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Saturday, February 8, 2020

WHO: Transmission of new coronavirus outside of China could increase

The World Health Organization’s director-general cautioned Saturday that transmission of the new coronavirus outside of China may increase and countries should prepare for that possibility.
“It’s slow now, but it may accelerate,” Tedros Adhanom Ghebreyesus said during a press conference in Geneva. “So while it’s still slow there is a window of opportunity that we should use to the maximum in order to have a better outcome, and further decrease the progress and stop it.”
Tedros’s warning came after health authorities in Singapore announced they had diagnosed the infection in a man with no travel history to China and no known link to other cases in Singapore.
Singaporean authorities suggested — but did not order — that large public events be canceled or deferred. If public events are held, temperature screening of attendees should be conducted and people who are unwell should be turned away, they said.
In Germany, health officials announced the 12th case in a cluster of transmission of the new virus — known provisionally as 2019-nCoV — that began when a Chinese woman who works for a German car parts supplier traveled to the company’s head office in Bavaria for meetings. The latest case is the wife of an employee of the company, who himself was confirmed as having the infection last week.
Also on Saturday, British health officials announced that five Britons who were at a ski resort in France were infected. The five — four adults and a child — had been in contact with a British man who had recently been in Singapore. That man was confirmed as a case on Thursday.
As of Saturday, there have been 34,598 confirmed cases in China and 288 cases reported by 24 countries outside of China, Tedros said. There have been roughly 730 deaths, most in China. It was reported Saturday that an American man who had been infected with the virus and treated in China had died.
The WHO has been insisting that containment of the virus — stopping the outbreak — was still the goal of the response. China has used unprecedented measures to try to stop the spread, including quarantining entire cities that are home to tens of millions of people.
The WHO has pointed to the fact that although cases of infection with this coronavirus have been detected outside of China, transmission of the virus in other countries has been limited.
During the press conference on Saturday, the head of WHO’s health emergencies program, Dr. Mike Ryan, said at this point it’s not clear why little transmission has occurred outside of China.
“The question remains as to whether we’re in a lag phase and the rate of infection [outside China] may pick up, or whether we’re seeing what is the natural history of the disease. It’s way too soon to tell,” Ryan said.
Infectious diseases expert Michael Osterholm warned that it is unwise to conclude that just because the world hasn’t yet seen outbreaks in other countries they won’t happen. It takes several generations of transmission — an imported case passed on to two others, who then infect two others and so on — before an outbreak takes off, he said.
“What we’re watching is the public health community trying to catch up to the speed of the virus,” said Osterholm, who is the director of the University of Minnesota’s Center for Infectious Diseases Research and Policy.
WHO cautions that transmission of the new coronavirus outside of China could increase

Biotechs in San Diego Join Race to Combat Coronavirus

Chinese scientists on Jan. 10 shared online the genetic sequence of a deadly strain of coronavirus. The next day, Inovio Pharmaceuticals whipped up a potential vaccine.
A crop of life sciences companies are rushing to combat the coronavirus outbreak, triggering big movements in their stocks and millions in grant funding. Part of the race is playing out in San Diego, home to Inovio’s research and development division, with others locally turning toward the disease.
The Coalition for Epidemic Preparedness Innovations awarded up to a $9 million grant to support Inovio’s vaccine. It’s in preclinical testing and could move into human trials by early summer.
While regulators could fast-track Inovio’s program, analysts have cautioned that a vaccine might not be approved for the wider public for at least a year.
“We’re going to move as fast as we can,” Inovio CEO Joseph Kim said over the phone.
Inovio’s technology revolves around DNA. So, the company only needed the genetic profile of the virus, instead of a sample of it, to develop a vaccine.
“We were able to rapidly respond,” Kim said. “This is a great opportunity for us to demonstrate the power of our DNA medicines platform.”
The new coronavirus, known as 2019-nCoV, originated in the Chinese city Wuhan. As of Feb. 5, more than 27,000 people worldwide have been infected, and 563 people have died from the disease. It lacks an approved vaccine or treatment.
Other drugmakers pursuing 2019-nCoV vaccines include Moderna, a Massachusetts company that also secured grant money.
Some pharmaceuticals want to repurpose existing drugs for 2019-nCoV.
Gilead Sciences in late January struck an agreement with Chinese authorities to test its experimental drug for the Ebola virus in coronavirus patients. The company is headquartered in Foster City, Calif.
Kim said Inovio’s work on related viruses prepared the company for 2019-nCoV.
In 2018, the Coalition for Epidemic Preparedness Innovations — the same Norwegian group that awarded Inovio the recent grant — gave the company $56 million to support clinical testing of vaccines for Lassa fever and Middle East Respiratory Syndrome, which also fall into the coronavirus family.
Inovio is based in Pennsylvania but has more than 165 employees in San Diego, the center of its 2019-nCoV endeavor.
Kim noted the company could land additional grant money to offset 2019-nCoV vaccine development and clinical testing costs. As such, he believes the potential vaccine could be profitable.

Virus Could Dissipate

But 2019-nCoV could dissipate before drugmakers reach the market with vaccines, leaving little demand. This has happened with other viruses.
“This is not an established market where you know you’re going to be able to sell a certain number of drugs,” said John McCamant, editor of the Medical Technology Stock Letter that’s aimed at investors.
He added the outbreak brought volatility to some biotech stocks. Certain investors are hunting for companies poised to benefit from coronavirus, while others are betting against these stocks.
Inovio saw stock trading volumes swell on Jan. 24 following the grant announcement. Its stock price also jumped, but the gains were largely erased by Feb. 5, with shares closing at $3.56.

Investor Interest

Investors are watching other Inovio programs. Its furthest along is VGX-3100, currently in a late-stage clinical trial to treat precancerous cervical lesions and infection brought on by HPV, or human papillomavirus.
With coronavirus spreading, another stock that’s been heavily traded: Aethlon Medical, amid speculation that the San Diego company could set its sights on 2019-nCoV. Its device has regulatory clearance to treat life-threatening viruses without approved therapies.
CEO Timothy Rodell said it’s unclear whether the company’s blood-filtration device could be of use for a virus that affects the respiratory system and digestive tract.
“We’re looking to be prepared if, in fact, it turns out we could be helpful,” Rodell said. “And we’re going to continue to do that with this epidemic, and incidentally with all the other epidemics to come.”
In late January, the World Health Organization declared 2019-nCoV a global emergency. Rodell, a physician by training, noted for perspective that the flu is deadlier and more widespread.
This influenza season in the U.S. has seen an estimated 19 million cases of flu, 180,000 hospitalizations and 10,000 deaths, according to the Centers for Disease Control and Prevention.
San Diego’s Ligand Pharmaceuticals helps pharmaceuticals discover and develop medicines — including for coronavirus. Its technology to boost drug solubility is baked into Gilead’s drug that’s undergoing testing for 2019-nCoV.
Other Ligand programs could shape additional coronavirus treatments in the works, the firm said. Unlike other companies associated with battling Coronavirus, Ligand’s stock avoided volatility.
Matt Foehr, president and chief operating officer of Ligand, said it’s too early to say whether coronavirus will be a major business driver.
“Time will tell,” he said.
Biotechs in San Diego Join Race to Combat Coronavirus

Despite Calls to Lower Drug Prices, Over 600 Medications Saw Increases in January

Even as lawmakers debate and malign proposed plans to lower the costs of prescription drugs in the United States, since the start of the year, prices have increased on more than 600 prescription drugs by an average of 5.2%.
That figure is based on an ongoing pricing analysis conducted by the organization GoodRx. According to the report, 100 different drug manufacturers increased prices on 619 drugs in the month of January. That is slightly higher than the first month of 2019, which saw 486 brand drugs increased by an average of 5.2%. In 2018, there were price increases on 580 branded drugs by an average of 8%, GoodRx reported.
Like last year, the price increases in January 2020 happened over the course of the month in something of a slower rollout. It was a similar pattern as to 2019’s price increases, the group said. The year before though, almost 90% of all price increases happened during the first week of January, GoodRx said.
January is the most common month for drug companies to increase prices. In fact, on Jan. 1, 2020, there were more than 250 drugs that saw an increase in price between 1% and 10%, with the average increase falling at about 5%. Over the past four years, the median increase has been 9% and 10%, according to an analysis conducted by healthcare research firm 3 Axis Advisors.
Some of the drugs that saw price increases during the month of January are among the costliest of medications according to their list prices, GoodRx noted. Among those is Humira, the blockbuster rheumatoid arthritis treatment, which saw a price hike of 7.4% this year. That followed increases of 9.7% in 2018 and 6.2% in 2019.
Other drugs that GoodRx singled out for increases this year include:
  • Xarelto: 4.9% increase
  • Spiriva: 6% increase
  • Myalept: 9.9% increase
  • Juxtapid: 9.9% increase
  • Jardiance: 4.9% increase
  • Januvia: 4.9% increase
  • Flovent: 3% increase
  • Eliquis: 6% increase
  • Chantix: 5% increase
  • Breo Ellipta: 3% increase
As drug prices continue to play a central role in U.S. electoral politics, many drug companies have pledged to keep price increases below 10%. However, there were also a couple of outlier drugs that saw price increases above 10% this year, GoodRx said. The group pointed to the antidepressant Marplan, which saw a 14.9% increase and ADHD treatment Cotempla XR, which increased 12.3%.
The list price is the price set by drug manufacturers and is then negotiated by payers. The list price is rarely the retail price a consumer pays.
https://www.biospace.com/article/more-than-600-drugs-saw-price-increases-in-january-analysis-shows/

Biotech Q4 Earnings: Restructuring, Overall Growth Are Themes

It was a busy week for biotech quarterly and annual reports. Here’s a look at some of the top stories.
Bristol-Myers Squibb announced fourth-quarter revenues of $7.9 billion, hitting a total of $26.1 billion for the full year. The big news for the year, of course, was its $74 billion acquisition of Celgene. At this time, the company is still reorganizing the assets and operations from that deal, although it also took time this week to announce that with drug development accelerator BioMotiv it was jointly launching Anteros Pharmaceuticals to focus on a new class of drugs for fibrotic and inflammatory diseases.
BioMotiv and Bristol-Myers Squibb inked a Strategic Partnership Agreement in September 2019. The intellectual property involved in the launch was developed at Yale University and in-licensed by Bristol-Myers Squib, and now is assigned to Anteros. This is the first company that has come out of the Strategic Partnership deal. The agreement allows Bristol-Myers Squibb to become a limited partner with BioMotiv with an option to invest further in selected projects. Once a preclinical candidate is identified, Bristol-Myers has the option to acquire the company from BioMotiv.
“By all measures, 2019 was a transformative year for Bristol-Myers Squibb as we progressed our strategy through the acquisition of Celgene, delivered strong operational and financial performance, and continued to drive important science for patients,” said Giovanni Caforio, Bristol-Myers Squibb’s chairman and chief executive officer.
AbbVie reported net revenues of $8.704 billion for the quarter, an increase of 4.8% on a reported basis from the same period last year. For the full year, the company reported $33.296 billion in revenue, up from $32.753 billion in 2018. The biggest news for last year was its acquisition of Ireland-based Allergan for $63 billion.
“Our strong performance this quarter completes another excellent year for AbbVie,” said Richard A. Gonzalez, chairman and chief executive officer of AbbVie. “The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter.”
Novo Nordisk announced its operating profit increased by 11% for the full year in Danish kroner and by 6% at constant exchange rates (CER). The company’s Diabetes and Obesity care sales grew by 10% in kroner and 6% CER, driven by Diabetes care of 4% CER and Obesity by 42% CER. Biopharma sales increased by 7% by kroner and 4% at CER.
“We are very satisfied with the financial performance in 2019,” said Lars Fruergaard Jorgensen, president and chief executive officer of Novo Nordisk. “The results reflect an accelerated sales growth in International Operations and a strong launch of Ozempic in particular in North America Operations and Region Europe. The Rybelsus launch in the USA is off to a good start, and we are pleased with the CV label indication for Ozempic in the USA, and the EU recommendation to approve Rybelsus, all for the benefit of patients.”
Merck reported fourth quarter sales globally of $11.9 billion, an increase of 8%. The full-year 2019 sales were $44.6 billion, up 11%. The sales were somewhat overshadowed by the announcement the company was spinning off products from its Women’s Health, Legacy Brands, and Biosimilars businesses. It plans to launch a new, independent, publicly-traded company to handle those products. No name for the new company has been announced.
“Over the past several years, we have purposefully shifted the focus of our efforts and resources to our best opportunities for growth,” said Kenneth C. Frazier, chairman and chief executive officer of Merck.
Frazier added, “This has led to the exceptional results we are reporting today. Given the opportunities now in front of us, we believe we can benefit from even greater focus. At the same time, we believe additional resources and focus will help ensure that our expansive portfolio, including many trusted and medical important products, reach their full potential.”
The argument is that the spinoff will result in two independent growth companies. They are expected to have improved strategic and operational focus, more flexibility to respond to customer needs and the market, simplified operating models, optimized capital structures and resource allocation, and better financial profiles for “unique and compelling investment cases.”
The new company will decrease Merck’s Human Health manufacturing footprint by about 25% and the number of Human Health products by about 50%.
https://www.biospace.com/article/q4-roundup-bristol-myers-squibb-abbvie-novo-nordisk-merck-gsk-and-sanofi/

Sell-siders on board with Bristol-Myers Squibb’s Q4 & outlook

Takeaways from Bristol-Myers Squibb’s (BMY -1.5%) Q4 beat this week:
Goldman’s Terence Flynn (Buy/$79): Solid Q4 and initial guidance for the combined company a “good starting point.” Believes EPS guidance for 2021 is “encouraging” but notes that expected EPS in 2022 reflects a “moderated” pace.
Guggenheim’s Seamus Fernandez (Neutral): Solid Q4, believes sales growth will be fine as it integrates Celgene. 2020/2021 guidance a relief to investors concerned with Otezla divestment.
JPMorgan’s Chris Schott (Overweight/$74): Solid Q4 with no major surprises. Key catalysts this year will be data readouts on Opdivo, BMS-986165 and Celgene pipeline.
Atlantic Securities’ Steve Chesney (Overweight/$78): Guidance provided a “comforting” look at near-term top and bottom growth prospects. Multiple pipeline updates could stoke share appreciation.
https://seekingalpha.com/news/3539775-sell-siders-on-board-bristol-myers-squibbs-q4-outlook

Tesla aims for restart in Shanghai next week

Tesla (NASDAQ:TSLA) is expected to resume production at its Shanghai factory on February 10.
Government officials in Shanghai will assist Tesla in the restart amid the coronavirus outbreak.
“In view of the practical difficulties key manufacturing firms including Tesla have faced in resuming production, we will coordinate to make all efforts to help companies resume production as soon as possible,” stated Shanghai municipal government spokesman Xu Wei.
Tesla warned on January 30 of a Model 3 production delay in China of a week to 1.5 weeks.
https://seekingalpha.com/news/3539869-tesla-aims-for-restart-in-shanghai-next-week

China confirms New Coronavirus infection through air via aerosol

China’s official health department confirmed on Saturday (February 8) that the new coronavirus can be transmitted through the air.
At a press conference held in Shanghai, health and epidemic prevention experts confirmed that in addition to direct transmission and contact transmission, the transmission route of New Coronary Pneumonia also includes “aerosol transmission”.
Aerosol is a colloidal dispersion system formed by solid or liquid small particles dispersed and suspended in a gaseous medium. In simple terms, aerosols are small liquid or solid particles that are stably dispersed and suspended in the air and cannot be seen by the naked eye.
The so-called “aerosol transmission” means that the droplets are mixed in the air to form an “aerosol”, which causes infection after inhalation.
Previously, on February 5, the National Health and Medical Commission’s website published the “Diagnosis and Treatment of New Coronavirus Infected Pneumonia (Trial Fifth Edition)”. To be determined “.
After an interval of 3 days, the aerosol transmission route was confirmed by the official Chinese health department.
The difference between aerosol and droplet transmission is the distance of transmission. Droplets and contact infections occur within a short range, while aerosols travel long distances, increasing the risk of contactless infection.
Aerosol infection
As the Chinese Lunar New Year Lantern Festival comes, health authorities warn that the virus is spreading among family members.
The Shanghai Health Department announced on February 8 that only 8 days and a half days, 5 new cases were confirmed, of which 2 were from overseas and 3 were residents of Shanghai. The total number of confirmed cases was 286.
Zeng Qun, deputy director of the Shanghai Civil Affairs Bureau, said at a press conference that the community is urged to pay attention to the prevention of cluster epidemics and to increase the awareness of family cluster epidemic prevention.
We must cancel all social gatherings and discourage relatives and friends in key epidemic areas from postponing their plans to Shanghai;
Normally open windows and more ventilation to maintain indoor air circulation;
Do daily household disinfection: wipe key points such as door handles, tables, chairs, and toilet seat cushions with 75% ethanol or chlorine-containing disinfectant;
Personal hygiene: Wash your hands with running water, soap or hand sanitizer before and after meals. Cover your mouth and nose with a tissue or elbow flexion when coughing or sneezing;
Avoid air and contact transmission: Family members should avoid contact with body secretions of people with suspicious symptoms, and do not share personal daily necessities; during meals, chopsticks are divided into meals, eat fast, talk less, communicate with each other, avoid handshake and hugs, smile with hands etiquette.
Epidemic prevention experts also recommend that, as a precautionary measure, remember to put on the toilet lid and flush the suspicious patient in your home before flushing the toilet.
After the spread of the Wuhan epidemic led to the Chinese authorities ’decision to block the city on January 23 to prevent epidemics, traffic in Wuhan, Hubei and surrounding provinces was severely affected. Airlines from multiple countries have suspended flights to and from Wuhan.
Wuhan, known as the “nine provinces’ thoroughfare”, is not only a transportation hub in China, but also a major industrial town in China. There are no statistics on the economic impact of the closure of Wuhan.
As Shanghai, the economic center of eastern China, if the epidemic is out of control, the impact on China and the world economy will be immeasurable.
Hong Kong isolation measures
The pneumonia epidemic caused by the new coronavirus spreading from Wuhan has still not shown signs of abating. Epidemic prevention measures in many countries and regions in the world are also tightening.
From Saturday (8th) in Hong Kong, all people entering Hong Kong from mainland China, including Hong Kong residents and foreign visitors, must be quarantined for 14 days: at home, in a hotel room or in a government isolation center.
A total of 26 confirmed cases from Hong Kong to Friday. The strike by medical staff in Hong Kong, which began on February 3, was also suspended on Saturday.
From January 30 to February 4, the Hong Kong government closed 10 entry and exit ports with mainland China. In response to the recent tide of people buying food and household goods in Hong Kong, the Hong Kong government stated that the epidemic prevention and control measures will not affect the mainland and Hong Kong’s freight traffic, and there is sufficient food supply.
Outbreak
As of February 7, more than 30,000 people have been diagnosed with infection in China, and the death toll has exceeded 700.
According to the World Health Organization, 270 cases have occurred in more than 20 countries outside mainland China.
In Wuhan, China, an American citizen has died of a new coronavirus. This is believed to be the first foreigner to die from the virus infection. Media reports said that the 60-year-old American woman had other health problems before her death.
In addition, the Japanese Ministry of Foreign Affairs said that a Japanese citizen who died in Wuhan Hospital had obvious symptoms of infection with the new coronavirus.
French health authorities have confirmed that five British tourists, four adults and one child, have been diagnosed with a virus in a ski area on the border between Italy and Switzerland in Haute-Savoie, eastern France. One of them has been to Singapore recently.
Three cases have been confirmed in the UK. Two of them were Chinese citizens, and the third was a British returning from Singapore.
Britain has so far withdrawn two groups of diasporas from China, both of which have been separated for 14 days.
About 150 people in the third batch of British evacuated people will leave China on Sunday (9th) and will be taken to a convention centre in Milton Keynes in central England for 14 days.
The UK Department of Health and Social Security announced that by Friday afternoon (7th) a total of 620 suspected cases had been detected in the UK and only 3 were confirmed.
https://www.bbc.com/zhongwen/simp/world-51427216