Oramed Pharmaceuticals Inc.
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Conclusion
While it looks like Novo's formulation may be more effective in terms of lowering glucose levels on a level equivalent, or near so to subcutaneous insulin, Oramed's so far looks effective in maintaining steady blood glucose levels. This may not be enough to treat late stage diabetics, but it may be very helpful to prediabetics and early stage diabetics who may do much better with some of the load taken off the pancreas.
Though speculative, Oramed's product may end up with a less serious long-term side effect profile due to the much larger and less concentrated target area in the small intestine vs. the duodenum alone. Add in the fact that Novo has already discontinued one of its GIPET products, acquired for only $13M, and the answer as to which product will be successful (possibly both) and to what degree, is not as clear cut as respective Phase II results may suggest.
For investors, obviously, Oramed has a much higher potential reward with a market cap of only $100M, with a potential downside on a failed Phase III of 30-50% considering the other possibilities for its absorption technology.
Cash can sometimes be an issue with biotechs of Oramed's size, but Oramed is very well capitalized at this point with over $35M in liquid assets thanks to tworecent milestone payments, and an average quarterly burn rate of about $2M this past year, translating to over 4 years of run room. Novo is the much more conservative choice.
http://seekingalpha.com/article/...ed-second-look-battle-oral-insulin
Oramed hopes to start Phase 3 oral insulin trial next year
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http://biotuesdays.com/2016/08/23/...-3-oral-insulin-trial-next-year/
Ich weiß bald nicht mehr wie man hier handeln soll.
Ich lass meine Shares weiter liegen - Sekt oder Selters
Bin seit paar Jahren investiert...war eigentlich nicht so geplant, aber ich glaube an die Story.
Also wie geht der Spruch...stay long and strong oder so ähnlich ;-)
Alles sehr merkwürdig - wann kommt der Befreiungsschlag?
Wirklich erst mit Phase 3?!
JERUSALEM, October 6, 2016 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, today announced it has received an additional milestone payment of $4 million from Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT). This milestone is part of a previously-announced license and investment agreement between Oramed and HTIT, and follows recent milestone payments of $4 million and $6.5 million.
http://www.oramed.com/investors/sec-filings/
wohl erst im 2. Quartal:
https://clinicaltrials.gov/ct2/show/record/...?term=Oramed&rank=1
Ergebnis der Dosisfindungsstudie erst Anfang nächstes Jahr, damit beginnt die Phase III bestimmt nicht vor dem 1. Halbjahr 2018:
https://clinicaltrials.gov/ct2/show/record/...?term=Oramed&rank=4
Brauchen eben Geduld. Hoffe, dass in diesem Jahr der Partner für Phase III gegunden wird.
http://data.cnbc.com/quotes/ORMP/tab/8
Vor kurzem hatte er noch 2,1 Mil. Aktien. Jetzt nur noch 1 Mil. Habe ich hier eine Verkaufs-Meldung verpasst oder hat die Differenz ein Investor enthalten?
Wenn dies heute passiert ist müsste die Meldung innerhalb von 72 Stunden kommen.
http://www.conferencecalltranscripts.org/NOTICE/summary2/?id=3443142
Das betrifft das Filling vom 11.01.2017.
Anbei eine Erklärung: The notice of effectiveness is a public declaration by the Securities and Exchange Commission that a public company's registration statement has been accepted. For shares in a public company to trade on the open market they must be registered by the company.
3 high-ranking companies on the diabetes market to watch in 2017
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Whereas DexCom is trying to replace the fingerstick test side of the equation, Oramed is trying to replace the injectable administration element of diabetes self-care. The company has developed a drug called ORMD-0801 an oral insulin pill. Oral insulin has long been the holy grail of the diabetes space. However, up until now, the successful development of an oral insulin asset has been a pretty much insurmountable task. The difficulty is rooted in bioavailability. Insulin is a very fragile peptide. When exposed to the gastrointestinal microenvironment (gut, liver, stomach etc.) it very quickly breaks down and in turn becomes ineffective. This is why current standard of care dictates insulin must be injected into the bloodstream subcutaneously. Direct access mitigates the degradatory impact the body has on the peptide, and in turn maximizes its efficacy in reducing blood glucose levels. A number of companies have attempted to package insulin in various forms, but all have been unsuccessful in being able to demonstrate a comparative clinical benefit to the current injectable standard of care when subject to clinical evaluation. That is, all except ORMD-0801.
Oramed has collected swathes of clinical data suggesting its oral insulin candidate is at least as effective as injectable insulin in lowering blood glucose levels, the latest of which came about as a result of a phase IIb study, with top line initially reported in May last year. This study showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change, of 6.47% from run-in, between placebo and active cohorts (p=0.0268). Additionally, the study demonstrated a solid safety profile for the drug, with no drug-related serious adverse events.
The final phase of clinical testing, a phase 3 study, was at the time reported as set to begin during late 2016 or early 2017. With the former bracket now passed, the assumption is that a pivotal trial should begin sometime this quarter. We expect the initiation of a pivotal oral insulin trial (one that will put Oramed at the front of the pack from a global oral insulin development perspective) to generate a large amount of speculative investor attention for the company. By proxy, we expect this attention will serve to underpin an upside revaluation in Orameds market capitalization as the year matures and the trial gets under way.
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http://born2invest.com/articles/...-diabetes-market-to-watch-in-2017/