MedPharm Holdings Corporation, to Be Acquired by Medicine Man Technologies, Addresses Outbreak of Vape-Related Lung Illnesses

大麻公司Medicine Man计划收购MedPharm,致力于解决电子烟相关的肺部疾病

2019-09-16 15:30:00 BioSpace

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 MedPharm Holdings , reiterated today its formal policy prohibiting the use of suspected unsafe chemical additives to its entire line of cannabis products, most notably its concentrates that are used in vape products. Furthermore, Medicine Man Technologies calls on the state of Colorado — and the other 49 states — to enact an industry-wide standard prohibiting certain excipients in vape products. MedPharm and Medicine Man Technologies are parties to a binding term sheet, pursuant to which Medicine Man Technologies will acquire MedPharm.    In recent weeks, there have been hundreds of reports of dangerous and deadly cannabis vaping-related respiratory illnesses characterized by severe pneumonia symptoms, shortness of breath, coughing, fever, fatigue, and respiratory failure. While the exact root cause of these illnesses has yet to be determined, health officials have begun focusing on the role of chemical additives found in many cannabis-containing vaping oils. Some of the suspected chemicals are vitamin E acetate, normally used in the food industry as a preservative, propylene glycol (PG), vegetable glycerin (VG), and medium chain triglycerides (MCT), which are all popular cannabis thinning agents. Some of these chemical additives (particularly PG and VG), when heated too high during the vaping process, can degrade into harmful cancer-causing byproducts, such as formaldehyde, acetaldehyde, and acrolein. The additives have also been linked to the presence of lipid-laden macrophages found in the lungs of people who suffer from this new vape-induced lung disease. The presence of these lipid deposits can, in turn, trigger inflammation in the lungs, a condition known as lipoid pneumonia. Many of these suspected additives simply haven't been evaluated for safety when inhaled and could very well be associated with the observed symptoms in the growing number of cases.  Of further concern, some black-market or counterfeit vape cartridges also contain undisclosed additives that can inhibit the proper functioning of the vaporizer and/or cartridge, which can also lead to safety risks and health issues for consumers. "Since its inception, MedPharm's philosophy has been to always provide cannabis products of the highest quality, purity, and safety," said Dr. Tyrell Towle, MedPharm's Director of Chemistry and Extraction. "We have always gone above and beyond to tightly control our processes and inputs. That is how we create products that are consistent from batch to batch and free from contamination. In fact, we have voluntarily implemented Good Manufacturing Practices (GMP) and received third-party GMP certification in early 2019." In that light, MedPharm committed to never use additives, diluents, viscosity modifiers, or any other substances to carry flavor or alter the behavior of its vaporizable concentrates. Based on its review of the cutting agent's chemical structures and available safety data, or lack thereof, MedPharm's scientists determined that to infuse any of the commonly used diluents into its BATCH or Become line of vape products represented an unacceptable health risk to its customers. Consequently, neither the BATCH nor Become brands contain PG, VG, MCT, or any other such substance. In fact, the only ingredients found in these brands are cannabis distillates and terpenes. The recent reported outbreaks of lung disease among some people who allegedly vaped cannabis oils with these chemical additives confirms this warranted caution. Given the recently reported lung injuries, MedPharm is renewing its commitment to not use any substance to dilute its vaporizable formulations. Furthermore, MedPharm plans to use its research license in Colorado to investigate the safety of vaporizing cannabis and substances that are commonly used in inhalable cannabis formulations. "At MedPharm and Medicine Man Technologies, we have always respected the health and safety of cannabis consumers and always used a science-based public health approach in our product development," commented Andy Williams, Co-Founder of MedPharm and Co-Founder and Chief Executive Officer of Medicine Man Technologies. "The cannabis industry simply does not need any bad actors or black-market manufacturers using questionable manufacturing practices and additives that may lead to a health crisis and additional public skepticism regarding the safety of our industry and products." Williams continued, "We are also going beyond simply sharing our policy statement prohibiting the use of dangerous additives internally. We are now asking for the pioneering state of Colorado to yet again lead the way for the cannabis industry and ban the use of such chemical additives in all cannabis products, including the concentrates used in vape products. Additionally, we hope that the other 49 states will follow suit and ban these additives as well. Too much is at stake for consumers and for the responsible cannabis companies that do place a priority on the health and safety of the public to not take action. Just because cannabis is still federally illegal and there are no current manufacturing regulations in place does not mean we as an industry cannot do the responsible thing for the good of all involved." Williams concluded, "Lastly, we also ask cannabis consumers to only buy reputable vape products that are free of these harmful chemical additives and only buy from a licensed dispensary. There are plenty of vape concentrates on the market that use all-natural, cannabis-derived terpenes instead of these potentially harmful chemical additives or are specially extracted without these or other potentially harmful additives." For more information about Medicine Man Technologies, please visit https://www.medicinemantechnologies.com. About MedPharm Holdings Corporation MedPharm Holdings owns a 15,000-square-foot manufacturing, research and development laboratory, and cannabis processing facility in Denver, Colorado. Since beginning operations in 2016, MedPharm has grown to a staff of 22 people, including a PhD of chemistry and extraction, Dr. Tyrell Towle. Additionally, Scott Karolchyk, the director of formulation development, is a member of the Colorado Department of Public Health and Environment, Marijuana Enforcement Division, Science and Policy Work Group. The goal of MedPharm is to provide a reliable clinical effect through the use of well-crafted and well-researched oil analytics and dosage forms. The company provides cannabis pharmaceutical-type products using good manufacturing practices (GMP) that include pre-formulation, formulation development, small-scale commercial manufacturing, analytical method development and validation, routine quality control analysis, and stability studies. MedPharm works to create pharmaceutical dosage forms and produce ingredients utilizing pharmaceutical technology to be used in the delivery of cannabis extracts. Take a 360-degree virtual tour of the MedPharm facility here: www.medpharmresearch.com. About Medicine Man Technologies Denver, Colorado-based Medicine Man Technologies (OTCQX: MDCL) is a rapidly growing provider of cannabis consulting services, nutrients, and supplies. The Company's client portfolio includes active and past clients in 20 states and seven countries throughout the cannabis industry. The Company has entered into agreements to become one of the largest vertically integrated seed-to-sale operators in the global cannabis industry. Current agreements will enable Medicine Man Technologies to offer cultivation, extraction, distribution, and retail pharma-grade products internationally. The Company's intellectual property includes the "Three A Light" methodology for cannabis cultivation and pending acquisition candidate MedPharm's GMP-certified facility, which has the first cannabis research license to conduct clinical trials in the United States. Management includes decades of cannabis experience, a unique combination of first movers in industrial cannabis, and proven Fortune 500 corporate executives.
MedPharm Holdings 今日重申其正式政策,禁止使用怀疑不安全的化学添加剂进入其大麻产品的整个系列,尤其是用于吸食产品的浓缩物。此外, Medicine Man Technologies 呼吁科罗拉多州(以及其他49个州)制定一项全行业标准,禁止在吸塑产品中使用某些辅料。MedPharm 和 MedicalMan Technologies 是有约束力的条款清单的缔约方, MedicalMan Technologies 将据此收购 MedPharm 。 最近几周,有数以百计的报告指出,危险和致命的大麻吸食相关的呼吸道疾病的特点是严重的肺炎症状、呼吸急促、咳嗽、发烧、疲劳和呼吸衰竭。虽然这些疾病的确切病因尚未确定,卫生官员已经开始关注化学添加剂在许多含大麻的食用油中的作用。一些疑似化学品是维生素 E 醋酸盐,通常用于食品行业作为防腐剂,丙二醇( PG )、蔬菜甘油( VG )和中链甘油( MCT ),这些都是流行的大麻稀释剂。 其中一些化学添加剂(特别是 PG 和 VG )在起泡过程中加热过高时,会降解为有害的致癌副产品,如甲醛、乙醛和丙烯醛。这些添加剂还与患有这种新的由 vape 引起的肺病的人的肺部中发现的富含脂质的巨噬细胞有关。这些脂质沉积的存在反过来又会引发肺部炎症,这种疾病被称为类脂性肺炎。许多这些可疑的添加剂在吸入时并没有进行安全评估,很可能与越来越多的病例中观察到的症状有关。 更令人关切的是,一些黑市或假冒的盒装也含有未披露的添加剂,可抑制蒸发器和/或盒装的正常运作,这也可能给消费者带来安全风险和健康问题。 “自成立以来, MedPharm 的理念一直是提供最高质量、纯度和安全性的大麻产品,” MedPharm 化学和提取主任 Tyrell Towle 博士说。“我们一直在努力控制我们的过程和输入。这就是我们如何创建从批处理到批处理一致且不受污染的产品。事实上,我们自愿实施了《药品生产质量管理规范》( GMP ),并于2019年初获得第三方 GMP 认证。 在这种情况下, MedPharm 承诺绝不使用添加剂、稀释剂、粘度改良剂或任何其他物质来进行风味或改变其蒸气浓缩的行为。根据对切削剂的化学结构和现有的安全数据的审查,或缺乏这些数据, MedPharm 的科学家确定,将任何常用的稀释剂注入其 BATCH 或成为 vape 产品线,对其客户构成不可接受的健康风险。因此,无论是 BATCH 还是成为品牌,都不包含 PG 、 VG 、 MCT 或任何其他此类物质。事实上,这些品牌中唯一的成分是大麻蒸馏物和萜类。 最近报道的一些人肺部疾病爆发,据称他们用这些化学添加剂吸食大麻油证实了这一点值得谨慎。鉴于最近报道的肺部损伤, MedPharm 公司再次承诺不使用任何物质稀释其可蒸发配方。此外, MedPharm 计划利用其在科罗拉多州的研究许可证,调查在非食用大麻制剂中常用的大麻和物质的蒸发安全性。 “在 MedPharm 和 Medicine Man Technologies 公司,我们始终尊重大麻消费者的健康和安全,在产品开发中始终采用基于科学的公共卫生方法,” MedPharm 联合创始人兼 Medicine Man Technologies 首席执行官 Andy Williams 表示。“大麻产业根本不需要任何不良行为者或黑市制造商使用可疑的制造方法和添加剂,这可能导致健康危机和公众对我们行业和产品安全的更多怀疑。” 威廉姆斯继续说,“我们也不仅仅是分享我们的政策声明,禁止使用危险添加剂内部。我们现在要求科罗拉多州再一次引领大麻工业,禁止在所有大麻产品中使用此类化学添加剂,包括用于吸食产品的浓缩物。此外,我们希望其他49个州也会跟进并禁止这些添加剂。对消费者和负责任的大麻公司来说,太大的风险,它们确实把公众的健康和安全放在优先地位,不采取行动。仅仅因为大麻仍然是联邦非法的,而且没有现行的生产法规,并不意味着我们作为一个行业不能为所有相关的利益负责。” 威廉姆斯总结道:“最后,我们还要求大麻消费者只购买信誉良好的 vape 产品,这些产品没有这些有害的化学添加剂,只从一家持牌药房购买。有大量的 vape 集中在市场上使用全天然的大麻衍生萜类,而不是这些潜在的有害化学添加剂,或特别提取没有这些或其他潜在的有害添加剂。 有关 Medicine Man Technologies 的更多信息,请访问 https://www.medicinemationtechnologies.com 。 关于 MedPharm 控股公司 MedPharm Holdings 在科罗拉多州丹佛市拥有一座占地1.5万平方英尺的制造、研发实验室和大麻加工设施。自2016年开始运营以来, MedPharm 已成长为22人的员工,其中包括化学和提取博士 Tyrell Towle 。此外,配方开发主任 Scott Karolchyk 是科学和政策工作组大麻执法司科罗拉多州公共卫生和环境部的成员。 MedPharm 的目标是通过使用精心设计和研究良好的石油分析和剂型,提供可靠的临床效果。该公司使用良好的生产实践( GMP )提供大麻医药型产品,包括预制剂、制剂开发、小规模商业制造。分析方法的开发和验证,日常质量控制分析和稳定性研究。MedPharm 致力于创造药物剂型,并利用药物技术生产用于输送大麻提取物的成分。在这里对 MedPharm 设施进行360度的虚拟参观:\160; www.medpharmesarch.com 。 关于医药人科技 科罗拉多州丹佛市的 MedicalManTechnologies 公司( OTCQX : MDCL )是一家快速增长的大麻咨询服务、营养和供应供应商。该公司的客户组合包括20个州和7个国家大麻行业的活跃和过去的客户。本公司已签订协议,成为全球大麻行业最大的垂直一体化种子销售运营商之一。目前的协议将使 MedicineMan Technologies 能够在国际上提供种植、提取、分销和零售医药级产品。本公司的知识产权包括大麻种植的“三 A 光”方法和即将收购的候选 MedPharm 的 GMP 认证设施,该设施拥有在美国进行临床试验的首个大麻研究许可证。管理包括几十年的大麻经验,一个独特的组合,在工业大麻的先驱者,并证明了财富500强企业高管。

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