Immupharma Share Discussion Threads

[flavio_monteiro] 26/12/2017 22:31

The suggestion that a single stock could lead some investors to become millionaires next year may sound fanciful but I think this is quite possible if events work out for small-cap drug discovery and development firm ImmuPharma (LSE: IMM). Let me explain.

Blockbuster potential
Over the last three months, shares in the AIM-listed company have climbed more than 200% in value as anticipation grows over the outcome of a Phase III clinical trial for Lupuzor — its 100%-owned potential treatment for Lupus.

Approximately five million people are believed to suffer from the chronic and potentially life-threatening autoimmune disease that can be a notoriously difficult to treat. In the last 50 years, only one therapy — GlaxoSmithKline̵6;s Benlysta — has been approved for use, despite its questionable efficacy and serious side-effects. In 2015, the drug achieved sales of over $400m. By 2020, this figure is expected to rise to $1bn.

Positively, data from Lupozor’s Phase IIb trial indicated that ImmuPharma’s treatment — which modulates rather than blocks the immune system — was both effective and safe. Moreover, the effectiveness of Lupuzor increased even after the three-month trial’s conclusion. Investors will be hoping that the 52-week, randomised and double-blinded study currently in progress (involving patients in the US, Europe and Mauritius) yields similar results.

In its most recent update on 21 December, the company revealed that all 200 participants had now received the full 12-month dosage and that the “robust safety record” shown in earlier trials continues to be seen. According to Chairman Tim McCarthy, the company looks forward “with continued confidence” to reporting on top-line results in Q1 of next year.

In the event of a positive outcome, ImmuPharma will then seek to exploit its Fast Track designation and push for approval from the Food and Drug Administration (FDA). Once received, the company would then be free to seek out a global licensing deal for taking Lupuzor to market or — perhaps more likely — consider takeover bids by deep-pocketed pharmaceutical giants at a price befitting its blockbuster potential. Given the suggestion that it could be used in the treatment of other diseases, the price could easily be in the billions of pounds. Right now, ImmuPharma’s market cap is a little over £200m.

Tempted? If so, it’s vital to consider the flip side of this investment.

A word of warning
Despite the encouraging outcomes of previous trials, the possibility of the drug failing to impress still remains. Plenty of highly promising treatments have disappointed at the last hurdle, resulting in significant capital losses for investors. Unless you’re willing to embrace this level of risk, Immupharma shouldn’t even make it on to your watchlist, let alone into your portfolio.

That’s why — as a holder of its stock — only a small proportion of my capital is invested in the company. This money can be lost. I might grumble and curse but — thanks to a degree of diversification — I won’t lose my shirt.

That said, if — and it remains a sizeable ‘if‘ — Lupuzor proves effective (or at least more efficacious than Benlysta), I’m confident that ImmuPharma could generate huge wealth for investors in a very short time period.

No investment is devoid of risk but only you can decide whether this is one worth taking.

[qs99] 26/12/2017 21:43

Well if nothing else it may stimulate some decent buying let’s see! Gla

[spawny100] 26/12/2017 19:44

Thanks waterloo. Interesting to see that article on Motley Fool. In my experience that site is full of very cautious investors obsessed with PE ratios so it's quite significant imo if some there are cottoning on to the potential here.

[waterloo01] 26/12/2017 17:40

The suggestion that a single stock could lead some investors to become millionaires next year may sound fanciful but I think this is quite possible if events work out for small-cap drug discovery and development firm ImmuPharma (LSE: IMM). Let me explain.

[allonblack] 26/12/2017 16:27

As a shareholder I was interested in the low dosage comment as on the surface it does appear valid. I would point anyone interested in this point or the company to the 2016 presentation by S Muller. It is superb.As far as I can tell there are a few key points on this stock and P140.1. The mechanism of action is now articulated but only recently appreciated (by a nobel prize for the discovery of autophagy in 2016.)2. 2016 also saw a few key research papers published on the link between autophagy and lupus.3. The more recent published research by SM is identifying more illnesses where P140 could be equally effective in treatment.4. The small dosage is due to the specificity of the chemical and its role. Simply put It is targeting a very small but pivotal chemical process. SM specifically talks about this in her presentation.Its pretty clear that drug companies must be watching the developments in understanding of autophagy and its links to autoimmune disorders. Having watched the 2016 SM presentation, quickly read the nobel prize on autophagy in 2016 and some research papers in 2016 linking the mechanism to lupus I am now really upbeat on a deal being done. Im not going to rave on about price or valuation but this an example of cutting edge science going under appreciated and being misunderstood.

[divinessence] 26/12/2017 16:21

hotting, a few really important points raised by you regarding Cephalon.

[hottingup] 26/12/2017 09:51

hamham, the sector trend is for out-licensing deals prior to Phase 3 and takeovers after Phase 3.

In Feb 2009, IMM out-licensed Lupuzor (pre-Phase 2b results, Nov 2009) to Cephalon for upfront payments of $45 million ($15 + $30), a further $500 million in cash milestones and 'high royalties on future sales". In late 2011, following the acquisition of Cephalon by Teva, Cephalon were legally obliged to return Lupuzor to IMM, who now again owns 100% of the Lupuzor asset.

IMM's original $545m deal with Cephalon shows just how impresssed Cephalon were with Lupuzor, even based on much earlier data; and how much more attention Lupuzor must now be receiving, plus how much more money IMM could now get based on a successful Phase 3 - probably as a takeover, particularly as there is now evidence that Lupuzor may be efficaceous in more than ten high value indications (not just lupus).





----------------------------

This promising small-cap stock could be a millionaire maker in 2018
Paul Summers
Tue. 26/12/2017



The suggestion that a single stock could lead some investors to become millionaires next year may sound fanciful but I think this is quite possible if events work out for small-cap drug discovery and development firm ImmuPharma (LSE: IMM). Let me explain.

Blockbuster potential

Over the last three months, shares in the AIM-listed company have climbed more than 200% in value as anticipation grows over the outcome of a Phase III clinical trial for Lupuzor — its 100%-owned potential treatment for Lupus.

Approximately five million people are believed to suffer from the chronic and potentially life-threatening autoimmune disease that can be a notoriously difficult to treat. In the last 50 years, only one therapy — GlaxoSmithKline‘s Benlysta — has been approved for use, despite its questionable efficacy and serious side-effects. In 2015, the drug achieved sales of over $400m. By 2020, this figure is expected to rise to $1bn.

Positively, data from Lupozor’s Phase IIb trial indicated that ImmuPharma’s treatment — which modulates rather than blocks the immune system — was both effective and safe. Moreover, the effectiveness of Lupuzor increased even after the three-month trial’s conclusion. Investors will be hoping that the 52-week, randomised and double-blinded study currently in progress (involving patients in the US, Europe and Mauritius) yields similar results.

In its most recent update on 21 December, the company revealed that all 200 participants had now received the full 12-month dosage and that the “robust safety record” shown in earlier trials continues to be seen. According to Chairman Tim McCarthy, the company looks forward “with continued confidence” to reporting on top-line results in Q1 of next year.

In the event of a positive outcome, ImmuPharma will then seek to exploit its Fast Track designation and push for approval from the Food and Drug Administration (FDA). Once received, the company would then be free to seek out a global licensing deal for taking Lupuzor to market or — perhaps more likely — consider takeover bids by deep-pocketed pharmaceutical giants at a price befitting its blockbuster potential. Given the suggestion that it could be used in the treatment of other diseases, the price could easily be in the billions of pounds. Right now, ImmuPharma’s market cap is a little over £200m.

[hamhamham1] 26/12/2017 09:28

I wonder if over the next few weeks a similar (pre results deal) is announced to the previous Cephalon one on the PhIIb results?
Obviously a lot higher figures for this latter stage :)
Cephalon paid ImmuPharma $15m before the results of the Phase IIb study for the exclusive option to enter into the worldwide licence. Following positive results of ImmuPharma’s Phase IIb study in early 2009, Cephalon exercised its option by paying a further $30m for an exclusive worldwide licence. This was part of a corporate deal worth over $500m in cash milestone payments, on top of high royalties on product sales. In addition, Cephalon assumed all responsibilities and costs for the development and commercialisation of Lupuzor.

[jpleight] 25/12/2017 13:56

my worry exactly... markets reopen tomorrow right?

[113mike] 25/12/2017 10:07

All seems too good to be true! let's hope it turns out good! GLA!

[hitsha1] 25/12/2017 09:47

Well here comes £40-100.enjoy the ride

[professor bang bang] 25/12/2017 09:15

Improvement rates with IMM's Lupuzor:

Phase 2b at 3 months = + 67.6%
Phase 2b at 6 months = + 84.2%
Phase 3 at 9 - 12 months = + 100% ??

For me its not now about whether lupuzor works but just how big the improvement will be at 9 and 12 months.

N.B.
Resetting the Autoreactive Immune System with a Therapeutic Peptide in Lupus
Prof. Sylvian Muller
Lupus (2015) 24, pg 412–418

"The phase IIb trial showed that after three months of therapy (three subcutaneous injections of 200 ug peptide/patient in addition to standard of care), Lupuzor improved Systemic Lupus Erythematosus Disease Activity Index score of lupus patients under active treatment by 67.6% versus 41.5% in the placebo group (p<0.025). After three additional months of follow-up, the improvement rate was 84.2% versus 45.8% (p<0.025). The side effect profile was unproblematic and the drug was well tolerated as evidenced by a very low drop-out rate."

www.lupuzor.com/Documents/Schall%20Muller%20Lupus%202015.pdf

[best1467] 24/12/2017 21:32

Mr T Your comments ref dosing are well founded and it's something That concerned me several months back .Im not sure if anyone knows or understands the exact reason or if most could understand even if there was an explanation.From what I've read and various presentations it appears to be down to the mechanism of action and where it occurs and that it targets the precise area required.
But the facts remain the dose been used did work in p2b with great results both efficacy and safety and I can't find a reason to believe why it shouldn't at least repeat in the p3 and that's all we need for a happy and fruitful 2018.

[l0ngterm] 24/12/2017 20:25

Mr t if you research further you will find this does occur. Similar scenarios were published in previous quotes and were covered on this board. But up to you I'll go with the fda, CNRS and the experts in the field on the this one

[hamhamham1] 24/12/2017 17:50

Mr T, I think you are devious bordering on the sinister. To make out you are trying to just determine how much to top slice your profit to date is a tad dubious? If you were as investigative (pre your 'share purchase') as you are now and had invested and were now sitting on a good profit then you wouldn't really be posting in this fashion. You would have been happy to get in and happy to bank a profit (without all this fuss) - leaving free shares to ride or to hold . Most odd behavior ;) Others may see as well?

[top tips] 24/12/2017 16:49

Lupuzor will absolutely smash Benlysta and be massive.

[englishlongbow] 24/12/2017 16:43

MrT, you prize loon. Lupuzor has more like a 95% chance of reaching the market and for several indications (as hottingup has already said). All it has do do is beat Benlysta.

1) Lupuzor produced the best ever efficacy and safety for a Phase 2b lupus drug (easily beating Benlysta) and feedback so far from Phase 3 suggests ongoing good safety (unlike Benlysta).

2) Lupuzor is also faster acting, cheaper to sell and has a higher profit margin than Benlysta.

3) Feedback from people who have taken Lupuzor has been amazing, e.g. Barbie Manchester and Melanie Regnaud. Barbie Manchester said she tried several Lupus drugs and for her Lupuzor was the best, and when she was taking it it was as if she did not have lupus.

4) Lupuzor targets the exact optimal point in the immune cellular chain to get a good result, unlike Benlysta.

"P140 peptide takes action further upstream in the immune response. It specifically shuts down so-called CD4 T-cells before they can aggravate the B-cells that cause Lupus." (IMM's website)

5) Lupuzor is a selective immuno-modulator, rather than a general immuno-suppressant like Benlysta, so Lupuzor has a key advantage and will automatically produce better efficacy and safety.

"This targeted approach marks a paradigm shift in treating autoimmune disease. Instead of shutting down otherwise healthy immune responses the T-cells are suppressed leaving the immune system modified but intact."(IMM's website)

6) They have perfected a way to extend the active life of the drug in the bloodstream.

7) Lupuzor has performed well preclinical in several other indications, supporting wider efficacy in multiple high value indications, so giving it multiple "bites at the cherry".

Lupuzor™ Symposium
8th June 2016 - 3:35 pm

41 min 40 sec onwards:


- Systemic Lupus Erythematosus (SLE) (Market size $4 bn) (SLE ends Phase 3, Jan 2018)
- Neuropsychiatric lupus (NPSLE)
- Gougerot-Sjögren syndrome (GSS) (Market size $2.2 bn by 2024)
- Rheumatoid Arthritis (Market size $28.5 bn by 2025)
- Gougerot-Sjögren syndrome (GSS) (Market size $2.2 bn by 2024)
- Crohn's Disease + Ulcerative Colitis (Market size $4 bn by 2022)
- Guillan-Barre disease
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Asthma (Market size $20.7 bn in 2015)

Other potential evaluations (to be tested Jun 2016 onwards):
- Scleroderma (Systemic Sclerosis, Raynaud)
- Psoriasis
- Multiple Sclerosis (MS) (Market size $20 bn by 2024)
- (Others to follow)

Negative preclinical results for potential re-evaluation:
- Type I Diabetes (Market size $43 bn by 2021)
- Amytrophic Lateral Sclerosis (ALS)

8) IMM have a new Lupuzor patent (granted 2017) covering key markets (USA, EU, China, India & Japan) to 2032 & use in the majority of autoimmune indications. A new patent has also been filed to cover non-autoimmune indications. (IMM, Sep 2017)

9) Lupuzor has a the 'gold standard' SPA and Fast Track status from the US FDA, putting it in an exceptionally strong regulatory position and guaranteeing approval within 6 months if it does OK, and market launch in 2018.

10) IMM raised sufficient cash in early 2017 to last to the end of 2018, allowing them to negotiate a Lupuzor deal or takeover of the company from a position of financial strength.

Basically Lupuzor is more efficaceous, safer, faster acting, and cheaper to make and sell than Benlysta, the platform is applicable to multiple high value indications, it will get to market to in 2018, they have a long and broad patent, a strong regulatory position, and sufficient cash to see them through a Lupuzor deal or takeover and market launch.

[mr. t] 24/12/2017 16:22

Dave, I think the category of drugs Lupuzor is in (peptide NMEs) has a 38%(ish) chance of success based on history. Although I get some reports say higher.Lupuzor has strong plus points (which have been well discused here) that increase chance of success. It also has negatives which I want to understand better to make a more informed choice about when & how much to topslice.If phase 3 is successful the rewards will be great so even with a 38% chance I'm pleased to hold a chunk of shares.

[mr. t] 24/12/2017 15:54

Thanks L0ngterm. The fact that it claims to increase efficacy is interesting too. I still think a 200mcg dose monthly is low.I've struggled to find any other drug for any disease that works at such a low dose. If anyone else knows of any other drug with this kind of dose I'd love to hear it. Or is Lupuzor in completely unchartered territory?I also can't get my head around why Lupuzor works at 200mcg monthly, but works less well with 1000mcg dose or when taken fortnightly. Most drugs have a stronger effect when you take more, the reason the drug dose is limited at a certain size is normally to reduce side effects.

[jpleight] 24/12/2017 13:08

Nobody knows what is going to happen but the risk/reward at the moment considering the current price is very very good imo. Once we get that update on last dosing/study complete without SAEs on january , this on its own should propel the price another 20-30% no probs. (judging from previous jumps in price) and then price may stay around the ?190-200 mark before readout?. All IMHO DYOR.

[davew28] 23/12/2017 20:27

Mr T,

You have said from your research that you think that Lupuzor may only have a 38% chance of being successful based on the success rate of NME's. Surely if you have researched this and you believe this, why are you so heavily invested in something that you think has such a high probability of failure? This sector is higher risk but I believe you are overstating this given the positives of what the company have thus far achieved with the drug developed by one of the leading scientists in Europe. A lot of the people within the company are heavily invested (financially and career) and obviously believe in the success of the drug but there are risks which have to be accepted and that is why the share is currently valued very modestly given the potential. As someone else stated there is very little else out there that matches the risk/reward ratio offered here. My advice would be to accept the risk or reduce your holding to a comfortable level where the risk is acceptable. Also as SK and others have mentioned, because effective Lupus drugs are virtually non-existent, the efficacy figures wouldn't have to be so great as they may have been if there were other options for suffers.

All IMV, DYOR etc

Best wishes all investors for a Great Christmas and 2018
Dave

[che7win] 23/12/2017 20:25

Yes, was going to ask about patent life.