IFPMA Statement on the launch of a new global collaboration to accelerate the development, production and equitable access to new COVID-19 tools :: Pharma industry body joins as founding partner a new global collaboration to accelerate the development :: IFPMA Backgrounder – COVID-19 ::

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IFPMA Statement on the launch of a new global collaboration to accelerate the development, production and equitable access to new COVID-19 tools
Geneva, 24 April 2020
Statement delivered by: Thomas Cueni, Director General, IFPMA
The biopharmaceutical industry is acutely aware of the enormous responsibility we have to patients and society to engage in unprecedented levels of collaboration to find a solution to COVID-19. We stand ready to bring to this partnership our unique knowledge and expertise in the discovery and development of medicines and vaccines, as well as our experience building manufacturing capacity and distribution networks. Today, scientists in the public and private sector hold the keys to our common goal: The swift end of the COVID-19 pandemic. We are proud to be part of this landmark global partnership and are fully committed to its goal to accelerate development, production and equitable global access to safe, quality, effective, and affordable COVID-19 therapeutics and vaccines. In the fight against COVID-19, we must ensure that no one is left behind. We will only succeed in this journey together.

Pharma industry body joins as founding partner a new global collaboration to accelerate the development,
Geneva, April 24, 2020: The world’s leading biopharmaceutical companies proclaimed their commitment to a landmark global partnership launched today and designed to accelerate the development and production of safe, effective and affordable therapeutics and vaccines available for all in a way that ensures nobody is left behind in the fight against COVID-19. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the body representing the innovative biopharmaceutical industry in Geneva, will join the global collaboration as a Founding Partner to represent industry.

The industry has been working flat-out to marshal its unique expertise to find a durable solution to the spread of COVID-19 and stands ready to scale up its work on an even more unprecedented scale in line with its previously expressed commitments. By joining the global collaboration, the innovative biopharmaceutical industry can work on an equal footing with all stakeholders to help speed up the development of safe and effective therapeutics and vaccines, share tools and insights to test potential therapies and vaccines, increase manufacturing capabilities and share available capacities and share real-time clinical trial data with governments and other companies around the world.

This collaboration is aligned with the innovative biopharmaceutical companies’ strong sense of responsibility to act together as well as in partnership with all stakeholders but also their determination to play the greatest possible role in the global response to the COVID-19 pandemic. The biopharmaceutical industry holds the keysto finding lasting and equitable solutions through new therapeutics and vaccines. Industry welcomes today’s acknowledgment of the critical role of the private sector in this fight..

 

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IFPMA Backgrounder – COVID-19
24 April 2020
[Editor’s Note:
IFPMA has re-organized its recurring “Backgrounder” providing an inventory of company initiatives involving development of vaccines, treatments and diagnostics under the categories below. Each category inventories company by company activity and we provide detail on vaccine-related activity. We recognize that some of the text may sound promotional.]

REPURPOSE EXISTING & TEST OF NEW TREATMENTS
As of 14 April 2020, the WHO’s landscape analysis of potential treatments for COVID-19 contains 133 therapeutics. Further, the WHO Solidarity Trial has brought together over 100 countries working together to find effective therapeutics for COVID-19 as fast as possible. IFPMA members have also been reviewing their drug portfolios, which involves scientists searching for potentially useful assets that could help with the development of new or repurposed treatments to fight against the novel coronavirus.

 

SHARE REAL-TIME CLINICAL TRIAL DATA WITH GOVERNMENTS & OTHER COMPANIES
The rapid virus sequencing by the scientific community enabled researchers to characterize and begin to understand the new threat posed by COVID-19. “Open Access” data-sharing channels are the backbone to securing a response capacity and have proven their worth with influenza networks. The rapid pace with which researchers have been able to understand this novel strain of virus and get medicines into human clinical trials is a testament to the lessons learned from past public health emergencies. The Global Initiative on Sharing All Influenza Data or GISAID Initiative, an open access platform partly funded by the private sector, played a critical role in sharing the first genome sequences of the novel coronavirus and centralizing their collection. This has proven vital in speeding up the sharing of information among scientists as well as public health authorities. But there is still a lot to learn about the virus, both in terms of how it spreads as well as what existing treatments may be effective in helping patients who contract the disease.

 

SPEED UP R&D OF SAFE & EFFECTIVE VACCINES
As of 23 April 2020, the WHO reports there are currently 6 candidate vaccines in clinical evaluation and 77 candidate vaccines in preclinical evaluation. Several biopharmaceutical companies are researching vaccine candidates for the prevention of COVID-19 and collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. IFPMA members are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available. This is a best-case estimate that assumes one or two of the first few vaccines that enter development and complete three phases of clinical trials will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the greater the chance of success.
CSL/ Seqirus provides scientific and technical expertise together with its established MF59® adjuvant technology to the University of Queensland in Australia to fast-track R&D of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology
GSK is partnering with Chinese biotech company Clover Biopharmaceuticals, providing it with its proprietary adjuvants which enhance the effectiveness of vaccines.
GSK is also collaborating with CEPI to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
GSK is collaborating with Innovax and Xiamen University, developing and testing a recombinant protein-based coronavirus vaccine candidate.
By mid-March, GSK further expanded collaborations to five partner companies and research groups across the world, including in the USA and China.
GSK entered into a collaboration with Sanofi to develop an adjuvanted vaccine for COVID-19, using innovative technologies from both companies. The vaccine would be ready to begin testing in humans in the second half of 2020.
Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC).
Johnson & Johnson and partners announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020. It is planning to rapidly scale up its manufacturing capacity with the goal of providing global supply of more than one billion doses.
Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The two companies plan to jointly conduct clinical trials initially in the United States and Europe across multiple sites by the end of April 2020. On April 22, the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection
Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development efforts of a SARS vaccine candidate using Sanofi’s recombinant DNA technology.
Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, will collaborate to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases.
Sanofi joined forces with GSK, sharing innovative technologies from both companies. For more details see GSK.
Shionogi’s subsidiary UMN Pharma Inc. is pursuing the discovery and development of a recombinant protein vaccine in a project supported by the Japan Agency for Medical Research and Development (AMED).
UCB is collaborating with The University of Oxford on a vaccine development.

 

DEVELOP DIAGNOSTIC TESTING & SECURE CONTINOUS SUPPLY
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world and governments are trying to ramp up their testing capacities. The biopharmaceutical industry is therefore pushing the boundaries, uniting and collaborating to increase and secure the production and development of diagnostics for COVID-19.

 

SECURE ESSENTIAL SUPPLIES FOR MEDICINES & VACCINES
IFPMA and its member companies are monitoring the impact the SARS-CoV2 outbreak and measures put in place by governments to prevent the spread of the virus (e.g. restrictions on travel, movement, border closures or measures on supply chain). Member companies are committed to ensure the continued supply of essential supplies for medicines and vaccines, for patients that suffer from chronic illnesses or other health conditions. Member companies are not aware of any near-term impacts on the availability of medicines and vaccines. They are continuously monitoring and proactively handling the situation as it develops and do currently not expect any long-term impact on the availability of medicines and vaccines, unless any disruption caused by the pandemic is sustained over the next several months.
Biopharmaceutical companies are working to prevent and mitigate any shortages through close coordination with national regulatory authorities and other global stakeholders, including the World Health Organization.
AbbVie is not anticipating disruption to the medicine supply for HIV patients as a result of the investigation of the effectiveness of HIV medicines against COVID-19.
Almirall will continue production of all its essential products and has increased production of specific medicines, such as paracetamol.
Bayer is continuing the production of medicines and health care products at their plant in Garbagnate, Italy for both the Italian and global market.
Biogen take the vital role they play in ensuring an uninterrupted supply of their medicines to patients very seriously. It does not anticipate any interruptions but cannot exclude the possibility that COVID-19 might have an impact on manufacturing capabilities in the future.
Boehringer Ingelheim ensures further discovery, development, production and supply of highly innovative medicines that are needed by patients around the globe.
Clinical and commercial supply chain teams at Bristol Myers Squib have proactively made sure raw materials and products reach their markets and clinical sites. It has not seen any disruption in its clinical or commercial supply chain due to the pandemic.
Chiesi Group will continue the production of all medicines without interruption at sites in Italy and abroad at the same high-quality standards. Currently, it is able to deliver medicines under normal production and distribution channels from all production plants in Italy, Brazil and France.
Seqirus has enacted its business continuity plans across the globe to minimise disruption to the manufacture and on-time supply of its influenza vaccines.
Daiichi-Sankyo announced it has not any shortage of its medicines. Its Supply Chain team is monitoring the evolving situation very carefully to maintain supply and delivery of these medicines.
Eisai maintains necessary stocks for the stable supply of medicines in addition to the stable production of medicines.
Eli Lilly launched the Lilly Insulin Value Program in the US allowing anyone with commercial insurance and those without insurance to fill their monthly prescription of Lilly insulin for $35.
Grünenthal is not experiencing any significant supply shortages. If their team detects any severe supply shortages that might potentially disrupt the supply of their products, affected partners will be informed as soon as possible.
Ipsen is closely working with national and international supplies to monitor the provision of goods and services, with the goal of continuing operations as seamlessly as possible. It does not anticipate any supply shortages.
LEO Pharma has activated business continuity plans to uninterruptedly supply patients with the medicines they need. LEO Pharma is taking additional measures to avoid any shortages of medicines or raw materials and to mitigate any interruptions.
Lundbeck has been extremely busy with taking precautions to provide treatments to the millions of people relying on them. Its supply chain remains intact and it has not experienced any supply disruptions.
Merck will continue to ensure access to Merck medicines at no cost for eligible patients (who have lost their jobs and health insurance coverage due to the pandemic) through its Merck Patient Assistance Program. Merck will also be making changes to other U.S. access and assistance programs due to the COVID-19 pandemic, including a temporary $0 co-pay for certain products for eligible privately insured patients who are enrolled in the Merck Access Program.
Merck and The Jenner Institute announced they have laid the foundation for large-scale production of The Jenner Institute’s COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Their joint team reduced process development time to two months from a year.
Novartis will continue to deliver their medicines to patients around the world and does not anticipate supply chain disruptions at this time.
Sandoz, the Novartis generics and biosimilars division, is maintaining prices on a basket of essential medicines that may help in the treatment of COVID-19.
Novartis encourages industry, governments and international institutions to work together to ensure adequate global access of medications to treat COVID-19 patients.
Novo Nordisk is ensuring the supply of their lifesaving medicines to people with serious chronic diseases across the globe. Novo Nordisk is applying its experience with Chinese lockdown measures around the globe to assure continuity of their supply chain
Roche is doing everything possible to ensure an adequate supply of their medicines. It calls upon governments to work with the industry to keep global manufacturing and supplies running by ensuring the free flow of vital goods across national borders, consider pragmatic temporary adjustments to regulations on packaging, reviews, customs etc. and to work together across governments internationally.
Sanofi to provide hydroxychloroquine (Plaquenil®) wherever possible and will secure appropriate supply levels of current approved indications.
Servier puts its best efforts forward to ensure the continuity of its production in order for its medicines to remain available to patients who rely on them. It therefore brings its expertise to the multi-stakeholder partnership “Health Innovation Coalition – Health Crisis” in France.
Teva is prepared for various scenarios and has inventory and redundancy plans in place to address potential shortfalls, if necessary. The supply chain for their key products, brand, generics and APIs remains largely uninterrupted with adequate inventory of products.

 

INCREASE & SHARE MANUFACTURING CAPACITY FOR MEDICINES & VACCINES
Biopharmaceutical companies are part of a wider research community which is collaborating to fast-track the development of therapeutics and new vaccines. Collaborating in this way could speed up development of resources to tackle this outbreak. It creates networks of centres of excellence that can deliver a real impact and a preparedness infrastructure which can be mobilized for future outbreaks. While there are still many unknowns about the virus, companies are entering in partnerships to scale-up production capacity.
Eli Lilly and AbCellera collaborate on AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
Under GSK and Sanofi vaccine development collaboration, both companies commit to create and supply sufficient quantities of vaccines that will help stop this virus. Both companies bring significant manufacturing capacity, and, if successful, we will be able to make hundreds of millions of doses annually by the end of next year.
Gilead has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
Johnson & Johnson announced plans to scale up its global manufacturing capacity with a goal of providing 1 billion doses of a safe and effective vaccine globally for emergency pandemic use on a not-for-profit basis.
Pfizer and BioNTech are jointly developing a COVID-19 vaccine, to be produced initially in the US and Europe. Manufacturing capacity will be scaled-up to support global supply. Pfizer will contribute its leading global vaccine clinical R&D, regulatory, manufacturing and distribution infrastructure and capabilities.
Pfizer is committed to use any excess manufacturing capacity and to potentially shift production to support others in rapidly getting life-saving breakthroughs into the hands of patients as quickly as possible.
Sanofi increased production capacity of hydroxychloroquine (Plaquenil®) by 50% and is on track to further increase production over the coming months.
Under Sanofi and GSK vaccine development collaboration, both companies commit to create and supply sufficient quantities of vaccines that will help stop this virus. See GSK for more details.
Teva is assessing additional production of hydroxychloroquine sulfate tablets with materials that are being sent to Teva from its ingredient supplier.
Teva’s global manufacturing network has been working tirelessly on securing and scaling production of both API and finished doses for potential treatments that my prove essential in treating COVID-19 everywhere Teva does business. UCB is assuring a reliable supply of medicines in every market it has a commercial presence in. It has not experienced shortages for any of our products due to this epidemic.

 

SUPPORT GLOBAL HEALTHCARE SYSTEMS
IFPMA member companies are committed to support health care system capacities and protect health care workers, particularly in the most hard-hit countries and vulnerable countries which are ill prepared to cope with an accelerating outbreak of COVID-19. When the novel coronavirus first emerged in Wuhan, China, IFPMA and its member companies started working with their teams on the ground, and with the Chinese authorities to ensure people can get access to necessary health care services. Given the spread of the virus to other regions across the world, IFPMA member companies have stepped up these efforts and are donating personal protective equipment and financial resources to ease the burden on health care systems. Company employees are also volunteering in community efforts to relieve the burden on healthcare systems.

 

FACTS & FIGURES
:: Number of IFPMA member companies involved in R&D for COVID-19 therapeutics, vaccines and diagnostics: at least 20 of IFPMA member companies are involved in COVID-19 focused R&D efforts
:: Number of clinical trials initiated/ supported by IFPMA member companies: 25 clinical trials evaluating the effectiveness of therapeutics for COVID-19
:: Average number of people enrolled in clinical trials by IFPMA members: On average with 350 participants (except the large-scale Gilead trials + Teva trial which all have above 1000 participants)
:: Value of monetary donations from IFPMA member companies: stands at least at $614 million to date
:: Value of non-monetary donations, such as medicines, personal protective equipment: stands at least at $38 million to date
:: Units of non-monetary donations, such as medicines, personal protective equipment: 25 million units of medicines, face masks, gloves, disinfectants, and the like