Oramed Pharmaceuticals Inc.
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NEW YORK, NY -- (Marketwired) -- 11/11/14 -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) is the subject of a new in-depth initiation coverage repot by Acceleron Equity Research.
Interested investor may get more information and a copy of the coverage report at: http://acceleronequity.net/ORMP.html
On November 3, 2014 ORMP announced very favorable top-line results from a Phase 2a trial for its oral insulin capsule in ORMD-0801 for Type 1 diabetes, addressing the multi-billion dollar diabetes market.
ORMP's unique Protein Oral Delivery (POD™) technology is a breakthrough in medical science that enables small proteins to travel through the gastrointestinal tract, via the liver, and into the bloodstream to treat a broad number of indications including diabetes.
POD technology addresses a market of roughly $50 billion worth of drugs and vaccines that are currently delivered via injections. This includes diabetes, the first indication pursued by OMRP, a market where $20 billion worth insulin was sold globally in 2013.
The Company's ORMD-0801 oral insulin capsule has the potential to create a new paradigm in the treatment of Type 2 diabetes by treating the disease at an earlier stage, thereby slowing its progression. Having completed a successful FDA Phase 2a trial in Type 2 diabetes, ORMP is now planning its Phase 2b trial for Type 2 diabetes.
ORMD-0901, an oral GLP-1 analog, addressing an annual $2 billion market is expected to enter Phase 1b trials in Israel by the end of 2014. In Q3 of 2013 ORMP submitted a Pre-IND package to the U.S. FDA. ORMP expects to begin a Phase II multi-center study for ORMD-0901 in Q3-2015.
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Media Contact:
Mike Morhamus
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855-216-8786
Source: Oramed Pharmaceuticals
http://acceleronequity.net/ORMP.html
Buy Empfehlung bei Ziel 45USD in 2015...schön wär es ja schon ne :-)
Woher hast du sie? Ich wollte sie kopieren und speichern, funktioniert aber nicht.
Leider nur ein Darstellungsfehler... also keine 100% plus
Leider...
Wie lange kann denn sowas dauern und weiß jemand ob kurz-/mittelfristig damit zu rechen ist?
kann also jederzeit kommen...
Oramed Pharmaceuticals recently announced topline results from a small (n=25) 8 week phase 2a trial, comparing the oral insulin ORMD-0801 dosed 3 times daily versus placebo in subjects with T1DM .
Primary endpoint was change from baseline in exogenous insulin requirements. Results showed an average decrease of 2.1 units in the active group (baseline: 67.8 U/day) vs an average increase of 2.8 units (baseline: 87.3U/day) in the placebo group, most of which was due to changes in bolus insulin requirements. The differences were not statistically significant, and there was a high degree of variability between individual patients.
Comment: The oral insulin dose was not disclosed. However, in a previous phase 2 trial in T2DM subjects, the ORMD-0801 was dosed as capsules containing 8 mg (230U) or 16 mg (460U) of human insulin per capsule , 18 June 2014). With three times daily dosing, these new results indicate a very low and variable bioavailability
Daher verzögert sich auch die Weiterführung bei T1D, die früher in den Berichten noch anvisiert war (für dieses oder das nächste Qu., ich kann mich im Moment nicht genau erinnern), jetzt aber fehlt...
Bei T2D hingegen scheinen die Wirkungen in den Studien bisher deutlich besser zu sein, allerdings gibt es dabei auch Patienten, die gar nicht ansprechen!
December 10, 2014 | By Eric Sagonowsky
Oramed Pharmaceuticals announced last week that the company received $5 million through a stock sale and agreement with Guangxi Wuzhou Pharmaceutical, which purchased 696,378 restricted shares of Oramed stock at $7.18 per share.
Oramed will use the funds on its U.S.-focused clinical development programs for its oral insulin for Type 1 and Type 2 diabetes indications, it said, as well as on preclinical and clinical studies of its GLP-1 analog project and for other general purposes.
Established in 2006, Oramed is a technology pioneer in oral delivery for drugs currently delivered via injection. The investment gives Oramed a cash position north of $20 million, which will allow the company to carry development activities over at least two years, COO Josh Hexter wrote in an email to FierceDrugDelivery.
Guangxi Wuzhou Pharmaceutical Group is a wholly owned subsidiary of the Guangxi Wuzhou Zongheng Group, a Chinese investment holdings company traded on the Shanghai Stock Exchange. The parent company focuses on pharmaceuticals, health and food products, while Guangxi Wuzhou Pharmaceutical Group is the largest pharmaceutical company in Guangxi, and among the 20 largest pharmaceutical companies in China.
"China is a huge opportunity for any diabetes therapy and especially an oral insulin," Hexter wrote. The COO added that the diabetes market there is approximately $3 billion annually and expected to grow at between 15% and 20% per year. "It's also a market which requires local 'know how' to enter successfully. Our interactions with Wuzhou as a shareholder to date have been fruitful and they are open to acting as a partner in helping with entry into this market. Discussion are still at an early stage."
"We are pleased to have Wuzhou as a new shareholder," noted Nadav Kidron, chief executive officer of Oramed, in a statement. "China offers a substantial market opportunity for our diabetes focused pipeline and we are delighted to have Wuzhou as a supportive shareholder, as they can help strategically guide our development and commercial entrance into China."
December 10, 2014
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, today announced that it has received$5 million in connection with the definitive agreement with Guangxi Wuzhou Pharmaceutical Co., Ltd., a subsidiary of Guangxi Wuzhou Zhongheng Group Company Ltd (SHA:600252) previously reported on November 3, 2014, for the purchase of 696,378 restricted shares of common stock for $7.18 per share, the closing price of Oramed's common stock on Friday, October 31, 2014, in a private placement.
Guangxi Wuzhou Zhongheng Group Company Ltd is an investment holding company publicly traded on the Shanghai Stock Exchange.
"We are pleased to have Wuzhou as a new shareholder," noted Nadav Kidron, Chief Executive Officer of Oramed. "China offers a substantial market opportunity for our diabetes focused pipeline and we are delighted to have Wuzhou as a supportive shareholder, as they can help strategically guide our development and commercial entrance into China," commented CEO Nadav Kidron.
Oramed intends to use the net proceeds from this offering for expenses primarily related to the Company's anticipated U.S. focused clinical development programs for its oral insulin for type 1 and type 2 diabetes indications, for preclinical and clinical studies of its oral GLP-1 analog project, and for general corporate purposes, including general working capital purposes.
This press release is neither an offer to sell nor a solicitation of an offer to buy any of the Company's securities. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
Das ist der Grund für meinen Ausstieg.
Vielleicht liege ich mit der Einschätzung aber auch voll daneben....tja, wenn ich das sicher wüsste ;-)