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Allergy Therapeutics PLC (AGY)     

banjomick - 01 Feb 2016 13:59

logo.png

Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

Chart.aspx?Provider=Intra&Code=AGY&Size=460&Skin=RedWhite&Scale=0&Type=2&Cycle=MINUTE1&Layout=Intra;IntraDate&E&Ind=VOLMA(60);&Layout=Intra;IntraDate&E=UK&YFormat=&XCycle=Hour2&Fix=1&SV=0Chart.aspx?Provider=EODIntra&Code=AGY&Size=460&Skin=BlackBlue&Type=2&Scale=0&Span=YEAR1&MA=&EMA=&OVER=&IND=VOLMA;&XCycle=&XFormat=&Layout=2Line;Default;Price;HisDate&SV=0

NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

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banjomick - 27 Oct 2016 17:06 - 54 of 159

27 October 2016 
Allergy Therapeutics plc
 
Issue of equity in respect of the exercise of options
 
Allergy Therapeutics announces the issue and allotment of 80,000 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 80,000 share options by certain employees.
 
Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8:00 a.m. on 3 November 2016. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.
 
Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 593,444,020 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 593,444,020. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.

http://www.moneyam.com/action/news/showArticle?id=5438949

banjomick - 02 Nov 2016 08:33 - 55 of 159

2 November 2016
 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
 
European Patent Office grants new and expanded patent underpinning Allergy Therapeutics' core Microcrystalline Tyrosine technology
 
Patent already granted in the United Kingdom and New Zealand
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, today announces that the European Patent Office has granted a broad technology patent relating to the Company's unique Microcrystalline Tyrosine (MCT) depot adjuvant manufacturing process. This patent covers the novel manufacture and physiochemical characteristics of MCT in combination with one or more antigens, further strengthening the Company's core intellectual property.
 
The granting of this patent further strengthens Bencard Adjuvant Systems, the wholly-owned division of Allergy Therapeutics which specialises in developing and optimising aluminium-free adjuvants for infectious diseases. Recent data generated have shown how MCT has a synergistic effect when coupled with another adjuvant from BAS's portfolio, Virus Like Particles (VLP), to create the adjuvant system AdSys-VcT. As recently announced, this adjuvant system demonstrated protective efficacy in a malaria model in a study performed in collaboration with the University of Oxford, UK.
 
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "We are pleased to expand this key patent and are excited by the potential for MCT as a core technology within our adjuvant portfolio to create novel and efficacious vaccines, both in allergies and also in infectious disease areas such as malaria and influenza. This further underpins the future pipeline for products, and the long term success of Allergy Therapeutics to continue innovating and producing novel medicines."

http://www.moneyam.com/action/news/showArticle?id=5441981

banjomick - 02 Nov 2016 09:11 - 56 of 159

From todays news "The granting of this patent further strengthens Bencard Adjuvant Systems, the wholly-owned division of Allergy Therapeutics which specialises in developing and optimising aluminium-free adjuvants for infectious diseases".

More info:

Bencard Adjuvant Systems
Bencard Adjuvant Systems is a division of Allergy Therapeutics UK; based in Worthing, on England’s south coast.

Bencard Adjuvant Systems specialise in developing and optimising adjuvants for infectious diseases, cancer immunotherapy and allergen immunotherapy and are committed to engaging in long-term partnerships with those who require our patented platform of adjuvant technologies.

Please click on the link below to download a copy of our brochure to find out more.

http://www.allergytherapeutics.com/media/1238/bencard-adjuvant-systems.pdf

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http://www.bencard-as.com/

banjomick - 30 Dec 2016 15:53 - 57 of 159

30 December 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the 'Company")
 
Grant of Awards under Long Term Incentive Plan
 
Allergy Therapeutics (AIM:AGY), the fully integrated pharmaceutical company specialising in allergy vaccines, announces that, pursuant to the Company's Long Term Incentive Plan ("LTIP") the following conditional awards of shares of 0.1 pence each were made to Executive Directors at nominal cost of 0.1 pence each on 30 December 2016.

The issuance and distribution of ordinary shares of 0.1 pence each under the LTIP is conditional on the satisfaction of performance conditions which include an earnings growth test over a three year testing period to 30 June 2019 and share price growth over the 3 year plan cycle.

http://www.moneyam.com/action/news/showArticle?id=5473207

banjomick - 06 Jan 2017 13:35 - 58 of 159

Broker 'nuts' about Allergy Therapeutics; reckons stock could double in value
08:34 06 Jan 2017

Initiating coverage of the vaccines business, finnCap set a price target of 40p a share based on its analysis of the company’s peer group.

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A leading small-cap broker said it is ‘nuts’ about Allergy Therapeutics plc (LON:AGY), which it reckons has the potential to double in value.

Initiating coverage of the vaccines business, finnCap set a price target of 40p a share based on its analysis of the company’s peer group. Currently, the stock is changing hands for just over 20p.

Analyst Mark Brewer reckons the allergy immunotherapy market is worth around US$800mln here in Europe and US$1.7bn in the US.

“The potential addressable market, however, is estimated to be much larger at nine billion dollars,” he added.

The company’s lead product is Pollinex Quattro (PQ), a short-course hay fever treatment administered by injection.

On sale here in Europe, it is undergoing trials ahead of regulator sign-off in the US. In fact Brewer reckons there is “substantial further upside” when PQ gets the green light Stateside.

“A development programme that should result in an approved product in Europe and the US in 2021 provides significant upside to the current valuation,” said the finnCap number cruncher in his investment conclusion.

“We consider the current share price to be out of line with its nearest peers.”

The 33-page report gives a comprehensive overview of Allergy and also provides some financial grist.

finnCap reckons Allergy will turnover £59.4mln this year, rising to £65.4mln and then £71.4mln.

Ian Lyall

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banjomick - 06 Jan 2017 16:26 - 59 of 159

Financial Calendar

16 01 2017 Trading update

01 03 2017 Interim Results 2017

banjomick - 07 Jan 2017 10:39 - 60 of 159

finnCap - Allergy Therapeutics, Initiation of coverage (Video)
Fri, 06 Jan 2017, 03:30pm GMT

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banjomick - 10 Jan 2017 10:47 - 61 of 159

By Harriet Mann | Mon, 9th January 2017 - 14:09

Allergy Therapeutics

With a quarter of the UK suffering from hayfever at some point in their lives and 10-30% of the global population afflicted, the European allergy immunotherapy market (AIT) is worth $0.8 billion (£0.66 billion). In the US it is worth more than double that, at $1.7 billion.

Look at the potential addressable market and its value surges to around $9 billion. This backdrop is perfect for pharmaceuticals business Allergy Therapeutics (AGY).

The allergy vaccination group's profitable European operation is busy gobbling up market share as it gathers financial momentum. Revenue is expected to grow 23% in 2017 thanks to foreign exchange tailwinds, and gross margin should climb 260 basis points to 73.6% as volumes grow on a fixed cost base.

Before crucial research and development costs and general operational spend, profit should jump by a third to £19 million, finnCap analysts reckon.

Outside the flagship European business, Allergy also houses a US division that is trialling the Pollinex Quattro treatment. While the group continues these studies finnCap thinks it will remain loss-making.

Trading at a chunky 45% discount to its peers, with a profitable business and healthy pipeline, the valuation looks unjustified. finnCap believes the shares are worth nearly double at 40p, which would give them a market value of £235 million.

http://www.iii.co.uk/articles/381415/top-10-small-cap-share-tips-2017

banjomick - 11 Jan 2017 12:09 - 62 of 159

The dates (previously posted 6th January) have changed slightly on the AGY website so I've updated the header accordingly:

EVENTS

19 01 2017 Trading update (tentative)
29 03 2017 Interim Results 2017 Announcement (tentative)

banjomick - 19 Jan 2017 08:27 - 63 of 159

19 January 2017 
Allergy Therapeutics plc
 
Trading Update
 
-      H1 reported revenues ahead of expectations
-      Regulatory update: Pollinex Quattro clinical development programs to proceed as planned
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today provides an update on trading for the six months ended 31 December 2016 ahead of its unaudited interim results to be announced on 29 March 2017.
 
Financials

Reported revenues for the six months ended 31 December 2016 are expected to be £40.4m (2015: £29.0m), representing 17.9% organic growth at constant currency* (39.3% growth on a reported basis, aided by the impact on euro revenues of the weak pound). This growth reflects continued strong momentum across the majority of the Company's key markets. In a flat European market, the Company is fuelling its growth by increasing market share in most of its key markets. The main contributions in terms of net sales growth were generated in Germany, Austria, Spain and The Netherlands. In terms of products, growth is being provided across the whole portfolio, with the Company's ultra-short course aluminium-free therapies being the main contributor. The Board expects continuing growth in the second half of the year.
 
The strength of the euro against sterling has also led to higher overheads and R&D costs as most of these costs are incurred in continental Europe in euros but are reported in sterling.
 
The cash balance at 31 December 2016 was £27.8m (£33.2m at 31 December 2015).
 
Regulatory

Further to the Company's announcement on 27 June 2016, the Company has held discussions with the US regulatory authorities in relation to its US Grass MATA MPL programme and is proceeding as planned with the safety trial (G104) in the USA and the Phase II conjunctival provocation test dose selection study (G205) in Europe in 2017, ahead of the planned pivotal Phase III trial (G306).
 
Commenting on the positive trading update, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The Company's progress continues according to our long-term plans both in gaining market share in our main territories and with our clinical development. Our 18% top line organic growth in real terms reflects the quality of our products, technology and team, and the underlying convenience of our ultra-short course vaccines. We are excited by the prospects of the Company as we continue expanding our operations in Europe, progressing our development pipeline and moving forward with a world-class portfolio of allergy vaccines.  We are confident about the full year and look forward to updating shareholders on further progress throughout 2017."
 
*Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements.

http://www.moneyam.com/action/news/showArticle?id=5482133

banjomick - 19 Jan 2017 08:51 - 64 of 159

Not to be sneezed at - Allergy Therapeutics revenues up 18%
07:42 19 Jan 2017

The company, which has developed short course inoculations against hay fever, said turnover was £40.4mln in the six months ended December 31.

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Allergy Therapeutics plc (LON:AGY) said it had gained share in a “flat” European market as it said sales had grown strongly in the first half of its financial year.

The company, which has developed short course inoculations against hay fever, said turnover was £40.4mln in the six months ended December 31.

That represents an increase of 18% at constant currencies or 39% when the translational currency effect of the weak pound is brought into play.

“We are excited by the prospects of the company as we continue expanding our operations in Europe, progressing our development pipeline and moving forward with a world-class portfolio of allergy vaccines,” said chief executive Manuel Llobet.

“We are confident about the full year and look forward to updating shareholders on further progress throughout 2017."

The drug development programme in the US and Europe is proceeding to plan, Allergy said.

Ian Lyall

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banjomick - 20 Jan 2017 07:54 - 65 of 159

20 January 2017
 
Hardman Research: Investment driving market share gains

Investment driving market share gains: AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies.

Pollinex Quattro continues to gain market share despite being available in Europe only on a 'Named Patient' basis.

Trials to obtain full regulatory approval as a biological have progressed well in the EU, and are back on-track in the US with a planned new safety trial.

AGY remains on course to have the first short-course allergy vaccine approved in both Europe and the US. Meanwhile, an excellent trading performance in 1H'17 shows that AGY is continuing to gain market share from its international peers.

Please click here for the full report:
http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/20.01.17-investment-driving-market-share-gains.pdf


http://www.moneyam.com/action/news/showArticle?id=5482889

banjomick - 23 Jan 2017 10:09 - 66 of 159

INTERVIEW: Zeus Capital Upgrade forecast for Allergy Therapeutics Plc
Uploaded by DirectorsTalk
Friday, January 20, 2017 at 9:45 AM EST

Allergy Therapeutics Plc (LON:AGY) is the topic of conversation when DirectorsTalk caught up with Dr Gary Waanders the Director of Healthcare Research at Zeus Capital. Gary explains whats driven growth in the 6 months to Dec 31st, affects on the full year and what other things should we be focusing on for Allergy Therapeutics.

http://www.directorstalk.com/interview-zeus-capital-upgrade-forecast-allergy-therapeutics-plc/

banjomick - 01 Feb 2017 08:01 - 67 of 159

01 February 2017 
Allergy Therapeutics plc
 
Positive Efficacy and Safety Data Shown in Peanut Allergy Vaccine
 
1 February 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive results from preclinical research into its unique therapeutic peanut allergy vaccine, Polyvac® Peanut. Having delivered these positive preclinical Proof of Concept results, Allergy Therapeutics will now progress the vaccine in accordance with its stated strategic plan when funding the programme and will proceed to Phase I development following completion of a first in man safety data trial.
 
The findings demonstrate that a single dose of the Company's virus-like-particles (VLP) adjuvant combined with recombinant peanut allergen successfully protected against anaphylaxis when challenged with peanut. Additionally, when examining symptom scores in the investigational model, those vaccinated with the candidate vaccine exhibited no symptoms compared to placebo. Furthermore, the safety profile of the product was evaluated via an intravenous challenge and found that the vaccine itself did not induce anaphylaxis in peanut sensitised subjects (a hypoallergenic vaccine).
 
Allergy Therapeutics' innovative peanut vaccine is focussed on a subcutaneous application of recombinant peanut allergen coupled with its state-of-the-art VLP adjuvant to increase the safety and efficacy profile. This approach aims to induce protective immunity, enabling shorter therapy duration and an enhanced safety profile and thus has significant implications for peanut allergy therapy with the potential to redefine the market for food allergy products. Alternative peanut vaccines in development often require repeated and long-lasting exposure transdermally or orally which may limit patient adherence.
 
Food allergy represents a significant and strategically important area for the Company, with peanut allergy treatments alone being an $8 billion p.a. addressable market globally. Allergy Therapeutics has the exclusive rights to develop VLP technology, a carrier system to present allergens to the immune system, for allergy vaccines.
 
Allergy Therapeutics intends to publish full data from this study in a peer-reviewed journal.
 
Commenting on the data, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Part of our international growth strategy has been to expand our immunotherapy platforms into other indications to widen our total addressable market. Consequently, whilst recognising the early stage nature of this project, we are extremely encouraged by these results. The data clearly demonstrate that when our unique adjuvant is coupled with recombinant peanut allergen it provides protection against anaphylaxis and also indicated no safety concerns often associated with traditional injected peanut vaccines. Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives. This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience."
 
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

http://www.moneyam.com/action/news/showArticle?id=5488908

banjomick - 01 Feb 2017 08:22 - 68 of 159

Allergy Therapeutics peanut allergy vaccine to move into phase I trials after pre-clinical success
07:44 01 Feb 2017

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

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Allergy Therapeutics (LON:AGY) will take its Polyvac vaccine for peanut allergy into a phase I clinical trial after it delivered positive pre-clinical results.

The findings showed a single dose of the company's unique adjuvant when combined with recombinant peanut allergen successfully protected against the serious allergic reaction anaphylaxis.

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

“Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives,” said Allergy Therapeutics chief executive Manuel Llobet.

“This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience."

Ian Lyall

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banjomick - 01 Feb 2017 12:56 - 69 of 159

Allergy Therapeutics hails progression of peanut allergy vaccine (Video interview)
12:40 01 Feb 2017

Allergy Therapeutics (LON:AGY) international medical director Dr Matthias Kramer talks to Proactive about the company taking its Polyvac vaccine for peanut allergy into a phase I clinical trial after it delivered positive pre-clinical results.

The company is developing Polyvac as a short course of injections that is safer and more effective than the current treatments.

http://www.proactiveinvestors.co.uk/companies/stocktube/6831/allergy-therapeutics-hails-progression-of-peanut-allergy-vaccine

banjomick - 08 Feb 2017 07:54 - 70 of 159

8 February 2017 
Allergy Therapeutics plc
 
Directorate Change 
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Mr Jeff Barton to the Company's Board as a Non-Executive Director, nominated by Abbott Laboratories, Inc. ("Abbot", NYSE: ABT) in replacement of Mr Jean-Yves Pavee who retires from the Board, both effective after close of business 7 February 2017.
 
Jeff Barton currently serves as Vice President, Licensing and Acquisitions, at Abbott. During his time in this role, Abbott has executed several strategically important transactions including the acquisition of St. Jude Medical, CFR Pharmaceuticals and Veropharm.  He has served Abbott since joining in 1990 in the Financial Development Training program, and during his career has held a variety of financial management positions across Abbott's businesses, including in Diagnostics, Nutrition and Pharmaceuticals. He previously served as Divisional Vice President and Controller for Abbott's North American Nutrition Business and as Area Finance Director for its Asian, African, and Middle Eastern Pharmaceutical unit. Mr Barton holds a degree in accounting from Indiana University, and a Masters of Management from the Northwestern University Kellogg Graduate School of Management. 
 
Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Jeff to the Board.  He brings extensive commercial experience, particularly in the United States, which will be valuable to our Company as we continue to execute our global strategy. We also wish to take this opportunity to thank Jean-Yves for his contribution and support to Allergy Therapeutics since 2014."
 
Jeffery Glen Barton, age 48, has no current or prior directorships in the past five years. Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies.

http://www.moneyam.com/action/news/showArticle?id=5493038

banjomick - 10 Feb 2017 22:41 - 71 of 159

Germany gains Strength in Allergy Immunotherapeutics

Clara Rodríguez Fernández Clara Rodríguez Fernández on 10/02/2017

Bencard Allergie is developing ultra-short course allergy immunotherapies, backed by a strong growth in its German market.

Bencard Allergie is the German subsidiary of Allergy Therapeutics in the UK, which develops allergy vaccines. The German company was the first to market allergoids for allergen-specific immunotherapies. These are proteins modified to be recognized by immune cells while inducing a less intense response mediated by IgE antibodies. Over time, the patient’s immune system is exposed to larger doses to develop tolerance to the original allergen.

Now, the company is about to start Phase III trials with its product Pollinex Quattro birch against birch tree pollen allergy. The treatment is an ultra-short course subcutaneous immunotherapy that reduces a whole year of therapy to a period ranging from 3 to 8 weeks. With it, the company uses the aluminium-free adjuvant MCT as well as MPL, unique to Bencard, which binds to the TLR-4 receptor of immune cells and specifically induces a TH1-type immune response.

On top of that, Allergy Therapeutics and its subsidiaries are working on a new approach for allergen immunotherapy using virus-like particles. Backed by promising preclinical data, the group is now planning to enter clinical trials with the technology to treat peanut allergy.

In the market, Bencard will face competitors like the Swiss Anergis, also working in ultra-fast immunotherapies, and the French DBV Technologies, developing a non-invasive skin patch for children with peanut allergy. For its part, the British Circassia recently faced failure from a Phase III trial in cat allergy that has halted the development of its whole allergy pipeline.

Despite having strong competitors, Bencard seems well positioned. Allergy Therapeutics recently reported that Germany is its biggest source of sales growth, where 60% of its revenues are contributed by Bencard. This is great news for the company and its subsidiaries, which are seeking approval for their products according to the new Therapy Allergens Ordinance (TAO).

These regulations, implemented in Europe back in 2008, are expected to translate into fewer approved products by fewer suppliers, but the team seems confident in its products and is also planning for launch in the US soon.

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banjomick - 14 Feb 2017 08:40 - 72 of 159

14 February 2017 
Allergy Therapeutics plc
 
Novel House Dust Mite Allergy Vaccine Gains Clinical Trial Application Approval
 
CTA approval in Spain for Phase I AM101 clinical study evaluating safety of adjuvanted, modified house dust mite allergy vaccine
 
14 February 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that the Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A) has received Clinical Trial Application (CTA) approval in Spain.
 
House dust mites are a major cause of perennial allergic rhinitis and allergic asthma1. Acarovac MPL builds on the strong foundation of technologies employed in the successful Pollinex® Quattro range of subcutaneous allergy immunotherapies, and builds on the demonstrated efficacy2 of the existing successful product platform of Acarovac PlusTM, the fastest growing "named-patient product" in Allergy Therapeutics' Spanish subsidiary. Acarovac MPL is the only house-dust mite immunotherapy in development utilising MCT® (microcrystalline tyrosine), a natural, biodegradable depot, and the adjuvant MPL for the treatment of perennial allergic rhinitis making this vaccine unique in a $1.5 billion per annum market3.
 
CTA approval has been granted and the Company now expects this formulation to begin Phase I studies immediately, to assess the safety and tolerability of two different dose regimens. Both treatment regimens include a two-to-four week initial up-dosing phase but differ in the duration of the later maintenance phase. The Phase I trial of 32 patients is expected to last one year, and to be delivered on-time in-line with the Company's stated strategic plan when funding the programme in November 2015. If the Phase I trial is successful, the Company expects to launch Acarovac MPL in Spain on a named-patient basis. 
 
Commenting on the CTA approval, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "By using the successful biodegradable adjuvant system of MCT® and MPL, integral in our seasonal marketed vaccines, in a perennial house dust mite vaccine, we aim to improve both safety and efficacy for the thousands of patients who suffer year-round due to house dust mite allergy. Acarovac Quattro will provide convenience to our patients and doctors and more efficient pharmacoeconomics. Effectively, the dosing regime in Acarovac Quattro has the potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform."

http://www.moneyam.com/action/news/showArticle?id=5495889

banjomick - 14 Feb 2017 09:24 - 73 of 159

Allergy Therapeutics launches phase I trial of dust mite inoculation
08:05 14 Feb 2017

A total of 32 patients will receive Acarovac MPL. The trial is expected to take 12 months from start to finish.

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Allergy Therapeutics plc (LON:AGY) said the phase I clinical study of Acarovac MPL has received official sign-off in Spain.

The trial will assess the safety and how well tolerated the new dust mite treatment is.
A total of 32 patients will receive Acarovac, which will be administered at two different doses. The trial is expected to take 12 months from start to finish.

If the phase I assessment is successful, Allergy Therapeutics will launch the inoculation in Spain on a named-patient basis. This is where doctors can prescribe a drug without it having received regulatory sign-off.

Acarovac MPL is the only house-dust mite immunotherapy in development utilising microcrystalline tyrosine, which is natural and biodegradable.

It also uses monophosphoryl lipid A, or MPL for short, as an adjuvant which enhances the body’s immune response.

Harnessing the two in tandem should improve both safety and efficacy for the thousands suffers, according to Allergy Therapeutics’ boss Manuel Llobet.

The new formulation has the “potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform”, he added.

Microscopic in size, the problems house dust mites create are significant and include perennial allergic rhinitis (non-seasonal hay fever) and allergic asthma.

The market is worth an estimated US$1.5bn annually.

Ian Lyall

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