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Oramed Pharmaceuticals (ORMP) Stock Surges on $50 Million Chinese Licensing Deal
azz che newzzzzzzzzzzzzzzzzzz
Oramed Signs up to $50 Million Licensing and Investment Agreements for Oral Insulin Capsule in China - Oramed Pharmaceuticals
questa biotec
è stata trovata dal sottoscritto
nel mondo sommerso dell'otc
anni anni anni anni fa$$$$$$$$$$$$$$$$$$$$$$
azz che newzzzzzzzzzzzzzzzzzz
Oramed Signs up to $50 Million Licensing and Investment Agreements for Oral Insulin Capsule in China - Oramed Pharmaceuticals
questa biotec
è stata trovata dal sottoscritto
nel mondo sommerso dell'otc
anni anni anni anni fa$$$$$$$$$$$$$$$$$$$$$$
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Oramed Pharmaceuticals (ORMP) Stock Surges on $50 Million Chinese Licensing Deal
azz che newzzzzzzzzzzzzzzzzzz
Oramed Signs up to $50 Million Licensing and Investment Agreements for Oral Insulin Capsule in China - Oramed Pharmaceuticals
questa biotec
è stata trovata dal sottoscritto
nel mondo sommerso dell'otc
anni anni anni anni fa$$$$$$$$$$$$$$$$$$$$$$
ti prenderò con BIEI!!!
axelvento
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Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (Oral Drug Delivery: A Better Life For Diabetics - Oramed Pharmaceuticals), 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.
http://photos.prnewswire.com/prnvar/20161109/437571LOGO
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.
"We are very pleased with the outcome and constructive advice received from the FDA during our meeting. We plan on implementing the FDA's feedback in the coming months which should facilitate the confirmatory Phase 3 study and registration of ORMD-0801." said Nadav Kidron, CEO of Oramed. "Additionally, the FDA's classification of ORMD-0801 as a BLA pathway and its significant commercial implications certainly is an additional exciting outcome for us."
http://photos.prnewswire.com/prnvar/20161109/437571LOGO
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.
"We are very pleased with the outcome and constructive advice received from the FDA during our meeting. We plan on implementing the FDA's feedback in the coming months which should facilitate the confirmatory Phase 3 study and registration of ORMD-0801." said Nadav Kidron, CEO of Oramed. "Additionally, the FDA's classification of ORMD-0801 as a BLA pathway and its significant commercial implications certainly is an additional exciting outcome for us."