PHARMACY MARKET

Pfizer and BioNTech Announce a Partnership with Biovac to Develop and Distribute COVID-19 Vaccine Doses in Africa

Pfizer | July 22, 2021

Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, also known as "Biovac," a South African biopharmaceutical business headquartered in Cape Town, to produce the Pfizer-BioNTech COVID-19 Vaccine for sale inside the African Union.

Biovac will manufacture and distribute COVID-19 vaccines as part of Pfizer and BioNTech's worldwide COVID-19 vaccine supply chain and production network, which currently spans three continents and includes more than 20 facilities. Technical transfer, on-site development, and equipment installation operations will begin immediately to enable Biovac's participation in the process.

Biovac's Cape Town plant is expected to be integrated into the vaccine supply chain by the end of 2021, according to Pfizer and BioNTech. Biovac will acquire drug substances from European facilities, and final dosage manufacturing will begin in 2022. Annual production will reach 100 million finished dosages at full operating capacity. All dosages will be delivered solely inside the African Union's 55 member states.

Quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program are all factors that Pfizer and BioNTech consider when selecting contract manufacturers. Since 2015, Pfizer and Biovac have collaborated on the Prevenar 13 vaccine's sterile formulation, fill, finish, and distribution.

Pfizer and BioNTech have delivered more than 1 billion doses of COVID-19 vaccine to more than 100 nations and territories across the globe. The companies are firmly committed to ensuring that all people around the world have equitable and affordable access to COVID-19 vaccines, actively working with global governments and global health partners to provide 2 billion doses to low and middle-income countries in 2021 and 2022 – 1 billion each year. This comprises a non-profit arrangement to provide 500 million doses to the US government, which the government will then give to the African Union and the COVAX 92 Advanced Market Commitment (AMC) nations, as well as a 40 million dose direct supply deal with the COVAX facility.

Both BioNTech and Pfizer worked together to create the Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's unique mRNA technology. In addition to the European Union, BioNTech has emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but it has been approved for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 12 and up. Unless the declaration is ended or the permission withdrawn sooner, the emergency use of this product is only allowed for the duration of the declaration that conditions exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act.

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The European regulators therefore considered that a change was needed. Following recent scandals such as the Poly Implant Prothese ("PIP”) scandali, certain initiatives were having already been taken under the current regime (a) to minimise the risk to patients' and (b) to reduce so called “notified body tourism” by increasing scrutiny on notified bodiesii; further harmonisation measures to improve patient safety were nonetheless deemed necessary.

Spotlight

The European regulators therefore considered that a change was needed. Following recent scandals such as the Poly Implant Prothese ("PIP”) scandali, certain initiatives were having already been taken under the current regime (a) to minimise the risk to patients' and (b) to reduce so called “notified body tourism” by increasing scrutiny on notified bodiesii; further harmonisation measures to improve patient safety were nonetheless deemed necessary.

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Acurx Pharmaceuticals to Join the Russell Microcap Index®

Acurx Pharmaceuticals, Inc. | September 06, 2021

Acurx Pharmaceuticals, Inc, a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company is set to join the Russell Microcap® Index when the market opens on September 20, 2021, according to a preliminary list of additions posted on September 1, 2021. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes. "Inclusion in the Russell Microcap Index reflects the ongoing achievement of our previously stated drug development objectives for our pipeline of DNA polymerase IIIC inhibitors, and the fact that, if approved, we would bring to market the first of a new class of antibiotics in over 30 years," said David P. Luci, President and CEO of Acurx. "Inclusion in the Index benefits our Company and stockholders by elevating our visibility within the global investment community. We look forward to continuing our progress towards completing the clinical development program for ibezapolstat, our lead antibiotic candidate targeting the treatment of C. difficile Infection and delivering on several key milestone catalysts through 2021 and 2022," concluded Luci. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. About FTSE Russell FTSE Russell is a global index leader that provides innovative benchmarking, analytics, and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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Lubrizol Life Science Launches Advanced, Natural Nutraceutical Solution to Support Mental Agility

Lubrizol Life Science | October 28, 2020

Lubrizol Life Science Health (LLS Health) launches ASTAGILE™ microcapsules, its new sustainable, organic-certified, astaxanthin (Haematococcus pluvialis), microencapsulated with spirulina. The two ingredients have been uniquely combined in a patent-pending product designed to promote mental agility and support healthy ageing for young and senior adults. Astaxanthin is a carotenoid found in freshwater microalgae, and spirulina is a type of algae. Both have numerous health promoting effects. To create the synergistic algae blend, LLS Health teamed with Neoalgae Micro Seaweeds Products, SL, a research and development company in Spain dedicated to microalgae biotechnology.

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Aidoc and Subtle Medical Partner to Bring End-to-End AI Solutions to Medical Imaging

Aidoc | September 15, 2021

Aidoc, leading provider of AI for medical imaging, announced today a partnership with Subtle Medical, developer of leading AI-based image enhancement bringing best-of-breed AI to both image acquisition and post-acquisition clinical workflows. Aidoc has developed the industry's most robust AI platform, delivering a unified and seamless cross-specialty AI experience for physicians in over 500 medical centers, including the largest clinical deployment of AI in healthcare at Radiology Partners. "Mainstream healthcare adoption of AI requires both a comprehensive package of premier AI solutions and an ability to deliver their results in a reliable and seamless manner across physician workflow, Through this partnership, we will provide health systems and imaging centers with Subtle Medical's optimal solution, now seamlessly delivered through a unified AI architecture. Our platform's ability to deliver interoperable AI solutions is a game changer for AI adoption." - Tom Valent, VP of Business Development at Aidoc. A pioneer in healthcare AI, Aidoc's FDA-cleared solutions analyze medical images for critical conditions and trigger actionable alerts directly in the imaging workflow supporting medical specialists in reducing turnaround time and improving quality of care. Subtle Medical's AI-powered software solutions, SubtlePET™ and SubtleMR™ are image enhancement tools that increase the efficiency of image capture by improving the quality of accelerated scans. This enables optimized scan times and can potentially increase the number of patients scanned per day. Subtle's solutions are compatible with all scanner brands, models and field strengths so institutions can see the benefit across their entire scanner fleet. "This agreement will provide our customers with a multimodality solution that includes acquisition workflow efficiencies and image quality improvements together with Aidoc's post-acquisition clinical workflow solutions, We believe that the integration of Subtle's AI-based software tools with the Aidoc platform will dramatically change the medical imaging equation." - Josh Gurewitz, Chief Commercial Officer at Subtle Medical. About Subtle Medical Subtle Medical, Inc. is a leading healthcare technology company making medical imaging faster, safer, and smarter. For more information, visit subtlemedical.com. About Aidoc Aidoc is the leading provider of artificial intelligence solutions that support and enhance the impact of physician diagnostic power - helping them expedite patient treatment and improve quality of care.

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