https://www.proactiveinvestors.co.uk Proactiveinvestors RSS feed en Mon, 22 Oct 2018 00:14:03 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - ImmuPharma boss excited by “blockbuster potential” of Lupuzor ]]> https://www.proactiveinvestors.co.uk/companies/news/205719/immupharma-boss-excited-by-blockbuster-potential-of-lupuzor-205719.html The chief executive of ImmuPharma PLC (LON:IMM) has told investors he is excited by the “blockbuster potential” of the company’s flagship lupus treatment, Lupuzor.

Earlier this month, ImmuPharma signed an agreement which will see it progress with a managed access programme, giving up to 500 lupus sufferers access to Lupuzor for a minimum of two years.

WATCH: ImmuPharma committed to Lupuzor ahead of managed access to programme

In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.

In April, the drug missed its primary endpoint in a late-stage study, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected in the second quarter of 2019.

Full regulatory approval

“It has been a busy period for the board following the announcement of the phase III trial results for Lupuzor in April 2018,” said chief executive Tim McCarthy.

“We were obviously disappointed with the outcome of the phase III trial results but are excited to be progressing the managed access programme with a new strategic partner, which allows lupus patients early access to Lupuzor.

“In the medium term, we remain focused on achieving the full regulatory approval of Lupuzor which we believe has the potential to be a ground-breaking drug for lupus patients with blockbuster potential in commercial terms.”

Nucant cancer programme making progress

Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.

The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.

A licence agreement between the two is expected to be signed by the end of the year, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all of the development costs for the Nucant programme.

All future commercialisation revenues will be shared equally, ImmuPharma said.

Ureka to be divested

As for the firm’s Ureka subsidiary, which is looking to develop treatments for type II diabetes and NASH, the decision was recently made to sell it.

Despite having “exciting and innovative technologies”, the board does not see as part of the long-term strategy.

As a result, the plan is to divest the Bordeaux-based subsidiary whilst still retaining an interest should any of its drugs achieve some commercial success further down the line.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years.  We are equally excited by the potential of both,” said McCarthy.

“We believe the strategy we announced earlier this month, together with a robust financial position, will create enhanced value for shareholders going forward.”

Well-funded

Speaking of that “robust financial position”, thanks to a £10mln fundraise in January, ImmuPharma had £9.0mln of cash in the bank (H1 17: £2.7mln) at the end of June. Net assets grew to £9.9mln (H1 17: £3.6mln).

The company posted a loss for the six months to June 30 of £4.1mln, up from £3.0mln a year ago, reflecting a slight rise in R&D costs.

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Wed, 26 Sep 2018 07:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205719/immupharma-boss-excited-by-blockbuster-potential-of-lupuzor-205719.html
<![CDATA[News - Managed access programmes offer an alternative way forward for drug companies ]]> https://www.proactiveinvestors.co.uk/companies/news/205331/managed-access-programmes-offer-an-alternative-way-forward-for-drug-companies-205331.html Managed access programmes (MAPs) have been around for some time, offering poorly people access to drugs that aren’t currently fully licensed or are unavailable in a particular country.

Patients often receive the new, unapproved medication on compassionate grounds, while the MAPs themselves tend to be overseen by specialist drugs firms.

Here in the UK, Clinigen has run over 250 programmes providing ‘off-label’ treatments to those in acute medical need.

Eighteen of the top 20 big pharmaceutical companies now provide early access to their drugs.

Source of rich data 

In fact, MAPs are becoming a rich data source with patient-reported outcome information bundled up with the stats gleaned from clinical trials, which is then submitted to the regulator.

“Merck ran a MAP programme for Keytruda that formed an invaluable part of the regulatory filing that they were able to get reimbursement on,” said Tim McCarthy, chairman of ImmuPharma (LON:IMM).

Keytruda is one of a new breed of immunotherapy drugs that could help revolutionise the treatment of the killer disease.

McCarthy’s reference to the Merck breakthrough was by way of example as of what can be achieved using MAPs as ImmuPharma prepares to go down the same route.

500 patients to be treated

It will offer 500 patients with the autoimmune disease lupus access to Lupuzor, which generated mixed data in phase III clinical trial.

“We can get valuable data on the drug,” McCarthy told Proactive’s, Andrew Scott.

“We call this real-world data. I should stress, this is not a clinical study. All patients will get the drug, there will be no comparator group, blinding or randomisation.”

The MAP will be around a tenth of the cost of the last ImmuPharma clinical with patients receiving the medication free of charge for two years.

“This approach is getting a lot of traction now in our industry,” said McCarthy.

FOR THE FULL PROACTIVE INTERVIEW CLICK THIS LINK 

Despite the phase III setback for Lupuzor, ImmuPharma still plans to make a regulatory filing.

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Thu, 20 Sep 2018 12:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205331/managed-access-programmes-offer-an-alternative-way-forward-for-drug-companies-205331.html
<![CDATA[Media files - ImmuPharma firmly committed to Lupuzor ahead of managed access programme ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/10512/immupharma-firmly-committed-to-lupuzor-ahead-of-managed-access-programme-10512.html Tue, 18 Sep 2018 14:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/10512/immupharma-firmly-committed-to-lupuzor-ahead-of-managed-access-programme-10512.html <![CDATA[News - ImmuPharma’s flagship lupus drug to be made available to patients ahead of regulatory filing ]]> https://www.proactiveinvestors.co.uk/companies/news/204410/immupharmas-flagship-lupus-drug-to-be-made-available-to-patients-ahead-of-regulatory-filing-204410.html Some lupus patients will soon have access to a potentially “ground-breaking” new treatment after Immupharma PLC (LON:IMM) signed an agreement which will see it press ahead with a managed access programme (MAP).

The deal with a specialist provider will allow up to 500 sufferers ongoing access to Immupharma’s flagship drug, Lupuzor, for a minimum of two years.

In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.

WATCH: ImmuPharma firmly committed to Lupuzor ahead of managed access programme

Earlier this year, the drug missed its primary endpoint in a late-stage study, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected in the second quarter of 2019.

READ: ImmuPharma says pre-clinical study points to other indications for Lupuzor

“The board has been focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and know-how,” said chairman Tim McCarthy.

“We are excited as a team to be progressing the MAP programme which allows Lupus patients early access to Lupuzor.

“In the medium term, we remain focused on achieving the full regulatory approval of Lupuzor which we believe has the potential to be a ground-breaking drug for Lupus patients and in turn has blockbuster potential in commercial terms.”

Nucant cancer programme making progress

Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.

The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.

A licence agreement between the two is expected to be signed by the end of the year, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all of the development costs for the Nucant programme.

All future commercialisation revenues will be shared equally, ImmuPharma said.

Ureka to be divested

As for the firm’s Ureka subsidiary, which is looking to develop treatments for type II diabetes and NASH, the decision has been made to sell it.

Despite having “exciting and innovative technologies”, the board does not see as part of the long-term strategy.

As a result, the plan is to divest the Bordeaux-based subsidiary whilst still retaining an interest should any of its drugs achieve some commercial success further down the line.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years,” added McCarthy.

“We are equally excited by the potential of both. We believe the strategy we have announced today for both, will create enhanced value for shareholders going forward.”

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Fri, 07 Sep 2018 08:05:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/204410/immupharmas-flagship-lupus-drug-to-be-made-available-to-patients-ahead-of-regulatory-filing-204410.html
<![CDATA[News - ImmuPharma says pre-clinical study points to other indications for lead drug ]]> https://www.proactiveinvestors.co.uk/companies/news/198848/immupharma-says-pre-clinical-study-points-to-other-indications-for-lead-drug-198848.html Pre-clinical work by ImmuPharma PLC (LON:IMM) on P140, the peptide currently being developed as Lupuzor for the treatment of people with lupus, reveals it may have other potential indications.  

The company's co-founder, Professor Sylviane Muller, and her team believe the drug could be deployed to treat an autoimmune disease called chronic inflammatory demyelinating polyneuropathy, or CIDP.

This a condition where medication is currently lacking and which is characterised by fatigue, diminished or absent tendon reflexes and sensory deficits, usually starting in the hands and feet.

CLICK HERE: For the full announcement 

The results of the pre-clinical study have been published in the Journal of Autoimmunity.

"Over the last couple of years we have provided further evidence of the role the P140 peptide can take in the potential treatment of other autoimmune diseases in addition to Lupus," said Muller.

"We are delighted that these results demonstrate positive pre-clinical data in a murine model of CIDP, which has no available disease-specific treatment.  We look forward to providing a further update on the progress of our CIDP programme in due course."

 

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Thu, 14 Jun 2018 08:02:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/198848/immupharma-says-pre-clinical-study-points-to-other-indications-for-lead-drug-198848.html
<![CDATA[Media files - ImmuPharma chairman more optimistic on results for its Lupuzor drug ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9392/immupharma-chairman-more-optimistic-on-results-for-its-lupuzor-drug-9392.html Tue, 29 May 2018 15:56:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9392/immupharma-chairman-more-optimistic-on-results-for-its-lupuzor-drug-9392.html <![CDATA[News - ImmuPharma shares jump as chairman upbeat after phase III data review for flagship drug ]]> https://www.proactiveinvestors.co.uk/companies/news/197804/immupharma-shares-jump-as-chairman-upbeat-after-phase-iii-data-review-for-flagship-drug-197804.html ImmuPharma PLC (LON:IMM) shares jumped 6.5% higher on Tuesday after its chairman Tim McCarthy said he believes Lupuzor has the potential to offer lupus sufferers a much needed treatment after researchers took a deeper dive into the data generated by its phase III clinical trial of the company's flagship drug candidate.

Top line results from the study issued last month revealed the treatment missed its primary endpoint. It was efficacious, just not at a level that could be described as statistically significant.

However, the outcome was more nuanced than binary and the latest update perhaps underlines the chairman's optimism.

WATCH: ImmuPharma chairman more optimistic on results for its Lupuzor drug

The analysis revealed that, in the European group of lupus sufferers, Lupuzor had a statistically significant 71.1% response rate against a 48.8% rate in the control group, which received a dummy pill plus the standard of care.

Mixed results in the US

It should be noted, and this is important to the analysis, that in the European group 79 patients, or just under 61% of the group, were anti-body positive, which is a biomarker of the disease. 

In the US study group only 40% were was antibody positive where you'd expect 60-70% to be in this category. This may explain why the out-turn for the US could best be described as "mixed".

So, in the American cohort there were 72 patients, of which 28 were antibody positive, split equally between the active and placebo group. Five people were "responders" in the group receiving medication, while in the control group six responded.

The  anti-body positive result in particular "could allow identification of patients that are more likely to respond positively to treatment with Lupuzor", ImmuPharma said.

Disease modifying agent

Chief scientific officer Robert Zimmer added: "Current treatments (monoclonal antibodies, steroids etc) prescribed to Lupus patients are essentially symptomatic treatments acting irrespectively of the antibody status of the patients. 

"The potential efficacy of Lupuzor seems to be correlated with the presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and we hope to confirm that Lupuzor will come to be considered as a disease modifying agent.

"We believe this is in line with what healthcare practitioners are seeking: precision medicines to target therapies, using biomarkers that reference precisely those patients who could benefit from the treatment options available. This should reduce healthcare costs and improve patient outcomes."

Chairman McCarthy said the ImmuPharma treatment had a "compelling product profile", adding that he was "highly encouraged" by the anti-body positive result.

"We continue to believe Lupuzor has the potential to bring a much needed treatment to Lupus sufferers around the world. We look forward to providing our shareholders with further updates as we move forward with this programme," he went on.

By mid-morning trading, Immupharma shares were ahead 6.5% at 29.4p.

In a note to clients, analysts at ‘house’ broker Northland Capital said: “These findings are a positive for the Company and the potential commercial value of Lupuzor.

“The anti-dsDNA autoantibody is a significant biomarker within the lupus population and indicates a potential target population for Lupuzor.”

-- Adds analysts comment, updates share price --

 

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Tue, 29 May 2018 08:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/197804/immupharma-shares-jump-as-chairman-upbeat-after-phase-iii-data-review-for-flagship-drug-197804.html
<![CDATA[News - ImmuPharma chairman and chief executive upbeat on Lupuzor; industry interest remains strong ]]> https://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html If it’s been a roller-coaster week for investors in the drug developer ImmuPharma PLC (LON:IMM), the stress doesn’t show in the demeanour of its two principals – chief executive Dimitri Dimitriou and Tim McCarthy, the chairman.

“Do we look down in the dumps?” asks McCarthy, before answering his own question. “Of course, we don’t.”

You’d suppose from the share price action there were more reasons to be fearful than cheerful following the publication of top-line data from the phase III clinical trial of Lupuzor, for the treatment of the autoimmune disease, lupus.

WATCH: ImmuPharma pair confident on dr​ug's future

On the face of it, the result wasn’t good as the drug missed its primary endpoint. It was efficacious, just not at a level that could be described as statistically significant; however, the devil was very much in the detail of the trial with a number of positives in the results that suggest the 67% fall in the share price this week was something of a knee-jerk reaction.

WATCH: Analyst gives his reaction to Lupuzor news

And these ‘positives’ also provide a very broad hint as to why Messrs Dimitriou and McCarthy were fairly relaxed when they joined Proactive 48 hours after the update.

First, there is more than a slim chance that the product will still make it to market and crucially, potential commercial partners are still interested in Lupuzor.

“We are at pains to point out this isn’t a failed drug,” said McCarthy.

“These are results for a drug that didn’t meet its primary end-point and that’s a difficult concept for a lot of people to understand.” 

As mentioned above, the data were nuanced rather than binary. As is normal for trial of this magnitude and importance, the ImmuPharma phase III study was a double-blind placebo-controlled study.

This is a simple concept: the doctors treating patients don’t know who is receiving the medication and who is being administered a pill or solution with no medical benefit at all – the placebo. Only at the end is it revealed who had what.

Nuanced results

The ImmuPharma trial was a little different. Patients in each group received the standard of care, which is normally some sort of steroid treatment, plus either the placebo or the Lupuzor.

So, while the response rate among the Lupuzor group was 52.5%, the placebo cohort showed an unusually strong response at 44.6%.

The latter number was higher than expected, based on what had been observed in phase II where the number was below 40%.

“If we had the same efficacy as we achieved in phase III and got the lower placebo response we saw in phase II then we would have seen statistical significance. That’s the subtle point,” said McCarthy.

And remember, patients in the placebo group probably weren’t responding to the placebo; rather, they were responding to the ongoing treatment they were receiving.

It is worth pointing out that 153 of the initial 202-strong patient group finished the 12-month course. In that smaller group, the response rate for Lupuzor was almost 70%, compared with 59% for the placebo.

Deep dive into the data 

In some cases, where patients possessed certain biomarkers, the response was statistically significant; indeed a small handful of patients went into full remission.

The plan now is to take a deep dive into the data. Then there are also conversations to be had with the regulators, who are likely to be a little more understanding than investors who bailed out.

“We need to have a discussion with the FDA [Food & Drug Administration] and EMA [European Medicines Agency] to see what they think because there have been trials where the end-point strictly speaking wasn’t met but the FDA understands what’s good for the patient and they understand context,” said CEO Dimitriou.

“You could have an optimistic scenario where you have conditional approval to make it [Lupuzor] freely available for the patient without having the formal approval. That’s the discussion to be had.”

More than 10 NDAs

At the same time, talks with potential industry partners are ongoing, with more than ten having signed non-disclosure agreements with ImmuPharma. The latest results don’t appear to have rattled potential collaborators.

“We sent them the top-line numbers to the people who we signed confidentiality agreements with. A lot came back the same day and some that didn’t have CDAs [confidentiality agreements] in place sent through CDAs the same day,” said Dimitriou.

McCarthy added: “The message to take away is we have done an awful lot of groundwork with these companies before we got these results. Within 48 hours we have shared the data and already had responses back.”

Agreeing a licensing deal traditionally takes around a year, though the competition can be a catalyst. And remember, Lupuzor has already been through the validation process having earlier in its history been licensed to Cephalon before the takeover of the US biotech saw the rights handed back.

But just why would big pharma be interested in Lupuzor?

Well, lupus sufferers, of whom there are around 5mln worldwide, are incredibly poorly served. The standard treatment is steroid-based, which has many side-effects, while the GlaxoSmithKline-made Benlysta, the first drug in the space for 50 years, also has significant drawbacks. This and the cost of Benlysta means that probably no more than around 13,000 patients have been treated.

A side-effect free alternative?

Even with that limited group, the GSK drug generated US$400mln of revenues. Imagine if you could get a side-effect-free alternative to market. One would assume the take-up rate would be much higher.

“Lupuzor is still a potential multi-billion dollar selling drug. The trial hasn’t done anything to alter that,” said chairman McCarthy.

“In fact, if anything it has proven what we have always been saying about its product profile. It does no harm and benefits patients.”

And all of this is said with a smile.

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Mon, 23 Apr 2018 11:18:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html
<![CDATA[Media files - Immupharma PLC still confident on Lupuzor's future ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9106/immupharma-plc-still-confident-on-lupuzor-s-future-9106.html Thu, 19 Apr 2018 12:34:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9106/immupharma-plc-still-confident-on-lupuzor-s-future-9106.html <![CDATA[Media files - ImmuPharma drug could still have a role in treating lupus – City analyst ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9078/immupharma-drug-could-still-have-a-role-in-treating-lupus-city-analyst-9078.html Tue, 17 Apr 2018 16:15:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9078/immupharma-drug-could-still-have-a-role-in-treating-lupus-city-analyst-9078.html <![CDATA[News - ImmuPharma drug needs further analysis; it could still have a role in treating lupus – City analyst ]]> https://www.proactiveinvestors.co.uk/companies/news/195172/immupharma-drug-needs-further-analysis-it-could-still-have-a-role-in-treating-lupus-city-analyst-195172.html ImmuPharma PLC's (LON:IMM) drug Lupuzor needs further analysis and certainly isn’t a bust, according to Vadim Alexandre, analyst at Northland Capital.

With shares down sharply on Tuesday, the reaction to phase III trial results for the lupus drug has been “knee-jerk” and probably not fully reflective of the outlook for the treatment, he said in an interview with Proactive’s Andrew Scott.

The readout from the study showed Lupuzor didn’t have a statistically significant impact on patients compared with the placebo plus the standard of care.

WATCH: Immupharma PLC still confident on Lupuzor's future

However, there are two points to grasp, Alexandre said. First, patients responded particularly well to the placebo plus standard of care because the cortical steroids worked. Second, the drug actually worked well in certain patient groups.

READ: Today's news

“We need to see more data,” Alexandre said. “There is a major unmet medical need and there has only been one drug out in the market in the last 50 years and that itself is not a perfect drug.”

On the news ImmuPharma is talking to potential partners, the Northland analyst added: “The primary end-point has not been met, but I think they will be looking at what the possibilities are for doing further and future trials.”

 

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Tue, 17 Apr 2018 14:55:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195172/immupharma-drug-needs-further-analysis-it-could-still-have-a-role-in-treating-lupus-city-analyst-195172.html
<![CDATA[News - ImmuPharma sees "significant opportunity" for lupus drug after phase III trial readout ]]> https://www.proactiveinvestors.co.uk/companies/news/195121/immupharma-sees-significant-opportunity-for-lupus-drug-after-phase-iii-trial-readout-195121.html ImmuPharma PLC (LON:IMM) said it believes there is a “significant opportunity” for its drug Lupuzor, used to treat autoimmune disease lupus, following the release of top-line results from a phase III trial.

The data revealed Lupuzor was more effective than the placebo (52.5% versus 44.6%). But because the response rate for those taking the non-active medication plus the “standard of care” was so high the end-point of the study was not achieved. That 'end-point' was a statistically significant beneficial impact from Lupuzor.

This initial readout was based on 202 patients, including those who withdrew from the trial.

WATCH: Drug needs further analysis, City analyst

The effectiveness among the 153 that got to the end of the course of treatment was 68.8% (versus 59.2% for the placebo).

Importantly, in patients who had a certain type of lupus biomarker called anti-dsDNA autoantibodies, Lupuzor worked well when compared with the placebo. Added to that, 7.6% of this group went into full remission, while none did in the placebo group.

The safety profile remained good with no adverse effects

Chairman Tim McCarthy said: “Lupuzor has demonstrated, in this study, a superior response rate over placebo and its exceptional safety, giving it, we believe, a compelling product profile.

“Whilst we are disappointed at the high response in the placebo plus standard of care group that resulted in statistical significance not being reached between the two treatment groups, we believe Lupuzor has the potential to bring a much needed safe treatment to the millions of Lupus sufferers around the world.

“We look forward to providing our shareholders with further updates in due course."

Further investigation merited

ImmuPharma said it believes the top line results “provide evidence for the continued investigation into the development and commercialisation of Lupuzor”. It thinks the drug has the potential to offer patients and physicians a much needed effective and safe treatment for lupus.

Following requests from both investigators and patients, ImmuPharma has begun a further study. This will allow all patients who took part in the phase III trial to receive Lupuzor plus the ‘standard of care’ medication for six months in what’s called an open-label scheme.

The results will be gathered independent of the pivotal trial just completed.

The plan is to look at the full dataset before making a decision, but the company said there is demand for a new lupus treatment.

Expressions of interest

It also said there had been “expressions of interest” in the Lupuzor programme and the phase III study.

“ImmuPharma is in ongoing discussions with a number of larger pharmaceutical companies,” it added.

“The results of this study will now be shared with those potential commercial partners. There can be no certainty as to the outcome or timing of these discussions.”

The shares fell 76%.

----adds share price---

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Tue, 17 Apr 2018 07:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195121/immupharma-sees-significant-opportunity-for-lupus-drug-after-phase-iii-trial-readout-195121.html
<![CDATA[News - ImmuPharma passes significant milestone; expects top line phase III data on flagship drug by the middle of next month ]]> https://www.proactiveinvestors.co.uk/companies/news/193677/immupharma-passes-significant-milestone-expects-top-line-phase-iii-data-on-flagship-drug-by-the-middle-of-next-month-193677.html ImmuPharma PLC (LON:IMM) said the database lock of its phase III clinical trial of Lupuzor, for the autoimmune disease lupus, is expected on April 6.

This is a significant milestone. It denotes the end of the pivotal study, but also prevents unauthorised or unintended changes to the information garnered.

This particularly important when the drug assessment is double-blind, which simply means the physicians don’t know whether patients are receiving the drug or a placebo with no medical benefits.

For more a fuller explanation of database lock, click here

Top-line results from the trial are expected by mid-April, ImmuPharma said after being updated by Simbec-Orion, the contract research firm carrying out the work.

Chairman Tim McCarthy said: "With the continued robust safety record of Lupuzor achieved over this trial, we look forward with confidence to reporting top line results in the near future."

A total of 200 lupus patients took part in the study, which it is hoped will provide a breakthrough for sufferers.

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

Strong cash position

According to the Lupus Foundation of America, around 1.5mln in the States have the condition, with 90% of those estimated to be women.

In a note to clients, analysts at ‘house’ broker Northland Capital said a £10mln raise completed in January, ImmuPharma is in a strong cash position.

“Should Lupuzor successfully meet the trial endpoints, the company will be in a strong negotiating position with potential partners,” it added.

Northland repeated its ‘buy’ rating and 181p target price on the stock.

In late afternoon trading, Immupharma shares were 2.4% lower at 124.5p.

 -- Adds broker comment, share price --

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Fri, 23 Mar 2018 07:24:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/193677/immupharma-passes-significant-milestone-expects-top-line-phase-iii-data-on-flagship-drug-by-the-middle-of-next-month-193677.html
<![CDATA[Media files - Exciting start to 2018 for ImmuPharma with pivotal data 'weeks away' ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8696/exciting-start-to-2018-for-immupharma-with-pivotal-data-weeks-away--8696.html Fri, 02 Feb 2018 13:25:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8696/exciting-start-to-2018-for-immupharma-with-pivotal-data-weeks-away--8696.html <![CDATA[News - ImmuPharma says it received strong institutional backing for £10mln City fundraiser ]]> https://www.proactiveinvestors.co.uk/companies/news/190525/immupharma-says-it-received-strong-institutional-backing-for-10mln-city-fundraiser-190525.html ImmuPharma PLC (LON:IMM) said it received strong backing from existing and new institutional investors for its £10mln City fundraiser.

The cash, raised by issuing shares at 144p each, will support future investment in the P140 peptide platform. It will also be used to meet the drug developer’s working capital requirements.

READ: ImmuPharma confident of topline results from Phase III Lupuzor trial this quarter

P140 is the bedrock for the company’s lead product, Lupuzor, on which a phase III clinical study was recently completed. Investors expect an initial read-out from the trial later this quarter.

Investment for the next period of growth

"We were approached by new institutions, introduced by Turner Pope Investments, keen to support ImmuPharma over the next period of growth,” said chairman Tim McCarthy of the additional funding.

ImmuPharma confirmed last week it had completed the pivotal phase III study of its Lupuzor, for the autoimmune disease lupus, leaving it on track to publish top-line data from the trial in the current quarter.

The last of the 200 patients recently attended their final assessment and data from the trial is being collected, checked and analysed.

AIM-quoted ImmuPharma said Lupuzor demonstrated a “robust safety profile” during the 12 month long trial, in keeping with what was seen in the successful phase IIb study.

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Wed, 24 Jan 2018 07:53:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/190525/immupharma-says-it-received-strong-institutional-backing-for-10mln-city-fundraiser-190525.html
<![CDATA[Media files - ImmuPharma confident of topline results from Phase III Lupuzor trial this quarter ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8635/immupharma-confident-of-topline-results-from-phase-iii-lupuzor-trial-this-quarter-8635.html Thu, 18 Jan 2018 15:55:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8635/immupharma-confident-of-topline-results-from-phase-iii-lupuzor-trial-this-quarter-8635.html <![CDATA[News - ImmuPharma completes phase III Lupuzor study; on track to publish top-line data this quarter ]]> https://www.proactiveinvestors.co.uk/companies/news/190211/immupharma-completes-phase-iii-lupuzor-study-on-track-to-publish-top-line-data-this-quarter-190211.html ImmuPharma PLC (LON:IMM) has completed the pivotal phase III study of its Lupuzor lupus treatment, leaving it on track to publish top-line data from the trial in the current quarter.

The last of the 200 patients has attended their final assessment and data from the trial is now being collected, checked and analysed.

READ: ImmuPharma says last patient dosed in Phase III clinical trial of lupus treatment, Lupuzor™

AIM-quoted ImmuPharma said Lupuzor demonstrated a “robust safety profile” during the 12 month long trial, in keeping with what was seen in the successful phase IIb study.

The phase III trial was what’s called a randomised, double-blind investigation, which means half the group were given the ImmuPharma drug, while the others will have received a placebo that has no impact on the condition.

Even the doctors will only have found out which group is which when the study finished.

ImmuPharma 'delighted' with study completion

“We are delighted to announce this major milestone for ImmuPharma in having completed on track this pivotal Phase III trial for Lupuzor,” said chief scientific officer Robert Zimmer.

“With the continued robust safety achieved over this trial, we look forward with continued confidence to reporting top line results of the study this Q1 2018.”

Following requests from both investigators and patients, ImuuPharma is also kicking off a ‘follow-up’ study which will allow eligible patients to continue to receive Lupuzor for another six months.

WATCH: Immupharma 'looking forward and planning for success' with Lupuzor

The results will be gathered as an ‘extension’ open label study – i.e. patients will know that they’re taking the drug – and will be independent of the original late-stage trial.

Debilitating disease

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

According to the Lupus Foundation of America, around 1.5mln in the States have the condition, with 90% of those estimateed to be women.

Successful trial data will lead to ‘significant rerate’

Despite that rise, house broker Northland Capital reckons they’re probably worth 181p and likely significantly more if the data comes back positive.

“With the trial now complete and all patients successfully monitored, Lupuzor continues to demonstrate a strong safety profile,” said Northland analyst Vadim Alexandre.

“Should Lupuzor successfully meet the trial endpoints, we estimate that ImmuPharma’s shares would significantly rerate to the upside.”

Alexandre added: “Finally, it is encouraging to see demand from patients for a follow-up study.”

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Thu, 18 Jan 2018 07:27:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/190211/immupharma-completes-phase-iii-lupuzor-study-on-track-to-publish-top-line-data-this-quarter-190211.html
<![CDATA[News - ImmuPharma says last patient dosed in Phase III clinical trial of lupus treatment, Lupuzor™ ]]> https://www.proactiveinvestors.co.uk/companies/news/189145/immupharma-says-last-patient-dosed-in-phase-iii-clinical-trial-of-lupus-treatment-lupuzor-189145.html ImmuPharma PLC (LON:IMM) has confirmed that the last patient has completed dosing within the 52-week, randomised, double-blinded, Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.

The specialist drug discovery and development company said 200 patients have been successfully recruited and dosed, with top line results remaining on track to be reported in the first quarter of 2018.

WATCH: Immupharma 'looking forward and planning for success' with Lupuzor

Commenting on the trial update, ImmuPharma’s chairman, Tim McCarthy, said: "We are delighted to announce this significant milestone that all patients have now completed dosing in this pivotal Phase III trial for Lupuzor™.”

READ: ImmuPharma banks extra £600,000 from Lanstead agreement

He added: “Importantly we continue to see robust safety and we look forward with continued confidence to reporting top line results of the study in Q1 2018."

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Thu, 21 Dec 2017 07:51:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/189145/immupharma-says-last-patient-dosed-in-phase-iii-clinical-trial-of-lupus-treatment-lupuzor-189145.html
<![CDATA[News - ImmuPharma phase III clinical trial remains on track; over half the patients have now completed the study ]]> https://www.proactiveinvestors.co.uk/companies/news/186627/immupharma-phase-iii-clinical-trial-remains-on-track-over-half-the-patients-have-now-completed-the-study-186627.html ImmuPharma PLC (LON:IMM) confirmed it is on track to publish top-line results from its phase III clinical trial in the first quarter of next year after it said over half the group had completed the full 12-month study assessing the performance of its potentially breakthrough treatment for lupus.

In all,116 of the 200 patients with the life-threatening auto-immune disease have been through the 52-week process looking at the efficacy of Lupuzor; all are now at or past the nine-month stage.

WATCH: Immupharma 'looking forward and planning for success' with Lupuzor

The phase III trial is what’s called a randomised, double-blind investigation, which means half the group will have been administered the ImmuPharma drug, while the others will have received a placebo that has no impact on the condition.

The doctors running the study will only know which group is which once the whole process is concluded.

At this stage they do know Lupuzor’s “robust” safety record remains consistent with what was seen at the successful phase IIb stage.

"The trial continues to progress on track and on time,” said chairman Tim McCarthy.

Debilitating disease

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

READ: Immupharma starts preparations for Lupuzor submission as trial makes good progress

The shares, up 84% in the year to date, marked time at 95p. City broker Northland reckons the stock is worth 185p.

“Should Lupuzor successfully meet the trial endpoints, we estimate that ImmuPharma’s shares would significantly rerate to the upside,” said analyst Vadim Alexandre.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also thought to be more effective than other products available, such as Glaxo's Benlysta.

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Thu, 02 Nov 2017 07:29:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/186627/immupharma-phase-iii-clinical-trial-remains-on-track-over-half-the-patients-have-now-completed-the-study-186627.html
<![CDATA[News - ImmuPharma banks extra £600,000 from Lanstead agreement ]]> https://www.proactiveinvestors.co.uk/companies/news/185026/immupharma-banks-extra-600000-from-lanstead-agreement-185026.html Lupus drug developer Immupharma PLC (LON:IMM) has raised £600,000 more than expected from its equity sharing agreement with financier Lanstead Capital, banking £5mln instead of the £4.4mln originally estimated.

The better than expected outcome reflects a trebling in the share price of Immupharma to 82p following increasingly upbeat statements about the progress of the Phase III trial of Lupuzor, its flagship Lupus treatment. Top-line Phase III results are due in the first quarter of 2018.

WATCH: Immupharma 'looking forward and planning for success' with Lupuzor

Immupahrma and Lanstead set up the facility in Feburary 2016, when the drug developer also raised £3.9mln through a placing at 26p.

Tim McCarthy, ImmuPharma’s chairman said in a statement: "Lanstead has been an important supporter of ImmuPharma and we are delighted how effectively the Sharing Agreement has worked for both parties.

READ: Immupharma starts preparations for Lupuzor submission as trial makes good progress

Nicholas Malins-Smith of Lanstead added: “Through the Sharing Agreement with Lanstead, ImmuPharma has been able to benefit, through the increase in its share price, by securing additional funds over and above the original subscription amount.”

 

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Wed, 04 Oct 2017 08:09:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/185026/immupharma-banks-extra-600000-from-lanstead-agreement-185026.html
<![CDATA[Media files - Immupharma 'looking forward and planning for success' with Lupuzor ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8148/immupharma-looking-forward-and-planning-for-success-with-lupuzor-8148.html Wed, 27 Sep 2017 08:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/8148/immupharma-looking-forward-and-planning-for-success-with-lupuzor-8148.html <![CDATA[News - ImmuPharma interims chart period of significant progress for lead drug ]]> https://www.proactiveinvestors.co.uk/companies/news/184642/immupharma-interims-chart-period-of-significant-progress-for-lead-drug-184642.html ImmuPharma PLC (LON:IMM) said the six months ended June has been a period of immense progress for the company and its lead drug Lupuzor, for the auto-immune disease lupus.

Lupuzor is currently undergoing a phase III clinical trial 200 in patients in the US, Europe and Mauritius – with 26% of the group having completed the 12-month course of treatment and everybody having passed the six-month milestone.

READ: Immupharma starts preparations for Lupuzor submission as trial makes good progress

Top line results from the study are due in the first-quarter of next year, while the firm said Tuesday it has initiated the first steps in the regulatory submissions process.

The company spent £2.3mln on research and development, while the loss for the period was £3mln (down from £3.7mln on the same period last year).

Having raised £4.1mln of fresh funds in March, ImmuPharma was sitting on £3.13mln as at June 30.

READ: ImmuPharma says more than a quarter of patients have now completed phase III lupus trial

“The board would like to thank its shareholders for their continued support, as well as its staff, corporate and scientific advisors and the CNRS for their ongoing collaboration," said chairman Tim McCarthy.

The CNRS, or the Centre National de la Recherche Scientifique, is France’s preeminent drugs research group and the company’s long-standing partner.

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Wed, 27 Sep 2017 07:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/184642/immupharma-interims-chart-period-of-significant-progress-for-lead-drug-184642.html
<![CDATA[News - Immupharma starts preparations for Lupuzor submission as trial makes good progress ]]> https://www.proactiveinvestors.co.uk/companies/news/184575/immupharma-starts-preparations-for-lupuzor-submission-as-trial-makes-good-progress-184575.html ImmuPharma PLC (LON:IMM) has started preparations for a new drug application of its lupus treatment Lupuzor with its Phase III trial now over half way through.

The AIM-listed group said the decision to start to manufacture commercial batches of Lupuzor was taken in anticipation of the trial's successful outcome and in consultation with its regulatory advisors.

READ: ImmuPharma says more than a quarter of patients have now completed Phase III lupus trial

Work is now underway on regulatory dossiers to support submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The manufacturing process will be part of these submissions, the company said in a statement.

Application to be reviewed within 6 months of submission

All patients in the Phase III Lupuzor study have passed six months while 52 patients or 26% have now completed the full 12 months of the study.

Top line results are on schedule for the end of the first quarter next year. 

Robert Zimmer, Immupharma’s chief scientific officer said: "We are delighted with the progress of the Lupuzor Phase III trial and are looking forward with confidence and planning for a successful outcome for the study.

“We are keen to ensure that there are no delays in submission to enable us to fully exploit our 'fast track' status, previously granted by the FDA, so that the company's package will be reviewed within 6 months of submission."

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Tue, 26 Sep 2017 07:59:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/184575/immupharma-starts-preparations-for-lupuzor-submission-as-trial-makes-good-progress-184575.html
<![CDATA[News - ImmuPharma says more than a quarter of patients have now completed phase III lupus trial ]]> https://www.proactiveinvestors.co.uk/companies/news/184350/immupharma-says-more-than-a-quarter-of-patients-have-now-completed-phase-iii-lupus-trial-184350.html ImmuPharma PLC (LON:IMM) saw its shares gain 5% today after the group said 52 patients have now completed the year-long course of treatment with its lead drug candidate, Lupuzor, for the life-threatening auto-immune disease Lupus.

They are among 200 sufferers taking part in the phase III study.

READ: ImmuPharma says 90% of patients have pass six-month milestone on key lupus trial

Because the trial is what’s called double-blind – meaning one group receives the treatment the other a placebo and not even the doctors know which group is which – ImmuPharma has no guide to efficacy at the moment.

We’ll know how effective Lupuzor is when the top line data is shared with the market in the first quarter of next year.

Robust safety profile

However, researchers do know the drug has a “robust” safety profile in line with what was observed in the phase IIb assessment.

As well as around a quarter of the patients having finished their course of drugs, all the people taking part in the trial are past the half-way mark (six months).

“We will now see an accelerated number of patients completing the full 12 months of the trial over the next couple of months,” said chairman Tim McCarthy.

READ: ImmuPharma says lead lupus drug development programme on track to deliver results in the first quarter of 2017

“Importantly, with Lupuzor being administered to greater numbers of patients over a longer period of time, we are delighted to be observing the continuation of our robust safety profile.”

In late afternoon trading, ImmuPharma shares were up 5.2%, or 2.5p at 50.74p.

 -- adds share price --

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Thu, 21 Sep 2017 07:19:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/184350/immupharma-says-more-than-a-quarter-of-patients-have-now-completed-phase-iii-lupus-trial-184350.html
<![CDATA[News - ImmuPharma says 90% of patients have pass six-month milestone on key lupus trial ]]> https://www.proactiveinvestors.co.uk/companies/news/180096/immupharma-says-90-of-patients-have-pass-six-month-milestone-on-key-lupus-trial-180096.html ImmuPharma PLC (LON:IMM) said more than 90% of the patients on its phase III clinical study of Lupuzor, for the autoimmune disease lupus, six months through the process.

In all 200 suffers were recruited to the trial and all of them have now past the three month stage.

A total of 46 patients, or just under a quarter, have completed the year-long assessment, while 40% have passed nine-months.

ImmuPharma said it remains on track to provide top-line results in the first quarter of next year.

The data was provided ahead of an investor update to be held in London that will be coupled with the company’s annual meeting later Friday.

“As the trial continues to progress, we are delighted to observe the continuation of our robust safety record, as Lupuzor is being administered to greater numbers of patients over a longer period of time,” chairman Tim McCarthy said

Big potential market

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also thought to be more effective than other products available, such as Glaxo's Benlysta.  ]]>
Fri, 30 Jun 2017 07:19:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/180096/immupharma-says-90-of-patients-have-pass-six-month-milestone-on-key-lupus-trial-180096.html
<![CDATA[News - ImmuPharma says lead lupus drug development programme on track to deliver results in the first quarter of 2017 ]]> https://www.proactiveinvestors.co.uk/companies/news/178623/immupharma-says-lead-lupus-drug-development-programme-on-track-to-deliver-results-in-the-first-quarter-of-2017-178623.html ImmuPharma PLC (LON:IMM) said its lead drug development programme remained on track to deliver top line results in the first quarter of next year.

Lupuzor, a treatment for the autoimmune disease lupus, is undergoing phase III clinical trials.

All 200 patients have passed the three-month stage, 28 have been treated for the full 12 months, while 80% of the group have had exposure to the drug for over six months.

The update was provided in the company’s full-year results statement in which the company said it was reviewing a number of options for its potential cancer treatment, IPP-204106, following a Phase I/IIa dose-finding study.

The financials revealed exactly what you’d expect for a life sciences company in the research and development phase – it was loss-making.

The deficit for the year to December of £5.3mln – which is also the amount the company spent on R&D. ImmuPharma’s net assets were £5.5mln.

In a note to clients, analysts at Northland said: “ImmuPharma's results demonstrate the Group's focus on completing its pivotal Phase 3 trial on Lupuzor (a potential breakthrough treatment for Lupus): most of the company's cash burn is deployed towards the trial.

“With a read out expected in Q1 2018, the trial is well on track.”

In late afternoon trading, Immupharma shares were 3.2%, or 1.75p lower at 53.00p.

 -- Adds broker comment, share price --

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Thu, 01 Jun 2017 07:35:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/178623/immupharma-says-lead-lupus-drug-development-programme-on-track-to-deliver-results-in-the-first-quarter-of-2017-178623.html
<![CDATA[Media files - Lupuzor safety profile 'holding up' - ImmuPharma's Tim McCarthy updates on Phase III study ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/7475/lupuzor-safety-profile-holding-up-immupharma-s-tim-mccarthy-updates-on-phase-iii-study-7475.html Wed, 17 May 2017 15:14:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/7475/lupuzor-safety-profile-holding-up-immupharma-s-tim-mccarthy-updates-on-phase-iii-study-7475.html <![CDATA[News - ImmuPharma says Lupuzor trial in 'new territory' and on schedule ]]> https://www.proactiveinvestors.co.uk/companies/news/177901/immupharma-says-lupuzor-trial-in-new-territory-and-on-schedule-177901.html ImmuPharma PLC (LON:IMM) is on schedule to publish first results from its phase III trial of lupus drug Lupuzor early next year with all 200 patients now having had at least three months worth of treatment.

The trial runs for twelve months and 28 patients have now received the full dosage, Immupharma said, while 166 are passed six months. 

Tim McCarthy, chairman, said: “We are now in important new territory with over 80% of patients having had exposure to Lupuzor for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile."

WATCH: Lupuzor safety profile 'holding up', says ImmuPharma boss

He added Immupharma would provide further updates from the study as it progresses through 2017.

Lupus (Systemic Lupus Erythematosus) is a chronic, potentially life-threatening auto-immune disease. Lupuzor affects the body's immune system so that it does not attack healthy cells and can halt the progression of the disease .

The drug has been granted Fast Track status by US regulator, the FDA, with the Phase III given leeway for fewer pateints than normal to be treated due to the strong safety and efficacy profile.

Of the 200 patients in the trial, 70 are in the US, 81 in Europe and 49 in Mauritius.

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Wed, 17 May 2017 07:41:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/177901/immupharma-says-lupuzor-trial-in-new-territory-and-on-schedule-177901.html
<![CDATA[News - Legal & General ups stake in ImmuPharma ]]> https://www.proactiveinvestors.co.uk/companies/news/175081/legal-general-ups-stake-in-immupharma-175081.html Insurance giant Legal & General Group Plc (LON:LGEN) has upped its stake in the AIM-listed specialist drug developer ImmuPharma PLC (LON:IMM).

L&G upped its stake in the recent £4.1mln fundraising, and now holds 4.45mln ImmuPharma shares representing 3.5% of the issued share capital.

“We are delighted to be able to disclose Legal & General's increased holding in ImmuPharma as one of our existing major institutional investors which participated in our recent successful £4.1 million fundraising demonstrating its continued support for ImmuPharma,” said chief executive Tim McCarthy.

City broker Northland Capital said L&G taking a larger piece of the pie was indicative of the kind of interest ImmuPharma is now generating among institutional investors.

“The announcement that L&G increased its stake in ImmuPharma demonstrates the strong interest in the company’s late-stage clinical drug development programme on Lupuzor, a potential treatment for Lupus,” said Northland analyst Vadim Alexandre.

“If approved, Lupuzor could achieve multi-billion dollar annual sales.”

Shares in ImmuPharma were modestly lower at 53.5p on Monday afternoon.

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Mon, 20 Mar 2017 14:35:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/175081/legal-general-ups-stake-in-immupharma-175081.html
<![CDATA[Media files - ImmuPharma chairman 'delighted' with £4.1mln fund raise support ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/7093/immupharma-chairman-delighted-with-41mln-fund-raise-support-7093.html Tue, 14 Mar 2017 05:50:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/7093/immupharma-chairman-delighted-with-41mln-fund-raise-support-7093.html <![CDATA[News - Drug developer ImmuPharma raises £4.1mln in oversubscribed placing ]]> https://www.proactiveinvestors.co.uk/companies/news/174597/drug-developer-immupharma-raises-41mln-in-oversubscribed-placing-174597.html ImmuPharma PLC (LON:IMM) said it has raised a total of £4.1mln from investors after an oversubscribed placing, with the new cash infusion to be used to strengthen its balance sheet as negotiations take place with potential commercial partners for its flagship drug, Lupuzor.

The life sciences group said the accelerated book-build offering saw around 7.884 mln new shares issued at 52p each, a modest discount to last night’s closing price, with the placing raising more than the around £3mln initially targeted.

In late afternoon trading, Immupharma shares were 1.5%, or 0.875p lower at 56.5p.

WATCH: Immupharma chairman 'delighted' ...

Tim McCarthy, Immupharma’s chairman, said: "We are delighted with the support we have had on this fund raise from both existing and new investors.”

He added: “The primary motivation for this successful fund raise is to further strengthen our balance sheet and enhance our position in ongoing and future negotiations with potential partners for Lupuzor.

“Additionally it also allows us to further invest in our earlier stage pipeline and the P140 platform. We look forward to providing our shareholders with further updates regarding our Lupuzor Phase III trial, as it progresses throughout 2017."

These are exciting times for ImmuPharma, one of a small handful of AIM drug development companies with a treatment in phase III clinical trials.

In its last update, on January 25, the company said 293 patients had been screened to take part in the efficacy study of the treatment for lupus, a life threatening auto-immune disease, and 200 were accepted.

Although the recruitment process only closed December for the year-long assessment two people have already completed the course.

In all, trials of the potentially breakthrough medication are being held at 28 sites in seven countries and over 80% of patients have been receiving the drug for at least three months.

As well as the two that have come completed the study, a further 24 patients had at the last update taken part for nine months and 50 for six months.

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also thought to be more effective than other products available, such as Glaxo's Benlysta.

 -- Adds final figure from closing of placing; chairman's comment --

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Fri, 10 Mar 2017 07:51:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/174597/drug-developer-immupharma-raises-41mln-in-oversubscribed-placing-174597.html
<![CDATA[Media files - ImmuPharma Chairman presents to investors at the Biotech Capital Conference ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/7004/immupharma-chairman-presents-to-investors-at-the-biotech-capital-conference-7004.html Wed, 01 Mar 2017 04:03:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/7004/immupharma-chairman-presents-to-investors-at-the-biotech-capital-conference-7004.html <![CDATA[Media files - 'We have absolutely no side effect profile in Lupuzor at all' says ImmuPharma chairman ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/6854/-we-have-absolutely-no-side-effect-profile-in-lupuzor-at-all-says-immupharma-chairman-6854.html Mon, 06 Feb 2017 08:18:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/6854/-we-have-absolutely-no-side-effect-profile-in-lupuzor-at-all-says-immupharma-chairman-6854.html <![CDATA[News - ImmuPharma "grossly undervalued", says broker as co updates on trial ]]> https://www.proactiveinvestors.co.uk/companies/news/172175/immupharma-grossly-undervalued-says-broker-as-co-updates-on-trial-172175.html Shares in ImmuPharma PLC (LON:IMM) jumped 8% after it updated on the progress of its phase-III clinical trial of flagship lupus drug, Lupuzor.

At 11.45am, the stock was changing hands for 50.2p, up 3.7p after the company said there had been strong demand from doctors wanting patients to participate in the study.

Analyst Vadim Alexandre, of the company’s broker Northland Capital, said Wednesday’s update provided “better visibility” on the trial timetable.

He said he expects top-line results in the first-quarter if next year, “a couple of months later than we originally expected—but now with a high degree of certainty”.

WATCH: City expert on the company's other potential blockbuster READ: ImmuPharma provides trial update

“Importantly, no drug related serious adverse events have been reported to date, indicating that the drug remains safe,” said Alexandre.

“We reiterate that should Lupuzor be approved, we estimate it could achieve multi-billion dollar annual sales.

“Consequently, we calculate that ImmuPharma is grossly undervalued.”

He reckons the stock is worth 171p.

Trial details.... 

Earlier, ImmuPharma said 293 patients were screened to take part in the efficacy study of the treatment for lupus, a life threatening auto-immune disease, and 200 were accepted.

Although the recruitment process only closed last month for the year-long assessment two have already completed the course.

In all, trials of the potentially breakthrough medication are being held at 28 sites in seven countries and over 80% of patients have been receiving the drug for at least three months.

As well as the two that have come completed the study, a further 24 have taken part for nine months and 50 for six months.

“With the trial on track and two patients already safely completing their 12 month dosing regimen, we look forward to providing further updates on this pivotal Phase III trial as it progresses through 2017," said ImmuPharma chairman Tim McCarthy.

The phase-III evaluation of Lupuzor is what’s called a double-blind placebo-controlled trial.

This means half the patients receive the treatment, while the other half are given a substance with no therapeutic value called a placebo. Neither the patient nor the tester knows the identity of those receiving the drug. 

Big potential market 

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also thought to be more effective than other products available, such as Glaxo's Benlysta. 

 

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Wed, 25 Jan 2017 11:42:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/172175/immupharma-grossly-undervalued-says-broker-as-co-updates-on-trial-172175.html
<![CDATA[News - ImmuPharma update reveals strong demand to take part in phase III lupus trial ]]> https://www.proactiveinvestors.co.uk/companies/news/172157/immupharma-update-reveals-strong-demand-to-take-part-in-phase-iii-lupus-trial-172157.html ImmuPharma PLC (LON:IMM) said there had been strong demand from doctors wanting to put patients on its phase-III clinical trial of Lupuzor.

In all 293 patients were screened to take part in the efficacy study of the treatment for lupus, a life threatening auto-immune disease, and 200 were accepted.

Although the recruitment process only closed last month for the year-long assessment two have already completed the course.

In all, trials of the potentially breakthrough medication are being held at 28 sites in seven countries and over 80% of patients have been receiving the drug for at least three months.

As well as the two that have come completed the study, a further 24 have taken part for nine months and 50 for six months.

“With the trial on track and two patients already safely completing their 12 month dosing regimen, we look forward to providing further updates on this pivotal Phase III trial as it progresses through 2017," said ImmuPharma chairman Tim McCarthy.

The phase-III evaluation of Lupuzor is what’s called a double-blind placebo-controlled trial.

This means half the patients receive the treatment, while the other half are given a substance with no therapeutic value called a placebo. Neither the patient nor the tester knows the identity of those receiving the drug.  

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also thought to be more effective than other  products available, such as Glaxo's Benlysta.

Analysts say if the trial is a success, the company could have a US$1bn drug on its hands.

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Wed, 25 Jan 2017 07:59:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/172157/immupharma-update-reveals-strong-demand-to-take-part-in-phase-iii-lupus-trial-172157.html
<![CDATA[News - ImmuPharma passes "major milestone" as it completes recruitment for phase III Lupus trial ]]> https://www.proactiveinvestors.co.uk/companies/news/170846/immupharma-passes-major-milestone-as-it-completes-recruitment-for-phase-iii-lupus-trial-170846.html ImmuPharma PLC (LON:IMM) Thursday confirmed it has completed patient recruitment for its phase III clinical trial of Lupuzor, a potentially breakthrough treatment for lupus.

It has delivered on its plan to have 200 sufferers of the life-threatening auto-immune disease taking part in the study by the end of the year.

Chairman Tim McCarthy said ImmuPharma had passed a “major milestone” and added that the company would update on progress throughout the year. In a previous update it said it expected to deliver “top-line results” at some point in 2017.

In regulatory terms, Lupuzor is in a strong position, already having received fast-track status from the all-powerful US Food & Drug Administration (FDA), which speeds up the approval process by shortening review periods.

ImmuPharma has also received regulatory approval to complete its trials under what’s known as a special protocol assessment.

This effectively guarantees the FDA will accept the trial results if they meet or exceed certain criteria.

Systemic Lupus Erythematosus (SLE), the most severe form of the disease, which Lupuzor is targeting, is debilitating and painful.

It sees the body's immune system turn against itself for reasons still not fully understood.

Symptoms include headaches, abdominal pain, chest pain, depression, psychosis and in some cases death.

It can affect various organs, including the heart and liver and is much more common in women, appears most often in African-Americans, Asians and Hispanics. It is estimated 5mln people globally have it.

Only one treatment - Glaxo's Benlysta - has been approved over the last 50 years. And, according to analysts, the product has proven a disappointment, in that it is only marginally effective while having side-effects.

Yet it still generates sales of around US$400mln, a figure that is predicted to grow to US$1bn by 2020.

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Thu, 22 Dec 2016 07:21:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/170846/immupharma-passes-major-milestone-as-it-completes-recruitment-for-phase-iii-lupus-trial-170846.html
<![CDATA[News - ImmuPharma’s valuation “way too low” ]]> https://www.proactiveinvestors.co.uk/companies/news/169087/immupharmas-valuation-way-too-low-169087.html The current valuation of drug discovery firm ImmuPharma PLC (LON:IMM) is well below where it deserves to be, according to an analyst at Northland Capital.

Vadim Alexandre has the stock as a ‘buy’ and has high expectations for the company, setting a price target of 171p.

“You’ve got a potential blockbuster drug [in Lupuzor], this [current] valuation is way too low for that programme on its own, and that says nothing about the oncology programme [either],” Alexandre tells Proactive.

“The current valuation of the business is too steep a discount, in my opinion, and there’s no value for any other programmes in the business [other than Lupuzor].”

Alexandre expects a couple pieces of news to move the share price considerably higher in the coming months.

He hopes to hear about the last patient being entered into the Lupuzor Phase III trial before the end of this year, which should mean that the data read-out will happen at some point in late-2017.

“The read out of that data is key. That is the most important piece of news flow I think this business can expect in the near-term,” the analyst claims.

“That would, in my opinion, hopefully drive the share price.”

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Wed, 16 Nov 2016 14:10:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/169087/immupharmas-valuation-way-too-low-169087.html
<![CDATA[Media files - Diversification key to ImmuPharma’s success, says Northland’s Alexandre ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/6401/diversification-key-to-immupharmas-success-says-northlands-alexandre-6401.html Wed, 16 Nov 2016 13:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/6401/diversification-key-to-immupharmas-success-says-northlands-alexandre-6401.html <![CDATA[News - ImmuPharma cancer drug's potential showcased in leading medical journal ]]> https://www.proactiveinvestors.co.uk/companies/news/169055/immupharma-cancer-drug-s-potential-showcased-in-leading-medical-journal-169055.html ImmuPharma PLC’s (LON:IMM) paper for a leading cancer journal reveals its latest development may offer a method of tackling difficult to treat forms of the disease.

As well as offering a new mode of action, IPP-204106 effectively increases the chemotherapy payload delivered to tumours.

About threefold increase of cytotoxic drug concentration and threefold decrease in tumour size have been observed in preclinical studies using the treatment.

WATCH: Analyst provides his valuation  READ: The full announcement from ImmuPharma 

So, the Nucant drug, as it is known, will be used to pre-treat cancer patients who then go on to receive the standard dose of a first-line chemo such as Gemcitabin.

It is hoped the approach will enhance the outcomes for people with pancreatic cancer, which killed Steve Jobs and Patrick Swayze and is effectively a terminal illness.

The latest update on IPP-204106 will be carried in Cancer Research, the medical journal of the American Association for Cancer Research.

“It is a pleasing validation of years of research by our scientific team and collaborators and gives us further confidence in the long term potential of our Cancer programme, this compound and its unique mechanism of action,” said head of R&D, Robert Zimmer.

The technology is being developed as part of ImmuPharma’s collaboration with France’s Centre National de la Recherche Scientifique. 

Share price and Lupuzor

The shares marked time at 36.19p each in late morning trade. Northland Capital analyst Vadim Alexandre reckons the current price seriously undervalues ImmuPharma’s prospects and reckons the stock is worth 171p.

That target is predicated on the value of the company’s lead drug, Lupuzor, for the autoimmune disease lupus, rather than IPP-204106.

“You’ve got a potential blockbuster drug [in Lupuzor], this [current] valuation is way too low for that programme on its own, and that says nothing about the oncology programme,” Alexandre told Proactive.

“The current valuation of the business is too steep a discount, in my opinion, and there’s no value for any other programmes in the business [other than Lupuzor].”

Alexandre expects a couple pieces of news to move the share price considerably higher in the coming months.

He hopes to hear about the last patient being entered into the Lupuzor Phase III trial before the end of this year, which should mean that the data read-out will happen at some point in late-2017.

“The read out of that data is key. That is the most important piece of news flow I think this business can expect in the near-term,” the analyst claims.

“That would, in my opinion, hopefully drive the share price.”

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Wed, 16 Nov 2016 07:32:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/169055/immupharma-cancer-drug-s-potential-showcased-in-leading-medical-journal-169055.html
<![CDATA[News - Legal & General revealed as ImmuPharma backer ]]> https://www.proactiveinvestors.co.uk/companies/news/168762/legal-general-revealed-as-immupharma-backer-168762.html Legal & General has disclosed it has a 3.43% stake in ImmuPharma PLC (LON:IMM), the specialist drug discovery and development company.

"We are delighted to be able to disclose Legal & General as one of the new significant and major institutional investors which participated in ImmuPharma's recent successful vendor placing,” said company chairman, Tim McCarthy.

ImmuPharma raised cash earlier this year to fund its share of the costs of developing Lupuzor, its potential blockbuster drug for the autoimmune disease Lupus, which is currently undergoing phase III clinical trials.

“One of the board's priorities is to maintain and strengthen our shareholder base. We are therefore delighted that such a highly regarded institution as Legal & General has demonstrated its support for ImmuPharma," McCarthy said.

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Wed, 09 Nov 2016 14:59:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/168762/legal-general-revealed-as-immupharma-backer-168762.html
<![CDATA[News - ImmuPharma tops up funds as Lupuzor trial progresses ]]> https://www.proactiveinvestors.co.uk/companies/news/167779/immupharma-tops-up-funds-as-lupuzor-trial-progresses-167779.html ImmuPharma PLC (LON:IMM) is to raise £800,000 to fund the ongoing phase III trial of its lupus treatment Lupuzor.

A bookbuild at 35p was held alongside a placing of 7.1mln shares held by Lanstead Capital.

Lanstead has a £4.4mln equity facility with the drug developer that was set up in February.

That agreement was set at a price of 26p per share but Immupharma’s share price has risen strongly since then.

As a result, Lanstead has brought forward the next six monthly payments, worth £1.5mln in total.

Immupharma said that this cash and the placing funds woul dbe used on Lupuzor’s ongoing phase III trial.

Some 200 patients will have been for the trial by the end of the year, Immupharma said last month.

Top line data is expected by the end of 2017.

Lupus is an as-yet incurable immune system disease, it can cause joint pain and fatigue, as well as damage to the skin and other organs.

There are 5mln sufferers globally and if successful Lupuzor could be a potential block buster drug analysts suggest.

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Fri, 21 Oct 2016 14:57:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/167779/immupharma-tops-up-funds-as-lupuzor-trial-progresses-167779.html
<![CDATA[News - ImmuPharma's lupus drug Phase III enrolment on track ]]> https://www.proactiveinvestors.co.uk/companies/news/166756/immupharma-s-lupus-drug-phase-iii-enrolment-on-track-166756.html ImmuPharma PLC (LON:IMM) said it was well on track to enrol its target of 200 patients by the end of the year as it focused on the late stage clinical development of its Lupus treatment, Lupuzor.

The group said it expects top-line data from its pivotal Phase III trial by the end of 2017.

It said it has started dialogue with a number of Lupus patient groups, both in the UK and the USA.

With 5mln sufferers globally, Lupuzor could be entering a potential multi-billion dollar market.

Lupus is an as-yet incurable immune system disease, it can cause joint pain and fatigue, as well as damage to the skin and other organs.

The group has already opened eleven sites in the US and five sites in Europe. Further sites in the UK and Italy are expected to open in the next few weeks.

The group saw an operating loss of £3.2mln, compared to £1.5mln in the previous period. Research and development expenditure was up at £2.5mln - compared to £0.87mln last year – mostly down to the Lupuzor Phase III clinical trial. The cash balance stood at £0.66mln.

Earlier this year the group raised £8.4mln to fund the Phase III Lupuzor trial and to support working capital.

The group reported progress across its pipeline, with its peptides platform having received €600,000 in grants to develop its diabetes and cancer treatment technologies.

“While there is still plenty of work for ImmuPharma to do, the progress made to date supporting the Phase III trial for Lupuzor is significant,” said Panmure Gordon’s Mike Mitchell.

The broker reiterated its “buy” recommendation and 100p target price.

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Fri, 30 Sep 2016 08:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/166756/immupharma-s-lupus-drug-phase-iii-enrolment-on-track-166756.html
<![CDATA[Media files - ImmuPharma PLC's Tim McCarthy talks about the “fantastic reaction” in United States for Lupus drug trial ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/5994/immupharma-plc-s-tim-mccarthy-talks-about-the-fantastic-reaction-in-united-states-for-lupus-drug-trial-5994.html Wed, 14 Sep 2016 13:58:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/5994/immupharma-plc-s-tim-mccarthy-talks-about-the-fantastic-reaction-in-united-states-for-lupus-drug-trial-5994.html <![CDATA[News - ImmuPharma "delighted" with clinical trial progress ]]> https://www.proactiveinvestors.co.uk/companies/news/165859/immupharma-delighted-with-clinical-trial-progress-165859.html ImmuPharma PLC (LON:IMM) said recruitment for the phase III clinical trial of its drug Lupuzor for the autoimmune disease Lupus remains on track with 11 sites in the US now up and running.

A further five centres - Czech Republic, France, Germany, Hungary and Poland – are currently recruiting patients, while studies in the UK and Italy will begin in the “next few weeks”.

At the same time around 10 patients have been pre-screened prior to dosing in Mauritius.

Chairman Tim McCarthy said he was “delighted at the continued progress” of the phase III trial.

The plan is to have recruited 200 people by the end of the year, with “top-line results” from the study expected by some point in 2017.

In regulatory terms, Lupuzor is in a strong position, already having received fast-track status from the all-powerful US Food & Drug Administration (FDA), which speeds up the approval process by shortening review periods.

ImmuPharma has also received regulatory approval to complete its trials under what’s known as a special protocol assessment.

This effectively guarantees the FDA will accept the trials’ results if they are positive.

Systemic Lupus Erythematosus (SLE), the most severe form of the disease, which Lupuzor is targeting, is debilitating and painful.

It sees the body's immune system turn against itself for reasons still not fully understood.

Symptoms include headaches, abdominal pain, chest pain, depression, psychosis and in some cases death.

It can affect various organs, including the heart and liver and is much more common in women, appears most often in African-Americans, Asians and Hispanics. It is estimated 5mln people globally have it.

Only one treatment - Glaxo's Benlysta - has been approved over the last 50 years. And, according to analysts, the product has proven a disappointment, in that it is only marginally effective while having side-effects.

Yet it still generates sales of around US$400mln, a figure that is predicted to grow to US$1bn by 2020.

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Wed, 14 Sep 2016 07:29:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/165859/immupharma-delighted-with-clinical-trial-progress-165859.html
<![CDATA[Media files - ImmuPharma PLC to open Lupuzor trial site in Mauritius ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/5923/immupharma-plc-to-open-lupuzor-trial-site-in-mauritius-5923.html Wed, 07 Sep 2016 14:18:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/5923/immupharma-plc-to-open-lupuzor-trial-site-in-mauritius-5923.html <![CDATA[News - Immupharma to recruit patients from Mauritius ]]> https://www.proactiveinvestors.co.uk/companies/news/162896/immupharma-to-recruit-patients-from-mauritius-162896.html ImmuPharma PLC (LON:IMM) said it will stage part of its phase III clinical trial of Lupuzor, its treatment for Lupus, in Mauritius, which has a high incidence of the life-threatening autoimmune disease.

In all 30 patients will be recruited as part of the 200-strong study.

The request to open a new site came directly from the government following a visit to the island nation by the drug’s inventor, professor Sylviane Muller.

She met with president Ameenah Gurib-Fakim as well as leading rheumatologists and the ministry of health as part of her visit at the invitation of Lupus Alert, a local foundation.

Chairman Tim McCarthy said: "We are delighted to have been requested by the Mauritian government and the country's leading Lupus specialists to participate in our trial.

“Mauritius with its high proportion of Lupus sufferers clearly highlights how necessary an effective Lupus therapy such as Lupuzor is needed for such a debilitating disease.

“We look forward to providing further positive updates on our Lupuzor Phase III study as it progresses further through this year and into 2017."

The company is expected to provide the “top line” results from this study by the end of next year.

The shares, up 39% in the last six months, advanced 11% to 37.75p in the wake of the update, valuing ImmuPharma at £46mln.

Following the update City broker Northland Capital repeated its 'buy' advice and 171p price target.

Analyst Vadim Alexandre said: "Mauritius has a high proportion of Lupus sufferers. The Mauritian Government's strong interest in Lupuzor demonstrates how Lupus is an unmet medical need for which an effective therapy is highly sought after."

----ADDS BROKER COMMENT & SHARE PRICE----

 

 

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Wed, 07 Sep 2016 07:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/162896/immupharma-to-recruit-patients-from-mauritius-162896.html
<![CDATA[News - Immupharma drug has billion dollar potential - Northland ]]> https://www.proactiveinvestors.co.uk/companies/news/128404/immupharma-drug-has-billion-dollar-potential-northland-128404.html If Lupuzor, the Immupharma PLC (LON:IMM) drug, is approved, it could achieve multi-billion dollar sales a year, suggests house broker Northland, which has started coverage.

It is a potential blockbuster, said the broker, which targets 171p for the share, underlining the potential upside, since the shares are currently at around 35p.

What's  more, as well as for life-theatening auto-immune disease Lupus,  the drug has also shown promise in several other major chronic inflammatory indications.

Phase III trials underway

Phase III trials are now taking place at up to 45 sites in the US and Europe, involving 200 patients,  and pharma company analyst Vadim Alexandre noted the study was "expected to generate top line results before the end of 2017".

"Should the trial prove successful, we estimate that ImmuPharma could strike a major licensing agreement with a commercial partner. Very few AIM-listed drug development companies have late-stage clinical assets of similar calibre."

In regulatory terms, the drug is in a strong position, already having received fast-track status from the all powerful US FDA, which speeds up the drug’s approval process by shortening review periods.

"Lupuzor has also received FDA approval to complete its trials under Special Protocol Assessment (SPA) which effectively guarantees that the regulator will accept the trials’ results if they are positive," also highlights Alexandre.

SLE the most severe form of Lupus

Systemic Lupus Erythematosus (SLE), the most severe form of the disease, which Lupuzor is targeting, is  debilitating and painful. It sees the body's immune system turn against itself for reasons still not fully understood.

Symptoms include headaches, abdominal pain, chest pain, depression, psychosis, and in some cases death.

It can affect various organs, including the heart and liver and is much more common in women, appears most often in African-Americans, Asians and Hispanics. It is estimated 5mln people globally have it.

Only one other treatment

Only one treatment - Glaxo's Benlysta (belimumab) has been approved over the last 50 years -  and Northland notes this has proven to be a disappointment, in that it is only marginally effective while also being associated with significant side-effects.

"Nonetheless, due to the unmet medical need in SLE, Benlysta has had significant success in the market. The drug generated over $400m in sales in 2015, with forecasts predicting annual sales to hit $1bn by 2020.

"We estimate that Benlysta provides a lower limit proxy for the future market potential of Lupuzor, especially given that Lupuzor may prove to be a better and safer drug," said Alexandre.

In addition, Benlysta is currently priced at US$35,000 per patient per year and is relatively expensive to produce and the amount of drug needed to treat patients is much higher than for Lupuzor, said the analyst.

"We estimate that Lupuzor, being a small peptide, will cost far less to manufacture and consequently could be priced at a significant discount to Benlysta."

Notably, to add to its potential, recently, ImmuPharma presented new evidence, which supported Lupuzor for several other major disease indications, including rheumatoid arthritis, Crohn’s disease, and asthma. 

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Wed, 20 Jul 2016 12:16:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/128404/immupharma-drug-has-billion-dollar-potential-northland-128404.html
<![CDATA[Media files - Lupuzor could treat a number of diseases, says creator ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/5132/lupuzor-could-treat-a-number-of-diseases-says-creator-5132.html Fri, 10 Jun 2016 08:44:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/5132/lupuzor-could-treat-a-number-of-diseases-says-creator-5132.html <![CDATA[News - Three small cap drugs stocks to watch for Phase 3 success ]]> https://www.proactiveinvestors.co.uk/companies/news/126830/three-small-cap-drugs-stocks-to-watch-for-phase-3-success-126830.html The track record of small-cap drug companies in getting their treatments into final phase three trials has been patchy.

Analysts say companies have often fallen at the early fences when drugs undergo initial efficacy and safety tests, or had to seek partners or suitors to fund further development.

But here’s three firms with chances of making it into the final straight on their own.

ImmuPharma has started dosing in Lupus drug trial

ImmuPharma PLC (LON:IMM) has launched phase three studies of its Lupuzor drug for life-threatening auto-immune disease lupus.

The company said on Tuesday that it had now started dosing Lupus sufferers with its Lupuzor treatment as part of phase three trials.

Recruitment of patients for the trials would take place at up to 45 investigator sites, including 10 sites in the US and 35 in Europe.

Further updates on the progression of the Lupuzor phase three trial will be announced, as appropriate, as the trial progresses.

There are an estimated five million people globally suffering from Lupus, with about 1.5 million patients in the US, Europe and Japan.

Chairman Tim McCarthy said: "This is a further key milestone for ImmuPharma's Lupuzor trial with now both the US and European sites dosing Lupus patients.

"We look forward to providing further positive updates on this Lupuzor phase III study as it progresses throughout this year and 2017."

Faron Pharmaceuticals set advancing ARDS treatment

London-listed Finnish group Faron Pharmaceuticals Oy (LON:FARN) has started phase three trials of its Traumakine drug for acute respiratory distress syndrome (ARDS).

Faron has teamed up with a Japanese licensing partner which has obtained positive results from a phase two study of Traumakine in Japan.

Analysts said Faron is also benefiting from the fact that Traumakine is based on a drug that has already been approved for treating multiple sclerosis.

Faron has developed an intravenously-administered form of the drug for ARDS, a severe disease with a reported mortality rate of about 30%-45% for which there is no approved pharmacological treatment.

It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of sepsis, pneumonia or significant trauma.

Faron's chief executive Dr Markku Jalkanen said: "Our Traumakine treatment is the only known intravenously administered human interferon-beta preparation.

"It is important that dosing is optimal for patients lacking peripheral circulation, as is the case with ARDS patients.

“We have carefully tested various ingredients to optimise interferon-beta use in these patients and have now completed all necessary tests for patent purposes.

“If our claims are approved, we could have a proprietary product for the next two decades.”

Motif Bio’s drug trial for skin infection to complete in 2017

Motif Bio Plc (LON:MTFB)  is in phase three trials of iclaprim, a treatment for skin infections.

Motif has announced the dosing of the first patient in two clinical tests of its lead antibiotic candidate iclaprim for treating acute bacterial skin and skin structure infections.

The trials are targeting a reduction in lesion size of at least 20% by 48-72 hours after treatment.

Motif expects to complete them in the second half of next year, paving the way for the drug to be launched in 2018 if they are successful.

Northland Capital Partners said Motif had passed milestones including getting approval for the trials, raising £25mln to fund them, appointing a company to conduct them and obtaining fast-track designation.

The broker’s Vadim Alexandre said: “We’re confident Motif will meet its goal of completing the trials by the end of 2017.”

Alexandre added that companies were responding to a pressing global need for new antibiotics and benefiting from regulatory changes and government incentives to encourage their development.

He said: “It’s good we have the phase three assets on AIM because it shows it’s do-able.”

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Tue, 07 Jun 2016 13:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/126830/three-small-cap-drugs-stocks-to-watch-for-phase-3-success-126830.html
<![CDATA[News - Immupharma moves forward with Lupus drug trials ]]> https://www.proactiveinvestors.co.uk/companies/news/126806/immupharma-moves-forward-with-lupus-drug-trials-126806.html Immupharma PLC (LON:IMM) has taken a step forward in its development of a drug to combat life-threatening auto-immune disease Lupus.

The company said the first European sites opened had now started dosing Lupus sufferers with its Lupuzor treatment as part of phase three trials.

Recruitment of patients for the trials would take place at up to 45 investigator sites, including 10 sites in the US and 35 in Europe.

Further updates on the progression of the Lupuzor phase three trial will be announced, as appropriate, as the trial progresses.

There are an estimated five million people globally suffering from Lupus, with about 1.5 million patients in the US, Europe and Japan.

Chairman Tim McCarthy said: "This is a further key milestone for ImmuPharma's Lupuzor trial with now both the US and European sites dosing Lupus patients.

"We look forward to providing further positive updates on this Lupuzor phase III study as it progresses throughout this year and 2017."

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Tue, 07 Jun 2016 07:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/126806/immupharma-moves-forward-with-lupus-drug-trials-126806.html