FDA bars critic from review panel of Biogen's controversial Alzheimer's drug

The U.S. Food and Drug Administration, citing conflict of interest, has recused a member of an 11-person advisory committee set to review Biogen Inc’s experimental Alzheimer’s drug aducanumab on Friday.

Mayo Clinic neurologist Dr. David Knopman confirmed on Monday that he was recused from the scheduled meeting of outside advisors to the FDA. Expert advisory panels often play an important role ahead of FDA approval decisions, although the agency is not required to take their advice.

Knopman, who said he was recused because of his involvement in conducting clinical trials of aducanumab, has been a vocal critic of the drug, including in a paper published on Sunday in the journal Alzheimer’s & Dementia.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” he wrote.

The FDA, which is slated to decide by early March whether to approve aducanumab, did not immediately respond to a request for comment.

If approved, aducanumab would be the first drug to treat an underlying cause of the fatal, mind-wasting disease, a field that has for decades produced nothing but failure. By 2025, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 7.1 million in the United States alone, according to the Alzheimer’s Association.

Biogen has said aducanumab, an antibody designed to remove harmful plaques from the brain, was shown in one of two major studies to significantly slow cognitive and functional decline. A second trial, however, showed a benefit only for a subset of patients who were given a high dose for at least 10 months.

Biogen abruptly ended a pivotal trial of aducanumab last year after an early look at results suggested it did not provide a desired benefit. Months later, the biotech company shocked many by reversing course, saying it had decided to seek FDA approval after all.

https://www.reuters.com/article/us-biogen-alzheimers-fda/fda-bars-critic-from-review-panel-of-biogens-controversial-alzheimers-drug-idUSKBN27I2DL

Britain extends payment freeze to coronavirus-hit borrowers

Britain’s financial watchdog said on Monday it would extend payment holidays on credit cards, car finance, personal loans and pawned goods before tougher coronavirus restrictions come into effect this week.

The Financial Conduct Authority (FCA) also extended until January the availability of deferrals for mortgage payments after Britain announced a one-month lockdown across England would start on Thursday to contain a second wave of the pandemic.

Consumers who have not yet had a credit payment deferral under guidance issued in July can request one that lasts for up to six months, the FCA said in a statement.

Borrowers who have already had one deferral would be able to apply for a second, the FCA said.

“Borrowers should only take up this support if they need it,” the statement added.

For high-cost, short-term credit such as payday loans, consumers could apply for a payment deferral of one month if they have not already had one, the FCA said.

“We will work with trade bodies and lenders on how to implement these proposals as quickly as possible, and will make another announcement shortly,” the FCA said.

The new lockdown coincides with the traditional start of the Christmas shopping season, a time of heavier use of credit cards and a critical period for retailers seeking to stay in the black for the year.

The FCA said it was also proposing that mortgage borrowers that have not yet asked for a repayment holiday could request one for up to six months in total duration.

Those who had already obtained an initial three-month deferral under guidance that expired last month, or have begun repayments on an initial deferral, could now request another three-month payment holiday, the FCA said.

Mortgage borrowers would have until Jan. 31, 2021 to request a deferral, and no one will have their home repossessed without their agreement until after that date, the watchdog proposed.

The proposals have been put out to public consultation until Thursday before final guidance is published.

“Lenders will provide information after today’s announcement on how to apply for this support,” said Eric Leenders, managing director of personal finance at UK Finance, a banking industry body.

https://www.reuters.com/article/us-britain-banks-credit/britain-extends-payment-freeze-to-coronavirus-hit-borrowers-idUSKBN27I0LX

Massachusetts announces Stay-at-Home pandemic restrictions

• Beginning on Friday, all residents of the state are advised to stay at home between the hours of 10 PM and 5 AM, according to a Department of Public Health Advisory.
• Gatherings during those hours in one's home with anyone outside of the household are verboten. Mask wearing is required when outside the home, even if socially distanced.
• Gatherings inside of homes are limited to 10 people, and outside to 25.
• Governor Charlie Baker is also mandating a 9:30 PM closing time for many businesses.
• Schools will remain open, with the governor noting kids in schools are not spreading events. At issue in causing spread, he says, are social events inside homes - mainly with young folks not being masked.
• https://seekingalpha.com/news/3629894-massachusetts-announces-stay-home-pandemic-restrictions
  

Germany requests 5% of EU supply of Gilead remdesivir

Germany has requested around 5% of the supply of remdesivir under a six-month European Union supply deal, its health ministry said on Monday, despite criticism of the deal due to a lack of evidence about the antiviral drug's effectiveness in treating COVID-19.

Berlin has requested 155,000 vials of remdesivir under the EU's six-month deal to buy up to 3 million vials from U.S. drug maker Gilead, the ministry said in a statement.

A course of treatment for COVID-19 requires six doses and costs 2,070 euros ($2,407) per treatment, under the terms of the deal.

Medical experts have called on Brussels to renegotiate the 1 billion euro contract signed with Gilead last month after remdesivir showed poor results in a large trial conducted by the World Health Organization.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-Germany-requests-5-of-EU-supply-of-remdesivir-31674521/

Regeneron slams the brakes on rare bone disease trial after patient deaths

Regeneron paused the phase 2 trial of its rare bone disease drug after multiple patients died in the extension part of the study. The company is reviewing the data “to better understand” the drug’s benefit-risk profile and has alerted regulators and the study’s independent data monitoring committee to the deaths.

The patients died in the open-label extension of the trial, in which all patients received the drug, garetosmab, Regeneron said in a statement Friday. This part of the study followed a 28-week period in which patients received either garetosmab or placebo. No patients died in the placebo-controlled portion of the study, the company said.

The company did not specify how many patients had died, nor did it say whether those patients had been in the garetosmab or placebo arms in the first part of the study.

Regeneron is developing garetosmab for patients with the inherited disorder fibrodysplasia ossificans progressiva (FOP), whose muscles and soft tissue gradually transform into bone, making movement difficult or impossible. This transformation sometimes happens spontaneously, but often follows an injury or illness. There is no treatment for FOP, but doctors may prescribe drugs to relieve pain and swelling.

The drug is designed to reduce the formation of heterotopic bone—or bone in the wrong place—by neutralizing the Activin A protein.

The phase 2 study, LUMINA-1, pitted garetosmab against placebo in 44 patients with FOP of varying severity, aged 18 to 60. Some patients in the study had difficulty moving specific parts of their body, while others had “near-total immobility.” Regeneron had planned to discuss a filing with regulators based on results from the first part of the study it unveiled in January.

After 28 weeks of treatment, patients taking garetosmab saw a 25% reduction in the number of bone lesions and a 90% drop in new bone lesions, Regeneron announced in January. The drug also beat placebo at preventing flare-ups, or episodes of localized inflammation, with a flare-up rate of 10% for the garetosmab arm compared to 42% for placebo.

As for safety, patients in both treatment arms experienced side effects, with all 24 placebo patients and 19 out of 20 garetosmab patients finishing the 28 weeks of treatment. Most side effects were mild to moderate, but two patients developed serious abscesses that required hospitalization during the open-label extension. Both continued on garetosmab.

https://www.fiercebiotech.com/biotech/regeneron-slams-brakes-rare-bone-disease-trial-after-patient-deaths

Siemens Healthineers Expects Growth in 2021 on Demand Recovery

--Siemens Healthineers issued guidance for fiscal 2021, expecting comparable revenue growth of between 5% and 8% from fiscal 2020

--The outlook is based on evidence that demand for therapies for chronic diseases is high, but also conditional on no further measures against Covid-19

--The German medical-equipment maker's profit and revenue declined in its fourth quarter

Siemens Healthineers AG said Monday that it expects growth in fiscal 2021 as routine testing is seen getting back to normal levels after declining due to the coronavirus pandemic.

The German medical-equipment maker issued guidance for fiscal 2021, saying it expects comparable revenue growth of between 5% and 8%. The company reported revenue of 14.46 billion euros ($16.84 billion) for its year ended Sept. 30.

Adjusted basic earnings per share are set to be between EUR1.58 and EUR1.72, compared with fiscal 2020 comparable EPS of EUR1.61. 

Siemens Healthineers said the outlook is based on the assumption that measures to stem the spread of the coronavirus won't affect demand.

During a call with reporters, management said the company is optimistic in their outlook for fiscal 2021, with drivers such as demand for therapies for chronic diseases still strong.

The company also proposed a dividend of EUR0.80 per share, corresponding to a pay-out ratio of 60% of net income.

In its fourth quarter, the company reported a decline in earnings and revenue, posting net income of 432 million euros ($503.1 million) for the period, down from EUR507 million a year earlier.

Revenue came in at EUR3.88 billion for the quarter, compared with EUR4.14 billion the previous year.

A consensus estimate provided by Vara Research had quarterly net profit at EUR402 million and quarterly revenue at EUR3.90 billion.

Adjusted basic earnings per share were EUR0.48 in the quarter down from EUR0.54 the year prior.

Adjusted basic earnings per share were EUR0.48 in the quarter down from EUR0.54 the year prior.

The company's equipment book-to-bill ratio--or the ratio of orders to revenue--was 1.15 in the fourth quarter, supported by major long-term contracts in the U.S., it said

https://www.marketscreener.com/quote/stock/SIEMENS-HEALTHINEERS-AG-42379342/news/Siemens-Healthineers-Expects-Growth-in-2021-on-Demand-Recovery-Update-31670940/

CureVac's COVID-19 vaccine triggers immune response in Phase I trial

CureVac’s experimental COVID-19 vaccine triggered an immune response in humans, the German biotech firm said on Monday, putting it on track to start mass testing this year as the race to end the pandemic heats up.

“We are very encouraged by the interim Phase I data,” Chief Executive Officer Franz-Werner Haas said in a statement.

The biotech firm is using the so-called messenger RNA (mRNA) approach, the same as Moderna as well as BioNTech and its partner Pfizer, although they started mass testing on humans in late July.

CureVac said its potential vaccine, known as CVnCoV, was generally well tolerated and trial results strongly supported the company’s plans to launch the final stage of testing involving about 30,000 participants before the end of the year.

CureVac - backed by German biotech investor Dietmar Hopp, the Gates Foundation and GlaxoSmithKline - said volunteers developed a level of neutralising antibodies on a par with people who had recovered from a serious case of COVID-19.

The pandemic, which has claimed more than 1.2 million lives globally, has triggered a scramble to develop a vaccine with about 45 experimental compounds being tested on humans.

Britain’s AstraZeneca, working with the University of Oxford, is also among the leading contenders with late-stage trial results expected this year. Their candidate is based on another virus, rather than mRNA, to deliver genetic instructions into the body for an immunisation effect.

Anthony Fauci, the top U.S. infectious diseases expert, said on Thursday that the first doses of a safe and effective coronavirus vaccine will likely become available to some high-risk Americans in late December or early January.

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CureVac’s hopes of offering a vaccine at much lower doses than its mRNA competitors may have been dented as it has picked the highest concentration of five dosages - from 2 to 12 micrograms per shot - for its prospective Phase III trial.

BioNTech and Pfizer have said the 30 microgram shot they opted for in their late-stage trial had previously been shown to produce antibody levels above those registered in people who had recovered from COVID-19.

Moderna, which like BioNTech expects to have the first efficacy data from its mass trial this month, is testing a 100 microgram shot that has also been shown to trigger an antibody response above that of recovered patients.

A CureVac spokesman said even at 12 micrograms its dosage was still a relatively low.

CureVac has said it was looking into a potential partnership with a major pharmaceutical company as it seeks to scale up development, production and distribution. The spokesman said on Monday that the firm was looking into various options.

The 20-year-old company, which went public on the Nasdaq exchange in August, said its Phase I study has so far enrolled more than 250 healthy individuals aged 18 to 60 years in Germany and Belgium.

It said its inoculation appears to also generate T cells against the coronavirus, another key indicator of an effective immune system arsenal, but more analysis of this was ongoing.

CureVac said side effects occurred mostly after the second injection of its two-dose regimen and included fatigue, headache, chills, muscle pain and, to a lesser extent, fever.

These conditions “resolved rapidly, usually within 24 to 48 hours”, it said.

https://www.reuters.com/article/us-health-coronavirus-germany-curevac/curevacs-covid-19-vaccine-triggers-immune-response-in-phase-i-trial-idUSKBN27I1DB