Pfizer Enters $6.7-Billion Acquisition Deal With Cannabis Pipeline


2021-12-22 03:13:00 Business Times


While Pfizer Inc. has become ubiquitous among those receiving COVID-19 vaccines, the American multinational pharmaceutical and biotechnology company is now betting on the cannabis industry. Last week, Pfizer announced it entered into a definitive agreement to acquire clinical-stage company Arena Pharmaceuticals Inc. to the tune of $6.7 billion, with a transaction valued at $100 per Arena share in cash. The press release for the proposed transaction omits any direct mention of Arena’s ties to the medical cannabis industry, but that pipeline is connected to cannabinoid therapeutics with an aim to help treat bowel disease, as reported by Forbes. According to Arena’s website, Olorinab is a drug candidate for the treatment of pain and is a “full agonist of the cannabinoid Type 2 receptor (CB2).” CB2 is an endocannabinoid receptor predominately associated with immune system responses. Among its active ingredients Olorinab includes the drug SR144528, which has been used to study the function of the CB2 receptor. RELATED: CBG: A New(er) Option for Cancer Treatment? Arena’s initial focus for Olorinab is on treating visceral pain associated with gastrointestinal disorders. An oral form of Olorinab is currently in a Phase 2 clinical trial evaluating its efficacy and safety in patients experiencing abdominal pain associated with irritable bowel syndrome, according to the company website.   Olorinab, through its selectivity for the CB2 receptor versus cannabinoid Type 1 receptor (CB1), remains under trials for pain relief without psychoactive adverse effects and is not currently approved for use by any health authority. While the CB1 receptor is associated with psychoactive, neuromodulatory and analgesic effects due to its activation by THC, CB2 is associated with anti-inflammatory and immunomodulatory effects but not psychoactive effects. Compounds found in cannabis, such as THC and CBD, can bind to both receptor types to signal that the endocannabinoid system needs to act, but the effects depend on the receptor and the cannabinoid’s interaction with the receptor. According to an introduction of the endocannabinoid system by Dr. Ethan Russo, a board-certified neurologist who’s studied cannabis and cannabinoids for more than 25 years, “Receptors may be thought of as locks, to which a corresponding chemical (natural or synthetic) will fit like a key, if it has the proper structure to conform to it.” Mike Gladstone, global president and general manager of Inflammation and Immunology at Pfizer, did not did specifically mention Olorinab in the acquisition announcement, but the press release did state that Arena’s portfolio includes diverse and promising development-stage therapeutic candidates in gastroenterology, among other branches of medicine. Arena’s portfolio also includes non-cannabinoid clinical avenues. “The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options,” Gladstone said. Pfizer expects to finance the transaction with existing cash on hand, according to the release. Under the terms of the agreement, Pfizer will acquire all of the outstanding shares of Arena common stock for $100 per share in cash.  Upon completion of the deal, Pfizer will join the likes of other big pharma companies in the cannabis space, such as Jazz Pharmaceuticals, which kicked off the 2021 international cannabis M&A season with a $7.2-billion blockbuster deal to acquire GW Pharmaceuticals, manufacturer of the FDA- and DEA-approved Epidiolex (a cannabinoid medicine used for treating children who experience seizures associated with two rare forms of epilepsy). Curaleaf Holdings, a vertically integrated multistate cannabis [and CBD] operator, is likely to face a wrongful death lawsuit, the latest in a string of lawsuits related to mislabeled products. Curaleaf is currently facing 10 lawsuits from consumers who allegedly ingested an incorrectly labeled CBD tincture that contained "undisclosed levels of THC," according to a product recall notice issued by the Oregon Liquor and Cannabis Commission (OLCC). The recall was issued Sept. 21 for a single batch of the mislabeled CBD product, which was produced by Cura CS LLC and sold under Curaleaf's Select brand. Curaleaf acquired Cura and its Select brand in 2019 in a $948.8-million all-stock deal. Peter Clateman, Curaleaf chief legal officer, tells Cannabis Business Times and Hemp Grower that about 500 bottles from the batch were sold. The OLCC expanded the recall Sept. 24 to include another Select tincture that said it contained 1,000 mg of THC on the label, but after a round of preliminary tests, the OLCC found that the product did not contain any detectable THC. According to OLCC, Curaleaf sold an estimated 630 units of the mislabeled tincture. Curaleaf acknowledged the mislabeling of the two tinctures was caused by "human error." "So, the most basic thing that happened is that there was an employee who mixed two sets of ingredients and put the THC-containing ingredients into the CBD product. It was error, and it was [a] clear error just because the products were labeled and the employee got confused. Instead of escalating or seeking to resolve the confusion, [he] just went ahead and filled the product," Clateman said. "We've done a root cause analysis, and that's where we got to. The employee's been reassigned out of production work." The mislabeled products have now led to multiple individuals filing lawsuits against the company, most of whom are being represented by Michael Fuller, a partner at the Underdog Law Office in Portland, Ore. Fuller said “dozens of people” contacted the firm expressing similar concerns related to the mislabeled products. "Most of them reached out to me through referral by reporters,” Fuller said. “An Idaho man was the first to contact the [law firm] about his experience after he was hospitalized." Fuller said the reporter who referred the plaintiff to the law firm recognized the firm from a previous class-action lawsuit Fuller filed against Cura for mislabeling cannabis products last year. The mislabeled products failed to state they contained non-cannabis-derived botanical terpenes, a mistake that Cura said was unintentional and due to “poor communication between its manufacturing and labeling and packaging personnel,” as reported by Portland Business Journal. (Cura also faced a $110,000 fine from OLCC for that mislabeling mishap, PBJ reported.)  "We negotiated a half-a-million-dollar settlement of that claim," Fuller said. "This shouldn't happen just because this is a relatively new industry. There's just simply no excuse for it, and they're setting the [legalization] movement back," Fuller said. "It's not accidents. It's cutting corners." Lawsuit Breakdown In the recent lawsuits, Fuller said all his clients–who range from males and females in their 30s to individuals in their late 70s–claimed they were experiencing "stroke-like" symptoms after allegedly consuming the mislabeled CBD product. Fuller said some of the alleged symptoms include slurred speech, loss of time, inability to stand, hallucination, psychosis, panic, pounding, heart rate, and thoughts that they were going to die. He said about half a dozen of his clients went to the emergency room following consumption–one of whom was allegedly life-flighted on two separate occasions after consumption, and another who allegedly had "unnecessary surgery" due to a misdiagnosed stroke. He added that many of his clients claimed they consumed the product multiple times without realizing it contained THC. The wrongful death lawsuit alleges the plaintiff who was life-flighted twice reportedly died from COVID-19 a few weeks after his second trip to the hospital following consumption; however, his family believes the "THC dosing was a substantial factor in his inability to survive COVID," Fuller said. "His family believes that it wasn't the THC that killed him, but his family believes that it was a substantial factor in affecting his health to where he was basically, after that experience, … convinced he was going to die; they say he was never the same," Fuller said, adding that the experience allegedly “weakened him.” His case is currently pending probate, Fuller said, and a wrongful death suit will be filed once the court approves the paperwork. “We're just waiting on the judge's signature,” Fuller said. “It's a very small county in Oregon called Lake County. And so, we don't have a lot of control over how quick things get processed there, but we've already drafted the lawsuit, and we just need the judgment from the Lake County judge appointing the personal representative because it's an estate claim and then the complaint will be filed." Fuller said all the claims are pretty "straightforward" product liability cases, as he believes Curaleaf is not denying that it "violated the law by putting THC in bottles that were advertised to only have CBD in them." On Dec. 16, Curaleaf's communications department offered the following response to Cannabis Business Times/Hemp Grower via email: Curaleaf Statement re: THC/CBD product labeling error While we cannot comment on any pending litigation, we can offer this response: A team member confused two containers during the filling and packaging process, one containing CBD and one containing THC. This resulted in a single batch of [CBD] tincture being labeled as THC [drops] and vice versa. The amount of THC was within the regulatory limit for a normal batch for our THC drops, but we understand that some customers may have consumed multiple doses. We have worked with the OLCC to recall the two batches in question, and the limited number of remaining units have been removed from sale. In response to this event, as initial steps, [we] have adjusted production practices and implemented new controls to improve quality assurance processes to further minimize the possibility of human error, enhancing camera visibility in product control areas and conducting additional training sessions with our production team. We will also be adding a secondary review of transfer of product between departments, batch records, and other documents.  We have also added a new Quality Technician position to [our Oregon facility], and have removed the individual responsible for the error during the filling and packaging process. We will continue to work closely with our local operations team to ensure safety and compliance best practices are followed in every step of production. Next Steps Some of the cases have already been settled. "Our approach has been to deal amicably and try to reach a settlement with people who have experienced negative effects from the product," Clateman said. The active cases will move forward separately, and Fuller said he expects some of them to be settled and others to go to trial by middle to late next year.  
虽然辉瑞公司(Pfizer Inc.)在接受新冠肺炎疫苗的人中已经无处不在,但这家美国跨国制药和生物技术公司现在正押注于大麻行业。 上周,辉瑞宣布达成一项最终协议,以67亿美元收购临床阶段公司Arena Pharmaceuticals Inc.,交易价值为每股Arena 100美元的现金。 据《福布斯》报道,拟议交易的新闻稿没有直接提到Arena与医用大麻行业的联系,但该管道与大麻素疗法有关,旨在帮助治疗肠病。 根据Arena的网站,Olorinab是治疗疼痛的候选药物,是“大麻素2型受体(CB2)的完全激动剂”CB2是一种主要与免疫系统反应相关的内源性大麻素受体。在它的有效成分中,奥罗瑞纳布包括药物SR144528,它已经被用来研究CB2受体的功能。 相关:CBG:癌症治疗的新选择? Arena最初对Olorinab的关注是治疗与胃肠道疾病相关的内脏疼痛。根据该公司网站,一种口服的Olorinab目前正在进行2期临床试验,评估其对患有肠易激综合征腹痛的患者的有效性和安全性。 Olorinab通过其对CB2受体与大麻素1型受体(CB1)的选择性,仍在进行无精神作用不良反应的止痛试验,目前尚未被任何卫生当局批准使用。CB1受体由于被THC激活而与精神活性、神经调节和镇痛作用有关,CB2受体与抗炎和免疫调节作用有关,但与精神活性无关。 大麻中发现的化合物,如四氢大麻酚和CBD,可以与两种受体结合,以表明内源性大麻素系统需要作用,但作用取决于受体以及大麻素与受体的相互作用。 伊森·鲁索博士是一名获得董事会认证的神经科医生,他研究大麻和大麻素超过25年,他在介绍内源性大麻素系统时说,“受体可以被认为是锁,如果相应的化学物质(天然或合成的)有合适的结构,就像钥匙一样适合它。”伊森·鲁索博士研究大麻和大麻素,他研究大麻和大麻素超过25年。 辉瑞全球总裁兼炎症和免疫学总经理迈克·格拉德斯通(Mike Gladstone)在收购公告中没有具体提到Olorinab,但新闻稿确实表示,Arena的产品组合包括胃肠病学和其他医学分支中多样化和有希望的发展阶段治疗候选药物。Arena的产品组合还包括非大麻素临床途径。 格拉德斯通说:“拟议中的对Arena的收购补充了我们在炎症和免疫学方面的能力和专业知识,这是辉瑞的创新引擎,为需要更有效治疗选择的衰弱性免疫炎症疾病患者开发潜在疗法。” 根据新闻稿,辉瑞预计将用手头现有现金为这笔交易融资。根据协议条款,辉瑞将以每股100美元的现金收购Arena普通股的所有流通股。 交易完成后,辉瑞将加入大麻领域的其他大型制药公司,如爵士制药公司,该公司以72亿美元的重磅交易拉开了2021年国际大麻并购季的序幕,收购了美国食品和药物管理局批准的Epidiolex(一种大麻素药物,用于治疗与两种罕见癫痫相关的癫痫发作儿童)的制造商GW制药公司。 垂直整合的多州大麻(和CBD)运营商库拉雷夫控股公司(Curaleaf Holdings)可能面临非法死亡诉讼,这是一系列与标签错误产品有关的诉讼中的最新一起。 根据俄勒冈州白酒和大麻委员会(OLCC)发布的一份产品召回通知,Curaleaf目前面临10起消费者诉讼,据称他们摄入了一种标签错误的CBD酊剂,其中含有“未披露的四氢大麻酚水平”。 召回于9月21日发布,针对一批标签错误的CBD产品,该产品由Cura CS LLC生产,以Curaleaf的精选品牌销售。2019年,Curaleaf以9.488亿美元的全股票交易收购了Cura及其精选品牌。 Curaleaf首席法律官彼得·克莱特曼(Peter Clateman)告诉《大麻商业时报》和大麻种植者,这批产品售出了约500瓶。 OLCC在9月24日扩大了召回范围,包括另一种精选酊剂,该酊剂在标签上表示含有1000毫克四氢大麻酚,但在一轮初步测试后,OLCC发现该产品不含任何可检测到的四氢大麻酚。根据OLCC的数据,Curaleaf估计售出了630单位标签错误的酊剂。 Curaleaf承认这两种酊剂的标签错误是由“人为错误”造成的。 “所以,发生的最基本的事情是,有一名员工将两套成分混合在一起,并将含四氢大麻酚的成分放入CBD产品中。这是一个错误,这是一个明显的错误,仅仅因为产品被贴上了标签,员工感到困惑。克莱特曼说:”他没有升级或寻求解决困惑,而是继续填充产品。““我们已经做了根本原因分析,这就是我们要做的。这名员工已经被重新分配到生产工作岗位。” 标签错误的产品现已导致多人对该公司提起诉讼,其中大多数由俄勒冈州波特兰市失败者律师事务所的合伙人迈克尔·富勒代理。 富勒说,“数十人”联系了该公司,对标签错误的产品表示类似的担忧。 富勒说:“他们中的大多数人是通过记者的介绍联系我的。一名爱达荷州男子住院后第一个联系(律师事务所)讲述他的经历。” 富勒说,将原告介绍给律师事务所的记者从富勒去年对库拉提出的集体诉讼中认出了该事务所。据《波特兰商业日报》报道,标签错误的产品未能说明它们含有非大麻衍生的植物萜烯,Cura表示,这一错误是无意的,是由于“其制造、标签和包装人员之间的沟通不畅”。(据PBJ报道,库拉还因标签错误事故面临OLCC 11万美元的罚款。)富勒说:“我们通过谈判达成了50万美元的索赔解决方案。” “这不应该仅仅因为这是一个相对较新的行业就发生。富勒说:”这根本没有借口,他们正在阻止(合法化)运动。“不是意外,是偷工减料。” 诉讼分项 在最近的诉讼中,富勒说,他的所有客户--从30多岁的男性和女性到70多岁的个人--都声称,他们在据称消费了标签错误的CBD产品后,出现了“中风样”症状。富勒说,一些所谓的症状包括口齿不清、浪费时间、无法站立、幻觉、精神病、恐慌、重击、心率和认为自己会死。 他说,他的大约六名客户在消费后去了急诊室--其中一人据称生命垂危--在消费后的两个不同场合,另一人据称因误诊中风而接受了“不必要的手术”。 他补充说,他的许多客户声称他们多次消费该产品,但没有意识到其中含有四氢大麻酚。 这起非法死亡诉讼称,据报道,两次生命飞逝的原告在消费后第二次去医院几周后死于新冠肺炎;然而,富勒说,他的家人认为“THC剂量是他无法在COVID中生存的一个重要因素”。 “他的家人认为不是THC杀死了他,但他的家人认为,这是影响他健康的一个重要因素,基本上,在那次经历后,……确信他会死;富勒说:”他们说他再也不一样了。“并补充说,据称这一经历”削弱了他。“ 富勒说,他的案件目前正在等待遗嘱认证,一旦法院批准文件,将提起非法死亡诉讼。 “我们只是在等待法官的签名,”富勒说。“这是俄勒冈州一个非常小的县,叫做莱克县。因此,我们对那里处理事情的速度没有很大的控制权,但我们已经起草了诉讼,我们只需要莱克县法官任命个人代表的判决,因为这是一项遗产索赔,然后将提交投诉。“ 富勒说,所有这些索赔都是相当“简单”的产品责任案件,因为他认为Curaleaf并没有否认它“在广告中只含有CBD的瓶子里添加四氢大麻酚违反了法律”。 12月16日,Curaleaf的通信部门通过电子邮件向《大麻商业时报》/大麻种植者做出了以下回应: Curaleaf声明:THC/CBD产品标签错误 虽然我们不能对任何悬而未决的诉讼发表评论,但我们可以做出以下回应: 一名队员在灌装包装过程中混淆了两个集装箱,一个装CBD,一个装THC。这导致单批[CBD]酊剂被标记为四氢大麻酚[滴剂],反之亦然。四氢大麻酚的量在我们的四氢大麻酚滴剂的正常批次的监管限制范围内,但我们理解一些客户可能已经消费了多个剂量。 我们已经与OLCC合作召回了两批有问题的产品,剩下的有限数量的产品已经停止销售。 作为对此事件的回应,作为第一步,[我们]调整了生产实践并实施了新的控制措施,以改进质量保证过程,进一步将人为错误的可能性降至最低,提高了产品控制区域的摄像机可见性,并与我们的生产团队进行了额外的培训。我们还将增加对部门间产品转移、批量记录和其他文件的二次审查。 我们还增加了一个新的质量技术员职位[我们的俄勒冈州工厂],并已删除了在灌装和包装过程中对错误负责的个人。我们将继续与当地的运营团队密切合作,以确保在生产的每一步都遵循安全和合规的最佳实践。 下一步 有些案件已经解决了。 克莱特曼说:“我们的方法是友好地处理,并试图与经历过该产品负面影响的人达成和解。” 活跃的案件将分别向前推进,富勒说,他预计其中一些案件将在明年中至晚些时候得到解决,其他案件将进行审判。