Search This Blog

Tuesday, February 4, 2020

Lonza keeps Chinese plants on ‘holiday’ as coronavirus builds momentum

Swiss CDMO Lonza is extending the Chinese New Year break at its four plants in China, but not to celebrate. The unplanned extension is a precaution as coronavirus continues to spread rapidly through the country.
The company is also imposing restrictions on travel to, from and within the country and requiring a two-week in-home quarantine on employees traveling from China to make sure there is no spread of the virus.
“As a responsible employer, we have taken measures to protect our employees and any third parties visiting our sites in China,” Lonza said.
Lonza said today it has halted operations at a drug formulation and pyromellitic dianhydride production plant in Nanjing, Jiangsu; a plant in Nansha, Guangdong that makes small molecule APIs and niacin; a plant in Suzhou, Jiangsu that makes drug capsules and microbial control solutions; and its biologics plant Guangzhou, Guangdong that is under construction so not operational.
It has no production facilities in the Hubei Province where the outbreak was first discovered, it said but is taking the steps as a precaution. It said most of the plants have decided to extend the holiday into this week as authorities monitor the outbreak.
The extended closure so far has resulted in only limited disruption of supplies, the CDMO said, but it is “assessing the impact” of potential delays to raw materials and finished products as the outbreak’s effects continue.
Lonza’s announcement follows that of Chinese CDMO WuXi Biologics which last week assured clients and the public that the spread of the virus would not affect its drug production schedule. As of a week ago, it said it is “working vigilantly to execute our Business Continuity Plan to mitigate any potential risk” and to ensure its products are unaffected by the outbreak.
Big Pharma players like Pfizer and Roche say they are not exclusively dependent on any supplies from China but there are some areas of concern for U.S. patients. China manufactures an estimated 97% of the country’s antibiotics and many of the APIs used by drugmakers. While no serious supply issues have surfaced, the virus continues to spread and seems to be picking up momentum according to Chinese statistics.
The China National Health Commission reported that through yesterday, confirmed cases have grown more than 3,000 to 20,438 and that there were another 64 deaths, bringing the fatality number to 425.
The infections also are growing globally as countries take measures to try to shield themselves. The U.S., Australia, Singapore, New Zealand and Vietnam are not allowing non-residents who have been to China recently to enter their countries. The U.S. has seen nearly a dozen confirmed cases and reported its first person-to-person transmission inside the country.

FDA OKs emergency use of coronavirus test

The FDA has signed off on the emergency use of a molecular diagnostic test developed at the Centers for Disease Control and Prevention (CDC) for 2019-nCoV, the coronavirus causing the current outbreak.
The test, previously limited to use at CDC laboratories, can now be used at any CDC-qualified labs across the U.S.
Related tickers: XLV, CODX, DGX, LH
https://seekingalpha.com/news/3538280-fda-oks-emergency-use-of-coronavirus-test

International Team Develops Promising Broad-Spectrum Antiviral Compound

Drugs to fight viruses, known as antivirals, are relatively recent inventions, with the first approved being in 1982. Since then, numerous others have hit the market, typically to treat HIV, hepatitis, herpes and others. They generally work by inhibiting virus growth, although viruses often mutate and become resistant to these drugs.
An international team of researchers led by the University of Manchester has developed a new antiviral using natural glucose derivatives called cyclodextrins, a type of sugar, which shows promise in treating a broad range of viruses, including herpes simplex, respiratory syncytial virus, hepatitis C, HIV, and Zika virus.
The researchers were from The University of Manchester, the University of Geneva (UNIGE), and the EPFL in Lausanne, Switzerland. The modified sugar molecules were capable of disrupting the outer shell of the virus, destroying them on contact. This approach appears to be effective against drug resistant viruses as well. Their research was published in the journal Science Advances.
“We have successfully engineered a new molecule, which is a modified sugar that shows broad-spectrum antiviral properties,” said Samuel Jones, from The University of Manchester, who co-led the research with Valeria Cagno from the University of Geneva.
Jones went on to say, “We have successfully engineered a new molecule, which is a modified sugar that shows broad-spectrum antiviral properties. The antiviral mechanism is virucidal meaning that viruses struggle to develop resistance. As this is a new type of antiviral and one of the first to ever show broad-spectrum efficacy, it has the potential to be a game changer in treating viral infections.”
They have patented the molecule and a spinout biotech company is being launched to develop it for commercial use. The researchers believe it has the potential to be used in creams, ointments and nasal sprays, although that will require significant time and development.
The investigators wrote, “A drug with an irreversible action, i.e., a virucidal drug, could be ideal to fight viral infection, given that it would not be subject to loss of efficacy upon dilution and have long-lasting effects. All previously identified virucidal molecules have toxic side effects that render their clinical use impossible.”
Cyclodextrins are naturally occurring glucose derivatives. They are used in many commercial applications, including drug delivery, air fresheners, cosmetics and food. Sulfonated cyclodextrins have shown antiviral activity against HIV only and were reversible and virus specific. Highly sulfonated gold nanoparticles have shown broad-spectrum virucidal properties. However, gold nanoparticiles are problematic as drugs because of unknown clearance mechanisms and potential long-term toxicity.
The researchers attached highly sulfonated chemicals to a U.S. Food and Drug Administration (FDA)-approved cyclodextrin scaffold, which resulted in a highly efficient virucidal broad-spectrum molecule that was effective in the lab and in animal models. It showed broad-spectrum activity against a wide variety of viruses from different families of viruses.
“We developed a powerful molecule able to work against very different viruses, therefore, we think this could be game changing also for emerging infections,” said Fancesco Tapparel, one of the senior authors, a researcher with EPFL.
https://www.biospace.com/article/antiviral-made-from-sugar-shows-promise/

HHS, Regeneron collaborating on coronavirus treatment

The Department of Health and Human Services (HHS) said Tuesday that it is collaborating with Regeneron Pharmaceuticals on a coronavirus treatment.
HHS said it would work with the company on monoclonal antibodies, which help prevent a virus from infecting human cells.
Regeneron previously worked on this type of treatment for Ebola and Middle East respiratory syndrome.
HHS is working with the company through a unit known as the Biomedical Advanced Research and Development Authority (BARDA).
“Working as public-private partners like we have with Regeneron since 2014, we can move rapidly to respond to new global health threats,” said BARDA Director Rick Bright.
The department also launched a website on Friday that allows companies to report work they are doing that could be helpful for diagnosing, preventing or treating coronavirus.
The virus has set off warnings as it has spread in China, infecting thousands of people and killing hundreds.
Dr. Anthony Fauci, the top infectious disease doctor at the National Institutes of Health, has said he hopes to start a phase one clinical trial on a vaccine for coronavirus in as soon as three months.
“We’re already working on it,” Fauci told Bloomberg late last month. “And hopefully in a period of about three months, we’ll be able to start a phase one trial in humans.”
https://thehill.com/policy/healthcare/481376-hhs-pharmaceutical-firm-collaborating-on-coronavirus-treatment

Neurocrine Biosciences EPS beats by $0.30, beats on revenue

Neurocrine Biosciences (NASDAQ:NBIX): Q4 Non-GAAP EPS of $1.05 beats by $0.30; GAAP EPS of $0.35 misses by $0.41.
Revenue of $244.1M (+85.8% Y/Y) beats by $12.56M.
https://seekingalpha.com/news/3538160-neurocrine-biosciences-eps-beats-0_30-beats-on-revenue

Qiagen EPS beats by $0.04, beats on revenue

Qiagen (NYSE:QGEN): Q4 Non-GAAP EPS of $0.48 beats by $0.04; GAAP EPS of $0.19 misses by $0.07.
Revenue of $413.47M (+2.6% Y/Y) beats by $5.05M.
https://seekingalpha.com/news/3538193-qiagen-eps-beats-0_04-beats-on-revenue

Gilead’s Biktarvy leads Q4 sales growth

Gilead Sciences (NASDAQ:GILD) Q4 results:
Revenues: $5,879M (+1.4%); product sales: $5,796M (+2.0%); HIV: $4,577M (+12.6%).
Key product sales: Biktarvy: $1,570 (+171.6%); Genvoya: $958M (-20.6%); Truvada: $768M (-6.7%); Odefsey: $435M (-2.9%); Descovy: $437M (+6.3%); Yescarta: $122M (+50.6%).
Net income: $2,696M (+999%); non-GAAP net income: $1,653M (-11.7%); EPS: $2.12 (+999%); non-GAAP EPS: $1.30 (-9.7%).
2020 guidance: Product sales: $21,800M – 22,200M; EPS: $5.15 – 5.55; non-GAAP EPS: $6.05 – 6.45.
https://seekingalpha.com/news/3538200-gileads-biktarvy-leads-q4-sales-growth