The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Some of the most robust evidence (suggesting no evidence of a link between ranitidine with cancer) was published in Sept 2023 in the The Journal of the American Medical Association (JAMA). Link below -
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10509724/
I have no idea how the ambulance chasers are going to dismiss this large multinational credible study, especially as its validity is supported by the publication in a leading peer reviewed American journal.
Another unjustified drop in SP yesterday, for a hearing in Delaware we’ve known about for some time? GSKs defence seems pretty strong.. Yes, there is a theoretical risk that NDMA in ranitidine could increase the risk of cancer, hence its removal from market, but as GSK are saying (quite correctly) there is now an increasing body of robust evidence, in large real world observational studies, (since the litigation was initially raised) which show no increase in cancer rates over the PPIs, or famotidine.. (one of many papers below)
https://pubmed.ncbi.nlm.nih.gov/34251045/
I’m still at a loss to understand why such a sustained hit on the SP. You can’t win a case purely on theoretical risk, especially if the subsequent robust clinical studies have disproven the theory…IMHO of course…
Feels like everyone thinks the drop in SP is overdone , but guess we'll have to wait for the judges now to agree
Pattern of up uptake in the UK - may be of some interest March showing strength..
https://openprescribing.net/chemical/0901011Y0/
Was there a reason the company didn't (or couldn't) apply to the Takeover panel for a Waiver? With other shares I've owned, where a shareholder increased their holdings above 30%, they didn't have to go through the whole process of making a mandatory offer, it was waived by the panel?
Thank you BigBiteNow for a very comprehensive response..
PG
Thanks KC - I should have pasted the full bullet (pasted below). I wondered whether it was a typo (e.g. should have been 48%) - as 38% is about what you'd expect for the quarter, so wasn't too sure if I missed their point..
Strong growth in U.S. Accrufer® prescriptions led by increases in March 2023: Prescriptions for the first quarter of 2023 continued to increase and amounted to over 10,500 with a significant acceleration in March, contributing 38% of total quarterly volume, showing the initial impact of the additional sales force by both companies.
Wasn't sure what they meant by "March, contributing 38% of total quarterly volume" as March makes up 34% of the days in Q1 anyway (Feb being only 28 days)... May have missed their point though, or it was a typo and they meant something like 48%?
At £2.4m market cap you'd think someone would take this company over ? Maybe Janssen could add this to their Christmas shopping list (well here's hoping).. they still have an invested interest.
On the positive side he has now secured 5m options at an exercise price of only 7.2p. One could argue it was in his interests (before such a grant) for the SP to crash to this level, in order to pick up options at such a low strike price. At least now it's in his best interests for the SP to actually rise...
It can't be in Janssen's interest to see MTPH run out of cash, given their ongoing collaboration/research programs + I don't think they would have agreed to carry on with MTPH if they thought MTPH wouldn't be around to finish the development work... Hoping if push comes to shove Janssen will step in, as again would not be in their interest for another large pharma to take over MTPH and control of all operations... Of course this all depends on how much value Janssen are actually putting on their ongoing Q-sphera developments... fingers crossed quite a bit, if MTPH deliver..
Hi NicetoMichu - accessing the RNS via this site I also have a blank in Box 7..
Good to see a new appointment this week, hopefully strengthening their BD activities.
On Monday, we welcomed Steve Ellul who joins Midatech Pharma PLC as VP of Business Development, responsible for all commercial activities for the company.
A chemist by training, Steve has spent more than 30 years in commercially focused roles across multiple sectors of the pharmaceutical industry.
Steve has led commercial teams at drug delivery organisations, including Eurand and Bespak, and has held senior roles at speciality pharma companies, Elan, Shire and Theravance Biopharma.
We are excited to have you on the team, Steve, and look forward to the successes the future will bring!
The RNS below is <5% in box 7, so unfortunately they may not be 0 yet? Thanks for sharing your guesses, and make sense to me at least (although I'm no expert in these things)
https://www.londonstockexchange.com/news-article/MTPH/holding-s-in-company/15322376
Agree ALGU - Certainly with EMA and FDA submissions the company will receive questions, from the regulatory authority, during the review process. I've never dealt with the Minzdrav but I'd be very surprised if there has been no communication since submitting a year a go.
The sentence they used in the RNS is interesting -- "While Ovoca cannot be definitive about timelines, management remains optimistic with regard to approval perspectives for Orenetide in Russia and is hopeful that the review process will be completed shortly. A further announcement in relation to the approval process will be released by the Company as and when appropriate". ...
I don't know how much we can read into "remain optimistic" but I see they have used "cautiously optimistic" in the past about the company's prospects.. . They also start the sentence with "While Ovoca cannot be definitive about timelines" - which is fair enough, but does that suggest more confidence "with regard to approval perspectives" ? I guess with the choice of words we can only assume that any correspondence to-date has not suggested a negative opinion at least?
That all said for those of us old enough to remember the game show 321, and trying to read into the clues, - I could never work out which ones related to the car, and which were dusty bin, so my interpretation may be way off.
Just wondering how between them they buy/hold over 8m shares but the SP doesn't move, and where do they get them from? I'm not so familiar with all the behind the scenes dealing, but half expected to see an RNS showing one of the institutions had sold? Like I say it's not really my area of expertise (my background is in pharma)
Wouldn’t expect figures in this RNS, as this is a joint venture, which should pay a reasonable chunk of MTPHs Q-Sphera expenditure going forward this year + a 300%-400% multiple (see 24mins in https://www.youtube.com/watch?v=-Sfno8oYQYc). Hopefully a licensing deal at the start or end of the Phase I study, then we should see some figures (upfront, milestones, royalties).
Should help extend the cash runway, and remove some uncertainty. Although being paid to develop products for the Janssen API's, most of the Q-Sphera development work they do, under the Janssen contract, will provide know how for developing other potential big pharma clients APIs. Wrote a post below about the options for the Big Pharma partner.. Announced today looks like Option 1 and hopefully therefore only a matter of time, all going well, before we move to option 2 (full licensing deal) or even 3 (buy-out - if allowable).. Janssen will know they are funding work that's increasing know how for Q-Sphera, and therefore potentially also helping competitors, if no excusive deal is done..
Is the question in relation to life cycle management of off patent drugs/MAbs e.g. adalimumab? If so once you significantly change the delivery of drug, or dose, and thus it's PK profile, you can no longer go down the biosimilar regulatory filling route, and would need to embark on a separate development program to gain approval. A biosimilar would also typically need a P3 for approval but will get all the indications granted for the original MAb on the back of a single P3. I'm positive about the technology, but believe its place is at the early stage of development (for reasons below)
Goes without saying last post was all IMHO of course - looks like I ran out of characters, so the end was removed!..
Bought in more last week (maybe a little early) but still attracted by their Q-sphera technology. Not for the reasons the company give, regarding life cycle management of off patent drugs/monoclonal antibodies (MAbs ), which is unlikely to happen. That would need new and costly clinical studies, making it hard to compete with generics/biosimilars on price, but I see huge value of Q-sphera for a big pharma company with a drug/MAb at an early stage of drug development for a couple of reasons 1) A novel delivery system makes it very difficult to copy a drug, once the active is off patent. With any MAb the patent will eventually expire, and the biosimilars take over, but if the marketed product used Q-sphera it would make it very difficult for a biosimilar to come to market, or if it did, hard for the biosimilar to argue it’s exactly the same to prescribers 2) The company has developed a MAb/drug that’s not commercially viable due to a high frequency of dosing/injections, so needs delayed release technology. Either way you’d need to incorporate the Q-sphera at the start of the clinical development program, not the end.
We know there’s a Big pharma on the side line. Assuming they've completed the animal work they have several options moving forward (as I see it).
1) Sign a service agreement with Midatech to scale up MTX 214/216 to commercial size batches. MTPH would effectively operate then as a CDMO (paid/contracted for service) to develop and manufacture these specific products. The Big Pharma company will need a near to final product before starting the clinical program (no point going into clinical phases with a product that’s going to change). Thus they will need large (ideally full scale/commercial) batches produced to GMP, although will only use a fraction for the clinical studies. If they are looking at a subcut injection then they may also want to make sure the pre filled syringes consistently deliver full drug doses (i.e. don’t clog). This will also need a fair bit of testing with potentially several thousand syringes. Needless to say they will expect MTPH to deliver all this in a timely manner
2) Go straight in with a licensing deal now (upfront, milestone, royalty) to license the Q-sphera technology for MTX 214/216 (or maybe even license the technology outright).
3) If not keen to have a future blockbuster reliant on Option 2, then buy out MTPH (assuming it’s an option). The market cap is pocket change to a Big Pharma, cash burn is relatively small, and the Big Pharma Co can take control/ownership of the program (even if only interested in the Q-sphera, and nothing else).
A few options on the table so not surprised by a delay in hearing the outcome. Do they go for option 1 first then consider 2 or 3, do they just go for 2 or 3 to prevent anyone else taking control etc. May take a bit of time but hopefully Q1 2022 will bring news on the mysterious partner – Stephen Stamp did mention in October, news was coming. .. Let's hope s
May be of interest - poster presentation this week
P1102 COSTS SAVINGS ASSOCIATED WITH FERRIC MALTOL AND THE REDUCED USE OF INTRAVENOUS IRON BASED ON REAL WORLD DATA
https://programme.ueg.eu/week2021/#/details/presentations/760