Tag Archives: Roche

Press Release: Roche develops new serology test to detect COVID-19 antibodies

  • The new Elecsys Anti-SARS-CoV-2 serology test can support the detection of antibodies against SARS-CoV-2 in patients who have been exposed to the virus which causes COVID-19
  • The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions
  • Roche aims to have this test available by early May, in countries accepting the CE mark1 and is actively working with the US Food and Drug Administration for an Emergency Use Authorisation2

Basel, 17 April 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease.

Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms.³ Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work. Once we understand more about the immunity of COVID-19, it could also help society return faster to normality.

Severin Schwan, CEO Roche Group: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available in laboratories around the world.

Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.

About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.

To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs and avoiding close contact with anyone showing symptoms of respiratory illness.

About Elecsys Anti-SARS-CoV-2 serology test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in vitro detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.⁴

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.

All trademarks used or mentioned in this release are protected by law.

References
[1] CE-IVD marking is granted  through completion of a comprehensive technical validation and self declaration under the European Directive for In Vitro Diagnostic Medical Devices.
[2] The Emergency Use Authorisation (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies https://www.fda.gov/home
[3] Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of Covid-19 at presentation – https://www.nejm.org/doi/full/10.1056/NEJMc2009316
[4] Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein

See original press release HERE

Press Release: Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

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.

All trademarks used or mentioned in this release are protected by law.


Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein

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.

Ny rapport fra Roche: Fremtiden er persontilpasset – men når kommer fremtiden?

Persontilpasning har alltid vært et ideal i medisinsk behandling. Å gi hver enkelt pasient den beste behandlingen krever at all relevant informasjon tas i bruk. Ved bruk av moderne teknologi som stordataanalyser og kunstig intelligens blir det mulig å finne sam- menhenger og mønstre som ikke er synlige for mennesker. Teknologien lager hypoteser og trekker konklusjoner, og kan komme med forslag til diagnoser og behandlinger.

Helsedirektoratet har på oppdrag fra Helse- og omsorgsdepartementet utarbeidet en nasjonal strategi for persontilpasset medisin i helsetjenesten (2017-2021) og definerer persontilpasset medisin:

«Med persontilpasset medisin menes forebygging, diagnostikk, behandling og oppfølging tilpasset biologiske forhold hos den enkelte. Målet med å ta i bruk persontilpasset medisin er å gi pasi- entene mer presis og målrettet diagnostikk og behandling, og samtidig unngå behandling som ikke har effekt».

I denne rapporten retter Roche oppmerksom- heten primært mot persontilpasset medisin i kreftbehandlingen. Det kommer stadig flere behandlinger rettet mot bestemte mutasjoner (skader i arvestoffet) i kreftsvul- stene. Det kan gi fantastiske muligheter for pasientene, føre til at stadig flere overlever, lever lenger og får færre bivirkninger og seneffekter.

Les hele rapporten HER.

International Leadership Interview: Rajji Mehdwan, General Manager, Roche Norge

Rajji Mehdwan

International Leadership Series

For the latest edition of AmCham’s International Leadership Interview Series, we sat down with Roche Norge General Manager and AmCham Board Member Rajji Mehdwan. Through a globe spanning career that has included stops in several European countries and the United States, Mehdwan has developed a keen sense of what it takes to be an international leader, a sense that has helped her and Roche improve the lives of patients across the world.

Where did you start? International experiences? Can you please give a brief description of how you got to where you are now?

I grew up in India but have since lived and worked in many different countries. I trained as a registered nurse and practiced at the Royal Free Hospital in London. I got to know the English patient care side well, which was pretty cool.

My goal at that time was to get more into hospital administration, but that wasn’t possible because I didn’t have a business background, which led me to business school in the US, followed by many interesting roles in management consulting, opening a startup, and working on the development side at Johnson and Johnson. 

I had always admired Genentech (a member of the Roche Group). I remember watching a TV-program where Genentech, along with some doctors in Boston, had figured out a way to starve tumors. Tumors, like anything else, need to feed, if you think of them as an organism. So, these researchers at Genentech had figured out a way to cut off the blood supply to tumors and the tumor then starves and dies.

Watching this super high-tech, cool science was so inspirational. I remember thinking, “Wow, one day I’d love to work for this company.”  Call it fate, a role opened up with Genentech a couple years later and I’ve never looked back since. That was eight years ago!

What are the important decisions you make as a leader of your organization and how do they impact its global presence? Share any recent examples?

I spend a lot of time reflecting on our long-term vision and strategy, thinking particularly about “What is our purpose?” and, “What impact do we want to have long term?” 

For example, the personalization of healthcare is becoming more and more of a reality. Roche has a lot to contribute in regard to accelerating the personalized healthcare environment in Norway.  One of the decisions we have recently made is to proactively reach out to public stakeholders and encourage co-creation and collaboration to accelerate the capture of meaningful data at scale. Meaningful data, including treatment data and comprehensive genomic data, will be critical in informing patient care, research, and development – and also help us make the system more efficient. Roche with its diagnostics capabilities, technology capabilities via companies such as Flatiron and Foundation Medicine, and our pharmaceutical arm can really bring a lot of expertise and knowledge to the table to help accelerate personalized healthcare in Norway. 

As an expat, I have had to remind myself that I am the one dropping into a new culture. The culture shouldn’t change to adjust to me, I need to adjust to the culture. You need to come in with a lot of respect for how Norwegians engage, how they do business, and how they are as people.

How do you build team morale and maintain the creativity of a diverse team within an international organization?

I believe people feel good when they are in an environment where they know ‘great things are happening,’ so I always start here. Roche is the biggest biotechnology company in oncology. We have one of the deepest pipelines. We’re in the business of bringing really meaningful medicines into diseases where there is high unmet need and our medicines can truly make a difference to people. This really excites the team in Norway.

We place an incredible focus on people at Roche. We spend a lot of time making sure our people have the right tools, have good training, and feel supported, empowered, and developed. The moment people feel that you have their back, that you care about their development – they give their best.

Would you use the same leadership style in a different organization? In a different country? How important is it to tailor your leadership style to your team and environment?

Yes and no. I believe no matter where you work you should be true to your leadership style. So that stays consistent. I tend to believe in the ‘servant leadership’ philosophy – my job as a leader is to be of service to my people. As an expat, I have had to remind myself that I am the one dropping into a new culture. The culture shouldn’t change to adjust to me, I need to adjust to the culture. You need to come in with a lot of respect for how Norwegians engage, how they do business, and how they are as people.

Where do new ideas and exciting proposals come from in your organization? Has your international experience helped you ‘think outside the box’ in your organization?

Ideas come from everywhere. We emphasize an organization where everyone has a voice. We’ve organized our business around different disease areas via multiple cross-functional teams. This cross-functional nature allows for a lot of creativity. 

I believe my international experience helps as I am able to act as the ‘connector.’ At Roche, we are 110+ countries, 93,000 employees. If you have a problem, there are 93,000 people you can tap into for solutions!

We’re living in an uncertain world where things are happening fast. Technology is exploding, our understanding of disease and science is increasing rapidly. We don’t have time to work on something for a year – it’s obsolete by the time you launch it.  Agility will be key to success

How do you ensure that your team and your company’s services are aligned to your company’s core vision?

At Roche our north star is to deliver better outcomes to more patients faster. I spend a lot of time providing clarity on our vision, our purpose, and the why. I believe once people understand the why, the relevance to them, and that they have something of value to contribute – great things happen!

What do you believe are shared traits among leaders? Any common mistakes? What is unique about being a leader in Norway compared to leading an organization in another country?

Strategy and vision. Your job is to set the tone, and you need to be very crystal clear on the direction of the company. Good leaders are also open, transparent, and authentic – I find people respond to that.

Common mistakes – As I said earlier, I have seen leaders who come in and don’t respect the culture. That can lead to a lot of problems

How do you continue growing and developing as a leader?

To grow I believe asking for feedback is critical. I often ask my team “What can I do better? What concerns you?” I also learn from making mistakes. I make many of them! But that is how you learn. 

You get the podium at Stortinget for five minutes, what topic(s) do you address and why?

How do we collectively ensure sustainability of our great healthcare system, where our patients get the best care and medicines when they need them most?

Norway has a great healthcare system when I compare it to other countries. I come from India, where healthcare is still largely for the rich.   

Norway has a very ambitious political agenda to provide the best healthcare for its people. For medicines, the ambition emphasizes speed and faster access to new medicines. However, in the implementation of this vision, the decisions that are being made today by budget holders are not delivering on the political ambitions.

In 2018, over 50% of new medicines got a no from Beslutningsforum. Cost, or budget impact, is the main driver of decisions. Medicines that have proven cost effective by the Norwegian medicines agency are still getting a no. Decision criteria are unpredictable, and often decisions are made on subjective criteria. In reality, the impact of all of this is that Norwegian patients do not have access to as many new and cutting-edge medicines as their neighbors in the Nordics and Europe. Norwegian patients are being given sub-optimal medicines, in some cases, due to economic reasons, and Norway has one of the highest times to market for new medicines, per the latest EFPIA report. 

My question for Stortinget is: Do we want Norway to continue to lead as a healthcare system, or are we okay being one of the slowest markets in Europe to give access to new products?

If we look at Germany as an example – patients come first. Patients have access to medicines right after regulatory approval, then the government negotiates with companies on price. And the Germans still manage to negotiate very well. They make it work – so can we!

Patient voice is being lost in Norway. I acknowledge that budget holders have good intentions and a tough job trying to balance patient needs and costs. My ask of parliament is – let’s solve this disconnect between political ambition and budget holders/decision makers so their decisions actually implement the political ambition we have. 

In the best healthcare systems that I’ve seen in the world, there is a partnership mindset between the government and industry. I would encourage us to do the same. 

Decision criteria are unpredictable, and often decisions are made on subjective criteria. In reality, the impact of all of this is that Norwegian patients do not have access to as many new and cutting-edge medicines as their neighbors in the Nordics and Europe.

What do you see in the next generation of leaders aspiring to run an international organization? Advice to them?

Agility will be the key to success. We’re living in an uncertain world where things are happening fast. Technology is exploding, our understanding of disease and science is increasing rapidly. We don’t have time to work on something for a year – it’s obsolete by the time you launch it. 

What is the latest time you responded to an email last night?

Last night it was pretty good, so 10 PM! I’m a bit of a workaholic, working on this!

Reuters: Lilly’s combo therapy succeeds in late-stage lung cancer study

Eli Lilly and Co’s combination cancer treatment met the main goal of a late-stage clinical trial testing it on patients with a form of lung cancer, the drugmaker announced on Tuesday.

Previously untreated patients with metastatic non-small cell lung cancer taking a combination of Lilly’s Cyramza and Roche’s erlotinib went longer before their disease started to worsen, study results showed.

Lung cancer is the leading cause of cancer death among both men and women, and each year, more people die of lung cancer than of colon, breast, and prostate cancers combined, according to the American Cancer Society.

Read entire article HERE.