Oragenics Completes Acquisition of Odyssey Health's Neurological Assets
Oragenics Completes Acquisition of Odyssey Health's Neurological Assets
January 02, 2024
2024年1月2日
Adds Clinical-Stage Product Pipeline, Expands Intranasal Drug Delivery Technologies,
增加了臨床階段的產品管道，擴展了鼻內給藥技術，
Names Michael Redmond as President of Oragenics
任命邁克爾·雷德蒙德爲 Oragenics 總裁
TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company") announces it has completed its previously announced acquisition of assets related to Odyssey Health, Inc.'s (OTCQB: ODYY) ("Odyssey") proprietary neurological drug therapies and technologies.
佛羅里達州坦帕--（美國商業資訊）--Oragenics, Inc.（紐約證券交易所美國股票代碼：OGEN）（“OGENICS” 或 “公司”）宣佈已完成先前宣佈的對奧德賽健康公司相關資產的收購。s（OTCQB：ODYY）（“奧德賽”）專有的神經系統藥物療法和技術。
The acquired assets include ONP-002 and a unique nasal delivery device, Odyssey's lead concussion asset, believed to be a first-in-class intranasal drug under development for the treatment of moderate-to-severe concussion in the acute through subacute phases. In preclinical animal studies, the asset demonstrated rapid and broad biodistribution throughout the brain while simultaneously reducing swelling, inflammation and oxidative stress, along with an excellent safety profile. Results from animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms including improved memory and sensory-motor performance, and reduced anxiety. ONP-002 has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated. Oragenics anticipates preparing for Phase 2 clinical trials to further evaluate ONP-002's safety and efficacy.
收購的資產包括 ONP-002 和一種獨特的鼻腔輸送設備，即奧德賽的主要腦震盪資產，據信這是首款正在開發的用於治療急性至亞急性期中度至重度腦震盪的鼻內藥物。在臨床前動物研究中，該資產在整個大腦中表現出快速而廣泛的生物分佈，同時減少腫脹、炎症和氧化應激，並具有出色的安全性。腦震盪後接受該藥物治療的動物的結果顯示，使用各種測試平台，包括改善記憶力和感官運動表現以及減少焦慮，均顯示出積極的行爲結果。ONP-002 已完成一項針對健康人體受試者的 1 期臨床試驗，顯示其安全且耐受性良好。Oragenics 預計將爲 2 期臨床試驗做準備，以進一步評估 ONP-002 的安全性和有效性。
Also included in the acquired assets are all of Odyssey's rights and interest in ONP-001, believed to be a first-in-class neurosteroid being developed for the treatment of Niemann Pick Type-C Disease (NPC), as well as Odyssey's proprietary powder formulation and its intranasal delivery device. Odyssey will retain its other assets and operations.
收購的資產中還包括奧德賽在 ONP-001 中的所有權利和權益，據信這是爲治療尼曼·皮克C型病（NPC）而開發的首款神經類固醇，以及奧德賽專有的粉末配方及其鼻內輸送設備。奧德賽將保留其其他資產和業務。
"We are delighted to complete this pivotal transaction following a favorable vote of shareholders at both companies. We expect that Odyssey's neurological pipeline will significantly expand our market opportunity and believe its technology complements our expertise in intranasal drug delivery. This acquisition also addresses a significant and growing health concern. There are an estimated 5 million concussions annually in the U.S., with up to half going unreported, underscoring a substantial market opportunity for an efficacious treatment," said Kim Murphy, Chief Executive Officer of Oragenics.
“在兩家公司的股東都投贊成票後，我們很高興完成這項關鍵交易。我們預計，奧德賽的神經系統產品線將顯著擴大我們的市場機會，並相信其技術可以補充我們在鼻內給藥方面的專業知識。此次收購還解決了一個重大且日益增長的健康問題。據估計，美國每年有500萬次腦震盪，其中多達一半未報告，這凸顯了有效治療的巨大市場機會。” Oragenics首席執行官金·墨菲說。
"Our decision to invest in this innovative therapy is driven by our commitment to pioneering solutions that build upon our expertise in intranasal drug delivery and our dedication to improving patient outcomes. These new pipeline candidates hold potential to deliver innovative treatments for millions affected by mTBI and NPC, and introduce Oragenics into a market that is projected to grow to $8.9 billion annually by 2027," added Ms. Murphy.
“我們之所以決定投資這種創新療法，是因爲我們致力於開創性解決方案，這些解決方案建立在我們在鼻內給藥方面的專業知識和我們對改善患者療效的承諾基礎上。這些新的候選藥物有可能爲數百萬受mTBI和NPC影響的患者提供創新療法，並將Oragenics引入一個預計到2027年將增長到每年89億美元的市場，” 墨菲女士補充說。
In conjunction with the transaction, Michael Redmond, who has served as President and CEO of Odyssey since 2018, was named President of Oragenics. Mr. Redmond has 35 years of commercial experience with medical device companies, having held various sales and marketing leadership positions that helped accelerate growth at companies to multiples of their previous revenue and valuation. Mr. Redmond also has significant experience in raising capital and securing licensing and distribution deals with major biotech and pharmaceutical companies. In his new position, Mr. Redmond will oversee the growth of Oragenics' neurology product pipeline and intranasal drug delivery technologies.
在這筆交易的同時，自2018年起擔任奧德賽總裁兼首席執行官的邁克爾·雷德蒙德被任命爲Oragenics總裁。雷德蒙德先生在醫療器械公司擁有35年的商業經驗，曾擔任過各種銷售和營銷領導職位，幫助公司加速增長，達到先前收入和估值的倍數。雷德蒙德先生在籌集資金以及與大型生物技術和製藥公司達成許可和分銷協議方面也擁有豐富的經驗。在新的職位上，雷德蒙德先生將監督Oragenics神經病學產品線和鼻內藥物遞送技術的發展。
Additionally, the Odyssey management and development team that led the ONP-002 clinical trial design and implementation for the treatment of concussion, will continue to oversee research and development of the newly acquired neurology assets at Oragenics. The team has experience in conducting clinical trials, developing drug formulations and commercializing pharmaceutical products across a broad range of indications.
此外，領導腦震盪治療的 ONP-002 臨床試驗設計和實施的奧德賽管理和開發團隊將繼續監督Oragenics新收購的神經病學資產的研發。該團隊在開展臨床試驗、開發藥物配方和將各種適應症的藥品商業化方面擁有豐富的經驗。
"I'm proud to join the executive team at Oragenics and look forward to continuing the development of ONP-002 and ultimately utilizing my experience in commercializing therapeutics. We intend to leverage our joint expertise and resources to expedite the development of this drug, with the goal of filling a critical gap in concussion care as we prepare for a Phase 2 clinical study in the first half of 2024. We believe this transaction also strengthens Oragenics' research and development capabilities, including the integration of key members of Odyssey's research and development team with the Oragenics team," said Mr. Redmond.
“我很自豪能加入 Oragenics 的執行團隊，並期待繼續開發 ONP-002，並最終利用我在療法商業化方面的經驗。我們打算利用我們的共同專業知識和資源來加快這種藥物的開發，目標是在我們爲2024年上半年的2期臨床研究做準備時填補腦震盪護理的關鍵空白。我們認爲，這筆交易還加強了Oragenics的研發能力，包括將奧德賽研發團隊的關鍵成員與Oragenics團隊整合，” 雷德蒙德說。
譯文內容由第三人軟體翻譯。