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Innocan Pharma Submits Investigational New Animal Drug Application to FDA's Veterinary Center

Innocan Pharma Submits Investigational New Animal Drug Application to FDA's Veterinary Center

Innocan Pharma向FDA兽医中心提交了新的动物药物申请
PR Newswire ·  07/26 16:00

HERZLIYA, Israel and CALGARY, AB, July 26, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that the FDA's Center for Veterinary Medicine (CVM) has granted the Company a sponsor fee waiver and assigned an Investigational New Animal Drug (INAD) number for its LPT-CBD (Liposome Platform Technology-Cannabidiol) product. This represents a significant step for the Company, as an INAD designation facilitates correspondence and data exchange with CVM to support LPT-CBD development as a new veterinary drug.

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The Company further announced that following the assessment of LPT-CBD's scientific package, the CVM recognized Innocan's contribution to pursuing innovative animal drug products and technology and granted the company a sponsor fee waiver for fiscal year 2024.

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Innocan's LPT-CBD is a proprietary drug delivery platform designed to provide prolonged-release CBD for chronic pain and well-being management in animals. Over the past year, repeated administration of LPT-CBD in dogs and other animals has demonstrated both efficacy and tolerability, providing sufficient evidence for the INAD application.

Innocan Pharma公司(CSE: INNO)(FSE: IP4)(OTCQB: INNPF)是药品和生物技术行业的先锋,总部位于以色列赫兹利亚和加拿大卡尔加里地区。该公司很高兴地宣布,FDA的兽药中心(CVM)免除了公司的赞助费并为其LPt-CBD(卡那比利脂质体平台技术)产品指定了一种新动物研究药物(INAD)编号。这代表了该公司迈出的重要一步,因为INAD的指定有助于与CVM进行通信和数据交流,以支持LPt-CBD作为新的兽药的开发。

"We are thrilled by CVM's response," said Prof. Chezy Barenholz, CSO of Innocan Pharma. "The granted INAD will allow us to advance the investigational studies of LPT-CBD and share knowledge to support future discussions with CVM on LPT-CBD's development plan. Moreover, the fee waiver, granted by CVM, supports our development and pursuit of innovative animal drug products and technology, further validating our approach and potential impact in veterinary medicine."

公司进一步宣布,在评估了LPt-CBD的科学计划后,CVM认识到Innocan为追求创新的兽药产品和技术作出的贡献,并为2024财年免除了公司的赞助费。

Dr. Eyal Kalo, R&D Director at Innocan, added, "LPT-CBD is a unique technology that has proven itself worthy of the INAD fee waiver granted by CVM. This will streamline our efforts to deliver a unique solution for chronic pain management to the animal market."

Innocan的LPt-CBD是一种专有的药物输送平台,旨在为动物提供缓释性的CBD,用于慢性疼痛和健康管理。在过去一年中,对狗和其他动物反复施用LPt-CBD已经证明了其疗效和耐受性,为INAD的申请提供了充分的证据。

About Innocan Pharma:
Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales.

关于Innocan Pharma:
Innocan是一家制药技术公司,掌握两个主要业务领域:制药和消费者保健。 在制药领域,Innocan专注于开发创新的药物递送平台技术,包括大麻素科学,以治疗各种疾病从而提高患者的生活质量。 此领域涉及两种药物递送技术:(i)LPT CBD负载的脂质体平台,有助于准确用量和CBD进入血液流的持久和受控释放。 LPT递送平台研究正在进行为两种适应症的临床前试验:癫痫和疼痛管理。 在消费者保健领域,Innocan开发和销售广泛的创新和高性能自护产品组合,以推广更健康的生活方式。 在这个领域,Innocan成立了一家名为BI Sky Global Ltd的合资企业,其专注于开发先进的定向在线销售。

Contact Information:

联系方式:

For Innocan Pharma Corporation:
Iris Bincovich, CEO
+1 5162104025
+972-54-3012842
+442037699377
[email protected]

对于Innocan Pharma公司:
Iris Bincovich,首席执行官
+1 5162104025
+972-54-3012842
+442037699377
[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

加拿大证券交易所及其监管服务提供方对本发布的信息的充分性或准确性未经审查或承担任何责任。

Caution Regarding Forward-Looking Information

关于前瞻性信息的注意事项

Certain information set forth in this news release, including, without limitation, the Company's plans for human trials of its LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. . The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of production and distribution arrangements.

Innocan Pharma公司的CSO Chezy Barenholz教授表示:“我们对CVM的回复感到非常高兴。这份INAD的授权将使我们推进LPt-CBD的调查研究,以及与CVM分享知识,进一步支持LPt-CBD的开发计划。此外,由CVM授权的赞助费减免支持我们开发和追求创新的兽药产品和技术,进一步验证了我们在兽医药品领域的研究方法和潜在影响。”同时Innocan的R&D总监Eyal Kalo博士补充道:“LPt-CBD是一项独特的技术,已经证明自己值得CVM免除INAD费用的授权。这将简化我们的工作,为动物市场提供解决慢性疼痛管理的独特解决方案。”该新闻稿中的某些信息,包括但不限于公司对其LPt-CBD平台进行人体试验的计划,都是适用证券法律的前瞻性信息。由于前瞻性信息的特性,它受到无数风险和不确定性的影响,其中一些是Innocan Pharma无法控制的。本新闻稿中的前瞻性信息基于Innocan的某些关键预期和假设,包括与产品有关的预期和假设,在各个管辖区满足监管要求以及生产和分销安排的顺利完成。

Forward-looking information is subject to various risks and uncertainties that could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import/export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner). The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks that impact Innocan can be found in Innocan's public reports and filings which are available under Innocan's profile at .

前瞻性信息会受到各种风险和不确定因素的影响,这会使实际结果和体验与本新闻稿中表达的预期结果或期望结果产生实质性差异。主要的风险和不确定性包括但不限于:全球和当地(国家)的经济、政治、市场和商业状况;政府和监管机构的要求和行动;可能破坏与供应商、制造商、客户、商业伙伴和竞争对手之间关系的风险。产品分销的性质本身也存在风险,包括进口/出口事项和未获得任何必要的监管和其他批准(或未能及时获得)。预计的进入市场时间表可能会因多种原因而改变,包括未能确保必要的监管要求或需要额外时间来完成和/或满足制造和分销安排。因此,读者不应对本新闻稿中所包含的前瞻性信息过于依赖。影响Innocan的其他风险的全面讨论可在Innocan在其个人档案下提供的公开报告和文件中找到。

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

读者应该注意到,不应过度依赖前瞻性信息,因为实际结果可能与前瞻性信息产生实质性差异。Innocan不会更新、纠正或修订任何前瞻性信息,除非适用法律要求或出于任何新信息、未来事件或其他原因。

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SOURCE Innocan Pharma Corporation

消息来源:Innocan Pharma公司

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