Summit Therapeutics Share Discussion Threads

[waterloo01] 26/9/2016 12:18

NICE have recently approved a treatment for the nonsense gene in DMD at around £220k a year.



Edit: I would also add it's not a very good drug but there isn't anything else....yet

[hlp_4u] 26/9/2016 12:15

As an ex NHS accountant I think 200k won't happen....it might in the US and countries with insurance policies but my view is that NICE will say it is a disease that affects children...few reach an active productive adulthood and will cap the cost at 5-7k per annum.....harsh but at 200k you threaten the free at the point of delivery approach of the NHS.

[someuwin] 26/9/2016 12:08

Summit Therapeutics plc Summit Receives Fast Track Designation From Us Fda For Ezutromid In The Treatment Of Dmd

26/09/2016 12:00pm

UK Regulatory (RNS & others)


TIDMSUMM


Summit Therapeutics plc

("Summit" or "the Company")

SUMMIT RECEIVES FAST TRACK DESIGNATION FROM US FDA FOR EZUTROMID IN THE
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Oxford, UK, 26 September 2016 - Summit Therapeutics plc (NASDAQ: SMMT,
AIM: SUMM), the drug discovery and development company advancing
therapies for Duchenne muscular dystrophy ('DMD') and Clostridium
difficile infection, today announces it has received Fast Track
designation from the US Food and Drug Administration ('FDA') for
ezutromid in the treatment of DMD. Ezutromid is a utrophin modulator and
represents a potential disease modifying treatment for all patients with
the fatal muscle wasting disease DMD.

"Fast Track designation underscores the importance that the FDA places
on developing new treatments for life-threatening disorders, such as DMD,
and aligns well with our recently outlined strategy to accelerate the
development of ezutromid to market," said Glyn Edwards, Chief Executive
Officer of Summit. "As a utrophin modulator, ezutromid has the potential
to significantly advance the state of care for all patients with DMD,
regardless of their underlying genetic fault. We look forward to
ezutromid's continued progress in our ongoing Phase 2 clinical trial,
PhaseOut DMD."

Fast Track is a process designed to facilitate the development and
expedite the review of drugs to treat serious conditions that address an
unmet medical need. Advantages of Fast Track designation include
opportunities for more frequent interactions with the FDA during all
aspects of development, submission of a New Drug Application ('NDA') on
a rolling basis, and eligibility for accelerated approval and priority
review. This designation is in addition to ezutromid being granted
Orphan Drug designation by the FDA and the European Medicines Agency.

[someuwin] 26/9/2016 12:04

Good news.

[freedosh] 26/9/2016 08:37

C.Diff is important and we have an excellent drug Abergele but treatment is short term and, subject to pricing, could be used as rescue treatment after cheap, less effective, drugs have failed. Better prevention will also play a role such as restriction on use of broad spectrum unnecessary antibiotics in hospitals and hand washing which is far superior to the daft alcohol based dispensers. The key though to answering your question is that DMD is an orphan disease that requires lifelong treatment and if you prolong that life then treatment is extended. Now, orphan designated drugs command premium pricing and I would anticipate an annual cost of,say, 100 - 200 thousand dollars -for life.
Search a disease called Paroxismal Nocturnal Haemaglobinuria for an equivalent. Company is valued at multiple Billions and puts Wainwright into context
I personally would accept dilution and keep Rid' but realise that is not a popular view

[waterloo01] 26/9/2016 08:34

abergele, you would think so but the difference is RDZ is likely to be priced at £1.5k a pop (and in principle one treatment course) while in DMD the price is likely around £200k per year, so despite the numbers of patients, the level of return is rather different.

[luminoso] 26/9/2016 08:19

Hmm nice buying to start the week.

[abergele] 25/9/2016 22:48

Call me daft or what but surely the CDIif angle is more lucractive than the
smaller amount of children(not that I want to see ,or believe that the boys are not suffering,also the families) with DMD have,but all people who enter our NHS Hospitals,for an operation,or treatment are at risk of catching this dreadful,Cdif...it eventually got to my uncle..and took him away.

A new antibiotic covers a wider spectrum of the population,or am I seeing this wrongly,,,I am a long standing shareholder now,and would like to be at breakeven soon before I die of old age,,,a more deadly proposition for the majority of the average shareholder here I bet,,70yrs old next year.

[hugus maximus] 25/9/2016 17:09

All interesting thoughts kmjs!

Meanwhile let's hope the Summit show gets back on the road this week with a resolve about topping up the coffers.

[kmjs] 25/9/2016 15:49

HM

I wouldn't dismiss SRPT coming for SUMM's DMD just yet, read the 2nd para of 21121
more closely.

They wanted to raise $225m and got $300m massively oversubscribed.

If they approached SUMM to buy just the DMD and were rejected, I could see them
take the company out and simply sell on RDZ, or even keep it until they saw if
governments were serious about throwing huge bounties to developers of new antibiotics.

It may not happen, but if I were their top man I would be looking for insurance,
because if the FDA do eventually "pull the rug", where does it leave SRPT?

[hugus maximus] 25/9/2016 14:04

Having followed the Sarepta story through the summer, it was a foregone conclusion that the minute they had an FDA decision (one way or the other), they would have to raise capital to fund the company's ongoing work. Whether it be to fund the re-working necessary for P2 as a consequence of an FDA "NO" or in the event of a "YES", simply to take the company on further toward producing the drug.

The Sarepta fund raise has absolutely nothing to do with the acquisition of another company.

I think you'll find that there is still very little interest in a small company based in Oxford, England ..... YET!

Meanwhile Summit's plot unfolds ... a placement or a C Diff deal?

Surely if it's a dilution with a placement, won't Glyn and the boys need to strike quickly while the iron's still hot? (And the share price warm.) Although I'd love to think otherwise, I don't believe this share price buoyancy based on Sarepta's FDA ridiculous news will last long and Summit need to show some purpose and direction in relation to their low cash deposit.

[sorrento06] 24/9/2016 21:21

Just to put this theory out there!Sarepta Therapeutics, Inc. (NASDAQ: SRPT), today announced that it has priced an underwritten public offering of an aggregate of 5.02 million shares of its common stock at a price to the public of $59.75 per share. Sarepta anticipates the gross proceeds from the offering, before deducting the underwriter discounts and commissions and other offering expenses, to be approximately $300 million. The offering is expected to close on or about September 28, 2016, subject to customary closing conditions.Sarepta intends to use the net proceeds from the offering principally for the continuation and initiation of further clinical trials, commercialization, manufacturing, business development activities including the potential licensing or acquisition of complementary products and technologies and other general corporate purposes.300,000,000.00 USD=231,356,520.40 GBPThat's about £3.74 a share, which is very near to Mr Mellon's £3+ tweet. Hmmmm. Was he telling the market what he would take? DYOR though!

[patviera] 24/9/2016 13:57

No 6 freedoshWe been no 500 every day for 2 yearsGet real mate

[chrisatrdg] 24/9/2016 11:15

21ST INTERNATIONAL WORLD MUSCLE SOCIETY CONGRESS
4-8 October 2016, Grenada, Spain

Further details on Summit posters and link below:

Wednesday 5 October 2016

16:00–17:30
Program/Neuromuscular Disorders 26 (2016) S55–S86 S63 Poster presentations 2: parallel sessions (P.100–215) – Poster area

P.144 Utrophin modulators significantly improve the muscular dystrophy in the mdx diaphragm
S. Guiraud; H. Chen; T. Kennedy; S. Squire; B. Edwards; D. Burns; N. Shah; A. Babbs; S. Davies; G. Wynne; A. Russell; D. Elsey; F. Wilson; J. Tinsley; K. Davies

P.145 Second generation utrophin modulator for the treatment of Duchenne muscular dystrophy
S. Guiraud; S. Squire; B. Edwards; H. Chen; D. Burns; N. Shah; A. Babbs; S. Davies; G. Wynne; A. Russell; D. Elsey; F. Wilson; S. Harriman; J. Tinsley; K. Davies

P.146 Utrophin modulation for the treatment of cardiomyopathy in mdx mice
D. Burns; S. Guiraud; C. Carr; S. Squire; B. Edwards; H. Chen; T. Kennedy; A. Babbs; N. Shah; A. Berg; G. Wynne; A. Russell; D. Elsey; S. Harriman; F. Wilson; J. Tinsley; K. Davies



Edit: Further posters on subsequent days to be added see below:

Thursday 6 October 2016

Poster presentations 3: parallel sessions (P.216–308) – Poster area
DMD treatment approaches I; (P.216–230) Chairpersons: Kay Davies and Eugenio Mercuri

15.00–16:30

P.223 Development of digital tissue image analysis solution for muscle biopsies in support of disease-modifying therapies for Duchenne muscular dystrophy
J. Tinsley; C. Pulliam; A. Milici; F. Aeffner; K. Davies; S. Moore

[waterloo01] 23/9/2016 19:50

Hard to disagree. Ultimately though, if it gets approval, the true value will out.

I also have a small stake in IMM

[kmjs] 23/9/2016 19:41

waterloo01

Yep I've also been here a long time.

The one thing that has always frustrated me is just how differently the markets
value UK v US companies. Potentially SUMM's DMD could benefit far more sufferers,
but look at the difference in values between the two companies. Having lived
in the US, it could simply be down to(until perhaps very recently) an inward looking
mindset, but again that is just my guess. IMO, even though SUMM listed in the US,there
doesn't seem to have been much interest, until SRPT appeared to have trouble getting
their "greenish light".

Look at IMM, potentially about a year from presenting pIII results off their own
back and the market cap. looks pretty low to me, but if it were a US company do you
think it would be anywhere near current value at this stage of it's trials?

[football] 23/9/2016 19:35

the yanks love taking a 10% profit

[waterloo01] 23/9/2016 19:26

Don't be surprised to see this drop on Nasdaq. Traders have seen a decent rise and might have held for a full week!

[luminoso] 23/9/2016 18:28

Could be it was marked up because of the disparity with the nasdaq price at the time ?

[solomon] 23/9/2016 17:04

Those trades reported between 15:52 and 15:54 are anomalous. I have convinced myself that they belong at around 09:20 when the offer jumped quickly from 121 to 128 without obvious reason at the time. It may be that I easily get myself convinced, but if my convincement is not confounded then my question is: Are the MM's allowed to do this?

[luminoso] 23/9/2016 16:15

AIM still lagging behind nasdaq price by some way. Another burst coming ?

[chrisatrdg] 23/9/2016 16:06

I agree with waterloo01 that it is DMD which is the prize that Summit are seeking & that of its major shareholder.I do not see this as changing (Now back in profit).

PS Pity that my Buy last week of 250 shares was not 25,000 but hey ho.

[waterloo01] 23/9/2016 15:59

kmjs, I originally invested because of the antibiotic, in the days when they had a whole host of potential therapies (including DMD)and were shooting off in all directions. Not good days, rectified when Glyn came on-board, so I'm not averse to just holding RDZ. However the really big prize is in the rare disease space (as you can see by SRPT valuation of over $2.5bn) and I've always understood the main shareholders were in it for this sort of return.

[solomon] 23/9/2016 15:45

Whatever happened to multibagger (the poster not the concept)? He used to have a lot of SUMM.

[kmjs] 23/9/2016 15:04

Well if we're guessing next move I'll go with...

SRPT buy our DMD for circa $100m. With the risk of their offering being rejected
further down the line I agree with Freedosh, it could be a good insurance policy.
I think they were aiming to raise $225m, so it looks like they already have an extra
$75m and being 4/5 times over subscribed (if true) should mean no probs if more needed.

Then, and where it I am at odds with Waterloo01, SUMM take RDZ all the way, because
I think governments are going agree huge bounty payments to bring forward new
antibiotics. This lack of new treatments is the one thing that IMO will make them
pay whatever is needed, and I'm not sure shareholders are quite tuned in to what
potential funding could be made available.

Just my guess, but we all like to play the game.