Motif Bio Share Discussion Threads

[h2owater] 10/4/2015 16:25

Next week FDA meeting

Quote from TIMES


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.

[aughton 3] 09/4/2015 07:28

Decent volume again

[timbo003] 07/4/2015 08:05

Thanks Cottoner

Antibiotic R&D has suddenly become a horny area again after decades of neglect. There couldn't really have been a better time to pick up cheap overlooked assets such as Iclaprim.

Happy days

[topinfo] 06/4/2015 23:47

Motif Bio ready to make mark in next generation of antibiotics
By Ian Lyall April 02 2015, 8:59am


Motif Bio is one of those extremely rare life sciences company that comes to a market with a drug ready to go into the final phase of clinical trials.



It is extremely rare that a life sciences company comes to a market with a drug ready to go into the final phase of clinical trials.
Motif Bio (LON:MTFB), which listed on AIM today, is in exactly this position.
What’s more it is in a very hot space - next-generation antibiotics - and has an ambitious plan to launch its first drug within 36 months.
Motif, led by former Merck executive Graham Lumsden, raised £2.8mln through the listing giving it a value of just short of £22mln at the current 34p price, itself a substantial premium to the 20p float (IPO) price.
Its lead drug, Iclaprim, is being acquired from Maryland-based Nuprim through an equity-only transaction with the acquisition expected to complete at the time of the Motif IPO.
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 US Food & Drug Administration’s (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.
Motif plans to carry out two: one will assess iclaprim’s efficacy in treating acute bacterial skin infection; the other, hospital acquired bacterial pneumonia.
The former is a common infection in patients that causes abscesses, and Lumsden said 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.
And as Lumsden pointed out: “It is important that in a hospital formulary setting they have a number of antibiotics they can use to treat patients.
“So Iclaprim is going to be in an important position in the formulary as it works in a completely different way [to other treatments].
“This is quite a competitive space, but there will be a place for Iclaprim.”
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 said.
“We have options. We can absolutely partner the asset to pay for the phase III programme, or – and only if we get an appropriate valuation going forward – we can look to raise funds.”

[cottoner] 06/4/2015 14:47

Finance is key to sick market
Oliver Moody Analysis
Published at 12:01AM, April 6 2015

Everyone who works on antimicrobial resistance agrees it is a looming catastrophe. According to the review panel set up by David Cameron last year, it could cause more deaths than cancer and cost the world’s economy $100 trillion by 2050.

Forget headlines about MRSA and C. difficile; greater “superbug” threats are emerging, such as strains of E. coli. Drug-resistant infections are estimated to kill 5,000 Britons a year.

Dame Sally Davies, the chief medical officer, has identified two main answers: use the antibiotics we have more sparingly, and develop new ones.
The first is difficult, the second is a tall order. It is thought to cost between £750 million and £1.2 billion to bring a new antibiotic to market, but drug companies tend to get higher returns from cancer treatments.

To clear this financial blockage in the antimicrobial pipeline, parts of the pharmaceutical industry suggest that health ministries could pay drug companies an annual lump sum for every antibiotic they bring to market, in return for being able to buy them at only slightly more than cost price.

Government advisers appear to favour pushing drug companies to look beyond balance sheets and spend more to avoid the savage costs of inaction.

[cottoner] 06/4/2015 14:46

Finance is key to sick market
Oliver Moody Analysis
Published at 12:01AM, April 6 2015

Everyone who works on antimicrobial resistance agrees it is a looming catastrophe. According to the review panel set up by David Cameron last year, it could cause more deaths than cancer and cost the world’s economy $100 trillion by 2050.

Forget headlines about MRSA and C. difficile; greater “superbug” threats are emerging, such as strains of E. coli. Drug-resistant infections are estimated to kill 5,000 Britons a year.

Dame Sally Davies, the chief medical officer, has identified two main answers: use the antibiotics we have more sparingly, and develop new ones.
The first is difficult, the second is a tall order. It is thought to cost between £750 million and £1.2 billion to bring a new antibiotic to market, but drug companies tend to get higher returns from cancer treatments.

To clear this financial blockage in the antimicrobial pipeline, parts of the pharmaceutical industry suggest that health ministries could pay drug companies an annual lump sum for every antibiotic they bring to market, in return for being able to buy them at only slightly more than cost price.

Government advisers appear to favour pushing drug companies to look beyond balance sheets and spend more to avoid the savage costs of inaction.

[cottoner] 06/4/2015 14:44

‘Narrow-minded’ drug companies forced to fund war on superbugs

Oliver Moody Science Correspondent
Last updated at 12:01AM, April 6 2015

Pharmaceutical giants face being ordered to plough their resources into fighting antibiotic-resistant “superbugs”, a senior government adviser has disclosed.

The increasing resilience of deadly bacterial infections is held up as one of the greatest threats to humanity and forecast to cause up to ten million deaths each year by 2050, but the struggle against it has been hamstrung by a severe shortage of new drugs.

David Cameron warned last year that antibiotics resistance could cast the world “back to the dark ages of medicine” as he commissioned Jim O’Neill, a prominent economist, to head an investigation into how to fix a “failed” market that has not produced a new class of antibiotic since 1987.
Dr O’Neill intends to put pressure on “narrow-minded” drug companies to pay their share towards an initial £1.4 billion global research fund when his panel publishes its list of policies for unblocking the antibiotics pipeline after the general election next month, he said. He has urged multinational drug firms to get to work on antimicrobial resistance or risk undermining routine surgery and cancer treatment.
His comments come as a government report estimated that up to 80,000 people could die in a single outbreak of infection due to the new generation of superbugs.
The National Risk Register of Civil Emergencies, a Cabinet Office document, said they were a “particularly serious” issue for the UK. It warned that in the event of a widespread outbreak, 200,000 people could be affected by a “bacterial blood infection that could not be treated effectively with existing drugs and around 80,000 of these might die.”

Dr O’Neill, a former Goldman Sachs chief economist, is leading talks with world economic heavyweights, including India, the United States and China, in an attempt to build a coalition to challenge “Big Pharma”. He believes Britain will be backed by the G7 group and asked Beijing for its support when it chairs the G20 this year.
Dr O’Neill thinks that about $25 billion (£17 billion) would be enough to develop ten “powerful” antibiotics. To finance that he wants to “encourage the industry to show something other than self-interest and to think about it a bit more broadly than they seem to”.

The scale of the challenge is underlined by figures seen by The Times that show that in 2007 patent offices around the world registered 2,214 new patent applications related to antibiotics. By last year that number had fallen to 198.

Nicholas Jones, a partner and pharmaceutical patent attorney at the law firm Withers & Rogers, who carried out the analysis, blamed generations of antibiotic misuse for the impending crisis and said: “The government needs to provide incentives to improve the risk versus reward profile of antibiotic research. At present it is simply not as commercially attractive as other areas.”

[cottoner] 06/4/2015 14:43

‘Narrow-minded’ drug companies forced to fund war on superbugs

Oliver Moody Science Correspondent
Last updated at 12:01AM, April 6 2015

Pharmaceutical giants face being ordered to plough their resources into fighting antibiotic-resistant “superbugs”, a senior government adviser has disclosed.

The increasing resilience of deadly bacterial infections is held up as one of the greatest threats to humanity and forecast to cause up to ten million deaths each year by 2050, but the struggle against it has been hamstrung by a severe shortage of new drugs.

David Cameron warned last year that antibiotics resistance could cast the world “back to the dark ages of medicine” as he commissioned Jim O’Neill, a prominent economist, to head an investigation into how to fix a “failed” market that has not produced a new class of antibiotic since 1987.
Dr O’Neill intends to put pressure on “narrow-minded” drug companies to pay their share towards an initial £1.4 billion global research fund when his panel publishes its list of policies for unblocking the antibiotics pipeline after the general election next month, he said. He has urged multinational drug firms to get to work on antimicrobial resistance or risk undermining routine surgery and cancer treatment.
His comments come as a government report estimated that up to 80,000 people could die in a single outbreak of infection due to the new generation of superbugs.
The National Risk Register of Civil Emergencies, a Cabinet Office document, said they were a “particularly serious” issue for the UK. It warned that in the event of a widespread outbreak, 200,000 people could be affected by a “bacterial blood infection that could not be treated effectively with existing drugs and around 80,000 of these might die.”

Dr O’Neill, a former Goldman Sachs chief economist, is leading talks with world economic heavyweights, including India, the United States and China, in an attempt to build a coalition to challenge “Big Pharma”. He believes Britain will be backed by the G7 group and asked Beijing for its support when it chairs the G20 this year.
Dr O’Neill thinks that about $25 billion (£17 billion) would be enough to develop ten “powerful” antibiotics. To finance that he wants to “encourage the industry to show something other than self-interest and to think about it a bit more broadly than they seem to”.

The scale of the challenge is underlined by figures seen by The Times that show that in 2007 patent offices around the world registered 2,214 new patent applications related to antibiotics. By last year that number had fallen to 198.

Nicholas Jones, a partner and pharmaceutical patent attorney at the law firm Withers & Rogers, who carried out the analysis, blamed generations of antibiotic misuse for the impending crisis and said: “The government needs to provide incentives to improve the risk versus reward profile of antibiotic research. At present it is simply not as commercially attractive as other areas.”

[davidcod] 06/4/2015 08:57

Interesting article. Thanks Aughton.

[davidcod] 05/4/2015 13:16

Duxy, looking for £1 in the near term. Will top slice there and leave the rest to run risk free.

[duxy786_2] 05/4/2015 02:47

Counting the days David. 50p target here to topslice. Now holding a substantial quantity. 3 year hold after that. This could be phenomenal when the offers from the big pharmas start coming in. Long term target £3

[topinfo] 04/4/2015 23:36

Full admission dccument and highlights just how well this company is put together in terms of data, vision, global pharma experience and what they are going to achice in a relatively short space of time. This really is a huge opportunity for investors of all types to get on board now and reap the rewards when the mkt cap soars to more realistic level for a company of Motifs calibre, and a company in this unique sector and at the stage that Motif are already at.

[topinfo] 04/4/2015 23:27

MANAGEMENT TEAM

Graham Lumsden, Chief Executive Officer

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

Robert Bertoldi, Chief Financial Officer

Robert Bertoldi, Chief Financial Officer of Motif, is also President and CFO of Amphion Innovations. Mr. Bertoldi was a founder President and CFO of Amphion Capital Partners LLC (the predecessor company) and VennWorks LLC. Mr. Bertoldi is also a general partner of Amphion Partners LLC (formerly known as Wolfensohn Partners, LP). Prior to that, he served as Chief Financial Officer for James D. Wolfensohn, Inc. and Hambro America Inc. He began his career at KPMG and left as a manager in the investment services department. Mr. Bertoldi received a B.A. in Accounting and Economics from Queens College, New York in 1976 and became a
Certified Public Accountant in 1978. He is a member of the AICPA and NYSCPA.

David Huang, M.D., Ph.D, JD, Chief Medical Officer

Dr. Huang is a senior pharmaceutical research executive, and the former Chief Medical Officer at ContraFect Corporation where he had the responsibility for the development of biologic anti-infectives, including bacteriophage lysins and monoclonal antibodies. Dr. Huang has also led drug development groups in anti-infectives at Pfizer and Boehringer-Ingelheim. Dr. Huang has 15 years of clinical, academic and research experience in medicine and in the subspeciality of infectious diseases. He has served as a faculty member at Baylor College of Medicine and currently as an adjunct Assistant Professor at Rutgers New Jersey Medical School. His research interests include bacteriology and virology, especially the epidemiology, pathogenesis, and treatment of multi-drug resistant organisms. He is well versed in the design, execution and close out of Phase I – III clinical trials for both antibacterials and antiviral agents. Dr. Huang completed his medical school at the University of Texas at Houston Medical School, and completed his internship and residency in internal medicine at the University of Texas at Southwestern and fellowship in infectious diseases at Baylor College of Medicine.

[topinfo] 04/4/2015 23:25

At Motif, members of our team have already developed blockbuster new drugs at the world’s leading pharmaceutical companies and are the named inventors on over 160 U.S.‐issued patents. With our deep drug discovery and development expertise, we have unique proprietary insights to fix flaws of existing first‐in‐;class drugs and to design best‐in‐class compounds. We have partnered with leading drug discovery and development companies. Together with a seasoned management team, Motif is positioned to rapidly identify and commercialize novel antibiotics.

[topinfo] 04/4/2015 23:16

You look at the board here at Motif and its just a brilliant team, including Ex Merck Execs, you dont get much better than this. What an astounding board here. This could be a huge % gainer over the coming weeks and months as the mkt and investors realize that this company was miss-priced on IPO and should have been valued at £60 Million + at the very least and could be worth say £200 million + in the future when full approval comes and it advances past phase 3 into full commercial approval status.

[davidcod] 04/4/2015 23:11

IMPORTANT: When the market opens on Tuesday, there will only be 7 days to FDA meeting.

[topinfo] 04/4/2015 23:11

Antibiotic developer Motif Bio enjoyed a successful listing, with shares leaping to 29.5p after being offered at 20p each. The biopharmaceutical company is working on a drug that will combat antibiotic-resistant bacteria.

[topinfo] 04/4/2015 23:10

Elsewhere on Aim, a brace of new listings was well-received by investors. Motif Bio, which is developing an antibiotic to use against drug-resistant bacteria, surged 10p – 50pc – to 30p on its debut,

[topinfo] 04/4/2015 23:07

Interesting Interview

Motif Bio in ‘right place at right time’ – CEO
By Sarah Lowther April 02 2015, 11:56am