Mallinckrodt postpones spinoff as opioid lawsuits mount


2019-08-08 16:02:00 FiercePharma


Mallinckrodt thought it had a plan to rehabilitate its image, rid itself of low-performing products and banish at least some of its legal problems. But now it's put that plan on hold. The Irish drugmaker said Tuesday it had postponed plans to spin off its specialty generics business as potential settlements in numerous opioid lawsuits against the company have created uncertainty about the to-be-independent unit's future cash flow.   Mallinckrodt's spinoff plan, announced in December, would create a new company under the Mallinckrodt name consisting of its specialty generics products, including oxycodone; active pharmaceutical ingredients; and the constipation drug Amitiza. What's left over—the company's specialty brands, including H.P. Acthar Gel—would operate under a new, as-yet-undetermined name and without the burden of potentially hefty opioid liabilities. The idea isn't dead, but now isn't the time, the company said Tuesday. “Mallinckrodt continues to actively consider a range of options intended to lead to the ultimate separation of the Specialty Generics business, consistent with its previously stated strategy,” the drugmaker said in a second-quarter earnings release Tuesday. Mallinckrodt is one a group of opioid makers that have been targeted in hundreds of lawsuits for their aggressive marketing as the nation’s addiction epidemic raged. In April 2018, the drugmaker was subpoenaed by a U.S. Attorney’s Office in Florida; it already faced civil investigative demands from officials in Missouri, Washington and Kentucky and subpoenas from New Hampshire, Kentucky and Alaska.   The drugmaker is also a defendant in a massive multidistrict litigation working its way through a court in Cleveland. In mid-April, Mallinckrodt joined Endo and Purdue in attempting to toss out an expert witness opinion stating the companies would have to pay around $480 billion to solve an opioid epidemic they helped fuel. The judge in that case, Dan Polster, denied the emergency motion and accused the drugmakers of seeking an “indefinite postponement” of the case. The spinoff would have disposed of that lawsuit burden along with the generic oxycodone product. But even the company left behind wouldn't be free of legal problems. A group of whistleblower suits accuse the company of paying doctors to prescribe its H.P. Acthar gel, one of the specialty brands that would stay behind. In early June, Mallinckrodt was hit with a new round of kickback allegations after agreeing to a $15.4 million payout with the feds to settle charges stemming from two whistleblower suits. The newest charges accused the company of funneling money through front funds to illegally subsidize Medicare copays and jack up the drug’s list price 85,000%.  Mallinckrodt acquired Acthar through a purchase of Questcor Pharma in 2014 and has argued the bulk of Acthar’s price hikes occurred prior to the acquisition. Acthar is facing even greater hurdles as pricing headwinds have pushed the drug’s sales forecast out of the billion-dollar range on the year. SVB Leerink analyst Ami Fadia called that lower forecast “disappointing” and predicted a stock price drop in response. On the whole, Acthar raked in $266.4 million in the quarter, a 9.1 decrease. Mallinckrodt specialty brands segment on the whole netted $627.8 million.
Mallinkrodt 认为,它有一个计划来恢复自己的形象,摆脱不良产品,至少消除一些法律问题,但现在它搁置了这个计划。 这家爱尔兰制药商周二表示,由于针对该公司的众多阿片类药物类诉讼可能达成和解,该公司推迟了剥离特种仿制药业务的计划。这给该独立子公司未来的现金流带来了不确定性。 去年12月宣布的 Malinckrodt 分拆计划,将创建一家新公司,名称为 Malinckrodt ,其特色仿制药产品包括羟考酮、活性药物成分和便秘药物 Amitiza 。 剩下的东西——包括 H.P . Acthar Gel 在内的该公司的专业品牌——将以一个新的、尚未确定的名称运营,而不承担潜在的巨额阿片类药物类负债。 该公司周二表示,这个想法并没有消失,但现在不是时候了。“ Malinckrodt 继续积极考虑一系列选择方案,旨在最终实现 Specialty Generics 业务的分离,这与该公司此前声明的战略一致,”该制药商周二在第二季度财报中表示。 Mallinkrodt 是一群阿片类药物制造商之一,随着全国吸毒者泛滥,他们因其侵略性营销而受到数百起诉讼。2018年4月,这家制药商被弗洛里达州的美国检察官办公室传唤;它已经面临密苏里州、华盛顿和肯塔基州官员的民事调查要求,以及新罕布什尔州、肯塔基州和阿拉斯加州的传票。 制药商也是一个通过克利夫兰法院进行的大规模多严格诉讼的被告。4月中旬, Malinckrodt 加入了远藤(Endo)和 Purdue ,试图提出一份专家证人意见,称两家公司必须支付约4800亿美元,才能解决它们帮助助长的阿片类药物泛滥。 该案的法官丹•波尔斯特( Dan Polster )否认了这一紧急动议,并指责制药商寻求“无限期推迟”此案。 分拆后将处理该诉讼负担连同通用的羟考酮产品。但即便是该公司也不会免受法律问题的困扰。一组告密者的诉讼指控称,该公司向医生支付了处方其 H.P.Acthal 凝胶的费用,而这正是该公司将留下来的一种特殊品牌。 6月初, Mallinkrodt 因同意向联邦政府支付1540万美元以了结两起举报人诉讼的指控而受到新一轮的回扣指控。最新的指控指控称,该公司通过预付资金非法补贴医疗保险公司的警察,并抬高了该药物的定价8.5万%。 Malinckrodt 在2014年通过收购 Questcor Pharma 收购 Acthar ,并辩称 Achar 的大部分提价发生在收购之前。 阿克查尔正面临更大的障碍,因为定价方面的不利因素使该药物的销售预测超出了今年10亿美元的范围。SVB Leelirink 分析师 AmiFadia 称,较低的预测“令人失望”,并预测股价会相应下跌。 整体而言,阿克查尔本季度获利2.664亿美元,减少了910万美元。Mallinkrodt 专业品牌细分市场的总净利润为6.278亿美元。