(AGY) Allergy Therapeutics
Summary
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| 06-12-11 | RNS |
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RNS Number : 3960T Allergy Therapeutics PLC 06 December 2011 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company")
6 December 2011
Unique to the market - The Anapen® 500mcg epinephrine auto-injector Life saving treatment for patients with anaphylaxis
Allergy Therapeutics plc (AIM: "AGY"), is pleased to announce that the updated Anapen® 500mcg epinephrine auto-injector device registered in the UK and Ireland will be available in both countries in early 2012. In September the Company obtained the exclusive distribution rights for Anapen® in the UK and Ireland.
As many as one million people in the UK are at risk from anaphylaxis which can be caused by food allergy, insect bites or stings, latex, drugs and other triggers.1,2 The incidence and prevalence of serious allergic reactions such as anaphylaxis are increasing rapidly, as are the number of hospital related admissions.3
The UK's Resuscitation Council has recommended a dose of 500mcg of epinephrine for adults. The Anapen® 500mcg, produced by Lincoln Medical Limited, is the only 500mcg epinephrine auto-injector currently available in the UK that has been licensed for use in adults with a body weight of 60kg and above. The product is also available in 300mcg and 150mcg doses.
Professor Jonathan Hourihane, Professor of Paediatrics at University College Hospital, Cork commented;
"This is an important development for the community care of adults at risk of anaphylaxis. Delay in receiving appropriate adrenaline is associated with severe adverse outcomes in anaphylaxis and a higher dose auto-injector has long been on the allergists' wish list for their patients."
Allergy Therapeutics has been selling Anapen® in The Netherlands since September 2010 and has also received the exclusive rights to distribute Anapen® in Italy, Spain, Belgium, Poland, Argentina, Venezuela, Colombia and Chile; all countries with promising market potential. The Company expects to launch Anapen® in these countries during the next 12 months, subject to regulatory approvals.
For further information:
Allergy Therapeutics +44 (0) 1903 845 821 Manuel Llobet, CEO www.allergytherapeutics.com
FTI Consulting +44 (0) 207 776 1200 Jonathan Birt/ Sue Quigley
Notes to editors
About Anapen®
Anapen® is indicated for the treatment of anaphylactic shock. Anaphylactic shock is a life threatening allergic reaction with increasing prevalence in all developed countries. Anapen® is the only epinephrine pen auto injector in the world with a 500mcg presentation. The 500mcg presentation is indicated for adults weighing above 60kg, giving Anapen® a strong competitive advantage.
The epinephrine pen auto injector market in the UK is valued at around £20 million and grew by 20% last year. Allergy Therapeutics expects sales in the UK and Ireland of up to £2 million during the next 12 months. Anapen® will be an important new product for the Commpany's UK sales force.
About Allergy Therapeutics Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving sales in the prior financial year of £42 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors. The Company is expanding its infrastructure into the Emerging Markets.
Footnotes
1 Resuscitation Council (UK). Emergency treatment for anaphylactic reaction: Guidelines for healthcare providers. January 2008
2 Simons GFE et al. Worold Allergy Organization Guidleines for Assessment and Management of Anaphlaxis. J Allergy Clin Immunol
3 Department of Health. Parliamentary written reply, 26 March 2009. Available at www.theyworkforyou.com/wrans/?id=2009-03-26c.266146.h
This information is provided by RNS The company news service from the London Stock Exchange More |
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| 28-11-11 | RNS |
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RNS Number : 8414S Allergy Therapeutics PLC 28 November 2011 28 November 2011
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Submissions of complete response to PEI in Germany and clinical study protocol to US FDA
Allergy Therapeutics plc (AIM: "AGY" or the "Company"), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that it has submitted its complete response to the Paul Ehrlich Institute ("PEI") on its Marketing Authorization Application ("MAA") for Pollinex® Quattro Complete Grass in Germany. Separately, the company has also submitted a detailed study protocol to the US Food and Drug Administration ("FDA") to enable the formal lifting of the clinical hold, allowing the MATA MPL development programmes in the US to progress.
The Company submitted its MAA for Pollinex Quattro Complete Grass to PEI, the Regulatory Authority for biological products in Germany, in March 2009. In June 2011 the company received the complete report on its application from the PEI which, in line with the normal review process, raised a number of questions on the submission. The Company has now formally updated its MAA and responded to the PEI and believes that it has now addressed all their questions.
In the US, at a meeting in March 2011, the FDA stated its intention to lift the clinical hold on the Investigational New Drug applications ("INDs") for the three MATA MPL development programmes pending agreement of future study protocols. The Company has now submitted a detailed study protocol to the FDA for its review and feedback.
The search for potential partners in the US is continuing and the agreement of the clinical studies and the formal lifting of the clinical hold will support this process.
Manuel Llobet, Chief Executive of Allergy Therapeutics, said:
"This is another significant step forward in the key regulatory activities in Germany and the United States which we have been progressing in parallel over the last few months. With our initiatives in Latin America, Allergy Therapeutics is now active on three continents, and we are making good progress towards achieving our ambition to be one of the top three companies in the global allergy immunotherapy field."
-Ends-
For further information
About Pollinex® Quattro Complete (MATA MPL) Pollinex® Quattro is a four injection therapeutic vaccine which is being developed for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis. This information is provided by RNS The company news service from the London Stock Exchange More |
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| 16-11-11 | RNS |
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RNS Number : 2463S Allergy Therapeutics PLC 16 November 2011 Wednesday 16 November 2011
Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company")
Result of Annual General Meeting
Allergy Therapeutics plc announces that at the Annual General Meeting held today, all the resolutions put to that meeting were duly passed.
For further information
This information is provided by RNS The company news service from the London Stock Exchange More |
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| 20-10-11 | RNS |
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RNS Number : 5827Q Allergy Therapeutics PLC 20 October 2011 20 October 2011
Annual Report and Accounts
Allergy Therapeutics Plc (the "Company") announces that pursuant to Rules 20 and 26 of the AIM Rules, the Annual Report and Accounts of the Company for the year ended 30 June 2011 and Notice of Annual General Meeting were posted to shareholders on Monday 17 October 2011.
The Annual Report and Accounts is available on the Company's website at the following address:
http://www.allergytherapeutics.com/Reports%20and%20Presentations%20Sub.aspx
The Notice of Annual General Meeting will shortly be available on the Company's website at the following address:
http://www.allergytherapeutics.com/AGM.aspx
In addition, Resolution 8.2 has been amended as follows:
The wording "up to an aggregate nominal amount of £31,077,161 being 31,077,161 ordinary shares representing not more than 10% of the issued share capital of the Company" should read "up to an aggregate nominal amount of £31,077.16 being 31,077,161 ordinary shares representing not more than 10% of the issued share capital of the Company".
It is proposed that at the AGM, which will be held on Wednesday, 16 November 2011, the Chairman will propose that resolution 8.2 be passed with reference to "an aggregate nominal amount of £31,077.16" rather than "an aggregate nominal amount of £31,077,161".
For further information:
This information is provided by RNS The company news service from the London Stock Exchange More |
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Perhaps I was being rather optimistic in expecting a reply after 2 months from the PEI regarding AGY's answers to their PQ questions. But I do hope it won't be long now- the waiting has been dragging on for such a long time- it must be frustrating for everyone.
George |
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| Sat 11:52 | ||||
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george,
Have a look at the 28 Nov 2011 RNS Rags Submissions of complete response to PEI in Germany and clinical study protocol to US FDA Allergy Therapeutics plc (AIM: "AGY" or the "Company"), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that it has submitted its complete response to the Paul Ehrlich Institute ("PEI") on its Marketing Authorization Application ("MAA") for Pollinex® Quattro Complete Grass in Germany. Separately, the company has also submitted a detailed study protocol to the US Food and Drug Administration ("FDA") to enable the formal lifting of the clinical hold, allowing the MATA MPL development programmes in the US to progress. The Company submitted its MAA for Pollinex Quattro Complete Grass to PEI, the Regulatory Authority for biological products in Germany, in March 2009. In June 2011 the company received the complete report on its application from the PEI which, in line with the normal review process, raised a number of questions on the submission. The Company has now formally updated its MAA and responded to the PEI and believes that it has now addressed all their questions. In the US, at a meeting in March 2011, the FDA stated its intention to lift the clinical hold on the Investigational New Drug applications ("INDs") for the three MATA MPL development programmes pending agreement of future study protocols. The Company has now submitted a detailed study protocol to the FDA for its review and feedback. The search for potential partners in the US is continuing and the agreement of the clinical studies and the formal lifting of the clinical hold will support this process. |
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| Fri 16:28 | ||||
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Found this on another Board, but if you want more rights for the small investors, then sign this petition on the government web site ,everything is private so nobody can find you name and address .And if you want to get our right's back then sign BE HAPPY REGARDS DAVE If every one puts this on their own boards this could spread across all the finnancial web site's http://epetitions.direct.gov.uk/petitions/16769 |
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| Thu 16:44 | ||||
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I am wondering whether anything has happened regarding the market authorisation of P Quattro, which I think has been in the "in box" of the PEI since spring 2009. Possibilities:
1. It has passed, but not officially yet. 2. They want even more time/data to look at. 3. A fail! We shall see. Or there may be something completely different happening. George |
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