Motif Bio Share Discussion Threads

[vulgaris] 09/8/2016 14:29

Oxford Whale ------ "To blame this on "market conditions" is risible. There is a raging bull market in the US and the biotech index is at a 6 month high. What is the real reason?"

I don't know, but can I suggest you go to EMA's 2009 rejection of this drug and read carefully

Ask yourself if Motif has done anything to address or overcome these 'major' objections, relating to both efficacy and toxicity? So far as I can see they have only changed the comparator, using vancomycin rather than linezolid---- It is arguable that vancomycin is a weaker comparator, but doubtful that it's significantly so in the context of (AB)SSSI. There's nothing can be done about the safety concerns: Motif have kept dosage essentially unchanged from Arpida's trials. What's more linezolid is now generic.......


>>>>>>>>>

FROM EMA report

Based on the review of the data on quality, safety and efficacy, the CHMP considers that the application for Mersarex (iclaprim), in the “the treatment of complicated skin and soft-tissue infections (cSSTI)”, is not approvable since identified "major objections" have not been resolved. These objections preclude a recommendation for marketing authorisation at the present time. The major efficacy and safety objections precluding a recommendation of marketing authorisation pertain to the following principal deficiencies:
• The applicant’s answers to the major efficacy objections and other concerns in relation to the efficacy results from the two pivotal ASSIST studies do not provide convincing clinical evidence in support of the non-inferiority of iclaprim to linezolid in the sought indication at large. Consequently, there is insufficient evidence to support a favourable efficacy conclusion for the use of iclaprim in the treatment of adult patients with cSSTI at the recommended dosage of 0.8 mg/kg twice daily (with a maximum of 100 mg per dose) up to 14 days.
The dosage regimen is not adequately supported by the rather limited clinical data especially in severe cSSTI nor the pharmacokinetic profile and experimental findings concerning T/>MIC; the major objection in relation to pharmacodynamics is not resolved whereas the assessment of the susceptibility table in section 5.1 of the SPC cannot be finalised.
• Iclaprim at the recommended dose level has a narrow cardiac safety margin. Iclaprim has demonstrated propensity to induce a dose dependent QTc interval prolongation in healthy subjects. The applicant’s clarifications and available limited database on iclaprim do not provide assurance for the safe use of Mersarex at the recommended dose level in the targeted population of patients at large.
• Similarly, there is insufficient assurance based on the limited available data that iclaprim is not hepatotoxic at the recommended dose level. It remains unclear why increase in ALT values develops long after stopping iclaprim despite the observation that in vitro mitochondrial toxicity data on human hepatocytes did not reveal adverse effects. Present limited patient database and analyses do not allow identification of patients (with normal or slightly increased LFT values at baseline) with increased risk for liver function test elevations in order to include targeted precautions in the SmPC for such patients. Although, in the light of present limited patient database a risk factor analysis (e.g. patients with underlying conditions, concomitant medications) is not expected to generate conclusive findings the applicant should conduct risk factor analysis with the available data collected in clinical programme in order to identify patients with increased risk for liver function test elevations.
Overall, the provided response of the applicant to CHMP Day 120 List of Questions does not change the earlier conclusion of the CHMP that on the basis of available data, the major cardiac and hepatic concerns outweigh the questioned benefit whereas there is no sufficient clinical evidence provided that Mersarex is beneficial in special patient groups failing other antibiotics or intolerant to standard antibiotics used in the treatment of cSSTI.



One of the problems about the much vaunted (and genuinely concerning) 'Lack of Antibiotics' and consequent pressure to 'find something' is that all sorts of very dubious, previously rejected, substances are being touted round in search for investors. Caveat Emptor is good advice in these circumstances.

[regandharry5] 09/8/2016 11:31

Yeah, bad news which ever way you look at it, like to think it wasn't the product, but when you see other's getting away in the US it makes you wonder.


If it isn't the product persay, could it be a competitor has an equally good product coming along that will as good.

[1savvyinvestor] 09/8/2016 11:31

Very bad news in my opinion . Like mtfb but sold yesterday and glad I did

[scott1000] 09/8/2016 11:13

Takeover bid?? that would stall the listing or the 55% variance between the IPO price of 47p and mtfb price of 63p yesterday... whatever it is.. I'm sure it will be made clear in time

[the oxford whale] 09/8/2016 09:58

To blame this on "market conditions" is risible. There is a raging bull market in the US and the biotech index is at a 6 month high. There have been plenty of other companies doing secondary offerings in recent days due to the favourable conditions. What is the real reason?

[bowles22] 09/8/2016 09:08

How is it an excellent opportunity to top up? The share price is back to where it was before all the nasdaq excitement and may well go lower with this very bad news that they cannot attract any interest in the US!

[adorling] 09/8/2016 08:32

Excellent opportunity to have topped up this morning for investors..

[tromso1] 09/8/2016 08:09

Northland Securities reiterates its buy rating

[a1samu] 09/8/2016 07:39

Obviously difficulties in attracting punters to subscribe to the offering!

Unfortunately not such a hot stuff after all!

Not what we were hoping for.

Not what the market was expecting.

[timbo003] 09/8/2016 07:29

I doubt if today's news regarding a delay in the Nasdaq listing will go down very well.

The reason given "market conditions" seems bizarre.

[gersemi] 04/8/2016 11:26

This is looking very good

[substp] 03/8/2016 18:15

It's done!

"Certification by the National Association of Securities Dealers Automated Quotation approving securities for listing"

[timbo003] 29/7/2016 08:44

It's the general meeting Monday (14.00) I'm in London Monday morning, so I think I will pop along to that if I finish in time.

[apad] 28/7/2016 19:41

Thanks, timbo. Should've done more reading before asking the question.
apad

[timbo003] 28/7/2016 19:37

>>>APAD

I refer you to my notes from the 2016 AGM and the Rocket bar Investor meeting

All will be revealed (links in the header and below)

[apad] 28/7/2016 18:56

As I understand it big pharma doesn't research new antibiotics because a successful drug would be kept back as a last resort, so wouldn't get widespread use/sales.

So, why is MTFB a good investment?

apad

[fillipe] 28/7/2016 10:33

Thanks, ds1.

I bit of decent NASDAQ news on top of that and we're "good to go"!

f

[dstorey1] 27/7/2016 13:30

Broker Upgrade.

Northland Buy with new target 140.

[timbo003] 15/7/2016 10:38

See today's morning Note from Beaufort on research tree (you need to register but its free)



EDIT: Sorry, false alarm, wrong board!

[gersemi] 15/7/2016 10:17

Interesting company indeed

[apad] 15/7/2016 07:36

IC:
MOTIF BIO (MTFB)
What we said: Buy
When: 28 April 2016
Price: 42p
Share price change to date: +14%
Antibiotics specialist Motif Bio (MTFB) is looking stateside for its next injection of capital to help fund the final trial of its ground-breaking antibiotic iclaprim. The Aim-traded company has filed an application to list on the tech-heavy US Nasdaq index and plans to raise up to $60m (£45m) in the process.
It’s not just for the money that this listing is attractive. Joining Nasdaq brings Motif closer to the Food and Drug Administration (FDA) – the regulatory body in the US which is responsible for approving all new drugs before launch into the world’s biggest healthcare market. Furthermore, US investors are generally thought to be less risk averse and therefore may be more willing to provide funds for the clinical trial as well as bidding up the share price.
With the potential to launch the first new class of antibiotic for 30 years, Motif Bio is certainly an exciting company. Now, with easier access to cash thanks to a US listing, the investment case looks all the more attractive. Buy at 48p. MB
Buy