Amphion Innovations Share Discussion Threads

[granada7] 16/4/2015 12:26

Motif Bio (MTFB.L, 28.50p) - Speculative Buy

Motif Bio, announced today that the U.S. Food and Drug Administration (FDA) has agreed to the proposed Phase 3 clinical development programme for the Company's lead product candidate, iclaprim. The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae). The FDA confirmed that two ABSSSI trials or one ABSSSI trial plus one HABP trial meeting their pre-specified primary endpoints are required for approval of iclaprim. Motif is working to determine the costs and timeline of these options.

Our view: It is quite exceptional to find an independent drug development company on AIM with a Phase 3 indication - by this time such prospects have nearly always found themselves absorbed into big pharma. Indeed, anyone searching for a peer group comparison would need to look to the US, where a few NASDAQ quotes can be found valuing such opportunities at, perhaps, ten-times or more that of Motif. As such, yesterday’s news is nothing short of dramatic. The FDA has, in fact, given two approvals - skin infection and pneumonia - for Motif proposed Phase 3 clinical development programme for the Company's lead product candidate, iclaprim. The emergence of multi-drug resistant bacteria has made antibiotics the global pharmaceutical development industry’s most urgent area of research and, importantly, Motif’s novel platform prospectively offers a range of further indications. Indeed, this under-utilized dihydrofolate reductase inhibitor (DHFRi) class, could in time become an integral part of hospital doctors' life-saving treatment strategies. So what next? From here, investors can expect exciting news flow as big pharma, keen to farm-in to its clinical development and commercialization start to get involved. This could produce large up-front phased payments direct to Motif along with an exceptional stream of royalties. Right now, Motif management is working to determine the costs and timeline of its various exciting options. Assuming that funds can be raised or a partnership can be entered into, the first Phase 3 trial for ABSSSI is expected to commence in the second half of 2015. Beaufort awards Motif a Speculative Buy recommendation.

[the stigologist] 16/4/2015 08:50

down it goes

[the stigologist] 16/4/2015 07:42

the last company the AMP conmen pump and dumpers pumped was KMK

look how badly that has done since it floated and as AMP dumped their stock

[cottoner] 16/4/2015 05:52

Update to a previous post, omitted a convertible loan MTFB have with AMP.

AMP's current MCAP is £8.1M.

AMP's stake in MTFB is currently £7.9M (44% of MTFB 18M MCAP) + a convertible loan in the amount of £2.39M. ($3.55M).

Thus, AMPs current holding in MTFB is worth £10.29M, equivalent to 127% of its current MCAP.


AMP also owns a 11.6% stake in Kromek (KMK) which currently has a MCAP of £41M , making AMP's stake currently worth £4.75M.

AMP of course has stakes in several other companies and is the sole owner of DataTern.

[cottoner] 15/4/2015 22:38

Dup - comp glitch!

[cottoner] 15/4/2015 22:38

Snippet from the Daily Mails Market Report

Recent AIM newcomer Motif Bio was chased up to 31.75p after the clinical stage biopharmaceutical company announced that the US Food & Drug Administration has agreed to the proposed Phase 3 clinical development programme for its lead product candidate, iclaprim, a treatment of acute bacterial skin and skin structure infections and hospital-acquired bacterial pneumonia.
Profit taking left the close 1p cheaper at 28.5p, which is still a 42.5 per cent rise from its placing price of 20p.


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[granada7] 15/4/2015 22:29

Stig

Why not post the facts....instead of selective information...

Analysts at Equity Development are of the opinion that once iclaprim gets the green light from the FDA, Motif’s stockmarket rating will soar and the company will be on the shopping lists of all the Big Pharma companies, if it isn’t already. The post-IPO value of the business could therefore be in the range of £45m-£60m and positive phase three results for iclaprim could double this figure.

M&A activity in the sector would add a further premium. Motif BioSciences has an experienced team of drug discovery scientists who used to ply their trade at drug giants Merck, Schering Plough, GSK and Bayer. Chairman Richard Morgan was co-founder of billion dollar-plus rated Celgene Corporation and also spent 15 years at Schroders. Morgan is also chief executive of AIM-listed Amphion Innovations, unchanged at 3.25p, which owns 38 per cent of Motif.


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[cottoner] 15/4/2015 22:26

Funding will likely come from an industry partner with deep pockets and the ability to fund iclaprim’s further development; however, Motif might even go it alone, Lumsden told Proactive Investors in a recent interview.

[the stigologist] 15/4/2015 22:19

they were looking for £16m !

and only managed to raise £2m

looks like there will be years and years and years of placings

"it will also undertake a fundraising of up to £16m to support the development of iclaprim."

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[cottoner] 15/4/2015 22:07

Funding will likely come from an industry partner with deep pockets and the ability to fund iclaprim’s further development; however, Motif might even go it alone, Lumsden told Proactive Investors in a recent interview.

[the stigologist] 15/4/2015 21:58

Watch out for the placing

[i like trees] 15/4/2015 21:46

Time for a buy first thing me thinks!

[cottoner] 15/4/2015 19:16

In fact AMP's current MCAP is £8.1M , so AMPs stake in MTFB is currently equivalent to 96% of its market cap.

AMP also owns a 11.6% stake in Kromek (KMK) which currently has a MCAP of £41M , making AMP's stake currently worth £4.75M.

AMP of course has stakes in several other companies and is the sole owner of DataTern.

[cottoner] 15/4/2015 19:08

UPDATE - Motif Bio given green light to start phase III clinical trials on breakthrough antibiotic
By Ian Lyall
April 15 2015, 2:30pm

Motif Bio (LON:MTFB) has been given the green light to begin phase III clinical trials on its next-generation antibiotic by the American regulator.

It has achieved this major landmark just weeks after listing on the London market and, dependent on funding or finding a partner, work could begin in the second half of the year.

Motif’s drug candidate, iclaprim, is designed to be effective against bacteria that have developed resistance to other treatments, so there are no surprises that it will at some stage be used to tackle so called Gram positive pathogens such as the hospital-acquired MRSA.


Motif initially wants to gain marketing approval for iclaprim’s use in acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP).

The US Food & Drug Administration (FDA) has said it must carry out either two ABSSSI studies, or one ABSSSI and one HABP trial.


Motif chief executive Graham Lumsden told investors: “Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilised dihydrofolate reductase inhibitor class, can become an integral part of hospital doctors' life-saving treatment strategies.”

To understand just how Motif finds itself with a phase-III-ready treatment one needs to rewind to 2009 and look at the stop-start development of antibiotics.Six years ago iclaprim was one of four antibiotics that, having sought the FDA final sign-off, were sent back for further trials.

The watchdog’s cautious approach can be traced back to the 2007 approval of the Sanofi-Aventis antibiotic, KETEK, which was linked to liver toxicity.
It later transpired that much of the KETEK safety data was bogus.

Today, two of the four drugs the FDA sent back for further testing– Dalvance and ORBACTIV - have been put through their paces and are now out on the market, vindicating earlier studies.

The FDA issued the developers with what’s called a Complete Response Letter (CRL) after sending it back for a further phase III trial.

It must be stressed that, for iclaprim at least, no safety concerns were raised in the CRL.


All that was requested in the letter was that another study be carried out that demonstrated the drug’s effectiveness.

The start phase III trials mark an early landmark. Motif is gunning for approval in bacterial skin infection first as it is a common complaint, which means it should be relatively cheap and easy to recruit patients.

However, it is also a crowded space with a number of competing treatments.
That said, iclaprim does have one advantage over the competition – it has a completely different mode of action, which means that hospital formularies should stock it as an alternative to the current gold standard treatment.

It will likely make a more tangible impact in bacterial pneumonia where the current treatment regime means 20-50% of patients die from the medical complication.

The trial for ABSSI is likely to take 18 months and analysts estimate it will cost in the order of £12-£15mln to complete.

The pneumonia study will be more costly and time consuming.
Funding will likely come from an industry partner with deep pockets and the ability to fund iclaprim’s further development; however, Motif might even go it alone, Lumsden told Proactive Investors in a recent interview.

Today's news will be a boon also for the AIM-listed intellectual property firm Amphion Innovations (LON:AMP), which owns a 44% stake in Motif.

Motif shares, listed at 20p, were changing hands for 28p each 2.30pm, valuing the business at £18mln. That means Amphion's stake is worth £7.8mln, which is the equivalent to 70% of its market capitalisation.

[alexios1201] 15/4/2015 07:49

16p TargetOver to you boys

[someuwin] 15/4/2015 07:36

Amphion Innovations PLC

15 April 2015

Amphion Innovations plc

("Amphion", the "Company" or the "Group")

Amphion Partner Company, Motif Bio plc, Gains FDA Agreement to Enter Phase 3 Clinical Development with Iclaprim

Iclaprim safety and efficacy to be studied by Motif in two serious and life-threatening infections

London and New York, 15 April 2015 - Amphion Innovations (LSE: AMP), a developer of medical, life science, and technology businesses, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has agreed to the proposed Phase 3 development programme for Amphion's Partner Company Motif Bio plc's ("Motif") lead product candidate, iclaprim. The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim in the treatment of acute bacterial skin and skin structure infections ("ABSSSI") and hospital acquired bacterial pneumonia ("HABP") caused by Gram positive pathogens, including resistant strains of MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae). The FDA confirmed that two ABSSSI trials or one ABSSSI trial plus one HAPB trial meeting their pre-specified primary endpoints are required for approval of iclaprim. Motif is working to determine the costs and timeline of these options. The first Phase 3 trial for ABSSSI is expected to commence in the second half of 2015.

Amphion owns 44.09% of Motif's issued equity in addition to a convertible loan in the amount of $3.55 million.

Richard Morgan, CEO of Amphion, commented:

"We are delighted to share the positive results of yesterday's meeting with the FDA. We welcome the support for studies that we believe will prove iclaprim to be safe and effective in treating serious and life-threatening infections including those caused by multi-drug resistant bacteria."

[ron64] 13/4/2015 11:45

They must be filling a buy?

[cottoner] 12/4/2015 13:30

Snippet from Luke Johnson's article in today's Sunday Times


Giant drug makers are paying insane prices for biotech firms because they appear to have lost the ingenuity and confidence to discover new drugs themselves.

[a1samu] 08/4/2015 07:47

When is a Claim Construction ruling likely?

[a1samu] 07/4/2015 13:00

In the 2014 interim report, issued in September 2014:

As we reported in our Annual Report and Accounts 2013, in April 2014 DataTern received a ruling from the FCCA, which its legal advisors considered favorable.

Following that ruling DataTern submitted a request to the FCCA for a reconsideration of certain aspects of the ruling, which were denied in July 2014 and so the ruling received in April is now final.

As a result the case in New York has now been terminated, with the result that the previously unfavorable Markman ruling of August 2012 has, in the case of Microsoft, been nullified.

DataTern has recently filed its appeal in the MicroStrategy case with the FCCA.

This was on hold, pending the resolution of the New York cases, but will now proceed and, if the court agrees to take the case, a hearing should be held by the end of the year and a ruling made by the end of the first quarter of 2015. There are 9 defendants in the MicroStrategy case.

The cases in Texas which were on hold pending the Microsoft appeal, are now moving ahead again and we expect to have a Markman hearing in Texas within the next six months. There are 8 defendants in Texas.

Our legal team, supported by our extensive team of technical and patent experts, continues to believe in the strength of our intellectual property.

Both of the two key patents have completed a comprehensive re-examination by the United States Patent and Trademark Office ("USPTO") and successfully emerged both fully validated and with additional claims added.

It remains the firm and considered opinion of our team that the two patents are both valid and being infringed by a wide range of companies that are practicing this critical art.

We believe that a Claim Construction ruling, which is fully reflective of our interpretation of the claims of the patents, would establish significant infringement by a large number of companies and we believe that we should be able to generate a significant amount of revenue from this asset over the next few years.

Under the sharing agreement with DataTern, FireStar Software, where the technology and patents were originally developed, would share directly in this revenue stream.

[f1araway] 07/4/2015 11:33

Yes I did avoid but only just!
I was almost taken in by the hype particularly by that of the TIMES.....

[chesty1] 07/4/2015 08:43

Well Well Well a classic AIM Pump & Dump....

I HOPE YOU ALL AVOIDED....

[cottoner] 02/4/2015 22:55

Mention in the Times Market Report

'Finally, Motif Bio made a decent debut on AIM. Placed at 20p each by Northland Capital, shares in the biotech minnow jumped 50 per cent to 30p. Motif is developing an antibiotic to treat skin infections'

[cottoner] 02/4/2015 22:41

Yet another positive report wrt Motif in the Daily Mail's Market Report

'Analysts believe several major pharmaceutical groups have Motif on their shopping lists'


Full snippet


'As expected, shares of Motif Bio staged a spectacular debut on AIM: listed at 20p, the shares soared to 48p before closing 50 per cent higher at 30p. The company has a clinical stage antibiotic, iclaprim, which has been designed to be effective against multi-drug resistant bacteria. Analysts believe several major pharmaceutical groups have Motif on their shopping lists.'

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