La Federación Mundial de Hemofilia (FMH) está monitoreando la fabricación, la seguridad y el suministro de terapias para el tratamiento de la hemofilia durante la pandemia por el coronavirus. La FMH publicará todas las cartas recibidas de las empresas farmacéuticas a este respecto, y no asume responsabilidad alguna por el contenido, u omisiones o errores en los comunicados que publique. Todas las cartas se publicarán excactamente como se hayan recibido de los fabricantes.
26 de marzo de 2020
How Pfizer is responding – Our Commitment to Support Continued Health and Safety
How to stay safe and prevent the spread.
Pfizer recognizes the public concern in relation to the current situation, which continues to evolve. We are committed to doing all we can to respond to the COVID-19 pandemic and have taken proactive steps to ensure the health and safety of our colleagues, maintain supply of our medicines to patients and help halt the spread of this disease.
“In this troubling time, Pfizer is committed to doing all we can to respond to the COVID-19 pandemic. Many companies, including Pfizer, are working to develop antiviral therapies to help infected patients fight this emerging virus as well as new vaccines to prevent infection and halt the further spread of this disease. Pfizer is working to advance our own potential antiviral therapies and is engaged with BioNTech on a potential mRNA coronavirus vaccine. We are committed to work as one team across the industry to harness our scientific expertise, technical skills and manufacturing capabilities to combat this evolving crisis.” – Albert Bourla, Chairman and CEO
The safety of our colleagues around the globe is paramount. We are taking appropriate steps to protect our colleagues and contractors, following all local government requirements and continuously monitoring the situation to provide appropriate guidance on work attendance, travel and personal protection and hygiene. This is important for the health and wellbeing of our colleagues, our patients, our customers, and our community.
Our Manufacturing and Supply Chain
Pfizer consistently and diligently monitors the supply of our medicines. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed.
Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. As of now, we have not seen a disruption in our supply chain, and all of our plants in impacted areas around the world are operational. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared.
We have increased production, shifted demand to the most critical products, and authorized overtime at many sites to meet patient needs. We have also implemented an enhanced demand monitoring and order management process and instituted a heightened logistics control program to ensure our products get from our sites to our customers. We have expanded the use of Digital Operations Center, which is a Pfizer-developed digital solution that enables our supply operations. The expansion provides visual management and action tracking capabilities that allow colleagues at our sites – either physically or virtually – to stay connected and work collaboratively while maintaining social distance guidelines.
For 170 years, our scientists and experts at Pfizer have addressed global health challenges, bringing forth a multitude of vaccines and therapies for patients suffering from many different conditions, including infectious diseases. In the case of COVID-19, we are committed to bringing forth medical solutions to address this pandemic.
As part of our immediate response, we identified anti-viral compounds in our libraries which have shown activity for highly related viruses and that may have potential to address COVID-19 based on our modeling. We are engaging with a third party to screen these compounds under an accelerated timeline and currently expect to have the results back by the end of March. We are also working with our partner BioNTech to co-develop a potential COVID-19 vaccine.
On a broader scale, Pfizer is committed to working as one team across the industry to harness our scientific expertise, technical skills and manufacturing capabilities to combat this evolving crisis. We have made five promises that will help scientists more rapidly bring forward therapies and vaccines to protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises.
Our Clinical Trials
UPDATE: March 25 —To avoid adding to the demands on the healthcare system during this unprecedented crisis with COVID-19, we are pausing for three weeks the recruitment portion of our new and ongoing global interventional clinical studies. We are taking this action in the interests of public health, so that our clinical site partners and we can concentrate on caring for patients in our ongoing clinical trials.
The pause will not affect China, Japan and South Korea, where recruitment will continue. This pause will also not apply to trials that are recruiting individuals with life-threatening conditions who have few or no other therapeutic options, including several oncology studies and our DMD gene therapy program. In addition, this decision will not affect studies that are already fully recruited.
Patients in our ongoing trials will not be impacted by this decision.
We have an important responsibility to the patients currently in our clinical trials. This decision will allow our investigators and us to focus on those individuals.
We will review this decision in three weeks and provide another update then. We expect over time to resume recruitment and new study starts on a country-by-country basis.
Importantly, this decision will not affect the start of our COVID-19 vaccine study with BioNTech, nor our intent to move with unprecedented speed in developing our antiviral and other compounds that may be useful in this crisis.
Our Relief Efforts
Pfizer is grateful to the medical professional on the front lines of this epidemic. We have an extensive global network of medical practitioners and experts, many of whom feel called to support their communities in the diagnosis, treatment and provision of public health support during this time. We respect their courage and selflessness to serve and have established a medical service policy that will allow these colleagues up to 13 weeks of paid leave, or longer if necessary, to provide this support.
Pfizer and the Pfizer Foundation have a long history of addressing humanitarian disasters. We are working with governments and international non-governmental organizations to respond to the COVID-19 pandemic by donating much needed medications and vaccines and working to support front line health workers. We continue to assess the needs on the ground to determine where more support is needed.
For more on Pfizer’s commitment to patients, read our five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19. For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future Results.”
23 de marzo de 2020
Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19
Grifols today announces that it has entered into a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients, process this specific plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin in its purpose-built facility in Clayton, North Carolina, for the isolated processing of immune globulins to treat emerging infectious diseases; and support preclinical and clinical studies to determine whether hyperimmune globulin made from the plasma of convalescent donors can live up to its promise as a viable treatment for COVID-19 disease and as a platform for the treatment of future emerging infectious diseases.
This innovative public-private partnership presents opportunities to expedite development and, if successful, availability of a front-line therapeutic in the face of the spreading COVID- 19 pandemic. The FDA is specifically working to reduce unnecessary regulatory hurdles and ensure a rapid turnaround without compromise to product safety or integrity.
As indicated by FDA Commissioner Stephen Hahn, M.D., during the President’s March 19 Coronavirus Task Force briefing, “There is a cross agency effort about…convalescent plasma. This is an exciting area…If you’ve been exposed to coronavirus and you are better…we could collect the [plasma], concentrate that…to be able to give that to other patients. The immune response could provide a benefit to patients.”
In addition to the development of a hyperimmune globulin as a therapy for COVID-19, Grifols is also providing support to utilize convalescent plasma for transfusion as a potential therapy by providing viral inactivation technology (methylene blue) to ensure inactivated plasma units for treatment use. (Grifols will be building a new facility in the Clayton site for this purpose.)
At Grifols we believe this current and extraordinary situation requires companies to strive more than ever to serve patients and society around the world and is proud to be working with the United States Public Health Agencies and personnel to combat COVID-19 disease.
This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses.
At the same time, in Spain Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals since, unlike in the U.S., in Spain there are no Grifols-owned plasma donation centers. In addition, the company is collaborating with certain hospitals in the design of diverse clinical studies on the use of certain plasma-derived products, such as intravenous immunoglobulin and alpha-1 antitrypsin, with the goal of proving their efficacy in the treatment of COVID-19.
In addition, Grifols has accelerated the development and validation of a proprietary technology TMA (transcription-mediated amplification) based diagnostic procedure, able to detect the virus with a sensitivity equivalent or even superior to that of PCR (polymerase chain reaction). The test will be performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day, and that will be ready in the following weeks.
We are very thankful to our Grifols employees for their efforts in these unsettling times, and especially grateful to our donors for continuing to donate plasma, helping us all to make a difference.
23 de marzo de 2020
Follow-up statement concerning the impact of SARS-CoV-2 on the supply of treatment for persons with hemophilia and von Willebrand disease
Following the previous statement shared with you on 3 March 2020, we would like to give you an update on Takeda’s plasma-derived therapies as the SARS-CoV-2 outbreak continues. At this time, we continue to foresee no near-term disruption in the supply of our products to treat persons with hemophilia and other rare bleeding disorders. We are closely monitoring the external environment and the situation as it evolves. Please rest assured that we will continue to provide updates as needed.
Since we shared the last statement, we are starting to see a moderate decline in plasma donation, which may be directly related to growing concerns about the SARS-CoV-2 virus. That being said, we would not expect to see an impact on planned supply of plasma-derived therapies through to the end of 2020. This is because the overall production cycle from point of plasma collection to finished medicine lasts several months, and our plasma stocks are currently at a sufficient level. At this time, it is still too early to predict any longer-term impact and we have been monitoring the situation closely and preparing mitigation plans. These plans cover all variables that influence plasma collections and we will be adjusting these, as needed, going forward.
Regarding safety, we are also engaging with the industry association (PPTA), blood and blood product collectors, patient organizations and governments to reinforce the safety of both whole blood and plasma donation, as well as to emphasize the continuing importance of this critical service, given patients with chronic and complex conditions depend on uninterrupted supply of their plasma-derived medicines.
To reiterate, our top priority is to do all we can to make sure our medicines and services continue to reach the individuals who rely on them, while we protect the health of our employees, those who work alongside them, their families and our communities.
We encourage and welcome all awareness and educational initiatives that will help ensure patients who rely on plasma-derived therapies continue to have care long-term. For more information on what Takeda is doing in response to the COVID-19 situation, please visit: www.takeda.com/newsroom/featured-topics/coronavirus-efforts.
20 de marzo de 2020
Update on Hemlibra supply amid 2019-nCoV (novel coronavirus)
The World Health Organization (WHO) has declared the 2019-nCoV (novel coronavirus) outbreak a global pandemic. We extend our heartfelt sympathies to everyone who has lost loved ones, to patients and healthcare professionals battling this devastating outbreak. With multiple countries implementing measures to slow the spread of the virus, based on the current situation, we wanted to provide an update to the community that Hemlibra supply continues to be stable for the foreseeable future.
We understand the importance of Hemlibra for people with hemophilia A and are committed to ensuring adequate supply. We are actively assessing and managing the situation on a daily basis, and have not identified any critical components that would impact our ability to supply Hemlibra in the future, based on current demand forecasts. Our global manufacturing network has robust plans for dealing with the impact of potential health and other global crises. All manufacturing sites have site-specific plans in place with the goal of avoiding interruptions of product manufacturing, packaging or delivery for all of Roche’s medicines, including Hemlibra. We are also engaged with all of our key suppliers to mitigate any potential impact to our supply chain.
We are continually taking proactive measures in collaboration with our logistics service providers to ensure the delivery of products to and from affected countries and regions remains stable. Should we become aware of any change to the supply or availability of Hemlibra at any point, we will inform the hemophilia community immediately.
We recognise that the public and private sectors across the globe need to work together to help effectively manage this developing situation. For further details on Roche’s efforts related to COVID-19 please refer to our statement and media releases on the Roche.com website.
10 de marzo de 2020
Our Response to COVID-19
At Sanofi, we have a simple purpose – to discover breakthrough medicines and vaccines to improve the lives of millions of people around the world. This drive to transform the practice of medicine has taken on increased urgency for everyone in the Sanofi family since the emergence of COVID-19 across the world.
Sanofi is rapidly responding to the evolving challenge of COVID-19. Our responsibility to our employees and their families, patients and caregivers, health care providers, public health officials and communities around the world drives us to act on our long history of innovation to bring cutting edge science and dedicated people to face this threat. We would like to take this opportunity to share our approach to this crisis.
Our current full statement can be found at: www.sanofi.us/en/about-us/our-stories/our-response-to-covid-19