Oramed Pharma conference call notes: Phase 2b success of ORMD-0801 in T2D; shares down 5%

May 18 2016, 11:32 ET | About: Oramed Pharmaceuticals... (ORMP) | By: Douglas W. House, SA News Editor

Key points from this morning's call hosted by Oramed Pharmaceuticals (ORMP -7.5%) regarding its announcement of successful results in a Phase 2b clinical trial assessing lead product candidate ORMD-0801, its oral insulin capsule, in type 2 diabetics:

ORMD-0801 will advance to Phase 3. Strategic partners sought.

Pooled data combined 16 mg and 24 mg dose cohorts. Awaiting results from various additional glucose measures, including continuous monitoring. Will be shared as soon as feasible. Primary endpoint is what's important. Secondary endpoints only exploratory? Hemoglobin A1c levels: need three-month data, only have one-month at present. No specific timelines given. Meeting with FDA will be scheduled as soon as possible.

Results from individual doses may be shared at a later time, but study was based on pooled data so not a priority at this point.

Co. believes oral insulin may enable treatment earlier in T2D.

One case of hypoglycemia in placebo group, one in the pooled group.

Current cash position: ~$36M. $10M - 15M in new capital expected in near term. More $ needed for Phase 3.

Investors are getting less enthused about the data. Shares have reversed and are now down 5%.

http://seekingalpha.com/news/...s-ormdminus-0801-t2d-shares-5-percent

Ob der Autor objektiv oder subjektiv bewertet, weiß ich nicht.

 

es.......  

http://finance.yahoo.com/news/...nnounces-positive-top-190000580.html

"We raise our valuation to $30 per share from previous $25.00 per share based on the positive top line results from the Phase IIb study. "

gn8  

Mal  die nächsten Tage abwarten.
Aber die Achterbahnfahrt scheint weiterzugehen.  

So bertichten die Israelis (Business daily "Globes")

....

Oral insulin is not a replacement for injections but is meant to treat Type 2 diabetics before they become “insultin-dependent”.

...

“The current trial compared the product to a placebo, and it showed a significant reduction in sugar levels in the blood at night, without side effects or hypoglycemia.”

http://www.globes.co.il/en/...phase-iib-oral-insulin-trial-1001125569

Michael Berelowitz, head of Oramed’s scientific advisory board, added: “These are very impressive results that confirm the efficacy of orally delivered, intestinally absorbed insulin. The promise of this more physiological delivery system for insulin is the inhibition of hepatic glucose production, which was clearly demonstrated via the significant reduction in night-time glucose levels in patients who received ORMD-0801.”

http://www.thepharmaletter.com/article/...hase-iib-oral-insulin-study

Einige Aktionäre sehen einen Zusammenhang mit dem niedrigen Kurs und den Optionsverfallstag am morgigen Freitag (Hexensabbat).

 

 

 

http://secfilings.nasdaq.com/...20INC.&FormType=8-K&View=html

 

http://www.oramed.com/investors/corporate-presentation/

gn8  

can lower diabetics' blood sugar levels

Researchers have announced that an insulin pill has successfully reduced night-time blood glucose levels in 180 patients with type 2 diabetes.

That's pretty exciting, because before this, it was assumed that insulin wouldn't survive the digestive juices of the stomach, so couldn't be delivered orally - hence the dependence on insulin injections. But this new mid-stage trial suggests for the first time that given the right dose, insulin tablets could really work.

Most importantly, if these findings are verified and repeated in additional trials, it would mean that the insulin tablets could delay or potentially even replace injections for patients with type 2 diabetes.

The research hasn't been published as yet, so we need to take these claims with a grain of salt for now. But the drugmakers behind the new treatment - a small Israeli company called Oramed Pharmaceuticals Inc - say they're now submitting their results for peer review.

...

http://www.sciencealert.com/...ll-can-lower-blood-sugar-for-diabetics

 

http://www.focus.de/gesundheit/videos/...gen-diabetes_id_5560536.html  

3000stk zu 8,57$ gekauft.
http://phx.corporate-ir.net/...SU9OX0lOU0lERVImZXhwPSZzdWJzaWQ9NTc%3d  

Daten ganz gut aus, mehr Details werden noch kommen.
Ich bin gespannt, wie es hier weitergeht...der Markt ist riesig für eine Insulinpille...  

aktuell erst mal wieder Bäumchen schüttel dich  

ja, is nicht zu glauben tztzzz.....  

Wann können wir mit den detaillierten Daten aus 2b rechnen?
Könnte doch nächste Woche kommen oder brauchen die noch mehr Zeit zum aufbereiten?  

Oramed to Present at the American Diabetes Association 76th Scientific Sessions

Jerusalem, June 9, 2016 -

... (automatisch gekürzt) ...

http://us9.campaign-archive1.com/...0e6e1ea6e5a5227&id=29bd083993

 

Also grundsätzlich wusste ich gar nicht das Tiere auch an Diabetes Typ 1 und 2 erkranken können.
Hierzu aber hier mal ein kurzer Artikel:

http://www.diabetes-ratgeber.net/Tiere

Das eröffnet ja wieder einen ganz neuen Markt...wenn wir jetzt noch die Tiere dazuzählen :laugh:  

http://secfilings.nasdaq.com/...20INC.&FormType=8-K&View=html

On June 13, 2016 (the "Effective Date"), Oramed Ltd. (the "Subsidiary"), a wholly-owned subsidiary of Oramed Pharmaceuticals Inc. (the "Company"), entered into a Service Agreement with XERTECS GmbH ("XERTECS"). This agreement is part of the requirements according to the Amended and Restated Technology License Agreement between the Subsidiary, the Company and Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”), dated December 21, 2015, as previously disclosed in the Company’s Current Report on Form 8-K, filed on December 28, 2015. According to the Service Agreement, XERTECS will provide services to HTIT on behalf of the Subsidiary, to ensure that part of the required support and services are provided to HTIT to enable HTIT to manufacture the product known as ORMD-0801 in the People’s Republic of China, Macau and Hong Kong at HTIT's facilities. The term of the Service Agreement is four years following the Effective Date.

As consideration for its services, the Subsidiary will pay XERTECS a total amount of up to €2,360,000, €800,000 of which is a non-refundable fee to be paid within 12 months from the Effective Date, and the remaining fee will be paid over the term of the engagement and based on the achievement of certain milestones.

 

http://www.xertecs.com/de/tabletten_coater.php

Die Nachricht ist vielversprechend. Also startet nun der Aufbau der Pillenproduktion in China. Somit ist Hefei Tianhui Incubator of Technologies (HTIT) mit den Ergebnissen der Phase 2b zufrieden. Somit erhalten die Basher auf Yahoo Message Board wohl doch nicht recht, dass HTIT nicht mehr an einer Zusammenarbeit mit Ora interessiert ist und die nächste Meilensteinzahlungen verweigern wird.

 

Kratzt es leider so rein gar nicht :-(
Krass  

Kurs soll unten gehalten werden, um Interesse bei anderen Unternehmen zu wecken. Hmm???

http://seekingalpha.com/article/...ogy-company-great-upside-potential

... this situation Oramed could have a good strategic advantage to be considered for an acquisition by pharma companies that have a major stack in the diabetes market and that are interested to address the quality of patients' life. This segment could probably interest companies as Sanofi and Novo Nordisk that are competing for a major stack in the diabetes sector.

... I am more confident about the acquisition theory. They want to maintain a low market capitalisation in order to generate interest.

 

Volumen aktuell im Keller - daher kaum Manipulation möglich.
Solange keine weiteren detaillierten Ergebnisse veröffentlicht werden, sehe ich kein großen Spielraum für den Kurs.
Alternativ clumby Studie kommen noch Ergebnisse und FDA Zulassung für Phase 3.

Was dem Kurs die nächsten Wochen helfen könnte - keine Ahnung:-(

Buyout evtl. während Phase 3
Bin gespannt wann die Chinesen anfangen zu produzieren.  

http://phx.corporate-ir.net/...RFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3  

Oramed Appoints Dr. Roy Eldor as Chief Medical Director

http://www.nasdaq.com/press-release/...edical-director-20160726-00728