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Eisai moves to next Alzheimer's trial; watchdog calls for US opioid moratorium


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Eisai moves to next Alzheimer's trial; watchdog calls for US opioid moratorium

Top news

* Shortly after discontinuing two late-stage trials of Alzheimer's disease drug aducanumab, Eisai Co. Ltd. said it started a global late-stage study of another drug for the disease. The Japanese drugmaker said it initiated a phase 3 study of BAN2401 in patients with early Alzheimer's disease. The trial, dubbed Clarity AD or Study 301, involves 1,566 patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia with confirmed amyloid pathology in the brain.

Biogen Inc. shares dropped more than 29% after news that the biotechnology company and Eisai will be discontinuing two late-stage clinical trials of their Alzheimer's drug aducanumab. Biogen shares fell to $226.88 apiece as of the close of U.S. trading March 21, down 29.23%. The Tokyo Stock Exchange, on which Eisai shares trade, was closed on the same day.

The drug aducanumab was intended to break down amyloid plaque buildup that is thought to worsen Alzheimer's disease. The companies stopped the phase 3 trials, called Engage and Emerge, after a futility analysis showed they would likely not meet their goals.

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Moody's said Biogen discontinuing the clinical trials for the experimental Alzheimer's drug aducanumab is credit negative for the company.

On the policy front

* U.S. consumer watchdog Public Citizen and the head of the U.S. Food and Drug Administration advisory committee that scrutinizes pain drugs filed a citizen petition calling on the U.S. government to impose a moratorium on approving any new formulations of opioids in the midst of the epidemic. The petition is calling for the moratorium to stay in place until the July 2017 recommendations from the National Academies of Sciences, Engineering and Medicine, aimed at preventing more opioid addictions and deaths, are fulfilled.

* Kentucky Attorney General Andy Beshear is investigating allegations of pharmacy benefit managers overcharging the state health insurance programs for drugs and discriminating against independent pharmacies. The investigation is exploring how pharmacy benefit managers hired by state Medicaid managed-care organizations and the state employee health plan have determined, billed and paid drug reimbursement rates over the past five years in Kentucky.

* Nearly 70% of air ambulance transports in 2017 resulted in out-of-network bills for patients, according to a new report from the Government Accountability Office, a nonpartisan Congressional auditor. After analyzing data from 20,700 transports, the report found that 69% of transports from air ambulances in 2017 were out of network, which can force patients to pay the majority of costly medical bills.

* The shortages of nurses at the U.K. National Health Service are expected to double and the shortfall of family doctors to treble, according to The King's Fund, Nuffield Trust and The Health Foundation. The think tanks said the NHS will need an extra £900 million in annual funding for training and developing staff and an additional 5,000 nurses recruited abroad each year until 2023-24 to address the workforce gap.

* Medtronic PLC's Conexus telemetry system, used to control and monitor the medical device company's implantable cardiac defibrillators, has been found to be at risk of exploitation and consequent interference by attackers within radio range, the U.S. Department of Homeland Security's Cybersecurity and Infrastructure Security Agency warned. The vulnerable products, which include the CareLink Programmer used by doctors to monitor implanted cardiac defibrillators, could potentially be intercepted by even low skill level attackers, the agency said in a March 21 advisory, rating the risk at 9.3 out of 10.

M&A and capital markets

* The CEO of Tianjin-based vaccine maker CanSino Biologics Inc., which plans to list in Hong Kong on March 28, is betting that his company can close the gap on vaccine manufacturing in China, where scandals in recent years have roiled the industry and created a crisis of confidence in the public sphere. The uproar over domestically produced vaccines mounted in 2018 after immunizations manufactured by Changsheng Bio-Technology Co. Ltd. for rabies, diphtheria, pertussis, whooping cough and tetanus were found to be faulty.

Drug and product pipeline

* In a draft report, the Institute for Clinical and Economic Review said esketamine was found to be effective for patients with treatment-resistant depression, with subjects receiving the drug plus antidepressant showing greater improvement in symptoms compared to those having placebo plus antidepressant. ICER, however, noted that the annual costs of esketamine are substantially higher than those of ketamine. The organization said the effectiveness of esketamine alone, without a change to the current antidepressant regimen, is not known at this time.

* GlaxoSmithKline PLC's experimental drug GSK2857916 lowered levels of blood cancer in certain patients during an early-stage study. The phase 1/2 study, named Dreamm-1, showed that the drug lowered the levels of disease in 60% of patients in the trial with multiple myeloma whose cancer had returned or was not responding to treatment. This data was identical to what was seen in a prior interim analysis, after more than a year of follow-up.

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* OPKO Health Inc.'s shares climbed over 8% after the company said its drug OPK88003 was better than placebo at reducing average blood glucose and weight in adults with type 2 diabetes and obesity in a mid-stage trial. The Miami-based biotechnology company evaluated the effect of increasing the dose of once-weekly injections of OPK88003 against placebo in 113 diabetes patients who had poor glucose control with metformin, a commonly prescribed generic drug.

* Genmab A/S said Johnson & Johnson submitted an application to the European Medicines Agency for the approval of Darzalex, also called daratumumab — in combination with lenalidomide, sold by Celgene Corp. as Revlimid, and dexamethasone — to treat newly diagnosed patients with multiple myeloma, a type of blood cancer, who are not candidates for high dose chemotherapy and autologous stem cell transplant. In 2012, Genmab granted J&J unit Janssen Pharmaceutica NV an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Operational activity

* Roche Holding AG filed a lawsuit alleging that former executives of Utah-based Alliance Medical Holdings, including former CEO Jeffrey Smith, profited from sales of low-priced diabetes test strips, Reuters reported. Roche claimed that the defendants sought fraudulent reimbursements that caused the Swiss drugmaker to wrongfully pay more than $87 million in rebates.

* Johnson & Johnson said it will record an intangible asset impairment charge related to the discontinued drug AL-8176, an investigational drug intended for treating respiratory syncytial virus, which causes lung and respiratory tract infections, and human metapneumovirus, which can cause upper and lower respiratory diseases. The impairment charge of about $700 million will be reflected in the company's first-quarter earnings.

* United Parcel Service Inc. is looking to test a U.S. service that brings nurses to patients' homes to vaccinate them, Reuters reported. Merck & Co. Inc. said it is considering collaborating with UPS, the world's largest package delivery company, for the initiative.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng rose 0.14% to 29,113.36, while the Nikkei 225 gained 0.09% to 21,627.34.

In Europe, around midday, the FTSE 100 was down 0.83% to 7,294.13, and the Euronext 100 decreased 0.99% to 1,037.66.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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