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Post by mnholdem on Sept 5, 2017 10:47:44 GMT -5
Oramed Announces Successful Meeting with FDA for Oral Insulin
PR Newswire
Sep. 5, 2017, 06:00 AM
JERUSALEM, Sept. 5, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has successfully concluded its meeting with the U.S. Food and Drug Administration (FDA) regarding ORMD-0801, the Company's novel oral insulin formulation.
At the meeting, the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801, would be a Biologics License Application (BLA). Such a pathway would grant a full 12 years of marketing exclusivity for ORMD-0801 if approved. On top of this, an additional six months of exclusivity can be granted if the product also receives approval for use in pediatric patients.
The FDA confirmed that the approach to nonclinical toxicology, CMC and qualification of excipients would be driven by their published guidance documents, consistent with the Company's expectations. They also made specific recommendations for clinical trials designed to provide pivotal data prior to registration. Since oral insulin may have a positive more physiologic first-pass effect on the liver with less systemic insulin exposure compared to traditional injectable insulin, at the suggestion of the FDA, Oramed also plans to initiate a three-month trial in patients with type 2 diabetes to evaluate the effect of ORMD-0801 on HbA1c, the main FDA registrational endpoint, later this year. In addition, the FDA confirmed the Company's ability to use insulin from different suppliers like HTBT (Hefei Tianmai Biotechnology Development Co., Ltd., Hefei, China) in the Phase 3 study.
Source: markets.businessinsider.com/news/stocks/Oramed-Announces-Successful-Meeting-with-FDA-for-Oral-Insulin-1002307937
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Post by peppy on Sept 5, 2017 11:07:24 GMT -5
Oramed Announces Successful Meeting with FDA for Oral Insulin
PR Newswire
Sep. 5, 2017, 06:00 AM
JERUSALEM, Sept. 5, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has successfully concluded its meeting with the U.S. Food and Drug Administration (FDA) regarding ORMD-0801, the Company's novel oral insulin formulation.
At the meeting, the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801, would be a Biologics License Application (BLA). Such a pathway would grant a full 12 years of marketing exclusivity for ORMD-0801 if approved. On top of this, an additional six months of exclusivity can be granted if the product also receives approval for use in pediatric patients.
The FDA confirmed that the approach to nonclinical toxicology, CMC and qualification of excipients would be driven by their published guidance documents, consistent with the Company's expectations. They also made specific recommendations for clinical trials designed to provide pivotal data prior to registration. Since oral insulin may have a positive more physiologic first-pass effect on the liver with less systemic insulin exposure compared to traditional injectable insulin, at the suggestion of the FDA, Oramed also plans to initiate a three-month trial in patients with type 2 diabetes to evaluate the effect of ORMD-0801 on HbA1c, the main FDA registrational endpoint, later this year. In addition, the FDA confirmed the Company's ability to use insulin from different suppliers like HTBT (Hefei Tianmai Biotechnology Development Co., Ltd., Hefei, China) in the Phase 3 study.
Source: markets.businessinsider.com/news/stocks/Oramed-Announces-Successful-Meeting-with-FDA-for-Oral-Insulin-1002307937
key words: and qualification of excipients www.oramed.com/wp-content/uploads/2017/06/OramedCorpPres-June-2017.pdf
The active protein is encapsulated in a capsule that features a highly protective coating that remains intact in the most acidic segments of the gut, as well as enzymatic support provided by specialized protease inhibitors.
Drug availability is further secured by an absorption enhancer supplement that facilitates protein passing across the intestinal barrier.
By preventing protein-drug breakdown in the gastrointestinal tract and promoting its crossing the small intestine, this breakthrough solution brings oral protein-drug delivery significantly closer to a reality. www.oramed.com/technology/
They are starting the FDA process? and trials?
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Post by joeypotsandpans on Sept 5, 2017 11:22:56 GMT -5
Oramed, thanks for the chuckle this AM....what a farce that one is, on a different note, nice to see relative strength (MNKD) vs. a broad market selloff, I plead that if buying to do so without using margin. The margin calls helped the short selling back in those down draft days, I would imagine most longs now have their shares banked w/o worry of margin or they hold options. LOL Oramed....good one MN!!!  |
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Post by liane on Sept 5, 2017 11:26:26 GMT -5
I'm with you joey: Oramed = Joke!
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Post by dreamboatcruise on Sept 5, 2017 13:55:23 GMT -5
Just curious, why specifically do people here consider it a joke? Are they misrepresenting the technology in some way? Is it unlikely to get approved for some reason?
And before we get the usual... yes, Afrezza is great. Let's just accept that all of us that hold shares believe that. Wanting to discuss Oradmed specifically in this thread.
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Post by peppy on Sept 5, 2017 14:45:47 GMT -5
Just curious, why specifically do people here consider it a joke? Are they misrepresenting the technology in some way? Is it unlikely to get approved for some reason? And before we get the usual... yes, Afrezza is great. Let's just accept that all of us that hold shares believe that. Wanting to discuss Oradmed specifically in this thread. I do not know a thing about oramed. I did not see that any clinical trials have been done.
It's a Long Way To Tipperary / Pack Up Your Troubles In Your Old Kit Bag - Robert Mandell
www.youtube.com/watch?v=FsynSgeo_Uo
(I do a walloping version of "Pack up your troubles in your old kit bag." Mannkind taught it to me.)
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Post by liane on Sept 5, 2017 16:05:04 GMT -5
Just curious, why specifically do people here consider it a joke? Are they misrepresenting the technology in some way? Is it unlikely to get approved for some reason? And before we get the usual... yes, Afrezza is great. Let's just accept that all of us that hold shares believe that. Wanting to discuss Oradmed specifically in this thread. So in order for insulin to be an effective exogenous drug, it needs to be absorbed in a precise quantity and stay in the bloodstream for a proper time. If you want to consider the oral route, it must survive denaturing by gastric acids and enzymatic proteolysis (cleaving large proteins into free amino acids, dipeptides and tripeptides) in the stomach and intestine. It very well may be that ORMP has developed a coating that protects the insulin payload and delivers it to the intestine initially intact. Now comes the tricky part. The intestine has virtually zero absorption of peptides longer than 4 amino acids. Insulin is 51 amino acids in length. So you have a big honking protein (insulin) delivered to the intestine, to an environment which is still enzymatically cleaving proteins, and to an environment that is incapable of absorbing it. My understanding is that Oramed is delivering massive quantities of insulin via the oral route. It's possible they are getting a very slight absorption, but the amounts and the timeframe are going to be highly variable. Not what you need for a drug such as insulin. |
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Post by mnholdem on Sept 5, 2017 16:17:24 GMT -5
I'm inclined to go with liane's opinion. Oramed does make a decent presentation of how their capsule survives through the gastric and protease attacks, but they don't really address the long-chain protein issue that liane addresses. Patients will want a pill, but any problems will be revealed in the FDA testing, which I suspect won't go well for their oral insulin.  |
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Post by dreamboatcruise on Sept 5, 2017 17:22:22 GMT -5
That does seem a stretch if the normal absorption is no more than a 4 amino acid peptide. Are there any other companies with approved or in trial API that are large proteins using oral route?
It does make sense that the first phase spike would be more effective if it did come from intestines directly to liver through portal circulation as happens with endogenous first phase insulin... but perhaps they are just blowing smoke that they've figured out how to get the insulin into the bloodstream from the intestines. If they do have a mechanism I wonder if it only works for the insulin it is delivered with or would you also start having other large molecules not normally absorbed then passing through to blood as well... and what would be the consequences of that?
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Post by peppy on Sept 5, 2017 17:45:43 GMT -5
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Post by liane on Sept 5, 2017 18:11:18 GMT -5
Just doing a quick search of ORMP's trials, they were administering doses of 8, 16 and 24 mg of insulin. This is equivalent to 230, 460, and 690 units of insulin. The response is less than spectacular: oramed.pdf (218 KB) |
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Post by peppy on Sept 5, 2017 19:14:06 GMT -5
Just doing a quick search of ORMP's trials, they were administering doses of 8, 16 and 24mg of insulin. This is equivalent to 230, 460, and 690 units of insulin. The response is less than spectacular: quote: This is equivalent to 230, 460, and 690 units of insulin
Thanks Liane, (a trial) I knew it would be more units, wow, those are units. How would oramed oral insulin be priced?
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Post by mango on Sept 5, 2017 19:15:26 GMT -5
Afrezza restores glucose homeostasis.
It appears oramed's insulin pill does not.
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Deleted
Deleted Member
Posts: 0
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Post by Deleted on Sept 5, 2017 20:53:15 GMT -5
This reminds me of the biotechnology company making news shortly after Afrezza approval that it was trying to use implantable metal cylinders filled with insulin. I cannot recall the name but can still recall the image from the WSJ. What was the name and what became of it?
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Post by mnkdfann on Sept 5, 2017 21:18:09 GMT -5
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