Walgreens Launches Gene and Cell Services as Part of Newly Integrated Walgreens Specialty Pharmacy Business




Walgreens Launches Gene and Cell Services as Part of Newly Integrated Walgreens Specialty Pharmacy Business

• Walgreens Specialty Pharmacy combines existing specialty assets, fully integrates AllianceRx and represents the company’s latest step to leverage its neighborhood pharmacies into fast-growing areas of healthcare
• Investments include new Gene & Cell Services Pharmacy and Innovation Center

DEERFIELD, Ill.–(BUSINESS WIRE)–Walgreens is expanding its specialty pharmacy services and investing in its capabilities as the company further grows its core pharmacy business to improve patient outcomes and provide greater value to payers and partners. The company today introduced Walgreens Specialty Pharmacy, a holistic offering that expands access to care for patients with complex, chronic conditions and enables partnerships that drive profitability for Walgreens’ pharmacy business. The company is also making investments that will transform its specialty pharmacy offerings, including gene and cell therapy services.

Under the new business, Walgreens Specialty Pharmacy has an unmatched offering and is the only specialty pharmacy in the market with the following services and assets at scale:

• Gene and Cell Services Pharmacy and Innovation Center – a dedicated 18,000-square-foot center in Pittsburgh, PA, with services and capabilities for these emerging therapies, including innovative solutions for managing the complexity of the supply chain, logistics and financing as well as clinical and social needs management to ensure success for patients and partners.
• Four central specialty pharmacies – each holding several national pharmacy accreditations – where pharmacists and care teams across the country work together to dispense highly complex medications and help patients manage chronic or rare diseases and conditions. These pharmacies hold distinctions in oncology and rare/orphan conditions and offer patients and caregivers clinical services that drive engagement, adherence and outcomes.
• Nearly 300 community-based specialty pharmacies across the nation – more than any other pharmacy. These specialty pharmacies are strategically located near medical office buildings and health systems, closely aligning care provision with local physicians, offering patients access to specialty medications faster than the industry average, as well as services like injection training, medication side-effect management and financial assistance coordination for medications.
• More than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support team members and dedicated Specialty360 teams that support all specialty condition and therapies.
• A growing roster of 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution drugs.

Walgreens Specialty Pharmacy is focused on breaking through healthcare system silos, bringing convenient access to hard-to-find medications and critical adherence support. Building upon the deep, trusted relationships Walgreens pharmacists have with providers and communities, the model enables more comprehensive care to ultimately help payers better manage specialty costs.

Accelerating Walgreens growth in one of the fastest-growing market segments

Specialty medications today account for more than 50% of prescription drug spend in the U.S.^[1] due to the increasing prevalence of chronic disease. There is a need for disease management solutions that are treated by specialty drugs. To advance solutions, Walgreens Specialty Pharmacy enables patient access to specialized treatments through a newly formed integrated care model, driving cost savings and efficiencies in care by uniting the company’s pharmacy teams and distribution network across providers, pharmaceutical manufacturers, health plans and payers.

“With approximately $24 billion in annual enterprise specialty revenue, Walgreens Specialty Pharmacy is the largest independent provider that offers the industry’s most robust specialty capabilities not vertically aligned with a pharmacy benefit manager,” said Rick Gates, chief pharmacy officer, Walgreens. “We have the flexibility to contract dynamically with any payer. We can partner directly with pharmaceutical manufacturers to facilitate products to market, including limited distribution drugs, and coordinate closely with providers to ensure patients experience a smooth start to treatment.”

Walgreens is building on its decades of experience serving the specialty pharmacy needs of commercial, Medicaid, Medicare, and other government and private payers. The company provides services or access to nearly all pharmacy benefit managers and major health plans— as well as alternative payment and service models that help health plans and PBMs differentiate themselves for their clients and members.

Delivering an integrated care model to patients who need it most

Effective August 1, 2024, AllianceRx Walgreens Pharmacy will become Walgreens Specialty Pharmacy. Patients of AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies now have access to resources that will build upon the expert care they already receive from their specialty pharmacist, including clinicians with key disease state expertise, nutritionists and care nurses. Specialty patients can also view their entire prescription profile at Walgreens, including their retail prescriptions.

“When a patient must confront a life-changing, serious health challenge and begins therapy for a chronic or complex condition, our pharmacists are right there to guide and care for them throughout their healthcare journey —from helping them order and take their medication to identifying financial assistance opportunities and working with their doctor and insurance plan to make sure they’re receiving the most coordinated care,” Gates said.

In addition, Walgreens has seen consistent growth through its wholly owned subsidiary Shields Health Solutions, the nation’s premier health system-owned specialty pharmacy accelerator. Shields specialty model provides integrated care solutions for local health systems and specialty pharmacy patients, working with over 1,000 hospitals across 45 states. The Shields business will continue supporting health systems specialty pharmacies, which complement Walgreens newly enhanced specialty pharmacy offerings.

The launch of Walgreens Specialty Pharmacy is the company’s latest initiative aimed at expanding the role its pharmacy teams play in patients’ lives and bringing their clinical expertise to help payers, providers, pharmaceutical manufacturers and partners deliver critical healthcare. It also further supports Walgreens’ efforts to achieve provider status for its pharmacists given their influence and integral role in healthcare delivery.

^[1] IQVIA. Global Use of Medicines 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-global-use-of-medicines-2023

About Walgreens Specialty Pharmacy

Walgreens Specialty Pharmacy holds several national pharmacy accreditations and services are offered to nearly 300 million covered lives across the country. At Walgreens, the term “specialty” covers services and medications for patients with rare, complex and chronic diseases like cancer, cystic fibrosis and Crohn’s disease, who often require additional support from their healthcare providers. Walgreens specialty pharmacists have additional training to better understand these specialty medications which have unique storage, temperature, and handling requirements; are given by infusion, injection or taken orally; and require close patient monitoring and ongoing clinical support. They also help patients find affordable access to high-cost medications, help with adherence barriers and support patients throughout their treatment.

About Walgreens

Walgreens (www.walgreens.com) is included in the United States segment of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 170-year heritage of caring for communities. As America’s most loved pharmacy, health and beauty company, Walgreens purpose is to champion the health and well-being of every community in America. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving approximately 9 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in local communities nationwide.

Contacts

Erin Loverher

Walgreens Media Relations

media@walgreens.com

Arcus Biosciences to Present New Data from Phase 2 Studies of Novel Immuno-Oncology Combinations at the 2024 ASCO Annual Meeting




Arcus Biosciences to Present New Data from Phase 2 Studies of Novel Immuno-Oncology Combinations at the 2024 ASCO Annual Meeting

• Updated data from EDGE-Gastric evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) cancers will be presented in a special ASCO plenary series rapid abstract update session by Yelena Y. Janjigian, M.D., Chief Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, and Lead Investigator for the EDGE-Gastric study

• Data from ARC-9 evaluating an etrumadenant plus zimberelimab-based treatment combination in third-line metastatic colorectal cancer will be presented in an oral presentation by Zev A. Wainberg, M.D., MSc, Co-Director UCLA Gastrointestinal Oncology Program, and Lead Investigator for the ARC-9 study

• Trial in Progress (TIP) poster for VELOCITY-Lung Substudy-03, a Phase 2 study of perioperative domvanalimab plus zimberelimab and chemotherapy in patients with resectable Stage II-III non-small cell lung cancer

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced three accepted abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 – June 4, 2024. The selected abstracts presented in partnership with Gilead Sciences provide strong support for the companies’ portfolio of investigational medicines across multiple types of cancer, including lung, upper GI and colorectal cancer.

“We will have two oral presentations for Phase 2 studies that highlight the potential for novel immuno-oncology mechanisms and combinations in gastrointestinal cancers,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “The EDGE-Gastric presentation will include the median progression-free survival (PFS) data for our Fc-silent anti-TIGIT antibody in combination with zimberelimab and chemotherapy in upper GI cancers, the same setting as our STAR-221 Phase 3 study. The ARC-9 presentation will include randomized PFS and overall survival data for an etrumadenant (our adenosine receptor antagonist)-based combination therapy versus regorafenib, an approved standard of care in third-line colorectal cancer.”

Three Accepted Abstracts Will Be Presented

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Domvanalimab, zimberelimab and etrumadenant are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal and lung cancers have not been established.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Communications

(650) 922-1269

hkolkey@arcusbio.com

PBIRx Growth Fueled by Johnson & Johnson ERISA Lawsuit




PBIRx Growth Fueled by Johnson & Johnson ERISA Lawsuit

A message from PBIRx Founder & President

MILFORD, Conn.–(BUSINESS WIRE)–#SOC2—A message from PBIRx Founder & President, Patricia Sirowich: PBIRx is a consulting and auditing firm totally focused on the pharmacy benefit for over thirty years. Concerns of pharmacy benefit mismanagement resulting in higher premiums, copays, coinsurance, drug costs, deductibles, and lower wages or limited wage growth caused one employee to allege a fiduciary breach in a 75-page lawsuit against Johnson & Johnson.

Self-funded ERISA plan sponsors and their benefit advisors are engaging PBIRx for our guidance to prevent their clients from being in a similar situation. There is a major focus on the exorbitant generic costs and especially Specialty generic drugs. Plan sponsors must demonstrate that there has been due diligence in evaluating, selecting, and monitoring of their PBM partner to ensure they are meeting their fiduciary responsibilities. The facts shared in this lawsuit have attracted multiple concerned mid to large size self funded Plan Sponsors to PBIRx and our all-inclusive pharmacy benefit consulting and auditing services.

PBIRx is one of the first “independent” pharmacy benefit consulting firms that not only prefers PBMs that offer transparency, but also allow PBIRx to audit our clients’ PBM pricing, rebates, clinical programs, and service level performance measured to contractual guarantees. We are the only consulting firm that requests a PBM contract with the Proposed financial model stated in the RFP with calculation methodology for each financial guarantee along with a repricing file. As an example, the generic price guarantee can be different from what is stated in the proposal, different than the repricing file, and different than the contract language, which forces the PBM to recognize that PBIRx is an experienced, knowledgeable, and detailed consulting firm. PBIRx is not a PBM, coalition, or optimizer, and fully discloses all fees.

Every client has different needs and cultures. PBIRx listens to and confirms with every client to be sure that there is a clear understanding of their pharmacy benefit strategies. It is well known that the top three PBMs are owned by or own an insurance company and as public companies are beholden to their stockholders and not necessarily the client. Yet even with that, some larger companies tend to want to work with the top three even though they know they will be paying more than they would with a mid-size transparent PBM.

Another example is that 90% of the time traditional and specialty generic drugs are lower in cost through the retail pharmacy if your PBM agreement has been negotiated with competitive guarantees. Specialty generics can be outrageously higher through a specialty pharmacy unless your consultant understands, negotiates, and audits specific guarantees. One word missing in the contract can cost a Plan Sponsor, depending on the size of the plan, hundreds of thousands of dollars or more.

Plan Sponsors should routinely have their pharmacy benefit contract and claims audited by an experienced pharmacy benefit auditor like PBIRx to ensure that contractual guarantees have been met and identify areas of improvement.

About PBIRx
Our mission is to create optimal healthcare outcomes while minimizing overall healthcare costs. PBIRx is not a PBM. Since its founding as the first pharmacy benefit consulting and auditing firm in 1993, PBIRx has saved clients over $381 million, combating excessive profits of PBMs and pharmaceutical manufacturers. As a client advocate and educator, PBIRx’s primary goal is to manage pharmacy benefit costs for clients with a major sensitivity to their diverse cultures and needs. Our deep knowledge and advanced tools have helped us build lasting relationships and empower our clients to unravel the complexities of the ever-evolving pharmacy benefit industry. We are proud to be recognized as an Inc. 5000 fastest-growing company, a SOC 2 Type 2 certified company, and a certified Woman Owned Small Minority Business Enterprise.

To learn more, please visit PBIRx.com and follow @pbirx on X or PBIRx on LinkedIn.

Contacts

For more information contact:

David Sirowich

Executive Vice President

203.882.1188 x207

dsirowich@pbirx.com

CORRECTING and REPLACING PharmaEssentia Appoints Robert Geller, M.D. as Head of Medical




CORRECTING and REPLACING PharmaEssentia Appoints Robert Geller, M.D. as Head of Medical

BURLINGTON, Mass.–(BUSINESS WIRE)–Please replace the release dated April 23, 2024 with the following corrected version due to multiple revisions.

The updated release reads:

PHARMAESSENTIA APPOINTS ROBERT GELLER, M.D. AS HEAD OF MEDICAL

PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced the appointment of Robert Geller, M.D. as Head of Medical.

Dr. Robert Geller is a medical oncologist with diverse expertise across the biotechnology industry and in academia, including in drug development, medical affairs, business development and as a clinical scientist. As the new Head of Medical at PharmaEssentia, Dr. Geller will be responsible for U.S. clinical operations, reporting to Chief Medical Officer, Albert Qin, M.D., Ph.D. Most recently, Dr. Geller was the Chief Medical Officer at Aravive Inc, where he was responsible for the medical oversight of clinical trials related to the development of batiraxcept, including a Phase 3 trial in platinum resistant ovarian cancer, as well as safety and pharmacovigilance. Prior, he served as Senior Vice President, Medical Affairs at Coherus Biosciences, where he was responsible for recruiting and reorganizing a Medical Affairs team to support post marketing of UDENYCA^®, and the expansion of the oncology franchise and ophthalmology and immunology pipelines. Dr. Geller has also held medical roles at Heron Therapeutics, Alexion Pharmaceuticals and Vion Pharmaceuticals. His clinical experience includes serving as Medical Director at several community and regional cancer centers across the country, as well as Partner in a specialty oncology/hematology practice. Dr. Geller received his M.D. from Harvard Medical School/Harvard-MIT Health Science Technology and an B.S./M.S. in physics from Massachusetts Institute of Technology.

“I am thrilled to welcome Robert to the PharmaEssentia family to help advance our commitment to provide new therapeutic solutions for patients with myeloproliferative neoplasms and other hematological diseases that have limited therapeutic options,” said Dr. Ko-Chung Lin, PharmaEssentia CEO. “This is an exciting time in our Company’s growth, as we continue to establish the clinical value of ropeginterferon alfa-2b-njft, marketed as BESREMi^®, for myeloproliferative neoplasms and to advance our pipeline; we look forward to Robert’s leadership and partnership with our physician and patient communities.”

UDENYCA is a registered trademark of Coherus Biosciences, Inc.

About PharmaEssentia

PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.

For more information about PharmaEssentia USA, visit the website, LinkedIn or Twitter.

Forward Looking Statement

This press release may contain forward looking statements, including statements regarding the clinical benefits to be derived from ropeginterferon alfa-2b, the commercial opportunity and competitive positioning, new indications or labeling for ropeginterferon alfa-2b, and business prospects for ropeginterferon alfa-2b. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward looking statements as a result of various factors. These factors include whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

© 2024 PharmaEssentia Corporation. All rights reserved.

PharmaEssentia, the PharmaEssentia logo, and BESREMi are trademarks or registered trademarks of PharmaEssentia Corporation.

Contacts

Media:
Muriel Huang, muriel_huang@pharmaessentia.com

Court Finds Advanced Cell Diagnostics Patents Invalid in Lawsuit with Molecular Instruments




Court Finds Advanced Cell Diagnostics Patents Invalid in Lawsuit with Molecular Instruments

LOS ANGELES–(BUSINESS WIRE)–#Biotech–Molecular Instruments, Inc. announced today that the Patents Court of the High Court of England and Wales has found two patents owned by Advanced Cell Diagnostics, Inc. (a Bio-Techne group company) to be invalid.

In a 2022 lawsuit filed in the United Kingdom (proceedings no. HP-2022-000026), Advanced Cell Diagnostics alleged that Molecular Instruments’ HCR™ RNA-ISH technology infringes European Patents (UK) 2,500,439 and 1,910,572. The Court has rejected that claim ruling that both patents are invalid (https://caselaw.nationalarchives.gov.uk/ewhc/pat/2024/898) with Mr. Justice Meade finding that Molecular Instruments’ primary evidence (on invalidity) is “really overwhelming in this case.”

“Our goal is to empower biologists, bioengineers, drug developers, and diagnostics developers by providing them with next-generation molecular tools that enable breakthroughs in their projects,” said Dr. Harry Choi, CEO of Molecular Instruments. “We felt compelled to fight this lawsuit to protect the ability of our customers to continue their research, as many customers working in challenging imaging settings cannot perform their experiments with any other technology. This judgment in our favor ensures that UK researchers will not be denied access to our game-changing HCR™ imaging platform.”

About the HCR™ imaging platform

HCR™ RNA in situ hybridization (RNA-ISH) leverages dynamic nanotechnology to enable small amplification components to first penetrate a biological sample without interacting and then autonomously grow bright amplification polymers at the site of RNA targets within the sample. This unique combination of properties enables automated chromogenic and fluorescent HCR™ RNA-ISH workflows to be entirely protease-free, preserving sample morphology and protein target integrity for native compatibility with existing immunohistochemistry (IHC)/immunofluorescence (IF) assays. Likewise, manual fluorescent HCR™ RNA-ISH assays offer unmatched performance, versatility, and robustness in samples of all varieties including whole-mount vertebrate embryos, multi-species environmental samples, thick brain slices, and ultrathick samples up to 1 cm.

About Molecular Instruments

Molecular Instruments® (www.molecularinstruments.com) develops and synthesizes molecular kits powered by the breakthrough HCR™ imaging platform for applications in academic research, drug development, synthetic biology, and clinical pathology and diagnostics.

Contacts

media@molecularinstruments.com
Joyce Yoo

Oncology Collaboration and Licensing Agreements Analysis Report 2024 with Directory of 3685 Deals Signed Since 2019 – ResearchAndMarkets.com




Oncology Collaboration and Licensing Agreements Analysis Report 2024 with Directory of 3685 Deals Signed Since 2019 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Oncology Collaboration and Licensing Deals 2019-2024” report has been added to ResearchAndMarkets.com’s offering.

Oncology Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to the oncology deals entered into by the worlds leading biopharma companies. Fully revised and updated, the report provides details of 3685 oncology deals from 2019 to 2024. The report provides access to deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms.

Understanding the flexibility of a prospective partner’s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred – contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of collaboration and licensing deals announced since 2019 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual licensing contract documents as submitted to the Securities Exchange Commission by companies and their partners.

The initial chapters of this report provide an orientation of oncology dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in oncology dealmaking.

Chapter 3 covers the financial deal terms for deals signed in the oncology field with stage of development announced. Deals are listed and sectioned by headline value, upfront payment, milestone payment and royalty rates.

Chapter 4 provides a review of the top 25 most active biopharma companies in oncology dealmaking. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 5 provides a comprehensive and detailed review of oncology deals signed and announced since 2019 where a contract document is available. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapter 6 provides a comprehensive directory of oncology deals listed by therapeutic target.

The report also includes numerous table and figures that illustrate the trends and activities in oncology deal making since 2019.

In addition, a comprehensive deal directory is provided organized by company A-Z and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

Key Benefits

Oncology Collaboration and Licensing Deals includes:

• Trends in oncology dealmaking in the biopharma industry
• Overview of collaboration and licensing deal structure
• Directory of oncology deal records covering pharmaceutical and biotechnology
• The leading oncology deals by value
• Most active oncology licensing dealmakers

In Oncology Collaboration and Licensing Deals, the available deals are listed by:

• Company A-Z
• Headline value
• Therapeutic area
• Technology type

Analyzing contract agreements allows due diligence of:

• What are the precise rights granted or optioned?
• What is actually granted by the agreement to the partner company?
• What exclusivity is granted?
• What is the payment structure for the deal?
• How are sales and payments audited?
• What is the deal term?
• How are the key terms of the agreement defined?
• How are IPRs handled and owned?
• Who is responsible for commercialization?
• Who is responsible for development, supply, and manufacture?
• How is confidentiality and publication managed?
• How are disputes to be resolved?
• Under what conditions can the deal be terminated?
• What happens when there is a change of ownership?
• What sublicensing and subcontracting provisions have been agreed?
• Which boilerplate clauses does the company insist upon?
• Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
• Which jurisdiction does the company insist upon for agreement law?

Key Topics Covered:

Chapter 1 – Introduction

Chapter 2 – Trends in oncology dealmaking

2.1. Introduction

2.2. Oncology partnering over the years

2.3. Oncology partnering by deal type

2.4. Oncology partnering by industry sector

2.5. Oncology partnering by stage of development

2.6. Oncology partnering by technology type

2.7. Oncology partnering by therapeutic indication

Chapter 3 – Financial deal terms for oncology partnering

3.1. Introduction

3.2. Disclosed financials terms for oncology partnering

3.3. Oncology partnering headline values

3.4. Oncology deal upfront payments

3.5. Oncology deal milestone payments

3.6. Oncology royalty rates

Chapter 4 – Leading oncology deals and dealmakers

4.1. Introduction

4.2. Most active in oncology partnering

4.3. List of most active dealmakers in oncology

4.4. Top oncology deals by value

Chapter 5 – Oncology contract document directory

5.1. Introduction

5.2. Oncology partnering deals where contract document available

Chapter 6 – Oncology dealmaking by therapeutic target

6.1. Introduction

6.2. Deals by oncology therapeutic target

Deal directory

• Deal directory – Oncology deals by company A-Z 2019 to 2024
• Deal directory – Oncology deals by technology type 2019 to 2024
• Deal type definitions

For more information about this report visit https://www.researchandmarkets.com/r/iqw5x0

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global COVID-19 Vaccines Strategic Research Report 2024 – ResearchAndMarkets.com




Global COVID-19 Vaccines Strategic Research Report 2024 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “COVID-19 Vaccines – Global Strategic Business Report” has been added to ResearchAndMarkets.com’s offering.

Global COVID-19 Vaccines Market to Reach 4.2 Billion Doses by 2025

The global market for COVID-19 Vaccines, estimated at 6.4 Billion Doses in the year 2023, is projected to reach 4.2 Billion Doses by 2025.

The COVID-19 Vaccines market in the U.S. is estimated at 285 Million Doses in the year 2023. China, the world’s second largest economy, is forecast to reach a projected market size of 1 Billion Doses by the year 2025. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach 1.8 Billion Doses by the year 2025.

The emergence of mRNA vaccines marks the beginning of a new era in vaccine development and medical therapies. RNA technology offers numerous benefits and holds potential for addressing future outbreaks. However, there are key challenges to overcome. mRNA vaccines have shown promise in combating not only COVID-19 but also cancer, opening doors for new application areas.

Vaccine passports have risen in importance, aiming to ease COVID-19 restrictions and ensure public safety, with developments focusing on digital certificates for enhanced efficiency. mRNA vaccines are touted to provide better protection against newer variants, prompting discussions around the need for booster doses. Vaccine alliances have been formed to ensure equitable access to supplies worldwide, while licensing and partnership deals are driving vaccine production forward on a global scale.

MARKET OVERVIEW

• Global Economic Update
• COVID-19 Vaccines – Global Key Competitors Percentage Market Share in 2023 (E)
• THE VARIOUS COVID-19 VIRUS VARIANTS
• AN OVERVIEW OF COVID-19 VACCINE ROLLOUT
• COVID-19 Vaccine Approval Details
• COVID-19 Vaccine Funding Details
• Pfizer/BioNTech’s COVID-19 Vaccine Receives World’s First Authorization
• UK Clinches the First Position in the World to Approve Pfizer’s Vaccine
• After UK, Pfizer’s Vaccine Gains Approval from the US and EU
• UK Clinches the First Position in the World to Approve Pfizer’s Vaccine
• After UK, Pfizer’s Vaccine Gains Approval from the US and EU
• After Pfizer, Moderna Vaccine Bags Coveted EUA from US FDA
• Moderna Kick-Starts Inoculation in the US
• AstraZeneca’s Vaccine – Third Globally to Obtain Approval
• Pfizer/BioNTech vs. Moderna vs. AstraZeneca vs. J&J Vaccine
• A Comparison of Pfizer, Moderna, and AstraZeneca COVID-19 Vaccine
• Johnson & Johnson’s Adenovirus-based COVID-19 Vaccine vis-a-vis Moderna or Pfizer
• Russia Commences Mass Vaccination from Mid-December, 2020
• China Awards Conditional Approval to First COVID-19 Vaccine from Sinopharm
• WHO Approves China`s Sinopharm Covid-19 vaccine for Emergency Use
• China Issues License for Vaccine Production to Overseas Partners
• Brazilian Authorities Approve Sinovac’s CoronaVac
• AstraZeneca’s Covishield and Bharat Biotech’s Covaxin Receive Emergency Use Approval in India
• Sanofi-GSK to Offer Vaccine at a Discounted Rate
• CanSinoBIO Claims No Blood Clot Issues from COVID-19 Vaccine
• Novavax Obtains First Authorization for its COVID-19 vaccine

mRNA: A NEW APPROACH TO MEDICINE

• mRNA Vaccine Marks Dawn of New Era of Vaccines & Medical Therapies
• RNA Technology: Benefits & Potential for Future Outbreaks
• Key Challenges
• mRNA Vaccines Could Vanquish COVID-19 and Cancer
• Efforts to Target New Application Areas

MARKET DYNAMICS

• Rise of Vaccine Passports: Key to Ease COVID-19 Restrictions & Ensure Public Safety
• Developments Regarding Digital Certificates
• COVID-19 Vaccine Passport: Insights & Progress
• Why Digital Format Holds Merits?
• mRNA Vaccines Offer More Protection Against Newer Variants
• Vaccine Companies Stress on Booster Dose
• Vaccine Alliances Ensure Supplies for All
• Licensing and Partnership Deals Worldwide Propel Vaccine Production

VACCINES FOR KIDS

• Kids: A Key to COVID-19 Controlling Efforts
• US FDA Approves Pfizer-BioNTech Vaccine in Kids aged 5-11 Years, and 12 to 15 Years Age
• Pfizer Approves Vaccine for Kids Aged 5-11 Years
• Moderna Begins Testing its Vaccine on Children Aged Below 12 Years (March, 2021)
• Oxford University Halts AstraZeneca COVID-19 Vaccine Trial on Children over Perceived Safety Concerns
• COVID-19 Vaccine Spikevax Approved for Children aged 12 to 17 in EU

FOCUS ON THE FRONTRUNNERS

• Moderna, Inc. (USA)
• Pfizer Inc./BioNTech (US/Germany)
• AstraZeneca/University of Oxford (The UK)
• Johnson & Johnson (USA)
• CanSino Biologics, Inc. (China)
• China National Pharmaceutical Group Co., Ltd. (Sinopharm) (China)
• Sinovac Biotech Ltd. (China)
• Novavax, Inc. (USA)
• Inovio Pharmaceuticals (USA)
• Sanofi/GlaxoSmithKline (France/UK)

INITIATIVES FOR EQUITABLE DISTRIBUTION OF VACCINES

• Fair Distribution of COVID-19 Vaccine
• Vaccine Nationalism Hampers Equitable Distribution of Vaccines
• COVAX Created to Ensure Fair and Universal Access to COVID-19 Vaccine
• COVAX Inks Additional Deals for Global Rollout of COVID-19 Vaccines
• African Countries Become Part of the COVAX Facility for Timely Access to Successful Vaccines
• COVAX Advance Market Commitment (AMC)
• World Economic Forum to Push COVID-19 Vaccine Production Capability
• Pushing Manufacturing Capacity to Fulfil Global Demand
• Technology Transfer and Other Payments

KEY VACCINE TECHNOLOGY PLATFORMS

• Inactivated Vaccines
• Inactivated Vaccine Candidate in Preclinical Development: As on Nov 19, 2021
• Protein-Subunit Vaccines
• Protein-Subunit Vaccine Candidate in Preclinical Development: As on Nov 19, 2021
• Non-Replicating Viral-Vector
• Non-Replicating Viral Vector Vaccine in Preclinical Development: As on Nov 19, 2021
• Replicating Viral Vector Vaccine Candidate in Preclinical Development: As on Nov 19, 2021
• Nucleic Acid Vaccines
• RNA Vaccine Candidate in Preclinical Studies: As on Nov 19, 2021
• DNA Vaccine Candidate in Preclinical Studies: As on Nov 19, 2021
• Replicating Bacteria Vector
• Live Attenuated Vaccines (LAVs)
• Live Attenuated Virus Candidate in Preclinical Studies: As on Nov 19, 2021
• Live Attenuated Bacterial Vector Candidate in Preclinical Studies: As on Nov 19, 2021
• Virus-like Particle Vaccines
• Virus-like Particles (VLP) Vaccine Candidate in Preclinical Development: As on July 27, 2021

WORLD COVID-19 VACCINE BRANDS

SELECT CORPORATE DEVELOPMENTS IN THE COVID-19 VACCINE MARKET: 2021

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A2 Bio to Highlight Progress of CAR T Clinical Programs in Three Poster Presentations at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting




A2 Bio to Highlight Progress of CAR T Clinical Programs in Three Poster Presentations at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

• Trials in Progress posters detail ongoing Phase 1/2 trials evaluating investigational Tmod™ CAR T cell therapies for the treatment of solid tumors
• Additional poster will demonstrate impact of expanded biomarker enrollment criteria in improving diversity in clinical trials based on Company’s pre-screening protocol

AGOURA HILLS, Calif.–(BUSINESS WIRE)–#A2Bio–A2 Biotherapeutics, Inc. (A2 Bio) a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, today announced the acceptance of three posters for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting May 31-June 4, 2024, in Chicago, Ill. A2 Bio will present two Trials in Progress on its first-in-human Phase 1/2 studies EVEREST-1 and EVEREST-2, and one poster highlighting the BASECAMP-1 master prescreening study protocol’s impact on increasing trial diversity.

Poster presentations on Saturday, June 1, 9:00 am – 12:00 pm CT

EVEREST-1: A seamless phase 1/2 study of A2B530, a carcinoembryonic antigen (CEA) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors associated with CEA expression also exhibiting human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH)

Session: Developmental Therapeutics – Immunotherapy

Presenting Author: Julian Molina, MD, PhD, Mayo Clinic

Abstract #: TPS2698

Poster Bd #: 162b

EVEREST-2: A seamless phase 1/2 study of A2B694, a mesothelin (MSLN) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors that show MSLN expression and human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH)

Session: Developmental Therapeutics – Immunotherapy

Presenting Author: Salman Punekar, MD, NYU Langone Health

Abstract #: TPS2699

Poster Bd #: 163a

Improving ethnic and racial diversity in biomarker-driven clinical trials: A proof of concept with the BASECAMP-1 master prescreening study of patients with high-risk solid tumors with human leukocyte antigen-A*02 (HLA-A*02) loss of heterozygosity (LOH)

Session: Care Delivery/Models of Care

Presenting Author: Caleb Smith, MD, Mayo Clinic

Abstract #: 1604

Poster Bd #: 475

About EVEREST-1

EVEREST-1 (NCT05736731) is a seamless Phase 1/2 study for A2B530, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod™ platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B530 consists of an activator that targets carcinoembryonic antigen (CEA) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with lung, colorectal and pancreatic cancers.

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study for A2B694, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod™ platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with lung, colorectal, pancreatic, ovarian and mesothelioma cancers.

About A2 Bio

A2 Biotherapeutics, Inc. (A2 Bio) is a clinical-stage biotech company developing first-in-class logic-gated cell therapies to address the high unmet need in cancers. A2 Bio invented the proprietary Tmod™ cell therapy platform to tackle the fundamental challenge in cancer treatment—the ability of cancer medicines to distinguish between tumor and normal cells. For more information, please visit the company’s website at www.a2bio.com.

Contacts

Christy Curran

Sam Brown, Inc.

christycurran@sambrown.com
(615) 414-8668

Antibe Announces Appointment of Receiver




Antibe Announces Appointment of Receiver

TORONTO–(BUSINESS WIRE)–$ATBPF–Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Company’s request for an extension of its previously announced stay of proceedings under the Companies’ Creditors Arrangement Act (the “CCAA”) was heard before the Ontario Superior Court of Justice (Commercial List) (the “Court”) on April 18, 2024 and the decision was reserved.

On April 22, 2024, the Court issued its decision terminating CCAA proceedings and appointing FTI Consulting Canada Inc. as receiver of Antibe.

The Company also announced that Roderick Flower, Robert Hoffman, Dan Legault, Walt Macnee and Yung Wu have resigned from Antibe’s Board of Directors. In addition, the Company today received notification from the TSX that it will be delisting Antibe’s common shares from the TSX effective as of May 24, 2024.

Contacts

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

New Pandemic Agreement: Pharma Wins, Developing World Loses, says AHF Global Public Health Institute




New Pandemic Agreement: Pharma Wins, Developing World Loses, says AHF Global Public Health Institute

MIAMI–(BUSINESS WIRE)–As the final Intergovernmental Negotiating Body (INB) meeting of the World Health Organization (WHO) Pandemic Agreement approaches, the AIDS Healthcare Foundation and the AHF Global Public Health Institute are voicing significant concerns about the April 16, 2024, Proposal for the WHO Pandemic Agreement.

This latest iteration of the text, which has been significantly watered down through the negotiation process, is filled with platitudes, anemic in obligations, and devoid of any accountability. Falling victim to least-common-denominator policymaking in Geneva, this text now lacks the requisite power to operationalize equity and achieve its intended objectives.

We express profound concern that developed nations have vehemently defended the private interest of pharmaceutical companies over the collective common interest of achieving global health security in a sustainable and equitable manner. Such disregard has been observed in the proposed compromise for the WHO Pathogen Access and Benefit-Sharing System (PABS), which the Lancet has described as not only “shameful, unjust, and inequitable” but also “ignorant.”

Under the present terms of PABS, a mere 20% of pandemic-related health products are guaranteed to the WHO in the event of a pandemic. As the Lancet points out, such an arrangement will effectively leave 80% of crucial vaccines, treatments, and diagnostics “prey to the international scramble seen in COVID-19.” Furthermore, such pandemic-related health products are now made available only in the event of a pandemic rather than upon the declaration of public health emergencies of international concern, as previously proposed. In addition, we consider that monetary financial contributions to PABS should not be “administered by WHO” but rather directed to existing global health financing mechanisms according to formulations agreed-upon in advance of the conclusion of negotiations.

Have we learned nothing from the COVID-19 Pandemic?

While the INB co-chairs, vice-chairs and some delegates have undoubtedly been working diligently to reach an agreement, a simple fact remains: equity will not be operationalized without effective mechanisms for accountability and enforcement.

Despite warnings by technical experts, the INB has persistently failed to incorporate tangible provisions for accountability and enforcement. In the current proposal, Article 8 language regarding Preparedness Monitoring and Functional Reviews has been withered to nothing; Article 19, Implementation and Support, contains no reporting or verification requirements; previously proposed mechanisms for an accountability committee have been deleted instead of strengthened, and the text now moves forward without any effective means for timely and accurate verification of party compliance.

Calls for strong mechanisms of accountability in the pandemic agreement are widespread but have not been heeded. They have been made by the United Nations General Assembly and prominent international bodies, including the Global Preparedness Monitoring Board (GPMB) and the Independent Panel for Pandemic Preparedness and Response (IPPPR). In addition to the GPMB and the IPPPR, the Panel for a Global Public Health Convention and Spark Street Advisors have also emphasized the critical need for independent monitoring.

The absence of any form of independent oversight is concerning because proven and practical experience confirms that relying solely on state self-reporting mechanisms does not work. Yes, instead of learning from the widespread delays and incomplete self-reporting experience of the International Health Regulations (IHR), the pandemic agreement promotes more of the same practices that have compromised global health security in the past. To ensure its objectivity and effectiveness, the agreement should, at minimum, consider establishing an independent oversight body that is “politically, financially, technically and operationally independent of the WHO and donors.”

In addition to oversight, accountability also requires a clear enforcement framework with incentives and disincentives for compliance. The two major treaties under the authority of the WHO – the Framework Convention on Tobacco Control and the IHR – are described in the literature as “plagued by incomplete compliance.” Incomplete compliance with the IHR, for example, “contributed to COVID-19 becoming a protracted global health pandemic.”

Compliance, however, has largely been ignored by all parties and brushed under the rug throughout the negotiations. This is reflected in the current text, which does not mention the word compliance even once. To this end, we echo the concerns of the Panel for a Global Public Health Convention that the idea of a Compliance and Implementation Committee should not have been dropped from the text.

We also support the Panel’s assessment that an independent and autonomous Conference of the Parties (CoP) is critical because pandemics are not just a health issue but a “societal and governmental priority” that requires a whole-of-government and whole-of-society approach. We are, thus, concerned that modifications to the proposed text, which now call for the WHO to function as the Secretariat for the entire agreement, undermine the independence of the CoP. We are also not clear how this agreement will secure the necessary financial resources to achieve its objectives.

To this end, we emphasize that member states should commit the necessary funding to establish a fit-for-purpose pandemic prevention, preparedness, and response architecture, taking into account the existing global health financing mechanisms. “One of the central failings of the IHR has been that its requirements for states to collaborate, including with respect to mobilizing financing, lacks specificity,” and that “without benchmarks, formulas, or other such details” such “requirements have little real force.” Here, the same mistakes are being repeated – most notably through the lack of binding financial commitments in the letter of the agreement. Furthermore, the removal of language from Article 20, calling for the development of a five-year financial implementation strategy is a step backwards.

We also highlight that the current text misses the opportunity to effectively engage civil society and other non-government actors. The sole mention of civil society, in Article 17, is immediately followed by a caution regarding potential conflicts of interest, as if conflicts only arise when civil society is involved. Despite their critical contributions during the COVID-19 pandemic and numerous previous health crises, the voices of civil society remain marginalized in the decision-making processes of the WHO, the pandemic agreement negotiations and its implementation. Moving forward, this could be solved by weaving civil society in the fabric of the CoP to ensure its meaningful participation.

In the final stretch of negotiations, countries will be wise to remember how we got here, what needs to be accomplished through this pandemic agreement, and most importantly – what the consequences will be if it fails. Hoarding of essential public health goods, and policies that tolerate corporate greed to take precedent over human lives should not be allowed anymore. We, therefore, urge that delegates heed the warnings of experts and take action to correct critical flaws in the proposed text. Empty handshakes in Geneva will not prevent another global health disaster, nor will it keep countries from trampling over each other when the next pandemic comes.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.9 million clients in 47 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

The AHF Global Public Health Institute is as a joint initiative of the AIDS Healthcare Foundation and the University of Miami created to engage in global public health policy analysis and research to generate objective evidence that can inform improvements in public health policy at the global, regional, national and local levels, particularly for infectious diseases. To learn more about the AHF Global Public Health Institute, visit https://ahfinstitute.org/.

Contacts

Guilherme Faviero
Director

AHF Global Public Health Institute at the University of Miami

+1 561.929.9339 mobile

guilherme.faviero@ahf.org

Denys Nazarov,
Director of Global Policy &

Communications, AHF

+1.323.308.1829

denys.nazarov@ahf.org