Lipoxen Share Discussion Threads

[buywell2] 18/7/2011 17:08

''Furthermore, a spray dried version of the vaccine was still efficacious even after storage at 37°C for 6 weeks indicating that there is the potential to create a formulation that can withstand storage outside of the cold chain.''

This has MASSIVE potential

If this technology can be applied to many other vaacines ..... think what I MAJOR Pharma will think of it ?

[buywell2] 18/7/2011 17:05

Because it is one of my top picks (no 2 ) ( see header ) .... like Lipoxen (no 3 )

I sometimes post Lipoxen news on my other threads if I think it's earth moving

[123asd] 15/7/2011 00:07

Buywell - why did you post this on the LPX thread, it has no relevance at all.

[buywell2] 14/7/2011 16:58

Good news from number 2

buywell2 - 14 Jul'11 - 16:38 - 1509 of 1509 edit


This is a BIGGY ..... Should be positive press comment


I will try to put some numbers together next week ..... but it looks like may well be circa £10m PLUS turnover wise , depends upon how many trusts install the FocalPoint machines, but it has the potential to MORE THAN DOUBLE EXISTING TURNOVER .

The GREAT news is that Source Bioscience is the ONLY provider whose automated screening technology has been granted approval

what does this mean ?

Well it means that Source's USA Billion dollar competitor's automated screening platform HAS NOT BEEN GRANTED APPROVAL for use in NHS cervical cancer screening.

Like I said a few months back ..... Source is now a buyout target for these guys as it WINS NHS cervical cancer business that they were hoping for.

You will also note that this same machine has capability for use in HPV screening , something that Source should be releasing an RNS about circa August/early September time. So a win/win for the NHS as the same machine gets used for two different screening needs.

The same USA company is also into HPV testing provision in Scotland ..... which means that any positive HPV outcome for Source makes them even a BIGGER threat to the Yank business.

VEY WELL DONE , a GREAT development for the company

One thing for sure the market hasn't got a clue about just how big a development this is ..... I will try to look back at a post on this thread I did a year back where I tried to put a handle on what FocalPoint take up would mean to the company.


NHS approval for automated cervical cancer screening
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TIDMSBS

13 July 2011

Source BioScience plc

("Source BioScience" or the "Company")

Source BioScience receives NHS approval for automated cervical cancer screening
technology

"No Further Review" capability could revolutionise screening process

Source BioScience (LSE: SBS), the international diagnostics and genetic
analysis business, is pleased to announce that the National Health Service
Cancer Screening Programmes ("NHSCSP") has approved the use of the BD
FocalPoint "No Further Review" technology for cervical cancer screening in the
UK. This is the only automated cervical screening technology which has been
approved.

The "No Further Review" technology can analyse and identify up to 25% of
screening samples that can be reported as "all clear", requiring no human
examination. With over 3.6 million tests being undertaken across England and
Wales during 2009/10, this represents a significant reduction in laboratory
workload, eliminating the need to employ costly, temporary locum staff.

NHSCSP, the governing body for cancer screening in the UK, informed NHS
laboratories of the decision to approve BD FocalPoint "No Further Review"
following recommendations from the Health Technology Assessment "MAVARIC"
trial, which was published in March 2011. The trial demonstrated the clinical
performance of the system compared with manual screening and its compatibility
with the planned introduction of HPV testing into the UK cervical cancer
screening programme during September 2011.

Dr Mina Desai, CBE, Head of Cytopathology Services at Manchester Royal
Infirmary said "As one of the lead investigators of the MAVARIC study, I am
pleased that the "No Further Review" category has been approved. The clinical
data from the study supports the decisions to implement it within the screening programme and will assist the laboratories in meeting the demands of the 14 day turnaround time."

Dr Nick Ash, Chief Executive of Source BioScience commented "We believe BD
FocalPoint is a huge step forward for cervical cancer screening progression in
the UK. "No Further Review" is a unique function of the BD FocalPoint system
and it is the only automated system of its kind approved and available in the
UK. Source BioScience will now be able to provide a complete solution for
cervical cancer screening from sample collection, processing, imaging and
diagnostic testing, including HPV testing."

--ENDS--

[the_doctor] 09/7/2011 14:09

123asd - sicilian is right! you are trying to suggest that the milestones are in the bag.
big milestones are meaningless - what matters for companies like this are the near-term cash flows

Lipoxen does have some interesting technologies though

I'd be interested to know what other vaccine storage approaches are in development - I have no idea
Anyone willing to provide an objective comparison?

[buywell2] 09/7/2011 10:53

I suggest you guys look at the IP that Lipoxen own that allows them to turn vaacines into crystals which make them

1. Temperature resilient , unlike vaacines that have to be transported in controlled cold containers around the world and are destroyed by high or freezing temperatures

2. Increases the shelf life of the vaacines by MANY years , as the crystals become normal vaacines again only when they are needed and put into solution


Now can some clever poster tell me what Major Pharmas that sell BILLIONS of dollars of vaacines EACH YEAR might think of such IP ?

[buywell2] 09/7/2011 10:46

sicilian_kan I suggest you read the above

It is there for all to see on the Lipoxen website and at the bottom of the thread header

[123asd] 08/7/2011 17:58

sicilian_kan - you are quite right, your post betrays very little knowledge of the company at all.

For a company valued by the market at $31m presently, $75m in milestone payments for ONE initiative (Factor VIII) with Baxter is emphatically NOT small beer to Lipoxen. At the time of the last payment Baxter also asked to widen the scope to include two new candidates. This is just one of many initiatives under way not just with Baxter but other pharma players.

A good point to start bringing yourself to some knowledge of the company would be to read the 2nd June published Finals here:

and the self-commissioned April 2011 GECR report here:

[sicilian_kan] 08/7/2011 17:41

I saw SLN (though I went for other reasons) at the recent ProActive meeting. Interesting, but no more than that. Didn't make me want to invest. As a tangent, I thought it particularly odd that the FD did the presentation.

[sicilian_kan] 08/7/2011 16:05

buywell2, those are big claims:

If I look at:



It suggests that in 2005, Baxter signed a deal worth $75m in milestones and royalties on top.

(a) This is a tiny/poor deal in pharma world, not a commitment in a big way as you put it.

(b) In 2010, there appears to have been an amendment to the agreement with Baxter paying $2m with a further $2m of warrants available, leaving $71m of the $75m remaining. I.e. Lipoxen have got $2m upfront in 6 years. How is this a commitment in a big way?

Am I missing something here? I confess I have not properly researched this company. I appreciate too that Baxter has over the years acquired 7,325,470 shares in placings etc. (current total value = around £800k). But this is hardly anything that would affect my views on the above.

[buywell2] 01/7/2011 10:29

The thing is that Baxter have committed to Lipoxen in a BIG way.

Lipoxen can earn up to $75m dollars from ONE molecule that a 'lead candidate' has been chosen for PLUS ROYALTIES

PLUS

we now can read in the latest report that BAXTER HAS PLACED ANOTHER TWO MOLECULES for Lipoxen to undertake tests on.

PLUS

BAXTER has become a MAJOR SHAREHOLDER of Lipoxen

Does not take much brain power to deduce that Baxter likes what Lipoxen does

Could be that Baxter may be about to buy the company

Maybe that is what the EGM will be about

[123asd] 01/7/2011 02:02

hashertu - I think most investors can draw the implication from what you report that the Board said - myself, I can't see any other interpretation other than that there will be an EGM soon, at which shareholders will be invited to vote on a Company-related matter. The nature of that matter is of course not clear to us at this stage.
As to your second paragraph above, I'm sorry but your meaning is not clear to me - could you elaborate and make clearer your statement? Are you quoting Mr Maguire in the last two sentences - i.e. that he said "Very interesting idea but at the moment their (Medgenics') proposition is "science fiction". A lot of hurdles for them to overcome before demonstrating a viable product"?
I think most long termers here are aware that Lipoxen is not the only game in town. I for one am not qualified to comment either on the technology nor on the progress of LPX's rivals. However, I do read the reports LPX puts out on the progress of their various initiatives, and to date am very encouraged by the data. I'd be interested to read your take on same.

[hashertu] 30/6/2011 19:30

At the AGM the board explicitly said that they expected to be meeting with shareholders again in the (relatively) near future.
What this means I do not know. Draw your own conclusions.

Scott McGuire was asked whether Medgenics posed a commercial threat to LPX.
He got quite animated. Very interesting idea but at the moment their proposition is "science fiction". A lot of hurdles for them to overcome before demonstrating a viable product.

[buywell2] 30/6/2011 17:12

Plus the influenza candidate (which rocketed LPX to 22p (see chart) , is getting attention, positive toxicology results should make it desirable for a major pharma, and HIV candidate is progressing, which could just turn out bigger than all the rest of the LPX portfolio put together if it pans out.


Lipoxen plans to undertake pre-clinical in vivo toxicity trials for its liposomal influenza candidate and will develop enhanced versions of its HIV vaccine candidate for non-human in vivo immunogenicity testing by the project sponsor, the International AIDS Vaccine Initiative ('IAVI').

[buywell2] 30/6/2011 17:07

Plus some very +ve news to come any time on MS developments which are being funded BY OUR PARTNER ..... so they must be VERY CONFIDENT about the outcome.

ImuXen pipeline

Pharmsynthez will take the liposomal Multiple Sclerosis candidate into a small controlled human Phase I clinical trial, at their expense later this year. The preclinical results for the Company's MS vaccine compared to "Copaxone" the
US$4.2 billion MS drug from Teva has demonstrated clear superiority.

[buywell2] 30/6/2011 17:04

Yet more news flow soon regarding CF development

PSA-DNase

PSA-DNase is a proprietary polysialylated DNase candidate that offers potential for use in cystic fibrosis treatment. It is designed to be a next generation of "Pulmozyme" from Roche which had sales of US$500
million in 2008.

Lipoxen's bio-betters pipeline contains an expanding portfolio of product candidates that are currently under development either in-house or with biotechnology and pharmaceutical partners. These new pipeline products have
a combined market potential of several billion dollars.

[123asd] 30/6/2011 16:58

This looks set to go further tomorrow - still relatively light volume and very little retracement off the day's highs. Perhaps news this week or next?

[buywell2] 30/6/2011 16:40

I have to say this sickens me

London, June 19 (IANS) Concerns have been raised in Britain over a European Union directive allowing drug tests on pets.

The plan could trigger a dramatic rise in the number of pets used in laboratory experiments, The Sun reported Sunday. British law allows tests only on animals bred for research.

'Dropping UK standards to meet the EU lowest common denominator is wrong and will be seen by the British public as a huge betrayal,' the report quoted a spokesman for the People for the Ethical Treatment of Animals as saying.

The European Commission, the executive body of the EU, has given the government till 2013 to adopt the legislation.

The directive will allow puppy farms and cat breeders in Britain to supply animals to laboratories abroad.

Ministers are concerned the directive would weaken Britain's tough animal welfare laws. Home Minister Lynne Featherstone has launched a three-month consultation exercise, the report said.

The British Union for the Abolition of Vivisection (BUAV) says that dogs, such as beagles, can have substances dripped into their eyes or be force-fed chemicals and drugs.




Cyprotex my number 1 choice see header, are being proactive in this matter in carrying the fight to the UK so called government.

I hope others join their fight and support them .... , nick, laurie that's you

June 9, 2011 - Pharmaceutical Safety Testing Open Letter
Cyprotex PLC
("Cyprotex" or the "Company" or the "Group")

Concerns About Pharmaceutical Safety Testing Cause Cyprotex to Join in Signing an Open Letter to Prime Minister David Cameron and Health Secretary Andrew Lansley

On behalf of Cyprotex PLC (AIM:CRX), Dr. Katya Tsaioun, Cyprotex's Chief Scientific Officer, has joined with a group of eminent UK clinicians and scientists who have written an open letter (see ) to Prime Minister David Cameron and Health Secretary Andrew Lansley expressing concerns about the escalating problems of drug failures and adverse drug reactions. Adverse drug reactions have reached epidemic proportions amid rising costs in prescriptions, with around 197,000 EU citizens dying every year because of the problem.

The letter, published 3 June 2011 in the medical journal, The Lancet, says the reliance on testing new drugs on animals before humans is partly to blame, with trials on non-humans frequently failing to translate to the clinic. The experts have called for the use of more human-biology-based experiments where chemicals are tested on human cells to see how people might be affected by new treatments.

Following publication of the letter, Cyprotex's CEO, Dr. Tony Baxter, was interviewed by Sky News (see ) at Cyprotex's laboratory in Macclesfield.

Pointing at the crux of the problem, Dr. Baxter said, 'A fundamental problem is that a rat is not a human. They are different sizes, have different metabolisms, and have different diets. So using animals to predict effects on humans is difficult. Fifty percent of compounds that prove to be safe in rats prove not to be safe in humans. So it really is the toss of a coin.'

Remarking on the issue, Dr Katya Tsaioun said, 'In the past few years there has been tremendous progress in developing drug safety tests based on human biology. Many of these models, such as Cyprotex's CellCiphr™ assay for liver toxicity, are now superior to animal testing. Yet, the pharmaceutical industry is hesitant to adopt these tests because regulatory agencies have yet to adopt them, which is in turn caused by the agencies' failure to investigate them. The open letter addresses this by calling for the UK Government to initiate a comparison of a set of human-biology-based tests with those currently used, as proposed in the Safety of Medicines Bill 2010-11, to see which are more effective for predicting the safety of medicines for patients. 148 Members of Parliament have already signed a motion in support of this proposal.

'Leading this initiative is the Safer Medicines Trust, an independent patient safety organization and registered charity (number 1039411). For more information see www.SaferMedicines.org.'

See the latest video of the Cyprotex CEO on Sky News

[buywell2] 30/6/2011 16:18

This has gone under the radar


PSA-rFVIII

Baxter' has selected a lead PSA-Factor VIII candidate, PSA-rFVIII, which is a longer-acting form of a Factor VIII molecule that uses the PolyXen® drug delivery technology. Global Factor VIII sales exceed US$5 billion.

With the selection of the lead candidate now completed and its progression into pre-clinical development,Lipoxen will continue to work with Baxter to achieve the remaining US$71 million in additional potential cash milestones payments due plus royalties.

The success of the Baxter partnership and its expansion to two further molecules with total global market of US$1.8 billion validates the Lipoxen business model where positive pre-clinical and clinical results lead to further partnering opportunities.

[buywell2] 30/6/2011 16:10

Here is a bit more , from the recent note as per the lipoxen website

Did you know that Baxter have put another 2 molecules for Lipoxen to test ?

''Baxter became the third largest shareholder and shortly after expanded the deal to include two additional drug candidates.''

Why the company did not put an RNS about this beats me as additional turnover will be coming in now.




Lipoxen has collaborations for drug development with the Serum Institute of India Ltd (India's largest biotech company and one of the world's largest vaccine companies) which have also become large shareholders alongside Russian
companies FDS Pharma and Pharmsynthez (a leading Russian pharmaceutical company listed in Moscow). The results generated in the clinic to date through these collaborations on potential BLOCKBUSTER candidates have been very encouraging. The Company's US$75 million license agreement for making bio-superior blood clotting agents with the global pharmaceutical giant, Baxter International, has progressed to such an extent that in 2009 Baxter became the third largest shareholder and shortly after expanded the deal to include two additional drug candidates.

Since this time, the company has realised equity placing and revenues in excess of £4 million from Baxter.

[jsbach123] 30/6/2011 16:06

Thanks for info buywell2

[buywell2] 30/6/2011 15:55

Also some +ve news due soon on "We have encouraging pre-clinical data on the Multiple Sclerosis vaccine candidate and we are still confident that this will be the first of the projects to reach the clinical trial stage early in 2011."

see page 6




Collaboration partner announces Moscow IPO
29 November 2010

Lipoxen announces that its collaboration partner, Pharmsynthez, a leading Russian research-based pharmaceutical company, has successfully listed on the Moscow Central Stock Exchange (MICEX).

Shares in Pharmsynthez began trading on the MICEX on Thursday 25 November following an IPO which raised over 528m RUB (c. £10.7m), giving Pharmsynthez a market capitalisation of 1716m RUB (c. £34.8m) on admission. Pharmsynthez becomes only the second biotech company to be listed on the MICEX. The capital raised will assist in funding clinical development of Lipoxen licensed candidates.

Lipoxen have six projects, three PolyXen and three ImuXen candidates, currently in pre‐clinical co‐development with Pharmsynthez. The programme is aimed at delivering human proof of concept data in early course and Lipoxen remains hopeful that a number of the potential candidates will deliver results that justify them being advanced into the clinic.

Commenting, M. Scott Maguire, Chief Executive Officer of Lipoxen, said:

"We're delighted that our partner Pharmsynthez has successfully listed on the Moscow exchange and we offer them our warmest congratulations. The funds raised by Pharmsynthez will be used to deliver their ambitious investment programme which will accelerate their growth and enable them to introduce their unique pharmaceuticals to Russian as well as International markets.

"We have encouraging pre-clinical data on the Multiple Sclerosis vaccine candidate and we are still confident that this will be the first of the projects to reach the clinical trial stage early in 2011."

[buywell2] 30/6/2011 15:42

I reckon phase 2b trials news is about to hit

Positive Phase II Clinical Data
16 December 2010

Lipoxen announces that it has received positive Phase II clinical trial results for both efficacy and toxicity from the Company's long-acting erythropoietin (EPO) candidate ErepoXen. EPO is a glycoprotein hormone secreted by the kidneys that controls red blood cell production.

ErepoXen is being developed as a long acting form of EPO for the treatment of anaemia in renal disease patients. ErepoXen uses Lipoxen's proprietary PolyXen drug delivery technology which improves the efficacy, stability and half life of protein drugs and reduces risk of toxicity.

Chronic kidney disease (CKD) is highly prevalent, with around 2.455 million people worldwide receiving renal replacement therapy at the end of 2009 - nearly 1.895 million on dialysis and just over 560,000 with a functioning renal transplant*. The number of people with CKD at the end of 2009 was 6 - 7% higher than at the end of 2008* and it has been forecast that this prevalence will continue to increase.

The Phase IIa trials, which consisted of 30 subjects, were carried out by the Serum Institute of India Ltd, India's largest biotech company. This was a multi-centre, randomised, open-label single, subcutaneous dose study of polysialylated erythropoietin to assess safety, pharmacodynamics and pharmacokinetics in chronic kidney disease patients not on dialysis.

Thirty subjects were enrolled into the study in three cohorts of ten subjects each. The subjects were either male between the ages of 18 or 70 or post-menopausal females under 70 years of age. The subjects were randomised to receive subcutaneous doses of either 0.5µg/kg, 1µg/kg or 2 µg/kg of polysialylated erythropoietin in the anterior femoral skin.

Dr Ashraf Mikhail, MB.Bch, MSC, MD, FRCP, MBA, Consultant Nephrologist at the Morriston Hospital and Senior Clinical Tutor at Swansea University has reviewed the study findings and has commented upon them as follows:

"The study confirms the findings of phase I trial. Polysialylated EPO is effective in increasing the reticulocyte count and thereby stimulating erythropoiesis in patients with Chronic Kidney Disease in a dose dependent manner. The rise in reticulocyte count is maintained for up to 28 days after a single injection. This finding suggests the drug may be effective when administered once monthly to patients with chronic kidney disease, thereby achieving maximal compliance and excellent outcome results". The results of the trial showed no adverse events, that the drug was well-tolerated and safe at all dose levels administered.

Lipoxen and The Serum Institute of India, as development partners in the project, will now consider the optimum development path for the commercialisation of this exitcing product candidate; this will include entering Phase II(b) trial in India as well as the possible out-licencing of the candidate to a commercial collaborator.

Commenting on the appointment, M. Scott Maguire, Chief Executive Officer of Lipoxen, said:

"I am absolutely delighted that this trial has delivered such excellent results and shown the potential for our PSA-EPO candidate to be a once-a month single dose therapy for renal disease patients. The Lipoxen Board will be working closely with our colleagues at Serum Institute to accelerate the commercialisation of this candidate. This is very exciting news indeed for Lipoxen and further underscores the viability of the PolyXen platform as a likely leading delivery methodology for a new wave of long-acting biosuperior biologic drug candidates."