIb dose finding study for Pollinex Quattro Birch in Germany and Austria earlier this year; we've completed the exploratory dose finding study in the US; set up the protocols for the Acarovac Quattro programme in Spain; and we have initiated the proof-of-concept plan for the VLP Peanut allergy vaccine in Switzerland.

"We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets."

*revenue growth is at constant currency and is supported by the Immunal acquisition.

[audigger] 27/6/2016 08:11

Just to clarify that I think my 14p guesstimate is where we'll settle in the months to come not today! As you say amongst the total chaos who knows.......answer is nobody!

[pugugly] 27/6/2016 07:51

In this market could get well and truely hammered - At a guess 20% hit - but what do I know !!

[audigger] 27/6/2016 07:32

Here comes a buying opportunity! I see a drop to 14p as very much on the cards. I am am disappointed that the company have chosen not to be transparent as to the reasons why they can't yet set doses going forward. Is the issue efficacy or safety? One has to suspect the latter so this could potentially be a major set back. I'm not going to sell but neither am I going to buy the drop unless there is more clarity as to what AGY intend to discuss with FDA. Again the lack of transparency is not what I expect from AGY unless there is a reason why they genuinely can't reveal the issue.

[jimmyloser] 27/6/2016 07:11

Oh dear.

And on the day we get this bombshell our former FD is granted share options!

Rich!

Read post 3107 again.

[audigger] 22/6/2016 07:04

That's shocking news for those that hold Circassia. At least for the products currently in trials for AGY efficacy has been established as indeed has safety so the risks of such a dramatic outcome are lower. Shame the share price doesn't currently reflect this

[algernon2] 21/6/2016 22:36

" MARKET REPORT: Drug pioneer Circassia Pharmaceuticals dives 66% as cat allergy remedy trials collapse "