Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
“We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalised with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
To date, there are several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.
However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the US Food and Drug Administration (FDA).
In addition to initiating this trial, Roche received FDA Emergency Use Authorisation for the cobas® SARS-CoV-2 Test on March 13, 2020, to detect the novel virus that causes COVID-19 disease. Learn more here.
About the Clinical Trial
Roche is initiating a randomised, double-blind, placebo-controlled Phase III study (COVACTA) to evaluate the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomisation, and an interim analysis will be conducted to look for early evidence of efficacy.
About Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe. In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled autoinjector ACTPen has been approved in the US and Europe. In Japan, Actemra is also approved for the treatment of Castleman’s Disease and Takayasu Arteritis. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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Tag Archives: Coronavirus
CNBC: Thermo Fisher ships coronavirus tests, aims to produce 5 million tests a week by April
The first batch of government-authorized coronavirus tests from Thermo Fisher Scientific have shipped off and the “dramatic ramp up” in production has begun, CEO Marc Casper told CNBC Monday.
“We have already about 1.5 million tests in stock. We began shipping them yesterday and today,” Casper said in a “Mad Money” interview with Jim Cramer. “But we’re ramping up to about 2 million tests in production a week, and then over the course of April we’ll be able to get that to about 5 million tests a week in terms of production.”
Read entire article HERE.
CNBC: Eli Lilly CEO aims to start testing coronavirus cure ‘this summer’
Eli Lilly CEO David Ricks told CNBC on Friday that his company aims to start testing a treatment for the globally spreading coronavirus in the coming months.
The pharmaceutical giant on Thursday announced that it has teamed up with the privately held AbCellera Biologics to co-develop a medicine for COVID-19, the disease caused by the virus that has sickened more than 137,000 people across the world and at least 1,700 in the U.S. as of Friday.
“The speed at which [pharma research] is unfolding is unprecedented in our industry. Literally, AbCellera started this work 11 days ago,” Ricks said in a phone interview with Jim Cramer on “Mad Money.” “We hope to be in a clinical trial this summer.”
Read entire article HERE.
San Diego Union-Tribune: Thermo Fisher set to produce test kits that can diagnose COVID-19 in four hours
Thermo Fisher Scientific, the world’s largest manufacturer of laboratory equipment, has announced that it has received emergency authorization to produce coronavirus test kits that can diagnose within four hours.
The company — based out of Waltham, Mass., with West Coast headquarters in Carlsbad — said the Food and Drug Administration’s approval late Friday will allow them to provide the high-speed tests to hospitals and laboratories, diagnosing as many as 5 million people a week, according to a statement.
“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific, said in a statement.
Read entire article HERE.
Aftenposten: Ny Roche koronatest åpner for massetesting i Norge
Den første av to nye maskiner som gjør det mulig å teste langt flere nordmenn for koronasmitte, ble fredag satt opp ved Oslo universitetssykehus på Ullevål.
Den andre Sveits-produserte maskinen kommer til Norge fra Tyskland mandag. Den skal stå ved Akershus universitetssykehus (Ahus).
Dette er et nytt og svært viktig bidrag i kampen mot koronaepidemien i Norge.
En av de store svakhetene i både norsk helsevesen og resten av verden, har vært svært lav testkapasitet. Selv om Norge er blant landene som tester flest, har mange mennesker er blitt nektet testing de siste ukene.
Les hele saken HER.
Starbucks: Tomorrow Will be Spring: One Global Company’s Steps to Navigate COVID-19 in China – and the Lessons Learned
Shortly before the Chinese New Year, Belinda Wong hung up the phone after a series of calls with her team. Alone in the quiet of her home, she contemplated everything they’d discussed. They were wrestling with a decision that would become one of the most momentous in Starbucks history.
As chairman and chief executive officer of Starbucks China, she’s lived and breathed the company’s mission to “Inspire and nurture the human spirit – one person, one cup and one neighborhood at a time.” She took pride in the role of Starbucks stores across the world as a third place, a place for human connection. But now, as she considered reports of an alarming new coronavirus outbreak, she knew she had to make a decision quickly whether to close thousands of stores across China to try to quell the spread.
Read entire article HERE.
World Oil: Coronavirus case reported on Equinor’s Martin Linge field offshore Norway
OSLO – Norwegian energy producer Equinor reported one person at the Martin Linge field in the North Sea has tested positive for the coronavirus. The person is not seriously ill.
Equinor is in dialogue with the Norwegian health authorities about further measures. The infected person has been in isolation in his cabin since March 9th. Measures to prevent further contamination for offshore installations has been introduced. It has not been decided when the person will be brought ashore.
The person arrived at the field just before noon on March 4th. The person had recently been to Austria. When Austria was listed as a high-risk destination, the person was quarantined on board and a test was conducted.
Read entire article HERE.
Forbes: Why US 30 Day Travel Ban On Europe May Ruin Your Trip (All US Citizens, Legal Permanent Residents, and Their Families Members Are Exempt)
The U.S. is banning most travel from Europe to the United States for 30 days due to the coronavirus outbreak. The travel restrictions do not apply to US citizens returning home from Europe, only to foreign nationals present in 26 European countries over a two week period ahead of their forecast arrival in the US.
This as actor Tom Hanks and his wife both test positive for the disease in Australia, and as the number of cases in the U.S. continues to rise to over 1,200–up tenfold in a week–with at least 38 deaths.
Neither the UK nor Ireland are included in the travel ban, which begins at midnight Friday March 13. It applies only to residents of the border-free travel Schengen zone of Europe.
Read entire article HERE.
The White House: Proclamation—Suspension of Entry as Immigrants and Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting 2019 Novel Coronavirus
On January 31, 2020, I issued Proclamation 9984 (Suspension of Entry as Immigrants and Nonimmigrants of Persons Who Pose a Risk of Transmitting 2019 Novel Coronavirus and Other Appropriate Measures To Address This Risk). I found that the potential for widespread transmission of a novel (new) coronavirus (which has since been renamed “SARS-CoV-2” and causes the disease COVID-19) (“SARS-CoV-2” or “the virus”) by infected individuals seeking to enter the United States threatens the security of our transportation system and infrastructure and the national security. Because the outbreak of the virus was at the time centered in the People’s Republic of China, I suspended and limited the entry of all aliens who were physically present within the People’s Republic of China, excluding the Special Administrative Regions of Hong Kong and Macau, during the 14-day period preceding their entry or attempted entry into the United States, subject to certain exceptions. On February 29, 2020, in recognition of the sustained person-to-person transmission of SARS-CoV-2 in the Islamic Republic of Iran, I issued Proclamation 9992 (Suspension of Entry as Immigrants and Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting 2019 Novel Coronavirus), suspending and limiting the entry of all aliens who were physically present within the Islamic Republic of Iran during the 14-day period preceding their entry or attempted entry into the United States, subject to certain exceptions.
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services, has determined that the virus presents a serious public health threat, and CDC continues to take steps to prevent its spread. But CDC, along with State and local health departments, has limited resources, and the public health system could be overwhelmed if sustained human-to-human transmission of the virus occurred in the United States on a large scale. Sustained human-to-human transmission has the potential to cause cascading public health, economic, national security, and societal consequences.
The World Health Organization has determined that multiple countries within the Schengen Area are experiencing sustained person-to-person transmission of SARS-CoV-2. For purposes of this proclamation, the Schengen Area comprises 26 European states: Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and Switzerland. The Schengen Area currently has the largest number of confirmed COVID-19 cases outside of the People’s Republic of China. As of March 11, 2020, the number of cases in the 26 Schengen Area countries is 17,442, with 711 deaths, and shows high continuous growth in infection rates. In total, as of March 9, 2020, the Schengen Area has exported 201 COVID-19 cases to 53 countries. Moreover, the free flow of people between the Schengen Area countries makes the task of managing the spread of the virus difficult.
The United States Government is unable to effectively evaluate and monitor all of the travelers continuing to arrive from the Schengen Area. The potential for undetected transmission of the virus by infected individuals seeking to enter the United States from the Schengen Area threatens the security of our transportation system and infrastructure and the national security. Given the importance of protecting persons within the United States from the threat of this harmful communicable disease, I have determined that it is in the interests of the United States to take action to restrict and suspend the entry into the United States, as immigrants or nonimmigrants, of all aliens who were physically present within the Schengen Area during the 14-day period preceding their entry or attempted entry into the United States. The free flow of commerce between the United States and the Schengen Area countries remains an economic priority for the United States, and I remain committed to facilitating trade between our nations.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States, by the authority vested in me by the Constitution and the laws of the United States of America, including sections 212(f) and 215(a) of the Immigration and Nationality Act, 8 U.S.C. 1182(f) and 1185(a), and section 301 of title 3, United States Code, hereby find that the unrestricted entry into the United States of persons described in section 1 of this proclamation would, except as provided for in section 2 of this proclamation, be detrimental to the interests of the United States, and that their entry should be subject to certain restrictions, limitations, and exceptions. I therefore hereby proclaim the following:
Section 1. Suspension and Limitation on Entry. The entry into the United States, as immigrants or nonimmigrants, of all aliens who were physically present within the Schengen Area during the 14-day period preceding their entry or attempted entry into the United States is hereby suspended and limited subject to section 2 of this proclamation.
Sec. 2. Scope of Suspension and Limitation on Entry.
(a) Section 1 of this proclamation shall not apply to:
(i) any lawful permanent resident of the United States;
(ii) any alien who is the spouse of a U.S. citizen or lawful permanent resident;
(iii) any alien who is the parent or legal guardian of a U.S. citizen or lawful permanent resident, provided that the U.S. citizen or lawful permanent resident is unmarried and under the age of 21;
(iv) any alien who is the sibling of a U.S. citizen or lawful permanent resident, provided that both are unmarried and under the age of 21;
(v) any alien who is the child, foster child, or ward of a U.S. citizen or lawful permanent resident, or who is a prospective adoptee seeking to enter the United States pursuant to the IR-4 or IH-4 visa classifications;
(vi) any alien traveling at the invitation of the United States Government for a purpose related to containment or mitigation of the virus;
(vii) any alien traveling as a nonimmigrant pursuant to a C-1, D, or C-1/D nonimmigrant visa as a crewmember or any alien otherwise traveling to the United States as air or sea crew;
(viii) any alien
(A) seeking entry into or transiting the United States pursuant to one of the following visas: A-1, A-2, C-2, C-3 (as a foreign government official or immediate family member of an official), E-1 (as an employee of TECRO or TECO or the employee’s immediate family members), G-1, G-2, G-3, G-4, NATO-1 through NATO-4, or NATO-6 (or seeking to enter as a nonimmigrant in one of those NATO categories); or
(B) whose travel falls within the scope of section 11 of the United Nations Headquarters Agreement;
(ix) any alien whose entry would not pose a significant risk of introducing, transmitting, or spreading the virus, as determined by the Secretary of Health and Human Services, through the CDC Director or his designee;
(x) any alien whose entry would further important United States law enforcement objectives, as determined by the Secretary of State, the Secretary of Homeland Security, or their respective designees, based on a recommendation of the Attorney General or his designee;
(xi) any alien whose entry would be in the national interest, as determined by the Secretary of State, the Secretary of Homeland Security, or their designees; or
(xii) members of the U.S. Armed Forces and spouses and children of members of the U.S. Armed Forces.
(b) Nothing in this proclamation shall be construed to affect any individual’s eligibility for asylum, withholding of removal, or protection under the regulations issued pursuant to the legislation implementing the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, consistent with the laws and regulations of the United States.
Sec. 3. Implementation and Enforcement. (a) The Secretary of State shall implement this proclamation as it applies to visas pursuant to such procedures as the Secretary of State, in consultation with the Secretary of Homeland Security, may establish. The Secretary of Homeland Security shall implement this proclamation as it applies to the entry of aliens pursuant to such procedures as the Secretary of Homeland Security, in consultation with the Secretary of State, may establish.
(b) Consistent with applicable law, the Secretary of State, the Secretary of Transportation, and the Secretary of Homeland Security shall ensure that any alien subject to this proclamation does not board an aircraft traveling to the United States.
(c) The Secretary of Homeland Security may establish standards and procedures to ensure the application of this proclamation at and between all United States ports of entry.
(d) An alien who circumvents the application of this proclamation through fraud, willful misrepresentation of a material fact, or illegal entry shall be a priority for removal by the Department of Homeland Security.
Sec. 4. Termination. This proclamation shall remain in effect until terminated by the President. The Secretary of Health and Human Services shall recommend that the President continue, modify, or terminate this proclamation as described in section 5 of Proclamation 9984, as amended.
Sec. 5. Effective Date. This proclamation is effective at 11:59 p.m. eastern daylight time on March 13, 2020. This proclamation does not apply to persons aboard a flight scheduled to arrive in the United States that departed prior to 11:59 p.m. eastern daylight time on March 13, 2020.
Sec. 6. Severability. It is the policy of the United States to enforce this proclamation to the maximum extent possible to advance the national security, public safety, and foreign policy interests of the United States. Accordingly:
(a) if any provision of this proclamation, or the application of any provision to any person or circumstance, is held to be invalid, the remainder of this proclamation and the application of its provisions to any other persons or circumstances shall not be affected thereby; and
(b) if any provision of this proclamation, or the application of any provision to any person or circumstance, is held to be invalid because of the lack of certain procedural requirements, the relevant executive branch officials shall implement those procedural requirements to conform with existing law and with any applicable court orders.
Sec. 7. General Provisions. (a) Nothing in this proclamation shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This proclamation shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This proclamation is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
IN WITNESS WHEREOF, I have hereunto set my hand this eleventh day of March, in the year of our Lord two thousand twenty, and of the Independence of the United States of America the two hundred and forty-fourth.
DONALD J. TRUMP
See orignial proclamation HERE.
Reuters: GSK to collaborate with Oslo-based CEPI in effort to develop coronavirus vaccine
British drugmaker GlaxoSmithKline Plc is collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) to contribute towards the effort of developing a vaccine for the coronavirus outbreak, GSK and CEPI said on Monday.
GSK will make its “adjuvant platform technology” available for developing a vaccine against the 2019-nCoV virus, according to the statement.
Read entire article here.