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Futura Medical General Discussion (no topic needed !)

lse:fum

#1

Futura planetary alignment? End of Q2 approaching …

  1. Discussions towards the out-licensing of MED2002 advanced materially during the year and, as previously stated, we believe that a commercial out-licensing agreement will be announced in the first half of this year though, of course, the timing will also be determined by the detail of negotiations.

  2. The UK regulatory submission of TPR100, our diclofenac gel for topical pain relief, is close to completion with filing expected in Q2 of this year by Thornton & Ross, a UK subsidiary of STADA. Under the terms of its licensing agreement, Thornton & Ross holds rights to manufacture, market and distribute TPR100 in the UK for the lifetime of the product’s patents, which run to 2028 in the UK.

  3. Our two manufacturing partners - TTK in India and our European manufacturer - have the required approvals to ship CSD500 to any country in which the product is approved. Last year TTK received regulatory approval from the relevant EU Notified Body to manufacture an extended shelf life product and we continue to work closely with regulators to gain approval for an extended shelf life product for our European manufacturer. We remain hopeful of approval by the end of H1 2018 from the same EU Notified Body for an extended shelf life product for our European based manufacturer, which will be based on two years’, real time data.

In particular point 3 is based on two years real time data so I am expecting an announcement soon.

If there are companies interested in both MED2002 and CSD500 then this should be another small step for FUM and a giant leap for EDkind.

Take your seats … for a trip to the moon or a trip to Tesco’s ?


#2

The 200 million dollar question remains very much alive…why wansn’t FUM being picked up before by let’s say Pfizer a couple of years ago? If they are really sitting today at the table to discuss a TTT, then their investment team has been doing a crappy job. They knew the Viagra moneymachine was going to run at a much slower pace in the near future. Why not put the right amount of money on the table to scoop up FUM.
It must be that Mr. B refused a TTT in the past because they were offered a silly amount in his eyes…so if we truly have faith in the BoD then those punchy numbers must at least represent an amount equal to or over 5 times FUM’s current market cap.
However, the MM do not seem to have any faith that this scenario could be even realistic. Even after good results being announced last April, the share price doesn’t find the fuel to climb significantly. So no one or nothing is making this 34 pence a share company move up, not even moments of speculation…and that in Pharmaceutical companies, with a company with this kind of pipeline, is somewhat worrying. If you look at for instance Ablynx, a Belgian Biotech company, their stock price did go up steady from a couple of Euro’s in the beginning many years ago until the final 45 euro that was being offered by Sanofi last month. It baffles me to why the share price remains so low with all this possible good news in the pipe line. It makes FUM indeed almost a once in a lifetime opportunity. If I look at the variety of OTC ED products being offered onto the Belgian market today, then MED has no competition as all these products are wanna be ED solutions.
Could it be possible that Pfizer wants to squeeze the Viagra lemon until the end and then come up with 2 new revolutionary products (MED and CSD) whereby they will state that Viagra wasn’t the best ED solution over all these years so that other competitors, with similar products as Viagra, are being tackled down?

Maybe I too have the FUM and Mr. B syndrome…seeing things that are not always there…


#3

Interesting link below from 23 Mar 2018, “Futura Medical spies opportunity in China”, is the heading in the margin (Anyone have access to page 6?) of an article on the Pfizer and Viagra OTC launch. Nice to see the two companies sharing headline news !! :wink:

CSD500 regulatory approval in China (population 1.4 billion) with their legacy of one child policy would certainly spark a bit of interest as compared to Kuwait (population 4 million).

Back in 2013 Ansell signed an agreement with FUM to sell CSD500 in China but in May 2017 Ansell sold it’s condom business for $800 million to a Chinese consortium (Humanwell Healthcare and CITIC). So I imagine there is a conversation to be had there!

The article also shows the potential size of the OTC market “in it’s first year of availability OTC (Viagra Connect) is likely to generate more than double the sales of the whole of the cough, cold and allergy remedies category” .

The FUM product line has so much potential that something has to give. . .

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.otc-bulletin.com/media/51967/OTC-Bulletin-499-FC.pdf&ved=2ahUKEwj3ncvV3u3bAhWBmRQKHTIeBwwQFjAAegQIABAB&usg=AOvVaw3ifYrtxmD_avrONyTjtEYH


#4

I can’t see a deal being done by the end of the month (IMHO). It’ll happen whenever it happens…Probably by end of July if we go by the timeline of first patient to be dosed by end of September.

The regulatory submission by STADA does confuse me. We also know STADA is already in the ED market and sells Generic Viagra… Are they holding back the regulatory submission on purpose pending closing of the negotiations (if they are one of the companies in discussion)? I can’t help but feel the answer is YES.

At the end of the day, Mr Barder has stated they are in discussions with some significant companies - I believe him.

He has also stated that “significant licensing deal/deals” are in progress - I believe him when he says this.

The companies in discussion have identified their initial target market and no doubt, the calculations for the market size have been run and form the basis of the licensing deal…The design of the phase 3 trials will recruit men from that population group and therefore they may be able to get away by making certain medical/marketing claims…The work is being done in the background… it’s not always evident but I hope our day is near…

GLA


#5

Yes, Aberdeen, I still think FUM are holding back on all fronts whilst the “MED” deal is in progress.

Just a waiting game now, I don’t think Mr B will deem it necessary to update the Market this week even if a deal is put back into H2, because I suppose the AGM statement in a round about way was the update telling us to expect some news flow in the current financial year. So no more timescales please, Mr B, just let nature take its course and when (or if!) it happens then it happens.

Therefore not much to add at this stage from me, other than I’m now leaning towards a deal with Pfizer after the red face incident at the AGM (and how did it play out after the awkward silence, fx2452?). Viagra is an extremely strong and well known brand name and MED could be sold under a name such as “Viagra gel” (as simple as that) as it wouldn’t take a mass marketing campaign to grab the public’s awareness. Also supports the CSD radio silence, not that Pfizer would take on CSD but rather it will be ditched explaining the non-launches.

All IMO of course and will speak again when the deal is revealed (between tomorrow and forever!).


#6

I think it would be only natural that Pfizer is one of the interested parties Tony.

Providing that there are no new interested companies, it is reasonable to expect that all parties due diligence procedures are well advanced.

I’d like to discuss the following though, - I want to know if you think it is pure fiction:

We are expecting FUM to announce regional licensees or a global licensee, prior to phase III trials start.
This is what we have been led to believe, but this was stated long before the PK study results were available, or negotiations had reached such an advanced stage, or phase III parts 1 & 2 invented.
FUM plans could have changed lately. FUM may prefer to go it alone on part 1 of phase III.

Announcing a global licensee for MED2002 is likely to bring a strong reaction from unsuccesful parties.
Because of the MED2002 patent and lack of alternative technologies, unsuccesful parties may be caused to start bidding for the company.
The bidding might depend on how much these parties wanted to acquire the patent, - the key to a $1 billion dollar / annum ED market, a market which is growing in size year on year due to increasing Diabetes diagnosis in overweight males.

Announcing a global licensee now, - before the phase III trials have begun, may not generate bids as large as making the same announcement after the first part of phase III trials has been successfully completed.

I recall Michael Flatley was trying to fund an Irish Dance company after he had hit the heights with ‘Lord of the Dance’.
He had ammassed considerable personal wealth and toyed with the idea of funding his plans himself.
He announced he wanted a financial partner and was inundated with offers from the strangest and the most impeccable sources.
It was their willingness to throw money at his project that caused him to realise that his chances of failure with his plans were minimal, and he decided to self finance his dance company’s next production. He subsequently made a much larger fortune.

If the advisers have given JB a better perspective of his bargaining position, and he does not ultimately discard their advise.
If the PK study results give him complete confidence in the likely outcome of MED2002 phase III trials.
If his fear of trials failure has diminished significantly after dicussing likely outcomes with Ken James and his team post PK study results.
If negotiations are exceeding his expectations, then I can see JB just might have decided to ‘go it alone’ on part one of the trials, - if he has the cojones.


#7

Trump, Excellent point about the growing population of men that are contraindicated due to taking medication that is not compatible with the PDE5 inhibitors… The forecasts point to this market increasing, something that was perhaps evident with the latest forecasts suggesting 12 to 15% of men being contraindicated (compared to 7.5% of men several years ago when FUM first commissioned the research)

All interesting and potentially very lucrative to FUM and any potential licensing partners… However I still see Mr Barder trying to close out a deal soon (that is the priority of the company as stated in the AGM Statement)

However I agree, signing a deal may upset any other rival companies and I can only hope a bidding war follows…

Everything is not what it seems and I am sure some serious discussions must be going on in the background… You may remember I was in talks with Kabey some time back… This is the response I got back on the 7th Feb when I enquired about the UAE.

"Registration almost done. But we are now producing the quantity it take three and half month "

Fast forward to end of June - No launch in the UAE even though approval was probably granted (given Kabey use the words registration almost done)

So, something is def brewing in the background that is leading to discussions taking so long and plans effectively put on hold.

GLA


#8

In mentioning the numbers of overweight men being diagnosed with Diabetes, I was drawing attention to the increasing trend of Diabetics with an ED diagnosis, who are distinct from those ED sufferers who are contraindicated with PDE5 inhibitors. I agree that it is meeting the needs of the latter population that interested parties have prioritised, as they currently have no treatment available.

‘However I agree, signing a deal may upset any other rival companies and I can only hope a bidding war follows…’

It is the timing of this deal that would change FUM’s fortunes significantly.
Futura will have to afford part one of a successful phase III trial demonstrating GTN safety and advocacy, before MED2002 becomes a more valuable product.

‘Mr Barder trying to close out a deal soon’ - Well I guess anyone in his shoes might feel he was obliged to make this statement at the AGM - especially as the news ban is complete.

I despair at what has become of CSD500, - I believe Kabey is a niche distributor who JB has left to their own devices.
Good luck to them.

I am sure that if an all female team of marketeers were to work on developing e-markets and selling to the increasing number of women condom purchasers, a totally different ethos / approach / set of opportunities would rapidly materialise. But there are no funds to explore any of this.


#9

Quick question - I’m sure I read somewhere that FUM think MED2002 may become available OTC after 3 years of being available in prescription form? Can someone confirm this?

Pfizer have been trying to get Viagra OTC for absolute ages!!

Appreciate any feedback on this…


#10

Hi Aberdeen et al. I can confirm that this was mentioned at the AGM- that the regulators have indicated there’s a good chance (which essentially means there’s an excellent chance as they wouldn’t have indicated so otherwise).

Mr Trump: Regarding closing a deal prematurely (i.e. Before part 1 of stage 3 clinical trials is concluded leading to a diminished deal value) I’d bet that the final deal will include a milestone payment arrangement for a successful passage through phase 3.

Like Aberdeen (& many others) my best guess is that we’re very close to the finish line. Am looking forward to reaching it (as I’m sure the board are too!)

Good Luck All!


#11

I thought this was interesting

German generic drug maker Stada (STAGn.DE) is buying the rights to anti-dandruff shampoo Nizoral from Johnson & Johnson’s (JNJ.N) Janssen Pharmaceutica and could announce further product acquisitions soon, its interim chief executive told Reuters
“I can imagine that we will announce another product deal before I leave,” Claudio Albrecht told Reuters, two months before permanent CEO Peter Goldschmidt is due to take over the helm.


#12

Just for those who don’t know

Stada sells Generic Viagra


#13

I don’t know what’s more of a rollercoaster, fum or watching England on penalties.

It’s coming home.


#14


#15

Stada did cross my mind as a possible suitor, Aberdeen, but with a relatively small turnover of a couple of billion and profits of approx 200 million I’m guessing they “shouldn’t” really be in the running to buy MED/FUM “if” the likes of Pfizer and/or RB are in the mix. It’ll be like Burnley bidding against Barcelona for the services of Messi (even though that’s probably an extreme example), but the big guns …………

……… dwarf Stada. Maybe once MED/Eroxon comes out of patent then Stada will get involved with it as a generic.(!?)

Stada’s recent purchase of Nizoral does appear to fit in with Stada’s objectives tho’. But maybe an outside chance (like England winning the World Cup, are you cheering for us, Aberdeen?), fuelled by the delay in updating the TPR situation.

And still no CSD update.

The Market still subdued because it hasn’t a clue. Not a sniff. So hoping FUM will soon appear as one of those envied overnight double/treble baggers (yes, it does happen even with FUM, aka Sept '16) but let’s hope “it sticks” this time round. (Permanent even).


#16

Tony, you’re absolutely right. Stada is small compared to the big guns. According to their website they are concentrating on Europe and Middle East.
So if Stada were/are involved with med, it most likely will be a regional deal. They are selling generic viagra at the moment but are keen to expand…especially with the backing of their cash rich new majority owners.
This opens up another can of worms if there are companies in the mix that were after a global deal.
What do they do? Accept it or up the ante?
All guess work. Time will tell.


#17

Yes, Stada certainly have the lout for a “regional” deal, Aberdeen. But seeing Mr B was confident of a deal being struck before the end of 2017 it seems almost certain the “advanced discussions” now relate to a global deal/TTT otherwise I’m guessing a couple of regional deals would have been completed by now.

And another day passes with no CSD launches or TPR update ………………


#18

If anyone has subscription to the Investor chronicle , be sure to read the cover story.

It’s very relevant to us.


#19
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0 voters

I emailed JB to ask if he had any idea how much longer it would take to get a 2 year CSD500 shelf life
decision from regulators:

‘We have been given guidance on timelines by the regulators but I am afraid cannot comment further until these are definitive.’ - was the response.

It appears JB is not confident guidance is meaningful.

I feel kept in the dark and fed on sh__ :mushroom:

Take part in the poll - how many months do you think we will need to wait?


#20

How long for the regulators to do their job? That’s pure guesswork…think of a number, double it and add 2.

Wasn’t there some talk that the EU regulator was experiencing delays?

Is the 2 year shelf life really that important?..I cannot remember Mr Barder saying that partners were delaying launches because they were waiting for 2 year ESL condoms (although to be honest we haven’t had any news on CSD500 for ages).

I did think that because the 18 month ESL has already been approved, we only have to submit the 2 year data and it should be a formality. Perhaps a question for Mr B.