TPR100: UK Regulatory Submission Butterflybill: Where has everybody gone? Hibernation? Wake us up when we get there
TPR100: UK Regulatory Submission Well I spend my days waking up checking for a RNS and then end up disappointed when there isn’t one, it’s like an endless cycle. The LSE board is quite entertaining to read though. Just feel like patience is key now even if no kind of deal is announced before the phase 3 trials. We could possibly be in an even stronger position if we complete the first part of the trials. Good luck all and hang on in there, our time will come.
TPR100: UK Regulatory Submission Where has everybody gone?
Everybody on Holliday ?
TPR100: UK Regulatory Submission New RNS. Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that its UK commercialisation partner for TPR100, one of the Company’s novel topical pain relief products, has filed the product’s marketing authorisation application with the UK Medicines and Healthcare products Regulatory Agency. TPR100 is licensed in the UK to Thornton & Ross, one of the UK’s largest consumer healthcare companies and a subsidiary of STADA. Thornton & Ross holds exclusive rights to manufacture, distribute and market TPR100 in the UK for the lifetime of the product’s patents, which run to 2028 in the UK. TPR100, which benefits from the rapid skin permeation rates offered by Futura’s proprietary DermaSys® delivery system, will be launched, once approved, as an over-the-counter and general sales ledger product for the local symptomatic relief of pain and inflammation in: trauma of the tendons, ligaments, muscles and joints, e.g. from sprains, strains and bruises localised forms of soft tissue rheumatism. Futura has achieved statistically significant pain relief in a clinical study compared with placebo for TPR100, which is a non-steroidal anti-inflammatory drug (“NSAID”) using diclofenac as its active ingredient. Good news on TPR but I guess not the RNS we’re all waiting for. Still no news on MED but I’m guessing discussions are still on going. It’s just good to have some news shouldn’t do the SP any harm.
An example I was wondering whether Brexit might delay things.
An example I’m guessing and it’s a wild guess, but I hope the reason why it’s taking so long is that it’s to do with Regional licensing deals and due to each company working at a different pace…
An example Today Novartis announced a collaboration with the rising Belgian-Dutch biotech player Galapagos. They will work together on the development of a new Eczema drug. What is included in this deal: -Novartis will fund the entire R&D program -Galapagos will receive a first licence payment of about €95 million -Milestonepayments are concluded, if everything goes as planned, for a total of €850 million -Royalty payment (no % given) once the product is launched. I do not know how much bigger the Eczema market is in perspective to the ED market. But this deal really shows the interest and commitment of a big player in a potential new product. Compared with FUM, FUM is already in a further stage of marketability (phase 3 trials ahead) imho. So, if there is a real interest by a big player, these 4 financial stages are currently being discussed… PUNCHY!!! Only one question remains…why is Novartis so eager to conclude this deal at this early stage and is the FUM deal still not yet signed?
Futura Medical General Discussion (no topic needed !) The ‘goinpharma’ website seems full of bite size stories that are easily accessed, and may contain relevant sources of info for any searches (particularly on big pharma) that you might be performing. The site is new to me, but maybe not to you. Below are two examples: Awesome revenue figures for Viagra - (not available OTC woldwide), but the UK alone has recently allowed Viagra OTC. GoINPHARMA – 17 Dec 17 Teva launches Viagra generic in US - GoINPHARMA Viagra was approved by FDA in 1998 and has fetched Pfizer billions of dollars worldwide since then. Considering the 2003-2014 period, Viagra’s total revenu Teva launches Viagra generic in US 17 DECEMBER 2017 - 10:20 Viagra was approved by FDA in 1998 and has fetched Pfizer billions of dollars worldwide since then. Considering the 2003-2014 period, Viagra’s total revenue is $21.975bn, that is $1.83bn per year on average. Viagra is sold at $65 in the US–the richest and leading market in the world–however a shift is approaching, as generics producers have now developed their own copies of Pfizer’s blockbuster. For instance, Teva last Monday presented its generic to Viagra two years before its patent expires, thanks to a Pfizer-Teva agreement signed in December 2013. The agreement will allow Teva to launch its generic earlier, in return for royalties on sales. Pfizer has entered into a similar agreement with another generics giant–Mylan. (Source: Deutscher Apotheker Zeitung) Pfizers’ response after GSK and RB. failed to purchase the Consumer Healthcare division a few months back: GoINPHARMA – 11 Jul 18 Pfizer to reorganize company into 3 units Ahead of today’s opening bell, Pfizer announced big plans to reorganize the group. Starting 2019, the company will be split into 3 units: Innovative Medici Pfizer to reorganize company into 3 units - 11 JULY 2018 - 15:47 Ahead of today’s opening bell, Pfizer announced big plans to reorganize the group. Starting 2019, the company will be split into 3 units: Innovative Medicines, including biosimilar and injectable drugs, and other products aimed at preventing infections in hospitals; Established Medicines, both for branded and off-label drugs; and Consumer Health. Such a reorganization follows Ian Reed’s group’s unsuccessful attempt to sell the Consumer Health unit, which has been estimated at $15bn. Starting as soon as next year, the 2 new Consumer Health and Innovative Medicines units should generate over 75% of the whole group’s revenue. According to a spokesperson, the reorganization is due to the company’s need to refocus assets. Not only but also: President Trump had a meeting with Pfizers’ Ian Read recently, and it has now been decided that the 8% hike in some drugs Pfizer announced at the beginning of July 2018 will not now take place. Any price increase decisions will be finalised at year end. Pfizers share price bombed on the news.
Clinical Trial Application Agree, Aberdeen. This wait is torture. It reminds me of that film “Midnight Express” where Billy Hayes was serving time in a hellish Turkish prison, but hoping for parole to get him out (akin to us FUM-sters waiting for Mr B to declare the MED deal). Only to be refused parole and having to spend another 25 years in hell. Will we be denied the same passage to “freedom” from being shackled to an underperforming FUM for the rest of our lives? Surely we must have a deal any day now. Almost FOUR MONTHS have passed since the results when FUM said ………. “Commercial out-licensing discussions at an advanced stage”
Clinical Trial Application Well, according to CRO Poland (and some other eastern European countries), approval for clinical trials is given within 60 days. So FUM, if dosing first patient by end of September will need to get their applications for regulatory approval in pretty soon, within the next two weeks and start recruiting patients well before the end of September… We really are getting to the business end now
Futura Medical General Discussion (no topic needed !) Yes, one by one the competition is getting blown away… Surely helps our cause. N4P were trying to reformulate Viagra to improve the speed of onset as far as I can tell… I nearly invested in IMM but held off because I didn’t like the way the chairman was coming across. He was sounding way tooooooo confident for my liking whereas Mr Barder is always reserved…when he does sound confident, he always adds some caution at the end of the sentence. So I think when he says “punchy numbers” it actually means “absolutely humongous”
Futura Medical General Discussion (no topic needed !) There have been one or two mentions of risk tonight, but Aberdeen has pointed out recently that there is very little risk when the active ingredient is safe, well tested, and widely used GTN. IMO that is why there are so many pharma interested in a MED2002 deal. Now we will use a concentration of GTN no higher than 0.6% in phase III, more de-risking has taken place. There is no credible patented competition, and we have heard of several drugs failing Phase II / III this year. The competing technologies are reducing one-by one.
Futura Medical General Discussion (no topic needed !) I voted 2 months as well, I like to think we can get a deal done before we start the phase 3 trials, if not I’m guessing fum will go alone for the first part of the phase 3 trials to get a better deal for the company. I have faith this will come good one day. At the end of the day it is a big gamble this sector with the examples you’ve given but the risk reward with fum I feel is a lot better than most. Good luck all. And it’s coming home.
Futura Medical General Discussion (no topic needed !) Pharmatom: Makes me wonder… Sometimes makes me wonder also, Pharmatom. When I saw IMM’s update a couple of months ago, I was gobsmacked to see that their chairman was Tim McCarthy. He was head at AZM about 10 years ago when he kept bigging them up but then an out of the blue (but I suppose a retreating SP gave the warning signals) RNS declaring administration lost me a grand. Big wow, not a lot (but it is when it can buy me 300 pints of beer) but it really annoyed me how it all happened.