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PharmaDrug's SecureDose Announces the Advancement of Process Development of Its Biosynthetic Formulation of Pharmaceutical Grade Cocaine

PharmaDrug's SecureDose Announces the Advancement of Process Development of Its Biosynthetic Formulation of Pharmaceutical Grade Cocaine

PharmaDrug 的 SecureDose 宣布推进其药用级可卡因生物合成配方的工艺开发
newsfile ·  04/16 08:44

Victoria's Chiral Labs to lead development of novel cocaine manufacturing process

维多利亚州的Chiral实验室将领导新型可卡因制造工艺的开发

Toronto, Ontario--(Newsfile Corp. - April 16, 2024) - PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances, natural medicines, and previously approved drugs, is pleased to announce that the Company's wholly-owned subsidiary, Securedose Synthetics Inc. ("SecureDose") has engaged Victoria-based Chiral Logistics Corp. ("Chiral Labs")  to advance and refine practical process development for SecureDose's provisionally patented novel Cocaine synthesis method. Processes developed by Chiral Labs for SecureDose will be the wholly owned intellectual property of SecureDose.

安大略省多伦多--(Newsfile Corp.,2024年4月16日)——专注于受控物质、天然药物和先前批准药物研究、开发和商业化的专业制药公司PharmaDrug Inc.(CSE:PHRX)(OTC Pink:LMLF)(“PHarmaDrug” 或 “公司”)欣然宣布,该公司的全资子公司Securedose Synthetics Inc..(“SecureDose”)已聘请总部位于维多利亚州的Chiral Logistics Corp.(“Chiral Labs”)来推进和完善SecureDose临时获得专利的实际工艺开发新的可卡因合成方法。Chiral Labs为SecureDose开发的流程将是SecureDose的全资知识产权。

Chiral Labs is a contract research laboratory specializing in chemical synthesis and process optimization in the pharmaceutical and natural science domains. Chiral Labs's Health Canada issued controlled substances licence allows them to work with a wide range of regulated compounds and a recent amendment to expand the licence to accommodate this research has been submitted for approval to Health Canada.

Chiral Labs是一家合同研究实验室,专门从事制药和自然科学领域的化学合成和工艺优化。Chiral Labs的加拿大卫生部颁发的受控物质许可证允许他们使用各种受管制的化合物,最近一项扩大许可证范围以适应这项研究的修正案已提交加拿大卫生部批准。

Robert Steen, CEO of PharmaDrug commented, "We are extremely excited to begin working with Chiral Labs. The work will focus on both fine tuning the process and producing a test batch to prove out our method and formulation. We will also seek to partner with a licensed contract commercial manufacturer to collaborate on tactical commercial methods with a goal to begin producing a larger commercial batch early next year."

PharmaDrug首席执行官罗伯特·斯蒂恩评论说:“我们非常高兴开始与Chiral Labs合作。这项工作将侧重于微调工艺,并生产一批测试以证明我们的方法和配方。我们还将寻求与一家获得许可的合同商业制造商合作,就战术商业方法进行合作,目标是在明年初开始生产更大的商用批次。”

The agreement was signed by both parties on April 8, 2024 and the terms of the contract agree to a fee rate of CAD 60,000 per month plus applicable taxes. A CAD 50,000 plus applicable taxes deposit was already paid against the first month. The project is anticipated to be completed in seven to nine months.

该协议于2024年4月8日由双方签署,合同条款约定每月6万加元的费用率加上适用的税费。第一个月已经支付了50,000加元外加适用的税款押金。该项目预计将在七到九个月内完成。

The SecureDose Pharmaceutical Cocaine Project

SecureDose 药用可卡因项目

SecureDose initiated work in 2023 on a project to develop a novel manufacturing method for the commercial-scale manufacture of cocaine to support safe supply programs. PharmaDrug has already filed a patent for a novel method of development utilizing biosynthetic chemistry (see press release dated March 13, 2024), which it believes will allow for cost effective and efficient Good Manufacturing Practice ("GMP") manufacturing of pharmaceutical grade cocaine at scale.

SecureDose于2023年启动了一个项目,该项目旨在开发一种用于商业规模制造可卡因的新型制造方法,以支持安全供应计划。PharmaDrug已经申请了一种利用生物合成化学的新型开发方法的专利(见2024年3月13日的新闻稿),它认为这将允许大规模生产药品级可卡因具有成本效益和高效的良好生产规范(“GMP”)。

PharmaDrug's innovative biosynthetic method aims to address these challenges by providing a reliable, clinically manufactured drug product for safe supply programs, potentially transforming the supply chain and offering new revenue or royalty stream opportunities through global partnerships and out-licensing.

PharmaDrug的创新生物合成方法旨在通过为安全供应计划提供可靠的临床制造药品来应对这些挑战,有可能改变供应链,并通过全球合作伙伴关系和外包许可提供新的收入或特许权使用费流机会。

The Company is dedicated to contributing to harm reduction and believes in a multi-dimensional approach to drug abuse, emphasizing the importance of biosynthetic versions of substances for a regulated pharmaceutical supply chain. PharmaDrug does not condone the abuse of drugs and the Company believes that rehabilitation should continue to be the main focus. However, drug abuse is a complex issue and rehabilitation is not always immediate or achievable for all victims in the short to mid-term. A significant portion of street drugs are contaminated with lethal substances like fentanyl and the supply chain cannot be controlled. Harm reduction for abusers should also be addressed. The Company believes that the only viable way to produce safe supply is to develop biosynthetic versions of these substances to be manufactured domestically in a regulated and pharmaceutical supply chain. The process being developed by PharmaDrug could potentially allow for the cost effective and efficient production of cocaine as a pharmaceutical-grade drug in a variety of facilities and at fairly low cost.

该公司致力于为减少危害做出贡献,并相信对药物滥用采取多维方法,强调生物合成版本的物质对受监管的药品供应链的重要性。PharmaDrug不容忍药物滥用,该公司认为康复应继续是主要重点。但是,药物滥用是一个复杂的问题,在短期至中期内,并非所有受害者都能立即康复,也无法实现康复。很大一部分街头毒品受到芬太尼等致命物质污染,供应链无法控制。还应解决减少施暴者伤害的问题。该公司认为,生产安全供应的唯一可行方法是开发这些物质的生物合成版本,在受监管的药品供应链中在国内生产。PharmaDrug正在开发的工艺有可能使可卡因作为医药级药物在各种设施中以相当低的成本生产具有成本效益和高效率。

Options Grant

期权补助

The Company granted 1.2 million options to a consultant on April 12, 2024. The options can be exercised at a strike price of 5 cents per PharmaDrug share for a period of two years from granting.  

该公司于2024年4月12日向一位顾问授予了120万份期权。期权可以在授予后的两年内按每股PharmaDrug股票5美分的行使价。

About PharmaDrug Inc.

关于 PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics and previously approved drugs. PharmaDrug owns 51% of Sairiyo Therapeutics ("Sairiyo"), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. PharmaDrug also owns 100% of SecureDose Synthetics Inc. ("SecureDose"), a pharmaceutical research and development company focused on the development of synthetic formulations of currently existing drugs for potential commercialization and distribution.

PharmaDrug是一家专业制药公司,专注于受控物质和天然药物(例如迷幻药和先前批准的药物)的研究、开发和商业化。PharmaDrug拥有Sairiyo Therapeutics(“Sairiyo”)51%的股份,Sairiyo Therapeutics(“Sairiyo”)是一家专门研究和重建成熟天然药物的生物技术公司,其目标是在美国和欧洲通过临床试验和相关的监管批准程序。Sairiyo目前正在开发头孢黄碱的专利重组配方,该药物已显示出相当大的经第三方验证的治疗传染病和罕见癌症的潜力。Sairiyo还在迷幻药领域进行研发,用于治疗非神经精神疾病。PharmaDrug还拥有SecureDose Synthetics Inc.(“SecureDose”)的100%股份,该公司是一家药物研发公司,专注于开发当前现有药物的合成配方,以进行潜在的商业化和分销。

For further information, please contact:

欲了解更多信息,请联系:

Robert J. Steen, Chairman and CEO
rob@pharmadrug.ca
(416) 400-7086

罗伯特·斯蒂恩,董事长兼首席执行官
rob@pharmadrug.ca
(416) 400-7086

Caution Regarding Forward-Looking Information:

关于前瞻性信息的注意事项:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

加拿大证券交易所尚未审查本新闻稿的充分性或准确性,也不承担任何责任。

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Forward looking statements in this press release relate to the ability to develop a novel manufacturing method for the commercial-scale manufacture of cocaine and the timing thereof, the ability to obtain the patent referenced herein,  and the development of the Company's business. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

本新闻稿可能包含基于当前预期的前瞻性陈述和信息。这些陈述不应被视为对公司未来业绩或业绩的保证。本新闻稿中的前瞻性声明涉及开发用于商业规模制造可卡因的新型制造方法的能力及其时机、获得此处提及的专利的能力以及公司业务的发展。此类陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致实际结果、业绩或成就与此类陈述所暗示的有重大差异。

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals..

前瞻性信息受已知和未知的风险、不确定性和其他因素的影响,这些因素可能导致公司的实际业绩、活动水平、业绩或成就与此类前瞻性信息所表达或暗示的结果存在重大差异。此类风险和其他因素可能包括但不限于:一般业务、经济、竞争、政治和社会的不确定性;一般资本市场状况和证券市场价格;公司未来经营的实际业绩;竞争;影响公司的立法变化;获得和维持所需许可证和批准的能力、以可接受的条件获得外部融资的时间和可用性;缺乏合格的熟练劳动力或关键人物的流失。

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company's disclosure documents on the SEDAR+ website at . Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information 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.

可能导致实际业绩与前瞻性信息存在重大差异的其他风险因素的描述可在SEDAR+网站上公司的披露文件中找到,网址为。尽管公司试图确定可能导致实际业绩与前瞻性信息中包含的结果存在重大差异的重要因素,但可能还有其他因素导致业绩与预期、估计或预期的结果不符。因此,读者不应过分依赖前瞻性信息。提醒读者,上述因素清单并不详尽。进一步提醒读者不要过分依赖前瞻性信息,因为无法保证前瞻性信息所依据的计划、意图或期望会实现。尽管管理层在编制时认为此类信息是合理的,但可能被证明是不正确的,实际结果可能与预期结果存在重大差异。

The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

公司的证券未根据经修订的1933年《美国证券法》(“美国证券法”)或适用的州证券法进行注册,未经注册或未获得此类注册要求的适用豁免,不得向美国个人或 “美国个人”(该术语的定义见《美国证券法案》)或适用的州证券法进行发行或出售,或为其账户或利益。本新闻稿不构成出售要约或征求买入要约,也不得在美国或任何将此类要约、招揽或出售为非法的司法管辖区出售证券。

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

本警示声明明确限制了本新闻稿中包含的前瞻性信息。本新闻稿中包含的前瞻性信息代表了公司截至本新闻稿发布之日的预期,因此,在该日期之后可能会发生变化。但是,除非适用的证券法明确要求,否则公司明确否认任何更新或修改任何前瞻性信息的意图或义务,无论是由于新信息、未来事件还是其他原因。

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