Amphion Innovations Share Discussion Threads

[hoggar] 29/3/2015 16:58

The following was posted by me on 2nd Feb (801) in order to give investors a resume to the background of this drug-:

The lead project rejected by the FDA was a funding issue by the patent holder Arpida Biotech to conduct extensive phase 3 trials stipulated by the FDA.

This antibacterial compound has been in existence since Arpida Biotech first patented the compound approximately fifteen years ago. Iclaprim was hailed by analysts in some quarters after completing phase 2 trials. However, 2008 saw the credit crunch and no possibility of further funding Iclaprim into phase 3 trials. A merger with Evolva was intended to take the drug forward but Evolva changed business strategy towards natural herbal compounds.

Evolva sold Iclaprim to a licensing Biotech company called Acino who in turn were bought out by Pharma Strategy Partners. Five years on, Iclaprim is now owned by an un-named US licensing Biotech company.

Motif has done a deal to hopefully raise the necessary phase 3 funds through an IPO to continue Arpida Biotechs research into Iclaprim and take it to full FDA approval.

[aughton 3] 29/3/2015 16:57

Timberwolf you sound desperate , fact is this could be entering phase 3 trials with a market cap of 11 million ?????

[timberwolf3] 29/3/2015 16:15

Hello Kammi! - just trying to understand why it failed approval both in Europe and USA fist time around. It would appear that Linezolid is a more effective drug



From EMA report;
iclaprim showed consistently less favourable results than linezolid across
all analysis sets and in both studies. The lower non-inferiority margin exceeded the -12.5% value per
study and the -10% for the combined data in favour of linezolid.

www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2010/07/WC500095022.pdf

For the record I don't believe everything I read in the press, I like to do a bit of my own research.

hxxp://www.bioworld.com/content/fda-rejects-arpidas-iclaprim-company-seeks-partner-0

[kammi1] 29/3/2015 15:36

Hi, Timber have you missed the boat or sold too early? Thes antibiotics are are for conditions that are at present untreatable and so need to show that they will work, all medication have toxicity and the effective dose neeeds to be worked out.Phase 2 showed excellent results so they need to do further trials. Your posts this morning show you are desperately trying to lower expectation that has been generated by media reports WHY?

[timberwolf3] 29/3/2015 15:28

I guess more worrying would be this ;

The FDA's analysis showed there were six deaths among patients treated with iclaprim in the two Phase III studies, with three of those deaths assessed by the agency as "possibly related" to the medication.

[h2owater] 29/3/2015 12:54

Motif Bio announces intention to float on AIM

3 February 2015 • Author: Motif Bio

Motif Bio announces intention to float on AIM

Motif Bio plc is seeking to raise at least £4 million through a placing of new ordinary shares (the “Placing”) and admission to trading on AIM.

Motif is a clinical stage biopharmaceutical company which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi). Discussions and negotiations with academic institutions and pharmaceutical companies are under way to build a portfolio of antibiotic candidates through licensing.

The Directors anticipate that iclaprim could be ready for commercialisation within approximately 36 months.

Business and Investment Opportunity

The Company has built a team of scientists and experts with extensive drug development experience and is raising at least £4 million through the Placing to:

advance the Group’s drug development programme, in particular iclaprim and MTF-001;
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; and to
provide the Group with additional working capital for at least 18 months.
Resistance to antibiotics is a major global public health threat. The world’s pipeline of novel antibiotics has not kept pace with the ability of certain bacteria to resist treatment with existing products. The Group has a clinical stage antibiotic, iclaprim, which has been designed to be effective against multi-drug resistant bacteria.

Iclaprim is being designed to be administered in hospitals as an intravenous infusion. The Directors believe the most urgent need for novel antibiotics effective against multi-drug resistant bacteria is in the hospital setting where patients often succumb to serious, life-threatening infections that require immediate treatment with the best available antibiotic. In the case of HABP, mortality rates for infected patients are currently between 20 percent and 50 percent. and extended hospital stays pose a burden to healthcare systems and can increase hospital costs by an average of approximately £26,000 per patient. In the Directors’ experience commercialisation of hospital products is relatively easy and can be done with fewer resources than commercialisation in the community because there are fewer hospital healthcare professionals to communicate with, compared to launching and educating the larger number of primary care and general practitioners in most countries.

Assuming that Motif receives regulatory approval to start Phase III testing in the second half of 2015, the Directors believe that iclaprim offers a rapid path to commercialisation, which would be expected to occur in 2018. A follow-on pipeline of preclinical antibiotics is being built to follow iclaprim.

Recent mergers and acquisitions demonstrate the increased activity within the antibiotic field. Paratek listed on Nasdaq in 2014, raising approximately US$100 million to develop a tetracycline antibiotic called omadacycline, whose Phase III studies are set to re-start in the first half of 2015. Paratek’s market cap increased to approximately US$574 million following the acquisition in January 2015 of Cubist by Merck & Co., Inc. for US$9.5 billion. Durata Therapeutics Inc. (NASDAQ: DRTX) was acquired by Actavis (NYSE: ACT) in October 2014 for US$675 million plus contingent value rights, following the approval for its first antibiotic in May 2014.

The Directors believe, assuming that iclaprim receives regulatory consent to commence Phase III trials, that the Company should be an attractive candidate for a strategic partnership with a large pharmaceutical company with commercialisation expertise and capabilities.

Commenting, Motif CEO, Graham Lumsden, said: “Growing resistance to antibiotics has been described as a worldwide threat to health and several different new antibiotics will be needed to stave off the impending crisis. Motif is developing iclaprim, a novel antibiotic that kills bacteria in a different way to most other antibiotics. We are excited by the opportunity to contribute potential solutions to the looming public health crisis and to share our progress with investors in the UK market.”

[timbo003] 29/3/2015 12:16

Just to expand on the previous comment.....


There is an urgent need to commercialise novel antibiotics to keep pace with the development of drug resistance.

Recent US government Intitiatives:

* GAIN Act (2012) “Generating antibiotic Incentives Now”
* Expedited approval process in U.S. (Goal: 6 months)
* Extended market exclusivity of ten years from date of approval.
* Combating Antibiotic Resistance report to President Obama (Sep. 2014)
* One of three areas of focus “increasing the rate at which new antibiotics, as well as other interventions, are discovered and developed”

Recent UK government Initiatives:

* House Of Commons Science and Technology Committee Report on Tackling Antimicrobial Resistance (July 2014)
* Recommended better pricing mechanisms, clinical trial regulation, patent extension and alternative financing mechanisms.


Difficult times in 2007/8 - Telithromycin (Ketek): Approved as a novel antibiotic, then associated with severe liver injury and fraudulent safety data. Approval of two of three Ketek indications withdrawn in 2007.


Iclaprim was one of four antibiotics not approved in 2007- 2010

Since 2010 there have been further developments with these 4 antibiotics

* Dalbavancin:
Durata Therapeutics redid Phase III programme with FDA approval in May 2014.

* Oritavancin:
The Medicines Company redid Phase III programme with FDA approval in August 2014.

* Omadacycline:
Paratek about to redo Phase III programme.

* Iclaprim:
Motif planning to redo the Phase III programme.

[f1araway] 29/3/2015 11:53

THE FOLLOWING IS THE ANSWER TO MY OWN QUESTION WHICH IS SAYING, "THE TIMES" WAS WRONG;
London and New York, 20 March 2015 - Pursuant to the Company’s statement on 2 February 2015, Amphion is pleased to confirm that its Partner Company, Motif Bio plc, will seek admission of its ordinary shares to trading on the AIM market of the London Stock Exchange. Admission is expected on 31 March 2015. As of 31 December 2014, Amphion owned approximately 38% of Motif.

Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Upon admission, Motif will have a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolatereductase inhibitor (DHFRi). Discussions and negotiations with academic institutions and pharmaceutical companies are under way to build a portfolio of antibiotic candidates through licensing.

The Directors of Motif anticipate that iclaprim could be ready for commercialisation within approximately 36 months.

[timbo003] 29/3/2015 11:51

>>>>timberwolf

What has changed?

To sum up concisely what is stated in the investor information pack: The regulatory environment has changed.

[timberwolf3] 29/3/2015 11:39

Regarding Motif, didn't the FDA and the EMA both refuse approval to Iclaprim on the grounds that it wasn't as good as other approved antibiotics like linezolid.

Back in 2009 Arpida who carried out two Ph. III trials of their antibiotic, iclaprim, compared to linezolid and failed to show non-inferiority.

My question is What's changed ?

[timbo003] 29/3/2015 11:39

I decided to apply for a few Motif shares in the forthcoming IPO.

The offer to apply came through from one of my brokers on February 26th, clients had around 24 hours to request the info pack (pathfinder prospectus and investor slide info pack) and to indicate how many shares they wished to apply for.

The info pack states that they were raising £4.3m in the first instance with more to follow to fund the development program.

The shares should qualify for EIS tax reliefs according to the info pack, so assuming the IPO price is 20p/share, the net cost for investors will only be 14p/share.

Oh and by the way, according to the info pack, the epic code will be MTFB

[f1araway] 29/3/2015 11:35

Does Motif start Tuesday or Thursday?

[dlm2602] 28/3/2015 17:01

Oopps

www.proactiveinvestors.co.uk/companies/news/67609/qa-amphions-morgan-says-co-is-looking-to-agree-fair-and-equitable-licence-arrangements-67609.html

[dlm2602] 28/3/2015 16:55

Ref my earlier post 869 and my view that although the Motif IPO is nice, the real game changer for AMP is the success or failure of Datatern in its pursuit of IP infringers. The link below (Apr-14) interviews Richard Morgan and he spells out the position well. They earned over $20m in licencing revenue up to 2006 before all the problems occurred so if the company is successful they should hopefully be able to claim for past (up to 9 years) non payments and further licence fees up to 2017 when it comes off patent. That could be a serious amount of money! On the negative side, it would have been nice to hear that the company has settled with some of these infringers by now. I hope / think this is going to be a volatile ride! IMHO. DYOR.

[...]

[h2owater] 28/3/2015 11:45

Graham Lumsden CEO MofitBio plc on 4 million IPO

Also mentions Durata:

DUBLIN, Nov. 17, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has successfully completed its tender offer to purchase all outstanding shares of Durata Therapeutics, Inc. (NASDAQ: DRTX), an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. As previously announced, Actavis offered to purchase all outstanding shares of Durata for $23.00 per share in cash, or approximately $675 million in the aggregate, and one contingent value right (CVR) per share, entitling the holder to receive additional cash payments of up to $5.00 per CVR if certain regulatory or commercial milestones related to Durata's lead product DALVANCETM are achieved.

[h2owater] 28/3/2015 11:37

Thanks hoggar, that's really interesting!


Ceo on comparables!

Paratek Pharmaceuticals Inc(NASDAQ:PRTK)

Listed Oct 2014 @$1.70 rose to $20.00 in the 1st few days! Then $35.00 by Xmas 2014!

Paratek Pharmaceuticals Inc(NASDAQ:PRTK)



Roll on IPO Thursday 2nd April!

[hoggar] 28/3/2015 10:58

From the horses mouth

[h2owater] 28/3/2015 10:52

Times mentions Mcap of Motifbio will be 11m

IPO price 20p

Daily Mail reckons Mcap likely to be to 40-60m post IPO! So that about 100p.

AMP will probably follow with 38% or 38p!

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.

Read more:

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Another GATE, whose ipo at 20p was 172p a week later!

[aughton 3] 28/3/2015 10:16

In the times as well saying expected to FLY

[tidy 2] 28/3/2015 09:06

Any idea what their ticker will be on listing?Motif, which will be renamed Motif Bio PLC on admission, is looking to raise around £4mln through its listing.

[h2owater] 28/3/2015 07:52

In the small caps, it has been a memorable week for life sciences start-up investor Amphion Innovations (LON:AMP), which surged 88.24% to 8p today as investors looked for a cheap way into Motif BioSciences.

AMP owns 38% of Motif, a New York-based drug developer which begins trading on AIM on Tuesday.

Motif has been tipped to shine post-flotation as it has iclaprim, a potential blockbuster antibiotic in its pipeline.

Motif, which will be renamed Motif Bio PLC on admission, is looking to raise around £4mln through its listing.

Amphion shares have soared since Monday and now trade at 7p.

[tidy 2] 27/3/2015 22:27

Well done supertag. How much did u invest? £50 ;)) lol. Well done matie

[supertag] 27/3/2015 20:49

Bought yesterday at 4.08p and sold at 14.33hrs today at 9.25p 127% profit. Now that is what I call a good day!
Will try to buy shares in the new company when it floats next week.

[bad robot] 27/3/2015 19:16

and you are named isis, hahaha tw@t. lolol