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Red Light Holland and PharmAla to Collaborate on Medical Psilocybin Development

Red Light Holland and PharmAla to Collaborate on Medical Psilocybin Development

Red Light Holland 和 PharMala 將合作開發醫用迷幻藥
newsfile ·  02/09 21:10
  • PharmAla will consult on GMP Drug Product and Regulatory Development for Red Light Holland
  • PharMala 將就 Red Light Holland 的 GMP 藥物產品和監管發展進行磋商

Toronto, Ontario--(Newsfile Corp. - February 9, 2024) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light Holland" or the "Company"), a company engaged in the production, growth and sale of functional mushrooms and mushroom home grow kits in North America and Europe and a premium brand of psilocybin truffles to the legal, recreational market within the Netherlands, in compliance with all applicable laws, is pleased to announce it has entered into a consulting relationship with PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) ("PharmAla"), to consult on the development of clinical-grade Psilocybin Drug Product extracted from Red Light Holland's naturally occurring psilocybin truffles.

安大略省多倫多--(Newsfile Corp.,2024年2月9日)——紅燈荷蘭公司(CSE:TRIP)(FSE:4YX)(OTCQB:TRUFF)(“Red Light Holland” 或 “公司”),一家在北美和歐洲生產、種植和銷售功能性蘑菇和蘑菇家庭種植套件的公司,以及向合法娛樂市場銷售優質迷幻藥松露品牌的公司荷蘭根據所有適用法律高興地宣佈,它已與PharMala Biotech Holdings Inc.(CSE:MDMA)(OTCQB:MDXF)建立了諮詢關係(”PharMala”),就從紅光荷蘭天然存在的迷幻藥松露中提取的臨床級迷幻藥品的開發提供諮詢。

"We are excited to partner with PharmAla as our GMP consultants and potentially as our exclusive sales agents once those products are fully developed. This partnership is perfectly timed, as our natural psilocybin microdosing capsules (developed from psilocybin truffles grown in our company's farm in The Netherlands), have completed their product specification which are based on the completed stability testing and COA's," said Todd Shapiro, CEO and Director of Red Light Holland. "Our goal with this agreement is to generate all documentation necessary to achieve sales of our Psilocybin products to Clinical Trials, Special Access Program customers and/or other emerging markets. PharmAla will also help Red Light with Regulatory Support and we are confident their knowledge, expertise and leadership, will help increase the efficiency of Red Light Holland in achieving our goal of supplying our psilocybin capsules to those in need, and creating positive change."

“我們很高興能作爲我們的GMP顧問與PharMala合作,並有可能在這些產品全面開發後成爲我們的獨家銷售代理。這種合作的時機恰到好處,因爲我們的天然迷幻藥微劑量膠囊(由我們公司荷蘭農場種植的迷幻藥松露開發而成)已經完成了基於已完成的穩定性測試和COA的產品規格。” Red Light Holland首席執行官兼董事託德·夏皮羅說。“我們在該協議中的目標是生成所有必要的文件,以實現向臨床試驗、特殊准入計劃客戶和/或其他新興市場銷售我們的迷幻藥產品。PharMala還將爲Red Light提供監管支持,我們相信他們的知識、專業知識和領導能力將有助於提高Red Light Holland的效率,實現我們向有需要的人提供迷幻藥膠囊的目標,並創造積極的變化。”

"As we have seen in the past number of months, the market for Psychedelic drug products is rapidly evolving. While we have seen significant preference on the part of clinicians for synthetic drug products such as our LaNeo MDMA, we know that there is also a powerful consumer preference for naturally derived products," said Nick Kadysh, CEO at PharmAla Biotech. "With the increasing number of markets allowing for medical use of Psilocybin, and with the ability to sell Psilocybin to properly licensed entities under the terms of our Controlled Drugs and Substances Dealer's License, we are pleased to act in a consulting basis for Red Light Holland to help them develop their product portfolio."

“正如我們在過去幾個月中看到的那樣,迷幻藥品市場正在迅速發展。PharMala Biotech首席執行官尼克·卡迪什說,儘管我們看到臨床醫生非常偏愛合成藥物產品,例如我們的Laneo MDMA,但我們知道消費者也強烈偏愛天然衍生產品。“隨着越來越多的市場允許將迷幻藥用於醫療用途,以及根據我們的管制藥品和物質經銷商許可證條款向獲得適當許可的實體出售迷幻藥的能力,我們很高興在Red Light Holland的諮詢基礎上採取行動,幫助他們開發產品組合。”

Under the terms of the contract, PharmAla's manufacturing experts have been retained by Red Light to consult and provide their expertise to Red Light in an all-cash consulting contract for one year, with the goal of developing GMP and regulatory documentation of Red Light's Psilocybin capsule products. The agreement also includes the provision that, upon completion of the Drug Product to specification, PharmAla and Red Light may enter into a sales agreement, where PharmAla would sell the products or provide them to its affiliates in global markets as Red Light's exclusive sales agent.

根據合同條款,Red Light聘請了PharMala的製造專家,通過爲期一年的全現金諮詢合同向Red Light提供諮詢和專業知識,目標是開發Red Light的迷幻藥膠囊產品的GMP和監管文件。該協議還包括一項條款,即藥品完成規格後,PharMala和Red Light可以簽訂銷售協議,根據該協議,PharMala將作爲Red Light的獨家銷售代理銷售產品或將其提供給其在全球市場的關聯公司。

About Red Light Holland

荷蘭紅光簡介

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale of functional mushrooms and mushroom home grow kits in North America and Europe, and a premium brand of psilocybin truffles to the legal, recreational market within the Netherlands, in compliance with all applicable laws.

Red Light Holland是一家總部位於安大略省的公司,根據所有適用法律,在北美和歐洲從事功能性蘑菇和蘑菇家庭種植套件的生產、種植和銷售,以及向荷蘭合法娛樂市場銷售psilocybin松露的優質品牌。

For additional information on the Company:

有關公司的更多信息:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlight.co
Website:

託德·夏皮羅
首席執行官兼董事
電話:647-643-TRIP (8747)
電子郵件:todd@redlight.co
網站:

About PharmAla

關於 Pharmala

PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla's research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a "regulatory first" organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

PharMala Biotech Holdings Inc.(CSE:MDMA)(場外交易代碼:MDXXF)是一家生物技術公司,專注於研究、開發和製造包括****在內的MDX類分子。PharMala的創立有兩個重點:緩解全球積壓的仿製藥臨床級****,以便在特定司法管轄區進行臨床試驗和商業銷售,以及開發同類新藥。PharMala是目前唯一一家爲臨床試驗以外的患者治療提供臨床級****的公司。PharMala 的研發部門已經完成了對多個知識產權家族的概念驗證研究,包括其主要候選藥物 ALA-002。PharMala是一個 “監管第一” 組織,成立的原則是,迷幻藥行業的真正成功只能通過與監管機構的良好關係才能實現。

For more information, please contact:

欲了解更多信息,請聯繫:

Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website:

尼古拉斯·卡迪什
首席執行官
PharmaLa 生物科技控股有限公司
電子郵件:press@PharmAla.ca
電話:1-855-444-6362
網站:

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

加拿大證券交易所及其監管服務提供商均未審查本新聞稿的充分性或準確性或承擔責任。

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

關於前瞻性陳述的警示性說明

This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events.

本新聞稿包含適用的加拿大證券立法所指的 “前瞻性信息”。這些陳述與未來的事件或未來的表現有關。使用任何 “可能”、“打算”、“期望”、“相信”、“將”、“預計”、“估計” 以及與非歷史事實的事項相關的類似表達方式和陳述均旨在識別前瞻性信息,並基於公司當前對此類未來事件的結果和時機的看法或假設。

The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company's performance, business objectives and milestones and the anticipated timing thereof, and costs in connection with, the execution or achievement of such objectives and milestones, including its plans to continue seeking legal opportunities to increase responsible access to natural psilocybin around the world and PharmAla's development and distribution of the Company's psilocybin; the Company and the Company's partners, including NUBU Pharmaceuticals and CCrest Laboratories, to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described, including bringing a microdosing product that has the potential of helping many people; complete stability tests; certificate of analysis meeting requirements for medical grade; Government of Canada, Government of Australia to down list psilocybin under its controlled substances list and under the stated timelines; the Company's continued commitment to its products for microdosing that can potentially be accessible in emerging legal markets worldwide; import license; future plans; finalizing report, participating in clinical trails or the special access program; and that the Company will provide updates with respect to its continued work with its partners on the microdosing capsules.

此處包含的前瞻性信息和前瞻性陳述包括但不限於以下方面的陳述:公司的業績、業務目標和里程碑及其預期時間,以及與執行或實現這些目標和里程碑相關的成本,包括其繼續尋求法律機會以增加全球範圍內自然迷幻藥獲取渠道的計劃以及PharMala對公司迷幻藥的開發和分銷;公司和公司的合作伙伴,包括NUBU Pharmicals和CCrest實驗室,將維持其規定的許可證,並獲得公司執行上述計劃所需的所有必要額外許可證和監管部門的批准,包括推出有可能幫助許多人的微劑量產品;完成穩定性測試;符合醫療級要求的分析證書;加拿大政府、澳大利亞政府將迷幻藥列入其管制物質清單和規定的時間表;公司的持續承諾轉到其微劑量產品,這些產品有可能在全球新興合法市場上市; 進口許可證;未來計劃;最終報告;參與臨床試驗或特殊准入計劃; 而且該公司將提供與合作伙伴繼續合作開發微劑量膠囊的最新情況。

Forward-Looking information in this press release are based on certain assumptions and expected future events, namely: the Company's ability to maintain or exceed its current performance, and carry out its business objectives and milestones and under the anticipated timing and costs in connection with, the execution or achievement of such objectives and milestones; the Company and the Company's partners' abilities, including PharmAla, NUBU Pharmaceuticals and CCrest Laboratories, to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described; Complete stability tests; the ability of the Government of Australia and/or New Zealand and/or Canada to down list psilocybin under its controlled substances list and under the stated timelines; the Company's ability to continue developing its products for microdosing that can potentially be accessible in emerging legal markets worldwide; future plans; finalizing report, import license; participating in clinical trails and/or Special Access Program; and the Company's ability to provide updates with respect to its continued work with its partners on the microdosing capsules.

本新聞稿中的前瞻性信息基於某些假設和預期的未來事件,即:公司維持或超過其當前業績、實現其業務目標和里程碑的能力,以及在與執行或實現這些目標和里程碑相關的預期時間和成本下的能力;公司和公司合作伙伴,包括PharMala、NUBU Pharmicals和CCREST Laboratories維持其規定許可證和獲得所有必要額外許可證的能力,以及公司執行上述計劃需要獲得監管部門的批准;完成穩定性測試;澳大利亞和/或新西蘭和/或加拿大政府在其受控物質清單和規定的時間表內向下列入迷幻藥的能力;公司繼續開發其微劑量產品的能力,這些產品有可能在全球新興合法市場上市; 未來計劃;最終確定報告、進口許可證;參與臨床試驗和/或特殊准入計劃; 以及該公司就其與合作伙伴在微劑量膠囊方面的持續合作提供最新情況的能力。

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company's inability to maintain or exceed its current performance, and carry out its business objectives and milestones and under the anticipated timing and costs in connection with, the execution or achievement of such objectives and milestones; the Company and the Company's partners' inabilities, including PharmAla, NUBU Pharmaceuticals and CCrest Laboratories, to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described; the Company's inability to continue developing its products for microdosing that can potentially be accessible in emerging legal markets worldwide; the Company's inability to provide updates with respect to its continued work with its partners on the microdosing capsules;

這些陳述涉及已知和未知的風險、不確定性和其他因素,可能導致實際業績、業績或成就與此類聲明所表達或暗示的結果存在重大差異,包括但不限於:公司無法維持或超過其當前業績,無法實現其業務目標和里程碑,以及在預期的時間和成本下無法執行或實現這些目標和里程碑;公司和公司合作伙伴的無能,包括 PharPhar 馬拉,NUBU Pharmicals和CCrest Laboratories將維持其規定的許可證,並獲得公司執行上述計劃所需的所有必要額外許可證和監管部門的批准;該公司無法繼續開發全球新興合法市場可能獲得的微劑量產品;該公司無法提供與合作伙伴繼續合作開發微劑量膠囊的最新情況;

Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

進一步提醒讀者不要過分依賴前瞻性陳述,因爲無法保證前瞻性陳述所依據的計劃、意圖或預期會實現。儘管管理層在編寫時認爲此類信息是合理的,但可能被證明是不正確的,實際結果可能與預期的結果存在重大差異。

Forward-Looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

本新聞稿中包含的前瞻性陳述受本警示聲明的明確限制,反映了公司截至本文發佈之日的預期,此後可能會發生變化。除非適用法律要求,否則公司沒有義務更新或修改任何前瞻性陳述,無論是由於新信息、估計或觀點、未來事件或結果還是其他原因,也沒有義務解釋後續實際事件與此類前瞻性信息之間的任何重大差異。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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