Amphion Innovations Share Discussion Threads

[h2owater] 01/4/2015 08:06

Nice write up in the times!This will fly later and tomorrow!

[cottoner] 01/4/2015 08:03

From Today's Times

A biotech minnow that professional investors believe could leap is coming to AIM tomorrow.
Motif BioSciences, which is developing an antibiotic to treat skin infections, will be rebadged Motif Bio and start life as a public company with a valuation of nearly £13 million.
Northland Capital, helping Motif to raise £3 million, is looking ahead to April 14, when the US Food and Drug Administration, the drugs regulator, meets to decide whether and when phase-III trials to determine the therapeutic effect of Iclaprim, Motif’s drug, can start.
Iclaprim fell before at a later stage, back in 2009. Northland puts that unexpected block down to issues at the FDA and believes it highly unlikely to happen again. Should the FDA grant permission for those trials to begin, Motif’s market value could rocket, biotech bulls said.
Richard Morgan, the Motif chairman, was instrumental in building Celgene into a $95 billion American pharma giant. He is also the chief executive of Amphion Innovations, itself quoted on AIM and still the owner of 44 per cent of Motif after flotation.
Amphion’s shares, barely 3p a week ago, dipped ¾p to 7¾p.

[aughton 3] 31/3/2015 12:49

All allocations were done last week I would chase up !

[timbo003] 31/3/2015 12:15

>>>>Aughton 3

If you are talking about AMP, I think best to hold in an ISA or SIPP if possible, assuming you buy them in anticipation of them going up (I hold a few in a SIPP)

If you are talking about Motif, the same applies (to shares bought in the market), but if you have subscribed to new shares in the placing (I have, but haven't yet heard about my allocation), then they will qualify for EIS tax breaks (effective price 14p/share rather than 20p/share), so I will hold them as certificates at least for the three year holding period, as one of the benefits of EIS qualifying shares is that all capital gains are tax free and you can claim loss relief against income tax if you sell at a loss after three years (or if they go belly up)

[aughton 3] 31/3/2015 10:07

One question Timbo if you think this is going up would you hold in physical shares and pay CGT or in a spread bet in a tax efficient way

[h2owater] 31/3/2015 09:34

We believe that the regulatory environment for antibiotics has become more favorable to the approval of potential antibiotic compounds. The urgent need for novel antibiotics is well recognized, with the passing in 2012 of the GAIN Act, which mandates accelerated approval times and extended market exclusivity in the U.S., and the publication by the FDA of revised, clear clinical trial guidelines. We believe this development is a major improvement as compared to the situation at the time of the earlier antibiotic submissions in 2008 and that this greatly enhances the likelihood of approval, assuming that the clinical trials are completed successfully.


Furthermore, three other antibiotics also failed to gain approval for commercialization around the same time iclaprim was submitted. These include dalbavancin, oritavancin, and omadacycline. Additional clinical trials were completed with dalbavancin and oritavancin; these antibiotics were approved by the FDA in May and August 2014 respectively. Omadacycline is expected to re-enter the Phase III trials in the first half of 2015.

[timbo003] 31/3/2015 08:53

Management will presumably be disappointed with the response to the Motif IPO.

The target was around £4.3M and it looks like they have achieved just £2.8m and what's this with Spreadex now holding 4 million shares (£800K worth worth)? that's a new holding from what I can gather from the pathfinder prospectrus.

So did Spreadex subscribe in the IPO? I may be wrong, but their name on the register does not inspirte confidence and does not suggest to me that they are likely to be long term institutional shareholders. Somehow I don't think MTFB are likely to heading skywards on their debut on Thursday.

[h2owater] 31/3/2015 08:40

Motif Biosciences


Only 2 days to IPO!

[chesty1] 31/3/2015 08:35

Here we go.....Typical AIM spike & dump.

Well done p&ders & sorry for anyone listening to em & buying in near the top, your locked in now.

[tidy 2] 31/3/2015 08:14

Sold here to load up on Oex. CPR and production starts April.

[65jack] 31/3/2015 07:51

Sold here to buy more TEA and HNR. nice little run from 3p here

[canalet3] 30/3/2015 19:11

She will be known as...........MTFB

[isis] 30/3/2015 18:19

What's the ticker for Motif?

[tidy 2] 30/3/2015 11:19

HNR moving

[timbo003] 30/3/2015 09:39

Looks like a sensible plan to me

from the pathfinder prospectus......



Iclaprim completed clinical development and marketing applications to the FDA and the EMA were submitted in 2008. At that time and based on the data submitted, iclaprim failed to gain approval from the FDA or the EMA. Three other new antibiotics also failed to gain approval for commercialisation around this time: dalbavancin, oritavancin and omadacycline.

Additional clinical trials were completed with dalbavancin and oritavancin and they were both approved by the FDA in May and August 2014 respectively.
Omadacycline is expected to re-enter the Phase III trials in the first half of 2015. In 2007, Telithromycin (Ketek) was approved as a novel antibiotic, and then associated with severe liver injury and fraudulent safety data which resulted in two of three Ketek indications being withdrawn and the Directors believed this led to a slowdown in new drug approvals.

In recent years, the Directors believe that the regulatory environment for antibiotics has become more favourable to the approval of potential antibiotic compounds.

The urgent need for novel antibiotics is well recognised, with the passing in 2012 of the GAIN Act, which mandates accelerated approval times and extended market exclusivity in the US, and the publication by the FDA of revised, clear clinical trial guidelines. The Directors believe this development is a major improvement as compared to the situation at the time of the earlier antibiotic submissions in 2008 and that this greatly enhances the likelihood of approval, assuming that the clinical trials are completed successfully.

Next steps

Iclaprim: Motif, Inc. has developed a clinical and regulatory strategy, addressing the deficiencies in the original development programme, with the intention of re-entering clinical testing with an i/v formulation for use in hospitals. The Company is seeking to confirm in meetings with the FDA and the EMA in the first half of 2015 that the clinical development plan for iclaprim meets regulatory guidelines and that two Phase III trials can be conducted as proposed. The two initially proposed indications are:

ABSSSI, a common serious infectious disease involving multi-drug resistant bacteria. Within the US hospitalised patients, skin and soft tissue infections were projected to increase by 176 per cent. from 1997 to 2009. The two Phase II trials with iclaprim, completed in 2008, demonstrated efficacy and safety in patients with cSSSI; and

HABP, a serious infection with a mortality rate between 20 per cent. and 50 per cent. and can increase hospital costs by an average of approximately £26,000 per patient. Iclaprim’s Phase II trial demonstrated excellent efficacy in patients with HABP and iclaprim was more effective and led to fewer drug-related adverse events than those treated with vancomycin.

The two trial protocols have been developed to be consistent with the latest published FDA and EMA guidelines.

A formal “Type C Meeting” request has been submitted requesting a meeting with the FDA in March 2015. Similar discussions are planned to take place with the EMA in the first half of 2015. Upon confirmation of the clinical development plan, the two Phase III trials are planned to be initiated in the second half of 2015. The first trial in ABSSSI is estimated to take approximately 18 months to complete. Once the clinical development plan is finalised following the FDA and EMA meetings, including the number of patients required to be included, and negotiations with CROs have been completed, the final clinical costs will be confirmed.

The Company is intending to seek to raise additional capital or enter into a strategic partnership with another pharmaceutical company in order to fund the second Phase III trial. Several development programmes and indications will be undertaken with the iclaprim assets and the Directors’ ambition is to have other new indications, formulations and combinations in clinical development by the end of 2016.

[hoggar] 30/3/2015 09:04

We must remember that investment houses and fund managers have teams of highly skilled pharmaceutical advisors who have the advantage of scrutinizing the potential claimed performance of a drug prior to IPO. The listing valuation will determine whether the institutions have done their homework on this drug and company management.

[h2owater] 30/3/2015 08:27

Listen to CEO:https://vimeo.com/118580722Graham Lumsden CEO MofitBio plc on 4 million IPOfrom DirectorsTalk PRO 1 month ago ALL AUDIENCESMotif is developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Motif has a lead antibiotic candidate, iclaprim, and MTF-001, a preclinical program to design a best-in-class dihydrofolate reductase inhibitor (DHFRi). Discussions and negotiations with academic institutes are under way to build a portfolio of antibiotic candidates through licensing. It is anticipated that Motif's lead antibiotic candidate could be ready for commercialization as early as 2018.Motif is planning to raise at least 4 million pounds through a stock market listing in London.Graham G. Lumsden, Chief Executive Officer of Motif, is responsible for all aspects of the strategy, management, and operations of the Company. Prior to joining Motif, Mr. Lumsden was a senior executive at Merck & Co., Inc. where he held commercial leadership positions in worldwide businesses including contraceptives and osteoporosis. Mr. Lumsden has a proven record of success leading change and delivering results in subsidiary and global leadership positions, including new product launches, pre-clinical/clinical development, regulatory strategy, cross-functional team leadership, IP strategy/litigation, and domestic/international sales and marketing. Mr. Lumsden is a member of the Royal College of Veterinary Surgeons (MRCVS), holds a postgraduate diploma from the Chartered Institute of Marketing (MCIM), and is a dual citizen of the U.S. and UK.

[jumbone] 29/3/2015 22:07

I can't answer that honestly.

But from what I see...

In an industry like pharma..

If there is even a half promising molecule that could be a cure for superbug infections

At the very least a dozen of the companies would have snapped it up in a blink for many hundreds of million USD

If ICLAPRIM landed up with an unnamed unknown biopharma company, for an undisclosed minuscule amount

If that molecule is available for less than half a mill USD for purchase by an even more unknown entity like motif...

This is not the NEXT BLOCK BUSTER... Far from it.

But stock market is a strange beast...

>>It ignores the likes of TECH's IPO and another ex button company's share explodes because they invested 100K in TECH.

>> It ignores the likes of FITB with a very promising product line and pumps up GATE

It ignores the HNR IPO and pumps GATE

Never the less.. To expect AMP's share to takeoff on the strength of motif's ICLAPRIM in my considered opinion is illogical.

[tidy 2] 29/3/2015 21:12

How's this going to effect the share price this week then I your opinion?

[jumbone] 29/3/2015 20:27

Augton:

If you think that ICLAPRIM is to enter Phase III trial you are in Cuckoo land

There was a very clear rejection of this drug by FDA

>> There was a 17 to 2 votes against the drug by the FDA's anti ineffectives drug advisory committee

>> In addition FDA suggested additional study or studies to prove it's EFFICACY

>> The estimated costs as per the CFO of Arpidia who owned that drug was between CHF 20 to CHF 40 That is $ 17.5 mill -- $ 35 mill

>> That approval filing was just for SKIN infections... NOT Superbug infections like MSSA & MRSA.

>> Motif Biosciences themselves admit that this usage should be through IV route

>> Any clinical testing against any superbug infections is going to cost them several fold more than just skin infection clinical trials.

>> This molecule was a DEAD molecule in Jan 2009, as soon as the FDA's CLEAR rejection of the drug

>> That was the reason why Arpidia sold this off

By the way, I am a long term holder of AMP from it's 2p days... Not intending to deramp... But cannot stop myself from posting FACTS

By the way, I come from the pharmaceutical Industry with 20 + years of international experience in senior management positions.


I am sure AMP will do well... But this molecule is not the route to it

[regandharry5] 29/3/2015 17:47

It would be very unfortunate if it turned out to be good and bad news at same time in that," The good news is Iclaprim has killed the infection, but the bad news is in doing so it has also killed the patient".