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.

Spotlight

Since the advent of the commercial Internet, digital technologies have empowered consumers worldwide, leading them to play an active and demanding role with the companies with which they do business. The rules of engagement have changed: By using the Internet, consumers can be heard, and they can influence other consumers powerfully. The Internet permeates every aspect of people’s lives and has transformed the way we live and work. The confluence of the Internet, social media and ubiquitous mobile devices has inalterably redrawn the contours of consumer empowerment. This tectonic shift is impacting the traditional interactions of healthcare professionals (HCP) and pharmaceuticals companies, even amid the regulatory scrutiny that is endemic to this industry.

Spotlight

Since the advent of the commercial Internet, digital technologies have empowered consumers worldwide, leading them to play an active and demanding role with the companies with which they do business. The rules of engagement have changed: By using the Internet, consumers can be heard, and they can influence other consumers powerfully. The Internet permeates every aspect of people’s lives and has transformed the way we live and work. The confluence of the Internet, social media and ubiquitous mobile devices has inalterably redrawn the contours of consumer empowerment. This tectonic shift is impacting the traditional interactions of healthcare professionals (HCP) and pharmaceuticals companies, even amid the regulatory scrutiny that is endemic to this industry.

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BUSINESS INSIGHTS

Athira Pharma Advances Phase 2/3 LIFT-AD Clinical Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Patients

Athira Pharma, Inc. | October 18, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The committee also determined that, with the additional enrollment of fewer than 150 patients for a total enrollment of less than 300 patients without background therapy the study will be well powered for the primary endpoint given the preliminary effect size observed. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition and function. Results from the completed exploratory ACT-AD Phase 2 study showed a favorable safety profile and suggested positive effects on measures of cognition function and neurodegeneration in patients taking fosgonimeton without background therapy. Guided by these results, the Company proactively amended LIFT-AD to focus on patients not on background therapy. The unblinded interim analysis was then conducted in approximately 100 patients not on background therapy to corroborate observations from ACT-AD and ensure LIFT-AD is well powered to determine the effect of fosgonimeton on clinically meaningful and commercially relevant endpoints. “The results from the data monitoring committee’s unblinded analysis give us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes. This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.” Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira “We are very excited by the results of this independent review as we believe they mitigate the risk of the fosgonimeton development plan, support the potential clinical benefit of fosgonimeton and inform the sample size needed to achieve success with LIFT-AD,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We are now targeting to complete enrollment in mid-2023 and report topline data in early 2024. Importantly, we have a strong balance sheet to execute our plans through key data readouts and beyond. Moving forward, we remain keenly focused on advancing this novel investigational therapy with the hope of positively impacting the lives of millions of Alzheimer’s patients. “Our goal with fosgonimeton is to demonstrate its ability to improve cognition and function and to ultimately provide neuroprotection. The ACT-AD study suggested these benefits, and the results of the LIFT-AD interim analysis corroborate those findings,” added Dr. Litton. “We believe any drug that can demonstrate neuroprotection could become a treatment of choice for mild-to-moderate Alzheimer’s patients.” About the LIFT-AD Clinical Study LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease. Patients are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale and function. Additional information on the LIFT-AD study can be found at: NCT04488419. About Fosgonimeton Fosgonimeton is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain. The ACT-AD trial was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health. About Athira Pharma, Inc. Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies and neuropsychiatric indications.

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PHARMA TECH

Xeris Biopharma Announces Research Collaboration and Option Agreement With Horizon Therapeutics plc for XeriJect™ Formulation of Teprotumumab

Xeris | November 24, 2022

Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed. “We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.” Paul R. Edick, Chairman and CEO of Xeris About XeriJect™ XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing. About Xeris Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.

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BUSINESS INSIGHTS

Vetsource Unveils New Brand Reflecting Company's Growth

Vetsource | November 17, 2022

Vetsource®, a pet health company designed to provide innovative pharmacy, technology and business services to those who care for pets, launched a new brand identity to signal the official start of three brands coming together as a single, unified portfolio of solutions for the veterinary industry. Already established as a leading provider of innovative prescription management and home delivery services for veterinary practices and pet owners since 2008, Vetsource announced the acquisitions of VetSuccess, a data and analytics provider, and Vet2Pet, a client engagement system, in 2018 and 2019, respectively. Since the acquisitions, the three companies have largely worked together under Vetsource corporate, while still maintaining their separate identities, to allow time to formalize and ease the transition for customers. Information about Vetsource's client engagement, and data and insights services can be found on Vetsource's new website at Vetsource.com, which received a complete redesign to reflect the company's rebrand and comprehensive solutions. The Vet2Pet and VetSuccess websites will be automatically redirected to Vetsource.com and will support access to customer logins. "Adding client engagement, and data and insights, to the Vetsource portfolio allows us to leverage their combined strength to add greater value for the industry. Our goal is to foster strong relationships and positive experiences so veterinarians can focus on what they do best – caring for pets." Kurt Green, Vetsource CEO The product sign-in URLs will remain the same for all three products. The Vet2Pet name will be retained as a product name under Vetsource's client engagement services. "There will be no disruption of service for any of our customers. They will receive the same support and access to services they always have," said Green. "When the companies joined, so too did the same innovative and talented team of people their customers know and trust. We're lucky to now count them as part of the Vetsource family." VMX attendees can find Vetsource at booth #1230 exhibiting its prescription management, client engagement and data and insights solutions for the first time as one united brand. About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and those who care for them. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement.

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