Allergy Therapeutics Share Discussion Threads

[gersemi] 21/9/2017 18:32

Tipped in the IC

Tip Update: Buy at 32.3p

Tip style - GROWTH
Risk rating -HIGH
Timescale - LONG TERM

Our previous tip -We said BUY at 19.8p on 21 Jul 2016
Tip performance to date - +63%

By Megan Boxall

The US allergy pharmaceuticals market has the potential to be very lucrative. Roughly 18m Americans sniff and itch their way through the hay fever season each year and, at present, treatment options are limited. But it is also a notoriously tricky sector to navigate. Allergy Therapeutics (AGY) is proof of that, gaining the go-ahead for the phase II clinical trial of its new grass allergy medicine – Pollinex Quattro (PQ) – after 10 years.

In 2007, Allergy’s final trial into the efficacy of PQ was put on hold after a participant reported numbness and weakening, which regulators couldn’t be sure had nothing to do with the treatment. That hold was only lifted in 2011, and since then the group has failed to show US regulators an acceptable dosage of the drug.

But with demand for PQ so strong, Allergy has been given the go-ahead to try again. The newest dosing study will begin imminently, according to management, and is expected to release results by the second half of 2018. If approved, PQ will be the first injectable allergy treatment available in the US.

But as well as sidestepping tight regulation, Allergy Therapeutics must hurdle another demon of the allergy drugs market: the placebo effect. In 1999 a food allergy vaccine made by Peptide Therapeutics successfully helped 75 per cent of patients on a clinical trial tolerate more of the food they were allergic to. Unfortunately, a similar number of patients on the placebo treatment responded the same way, meaning the trial was deemed a failure. It was a similar story at Circassia (CIR) last year when its cat allergy treatment failed to show any significant benefits above the placebo drug, which had improved symptoms by 59 per cent. Many academic studies have found this high placebo effect to be common in allergy drugs trials, but no-one can fully explain why.

Allergy Therapeutics should be more immune to placebo effect than its peers. PQ has already successfully improved the symptoms of more than 250,000 patients and is marketed in seven countries. Moreover, the trial has not been designed using the self-report measures that have caused problems for many allergy studies; instead patients’ eyes will be observed for signs of improvement before and after treatment.

IC View

Investors have been slow to forgive Allergy Therapeutics for its US misfortunes. The share price has gained good momentum in the past few months, but at 32p it is still far from its 2006 highs. There are factors to be wary of that are outside of the company’s control, such as tight US allergy regulation, but demand for PQ is clearly high. If Allergy can crack the tough US regulatory environment, the financial rewards could be big. Buy.

Last IC View: Buy, 25p, 03 Apr 2017

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[jimmyloser] 18/9/2017 07:11

It seems that we all know what role Tim H. is going to be doing over the next twelve months.

Allergy just go from strength to strength - Good Luck AGY.

[jimmyloser] 12/9/2017 13:14

With Tim being earmarked for USA/FDA link, then you can guess how the trials are goingAgree AuDigger, by the end of thr month we will be on the radars.Impo

[audigger] 12/9/2017 12:07

Looks like we may be seeing the start of a re-rating based on future potential. All the pieces are coming together; lets just hope that biology behaves itself!

[jimmyloser] 11/9/2017 07:24

Wow, that really does shout that we are now very confident about the outcome of current trialsUSA back on track!Well done AGYimpo/dyo

[qackers] 01/9/2017 14:48

Reminder of trading update
Allergy Therapeutics PLC Trading Update

18/07/2017 7:00am
UK Regulatory (RNS & others)

Allergy Therapeutics (LSE:AGY)
Historical Stock Chart
2 Months : From Jul 2017 to Sep 2017

Click Here for more Allergy Therapeutics Charts.
TIDMAGY

RNS Number : 3133L

Allergy Therapeutics PLC

18 July 2017

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Group")

Trading Update

15% constant currency revenue growth

Double-digit compound annual revenue growth over the past 18 years

18 July 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2017 ahead of its Preliminary Results to be announced in September 2017.

Financials

Revenues for the year are expected to be ahead of market expectations at GBP64.1m (2016: GBP48.5m). This strong performance represents 15% annual growth on a constant currency basis and 32% on a reported basis which reflects the favourable euro exchange rate. The Company is continuing to gain market share within its core markets in Europe. Revenues have grown over the past 18 years at a double-digit compound annual growth rate. Research and development expenditure for the 2017 financial year is anticipated to be lower than market expectations due to the phasing of activities across the year end and these costs will now be incurred in financial year 2018. The ongoing pipeline trials continue to progress well and timing remains in line with Board expectations.

The cash balance at the end of June 2017 was GBP22.1m (30 June 2016: GBP23.4m).

Products

Allergy Therapeutics' market penetration has continued with strong growth in Pollinex Quattro and Pollinex. Venomil sales have also performed well due to the pre-stocking of raw materials compared to elsewhere in the market where there have been shortages of stock. Sales of the newer products in the Group's portfolio (Synbiotics and Acarovac) continue to develop well.

Pipeline

In Europe, recruitment of patients for the pivotal Phase III PQ Birch trial is on track with the trial still expected to start in the autumn of 2017. Likewise for the US, the Phase II Grass MATA MPL trial is also still planned to start this autumn. Patients for the Acarovac Quattro Phase I trial are being recruited and results continue to be expected in the autumn of 2018.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "Revenue growth of 15% at constant currency reflects the continued strong performance of the product portfolio and its growing market share. Our successful strategy focuses on our patient-convenient products and controlled investment in our development pipeline to expand our addressable market. Our double digit CAGR of revenue over the past 18 years demonstrates that we have a robust, reliable and successful business model."

This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.

- ENDS -

[qackers] 01/9/2017 14:45

Results 28th September. Steady stream of small buys going through.

[audigger] 26/7/2017 12:27

I wouldn't complain as it presents a buying opportunity!

[richsawko] 26/7/2017 12:00

Is this the annual trudge down to mid 20's again? Seems to happen every year

[audigger] 19/7/2017 08:21

Approaching 35p by the end of the day would be good!

[jimmyloser] 18/7/2017 19:52

This was off target....updated to approaching 40p by October lol
Depending on the trials news.

jimmyloser
26 Jun '17 - 20:59 - 3270 of 3291 0 0 Edit

Into the thirties this side of October and the rest is beyond my crystal ball. lol

[richtea2517] 18/7/2017 19:42

Hop on the fun bus

[jimmyloser] 18/7/2017 16:34

Great day and truly deserved for the hard work put in here.

I see Finncap have upped their target, fwiw, so has jimmyloser!

[shauney2] 18/7/2017 11:53

finnCap up their target to 46p from 43p

[audigger] 18/7/2017 07:44

Impressive performance. Lets hope the share price can replicate this!

[jimmyloser] 18/7/2017 07:23

Well done and thanks to all at AGY.

You will not see many updates better than that one!

[jimmyloser] 12/7/2017 13:25

Not what it seems. It was me that took the price down by moving from one account to another this morning.

[audigger] 12/7/2017 13:06

Clearly not!

[jimmyloser] 11/7/2017 12:22

It could well be...................

17 07 2017
Trading update

[audigger] 11/7/2017 10:07

Are seeing the start of a rally ahead of next week's trading update?

[audigger] 06/7/2017 07:48

Excellent. The potential of these adjuvants is huge.

[jimmyloser] 06/7/2017 07:09

NON RNS Alert

Allergy Therapeutics PLC Publication of adjuvant studies in journals

06/07/2017 7:00am

RNS Non-Regulatory

Allergy Therapeutics PLC

06 July 2017

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Group")

Two studies of adjuvants in malaria and influenza vaccines published in peer-reviewed journals

Publications demonstrate the potential of Allergy Therapeutics' novel adjuvant systems in infectious diseases, further broadening the product pipeline

6 July 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that two preclinical studies carried out through its Bencard Adjuvant Systems division have been published in peer-review journals.

The two papers report that the novel depot adjuvant behind Allergy Therapeutics' successful allergy immunotherapy Pollinex(R) platform, microcrystalline tyrosine (MCT), both alone and in an adjuvant system, have broad applications and elicit high, sustained antibody titres demonstrating enhanced protective efficacy compared to conventional adjuvants including aluminium.

Commenting on the recent publications, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "These publications underpin the strategy for our Bencard Adjuvant Systems division, which focuses on extending the use of MCT(R) and VLP in further developing vaccines against unmet needs, and new and emerging infectious diseases that require an effective depot adjuvant."

The two publications are:

Comparison of a novel microcrystalline tyrosine adjuvant with aluminium hydroxide for enhancing vaccination against seasonal influenza: Heath et al., BMC Infectious Diseases (2017) 17:232

The paper authored by principal scientist Dr Matthew D. Heath & collaborators from Public Health England discusses the use of MCT(R) in a seasonal influenza vaccine model. The use of MCT(R) displayed higher binding affinity compared to the conventional depot adjuvant, aluminium, demonstrating the suitability of MCT(R) as a depot adjuvant in applications outside of allergy immunotherapy. MCT(R) elicited an immune response (HAI titre) indicative of protection in a pre-clinical model. The data provide evidence of the suitability of using the MCT(R) platform in an influenza model and address some of the issues associated with weakly stimulating vaccine targets/antigens.

Virus-like particle (VLP) plus microcrystalline tyrosine (MCT) adjuvants enhance vaccine efficacy improving T and B cell immunogenicity and protection against plasmodium berghei/vivax: Cabral-Miranda et al., Vaccines (2017) 5;10.

This publication authored with The Jenner Institute at the University of Oxford has been published investigating the use of adjuvants MCT and adjuvant system MCT+VLP (AdSys-VCT) in malaria. In a pre-clinical model, malaria antigens conjugated to VLP and formulated in MCT induced highest antibody responses, highest T-cell responses, and offered the best protection against malaria compared with antigens formulated with aluminium. Moreover, the study demonstrated that MCT(R) alone is able to elicit high and sustained IgG antibody responses that are specific and protective against P.vivax (malaria).

[audigger] 27/6/2017 17:34

We shall see. At least the timing of my top-up looks to have been good for once! As FarmerG mentioned yesterday, it would be good to see some clarity on timing particularly for the US, accepting all the caveats and uncertainties...