Allergy Therapeutics Share Discussion Threads

[audigger] 06/7/2015 07:28

More good news. May be the only blue on my screen today amongst the see of red!

[jimmyloser] 02/7/2015 08:40




2 July 2015



Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")



Company to Host Key Allergy Conference





Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that it is hosting the Eighth Annual Adjuvants in Allergy Conference in Amsterdam on the 2-4 July.



At the conference, Dr. Albert Roger Director of the Allergy Unit at Universitari Hospital Germans Trias Pujol, Badalona Spain, will present data from the Company's recent Acarovac efficacy study for the treatment against house dust mite allergy. Acarovac has been Allergy Therapeutics strongest growing treatment in Spain this year and it is one of the Company's new generation of products developed to address the perennial allergy market with innovative and short-course therapies.



The conference provides an outstanding opportunity for scientific debate and dialogue amongst 200 specialists in respiratory diseases and allergology from all over Europe and America. New perspectives and innovations in allergy treatment will be presented by international key opinion leaders in order to initiate the process of global shared knowledge in these areas and ultimately lead to improvements in patient outcomes.



There is an exciting programme of topics to facilitate in-depth discussions, which include, the impact for allergists on changes to the climate and migration patterns, the distribution of pollen counts and their annual patterns, the generation and maintenance of allergen specific T-cell tolerance, options and strategies for primary and secondary prevention of atopy and asthma, and the dramatic increase in the prevalence of allergic diseases.



Manuel Llobet, Chief Executive Officer, commented:

"Allergy Therapeutics is proud to host the Eighth Annual Adjuvants in Allergy Conference, a highly scientific open forum to discuss allergy topics with expert key opinion leaders and allergists from around the world. The aim of the conference is to encourage the medical community to consider innovative solutions for patients suffering from allergies and we are excited to be at the forefront of these discussions."

[jimmyloser] 02/7/2015 07:53

Yep, I tend to agree with you. I still have this down for September 2017 before we see the real excitement.
Looks like we may have an early doors step in the right direction!!

[audigger] 02/7/2015 07:24

Nowt wrong with a bit of exposure either; always good to see a company engaging in the underlying science. We may see 30p by end of July especially if Greece sorts itself out and there is a general market bounce back.

[jimmyloser] 01/7/2015 22:34

September is my target time for that. Providing that..........?

[audigger] 01/7/2015 22:10

Looking like it's trying to breakout to 30p.....

[qackers] 26/6/2015 12:41

Nice positive write up from Proactive investors. See note at end of article. Panmure Gordon looking for 33p





Allergy Therapeutics’ momentum renewed with US programme kick-start
Share
13:29 25 Jun 2015

Allergy Therapeutics has renewed momentum - as its announcement this morning showing a kick-start to its US growth ambitions aptly demonstrated.

"We've really de-risked the proposal from the one we outlined in the fundraising," finance director Ian Postlethwaite told Proactive.
Allergy Therapeutics (LON:AGY) has renewed momentum - as its announcement this morning showing a kick-start to its US growth ambitions aptly demonstrated.

Following what it called "productive" talks with the all important US Food and Drug Administration (FDA), the pharma group is to resume its clinical programme of grass allergy product Pollinex Quattro in a bid to take it through to a market launch in 2019.

It is a milestone, not least as it draws a line firmly under past problems with the pipeline.

In 2007, the FDA put a stop to the development of Pollinex after one patient had an adverse reaction to the grass allergy injection.

Those familiar with the story will know the firm now has the financial wherewithal to start this process again and to advance the development pipeline, having raised £20mln via a placing in March this year.

"We've really de-risked the proposal from the one we outlined in the fundraising," finance director Ian Postlethwaite told Proactive.

It now sets in train clinical trials, scheduled to start in September this year, with contract research organisation Inflamax set to run the studies, which represents a further de-risking.

Postlethwaite is optimistic that the product will hit the US markets at the right time, when the market may be more receptive to a European type model.

The firm is already an established provider of allergy vaccines in Europe but this will mark its first foray into the US.

Currently, the market across the pond is very different in that manufacturers sell bulk products to individual US allergists, which then make up their own products. But there is a shift now taking place, as Postlethwaite explained, as evidenced by a couple of European players recently having vaccines registered in the US.

Allergy has already spent U$100mln on the Pollinex programmes and also in the pipeline are similar treatments for ragweed and tree pollen.

Unlike grass, these are not funded, but Postlethwaite notes that only a phase III trial is still required for ragweed and a phase II for the tree candidate.

One option he says is available to the company would be to out-license these products - a growing trend in the pharma world.

It is worth noting that Allergy, via its core European business, is cash generative. It recently funded the purchase of Spanish vaccine specialist Alerpharma from its own coffers.

The interim results revealed the group posted double digit revenue growth, due to increased market share, bringing it to just over £30mln and an operating profit of £7.5mln, up 13% on the year earlier.

On the balance sheet, the group improved the cash position to £8mln compared to £5.2mln in the first half of 2014.

Panmure Gordon in a note following the results in March issued a target price of 33p and gave an upbeat assessment of prospects.

“The company continues to take market share from its competitors and despite exchange rate head winds, the business is taking advantage of its product differentiation,” analyst Savvas Neophytou said in the note.

Shares added 4.24% to 21.50p today.

[jimmyloser] 26/6/2015 09:06

It is truly nice to see confidence gaining in the AGY managements strategy, it was obviously evident when they raised £22million+

They just do not put a foot wrong in my eyes nor can they!

Go for it AGY!

[audigger] 25/6/2015 07:58

At last the news we have been waiting for. Not sure what response we'll see in the share price today, but rest assured if these trials are successful then we're looking at several multiples of where we are now. I guess it depends how many people will invest based on US income potential as opposed to waiting until actual income. That said, lets not forget the Co is already profitable based on its Eu business which is growing.....

[jimmyloser] 25/6/2015 07:05

FANTASTIC
Thank you AGY

[jimmyloser] 06/6/2015 21:59

I too am puzzled. A few nuggets in there I thoughtIn addition to progressing our USA etc. progressingImmediately earnings enhancingState of the art manufacturing Etc

[audigger] 05/6/2015 11:53

Interesting! Strange that the share price hasn't moved in response to this news....

[jimmyloser] 01/5/2015 08:14

That appears to be that 600k overhang gone!

impo.

[audigger] 15/4/2015 17:15

Could well be buys. Not much volume at the moment.Just sold my Persimmon holding today (nice eaner that was!) so may well top-up on these.....just trying to get the timing right, which usually I don't!

[jimmyloser] 15/4/2015 15:15

AuDigger
It looks like sells at 19.65p now and buys at 20.3p

Lots of nibble type buys going through

Do you agree?

[audigger] 14/4/2015 08:53

Seems to have been a lot of low volume selling over the last week. Looks like its been walked down prior to what we hope is good news on the Phase III trial.

[audigger] 09/4/2015 13:23

They did say that and I would expect an RNS as its key news. May be FDA are dragging their heels, not unknown!

[jimmyloser] 09/4/2015 07:52

AuDigger
Didn't they indicate that they expected clearance for the trials from the FDA in mid March? Do you feel that they would have to RNS that news?

jl

[audigger] 09/4/2015 07:37

All good stuff. Invesco almost doubled thier holding. Looking like the new placing has found several good homes. Is it time for the crawl back up to 30p?

[audigger] 09/4/2015 07:37

All good stuff. Invesco almost doubled thier holding. Looking like the new placing has found several good homes. Is it time for the crawl back up to 30p?

[jimmyloser] 07/4/2015 15:15

Good post and appreciated.

[qackers] 07/4/2015 14:36

Allergy Therapeutics sees US breakthrough as route to global success
By Ian Lyall April 07 2015, 2:03pm “We are at an inflexion point,” says chief executive Manuel Llobet.“We are at an inflexion point,” says chief executive Manuel Llobet.

It came and went with little fanfare, but March 30 was a red letter day for Allergy Therapeutics (LON:AGY).

A shareholder meeting signed off a £20mln share placing that will allow the company to take its Pollinex Quattro Grass product through to registration in 2019.

If the product jumps through the final regulatory hoops (and analysts say it has a decent chance of success) then a US$2bn a year market beckons.
The funding drives the company forward into new territory; but it does something else. It draws a line under the past – a difficult period that followed the US Food & Drug Administration’s (FDA) decision in 2007 to halt development of Pollinex after one patient had an adverse reaction to the grass allergy injection.
The worries, which centred on the adjuvant used to enhance the therapeutic impact of the drug, proved to be unfounded.

However, it took five years to have the hold lifted on the clinical trial and a further four to get to this stage. “We are at an inflexion point,” says chief executive Manuel Llobet. “The immunotherapy business today is basically European, but it is going to become global very soon.”

Pollinex is an injection that inoculates the patient against the irritating and some cases debilitating allergic reaction to grass pollen.
Following in its wake are similar treatments for ragweed and tree pollen and, further down the line, dust mites.

However, Pollinex Quattro Grass is the pathfinder. It will be the first subcutaneous (injectable) vaccine on the market in the US. And, if it is successful, it will be one of three or four clinically approved immunotherapies that offer lasting relief from allergies rather than simply treating the effects of allergic rhinitis (the catch-all term for the annoying inflammation of the nasal airways).

While there are injectables in the US, there is no substantive clinical evidence the current crop work. “People are poorly served with primitive treatments and long courses of injections,” CEO Llobet explains. “We will bring a product to market that is an ultra-short course of vaccines with clinical evidence and standardisation. We think it will be a breakthrough in the US market.”

First Pollinex must go through a phase III clinical trial that will assess efficacy prior to the drug being signed off by the US FDA.

It is worth pointing out that U$100mln has been spent to date on the treatment, and was in the throes of carrying out a phase III study when development was halted.

The FDA has asked Allergy’s researchers to use something called an environmental challenge chamber for its next clinical assessments for approval.
It sounds medieval, but in very basic terms the challenge chamber is a room where the level of allergens is closely monitored. “With this you can really control the conditions,” says Llobet. “So you can be sure that patients are challenged properly with the amount of pollen – the measure of the efficacy is more accurate as you have the patients under controlled conditions. “It is good news to have this second phase-III in this form because I would say it is at less risk from the variability of the weather impacting on the pollen counts that occurs in the field.”

Companies with a drug at this advanced stage normally seek outside help from a larger pharmaceuticals company ready to share the costs and the risks associated with this last stage of development. Conversations were had, but none of the firms Allergy’s team spoke to came up with the right financial solution that made a partnership worthwhile. It will reassess its alternatives once the regulatory process is out the way, but Llobet says he is keeping his and the firm’s options open. “It is not like we need a massive sales team. I’d say 50-60 reps would cover most of the [US] prescription universe. So if we don’t find the right partner we will go it alone,” the Allergy Therapeutics boss said.

So far we have talked only about the US, where it is yet to make a sale. Yet in Europe, Allergy Therapeutics is a revenue-generating, profitable firm thanks to its Pollinex products, Acarovac for mite allergy, its penicillin diagnostic and treatments for wasp and bee stings.

The interim results revealed the group generated revenues of just over £30mln and an operating profit of £7.5mln, up 13% on the year earlier. “The performance of all our products was good. They all grew 11% and did so across our main markets,” finance director Ian Postlethwaite reveals.

The share price naturally came under pressure following the announcement of the placing on March 10 and the stock is trading at around 20p.

Panmure Gordon in a note following the results on March 2 issued a target price of 33p and gave an upbeat assessment Allergy Therapeutics’ prospects. “The company continues to take market share from its competitors and despite exchange rate headwinds, the business is taking advantage of its product differentiation,” analyst Savvas Neophytou told investors.

[audigger] 02/4/2015 07:35

Odey in for 28 million. I wish I had 28 million of these!