Johnson & Johnson Expands Partnership With HHS to Find Coronavirus Treatment

February 18, 2020

Johnson & Johnson said it will work with the Rega Institute for Medical Research in Belgium to identify antiviral, therapeutic candidates to treat the disease caused by the novel coronavirus, in an expanded effort with the Department of Health and Human Services.

Janssen Pharmaceutical Cos., a J&J company, and the department’s Biomedical Advanced Research and Development Authority will share costs in discovering the treatment, the company said Tuesday.

J&J last week said it will work with HHS to accelerate the development of a potential coronavirus vaccine.

J&J shares rose 0.2%

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Expands-Partnership-With-HHS-to-Find-Coronavirus-Treatment-30013158/

China to grant tariff exemptions on 696 U.S. goods to support purchases

China will grant exemptions on retaliatory duties imposed against 696 U.S. goods, the most substantial tariff relief to be offered so far, as Beijing seeks to fulfill commitments made in its interim trade deal with the United States.

Tuesday’s announcement comes after the Phase 1 trade deal between the two countries took effect on Feb. 14 and is the third round of tariff exemptions China has offered on U.S. goods.

China has committed to boosting its purchases of goods and services from the United States by $200 billion over two years as part of the agreement, and has already rolled back some additional tariffs on U.S. imports after the deal was signed.

U.S. goods eligible for tariff exemptions include key agricultural and energy products such as pork, beef, soybeans, liquefied natural gas and crude oil, which were subject to extra tariffs imposed during the escalation of the bilateral trade dispute.

The coronavirus epidemic that emerged late last year in China has raised concerns about its ability to meet the purchasing targets, however. Authorities throughout the country imposed major restriction on travel and transportation to curb the spread of the virus, which has killed nearly 1,900 and infected more than 70,000 in the country.

The containment efforts have kept factories shut or operating with drastically reduced staff, hitting production. The public has also been discouraged from leaving their homes or going to public places, also stunting consumption.

White House adviser Larry Kudlow said earlier this month that Chinese President Xi Jinping told U.S. President Donald Trump during a recent call that China will still meet its Phase 1 trade deal purchasing targets.

Beijing’s announcement on Tuesday emphasized that Chinese firms will submit applications for tariff exemptions based on market conditions and commercial considerations.

“Unless the state forcefully asks firms to apply for tariff exemption and buy U.S. soybeans, crushers would still go for Brazilian beans, based on market free will,” said a trader, adding that Brazilian beans are of good quality and price this year.

Other products subject to exemption on additional tariffs imposed include denatured ethanol and wheat, corn and sorghum. Some medical devices and metals including copper ore and concentrates, copper scrap and aluminum scrap are also subject to exemption.

Pharmaceutical products such as recombinant human insulin and some antibiotics are also among U.S. products eligible for tariff exemptions.

Firms can start submitting their applications on March 2, and any exemptions granted will be valid for one year.

https://www.marketscreener.com/news/China-to-grant-tariff-exemptions-on-696-U-S-goods-to-support-purchases–30009802/?countview=0

Sanofi to work with HHS to develop coronavirus vaccine

The drug maker Sanofi Pasteur is entering the race to develop a vaccine to protect against the new coronavirus sweeping through China, the company announced Monday.

David Loew, Sanofi’s global head of vaccines, announced the company would partner with the U.S. Biomedical Advanced Research and Development Authority — known as BARDA — to make a vaccine using the company’s recombinant DNA platform.

Loew said the company’s previous work to develop a vaccine for SARS — a cousin virus — gives it a leg up on this work.

“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said Loew.

“While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak,” he said.

Loew said the company expects to have a vaccine candidate — a prototype — to test in vitro within six months and could be ready to test the vaccine in people within a year or 18 months.

Loew noted the DNA recombinant platform is already used to make flu vaccine licensed in the U.S., which means regulators are familiar with it. Sanofi also has large-scale manufacturing capacity for these types of vaccines.

Sanofi is the second major vaccine maker to announce it will try to make a vaccine against the new virus, which has infected over 70,000 people, mostly in China. Johnson & Johnson’s vaccine division, Janssen, has also announced it will try to make a vaccine.

Sanofi announces it will work with HHS to develop coronavirus vaccine

Studies of Gilead coronavirus drug proceeding slowly

Wuhan-based clinical trials evaluating Gilead Sciences’ (NASDAQ:GILD) antiviral drug remdesivir for the potential treatment of SARS-CoV-2 infection are proceeding slowly due to the lack of qualified participants. Total projected enrollment is 761, but only 168 have been recruited after 10 days since eligible patients must not have taken other treatments within 30 days.

Severely ill patients must be within 12 days of disease onset according to screening criteria. Mild and moderate patients need to be within eight days of onset. All must have lab test-confirmed infection. The main issue is than many have already started taking medicines at home, either those recommended by state media or based on online information, while waiting to be admitted to hospitals.

According to a Ministry of Health official, antimalarial drug chloroquine and flu drug favipiravir have shown some efficacy in ongoing studies.

https://seekingalpha.com/news/3542575-studies-of-gilead-coronavirus-drug-proceeding-slowly

Expanded use of Pfizer’s Vyndaqel Ok’d in Europe

As expected, the European Commission approves Pfizer’s (NYSE:PFE) Vyndaqel (tafamidis) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), the first drug approved in Europe for the indication.

About two months ago, the advisory group CHMP adopted a positive opinion backing approval.

https://seekingalpha.com/news/3542580-expanded-use-of-pfizers-vyndaqel-okd-in-europe

Medtronic slips on revenue miss

Medtronic (MDT) Q4 results:

Revenues: $7,717M (+2.3%); Cardiac & Vascular Group: $2,819M (+1.2%); Minimally Invasive Therapies Group: $2,176M (+2.4%); Restorative Therapies Group: $2,111M (+4.2%); Diabetes Group: $610M (unch).

Net Income: $1,915M (+50.9%); EPS: $1.42 (+51.1%); non-GAAP Net Income: $1,949M (+11.3%); non-GAAP EPS: $1.44 (+11.6%).

CF Ops: $5,784M (+17.6%).

Fiscal 2020 Guidance: non-GAAP EPS: $5.63 – 5.65 from $5.57 – 5.63.

Fiscal Q4 Guidance: Revenue growth (organic): ~4.5%; EPS: $1.64, excluding any impact from COVID-19.

COVID-19 is expected to negatively affect the company’s Q4 financial results.

Shares are down 2% premarket.

Previously: Medtronic EPS beats by $0.06, misses on revenue (Feb. 18)

https://seekingalpha.com/news/3542603-medtronic-slips-2-premarket-on-revenue-miss

BioXcel announces new mid-stage study of BXCL501

Researchers at Yale University have launched a Phase 2 clinical trial evaluating certain biomarkers associated with agitation in schizophrenia patients who are receiving BioXcel Therapeutics’ (NASDAQ:BTAI) BXCL501.

The company aims to use biomarkers (heart rate variability, actigraphy, electrodermal activity and EEG) to identify additional indications that exhibit the same physiological signals of hyperarousal, potentially expanding the use of BXCL501.

Topline data should be available in next quarter.

BXCL501 is a sublingual thin film formulation of a sedative called dexmedetomidine, the active ingredient in Pfizer’s Precedex, approved in the U.S. in 1999 as a short-term sedative and analgesic in critically ill or injured patients on mechanical ventilation in an ICU setting.

Shares up 3% premarket on light volume.

https://seekingalpha.com/news/3542610-bioxcel-announces-new-mid-stage-study-of-bxcl501-shares-up-3-premarket