Novartis faces further fallout over Zolgensma


2019-08-19 13:00:51 Financial Times


Donato Paolo Mancini in London and Hannah Kuchler in New York An executive at Swiss drugmaker Novartis sold SFr925,400 worth of shares 18 days before the US Food and Drug Administration said it was investigating data manipulation on tests for the world’s most expensive drug, Zolgensma.  The US regulator warned earlier this month that Novartis was facing possible civil or criminal charges over manipulated data in early stage testing of the drug on animals, sending shares down 3 per cent that day. The FDA stressed that trials in humans showed that Zolgensma was safe enough for approval, and did not recommend pulling it from the market.  The transaction, worth about $944,000, was executed on July 19 by an unnamed individual, according to a regulatory filing at the Swiss stock exchange. The filing says it was carried out by an “executive member of the board of directors” or a “member of the executive committee”. Other filings for similar transactions do not list the identities of those involved. Swiss law requires only the ties linking individuals to companies, but not the names, to be disclosed.  Novartis said the share sale was not related to Zolgensma. “As is usual in such cases, the transaction was thoroughly checked beforehand and then approved accordingly,” it said on Monday. “The person in question was not in possession of relevant material information.”  The company is facing an escalating backlash in the US amid allegations that it tampered with trial data that formed part of the approval package for Zolgensma, a gene therapy to treat spinal muscular atrophy that sells for $2.15m.  News of the share sale comes a week after the company disclosed it had put two senior scientists on administrative leave more than a month before it told the US agency about the botched data, which was collated at AveXis, a gene therapy outfit the Basel pharmaceutical group bought last year for $8.7bn.  Republican and Democratic senators have attacked Novartis over the data manipulation and called on the FDA to censure the drugmaker over its handling of the problem. The company waited until it had completed an internal investigation before it told the regulator, a month after the drug had been approved in May. The issue marks the first big test for Vas Narasimhan, who became chief executive last year. After it was disclosed that his predecessor, Joseph Jimenez, paid a company owned by US president Donald Trump’s former personal lawyer Michael Cohen more than $1m for “advice”, Dr Narasimhan refocused the company on higher-value drugs, while promising greater transparency and accountability in its practices.  Novartis shares, which reached historic highs in July, boosted by upgraded quarter-on-quarter guidance, were flat on Monday.
伦敦的 Donato Paolo Mancini 和纽约的 Hannah Kuchler 瑞士制药商诺华(诺华(Novartis))的一位高管在18天前卖出了价值9.25400瑞士法郎的股票,当时美国食品和药物管理局( FDA )表示,正在调查有关全球最贵药物佐尔甘斯曼( Zolgensma )试验的数据操纵。 美国监管机构本月早些时候警告称,诺华( Novartis )可能面临民事或刑事指控,指控其在动物药物早期试验中操纵数据,当日股价下跌3%。FDA 强调,人体试验表明佐尔格森玛足够安全获得批准,不建议从市场上撤出。 瑞士证券交易所( Swiss Stock Exchange )的一份监管申报文件显示,这笔价值约94.4万美元的交易于7月19日由一名未透露姓名的个人执行。该文件称,它是由“董事会执行委员”或“执行委员会委员”执行的。其他类似交易的备案文件没有列出相关人员的身份。瑞士法律只要求披露个人与公司的联系,而不是姓名。 诺华(Novartis)表示,此次股权出售与 Zolgensma 无关。该公司周一表示:“与通常情况一样,交易事先经过彻底检查,然后得到相应批准。”“有关人员没有掌握相关的重大信息。”这是一个很好的例子 该公司在美国面临越来越大的反弹,因为有人指控该公司篡改了临床试验数据,这些数据构成了 Zolgensma 批准方案的一部分。 Zolgensma 是一种治疗脊柱肌肉萎缩症的基因疗法,售价215万美元。 此次股票出售的消息传出一周前,该公司披露,已有两名高级科学家被停职一个多月,然后才向这家美国机构通报了这些数据造假的情况。这些数据是由巴塞尔制药集团( Basel Pharmaceutical Group )去年以87亿美元收购的基因治疗机构 AveXis 整理的。 共和党和民主党参议员抨击了诺华(Novartis)公司的数据操纵行为,并呼吁美国食品和药物管理局谴责诺华公司处理这个问题。该公司等到内部调查完成后才向监管机构表示,5月该药物获得批准一个月后。 这是纳拉希姆汉( Vas Narasimhan )的首次重大考验,纳拉希姆汉去年成为该公司首席执行官。 纳拉希姆博士透露,他的前任约瑟夫•吉姆内兹( Joseph Jimenez )向美国总统唐纳德•特朗普( Donald Trump )前私人律师迈克尔•科恩( Michael Cohen )拥有的一家公司支付了逾100万美元的“建议”费用,之后他将公司的重心重新转向了价值更高的药品,同时承诺提高其做法的透明度和问责制。 诺华( Novartis )股价周一持平。受季度环比指引上调的推动,该公司股价在7月份达到历史高位。