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Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease

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Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease

December 06, 2022: “Pfizer Inc. and Clear Creek Bio, Inc. announced a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19.

PLpro is an essential enzyme, which, along with the main protease (Mpro), plays an important role in viral replication.

This program will expand Pfizer’s innovative anti-infective pipeline and, if successful, will complement Pfizer’s existing portfolio of COVID-19 products with direct-acting antiviral agents against different SARS-CoV-2 targets.

“COVID-19 has proven to be a devastating and highly unpredictable disease, one with the potential to remain a global health concern for years to come,” said Charlotte Allerton, Chief Scientific Officer, Anti-Infectives and Head of Medicine Design, of Pfizer.

“It is critical that we try to stay ahead of the virus, continuing to advance clinical development opportunities for our current oral therapy as well as innovating through our internal programs and strategic partnerships to bring forward additional monotherapy and/or combination treatment candidates that we believe may play a role in the ongoing fight against COVID-19.”

“As COVID-19 continues to evolve, there is a significant need for oral antivirals with novel mechanisms of action,” said Vikram Sheel Kumar, M.D., Chief Executive Officer of Clear Creek Bio.

“We explored the druggable SARS-CoV-2 genome and identified PLpro as a promising and untapped target. Leveraging our team’s expertise and success in bringing novel drugs from idea to approval, we internally developed highly potent PLpro inhibitors.

We look forward to working with Pfizer, a global leader in antiviral development, to advance a new class of oral antivirals for COVID-19.”

Under the terms of the agreement, the two companies will work together to identify a PLpro candidate to progress into the clinic, at which time Pfizer will be solely responsible for further development and commercialization activities.

Clear Creek Bio will receive an undisclosed upfront payment and will be eligible to receive additional potential milestone payments plus royalties on future product sales.

About SARS-CoV-2 PLpro
SARS-CoV-2 has two essential proteases, the main protease (Mpro) and the papain-like protease (PLpro), both required to fully process the viral polyprotein and assemble a functional replicase complex.

In addition to its critical role in viral replication, the PLpro also contributes to dysregulation of host innate immunity and immune evasion.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-clear-creek-bio-collaborate-research-program

Bayer Launches Industry-First Public Database Listing Company’s Science Collaborations and Partnerships in the U.S.

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Bayer Launches Industry-First Public Database Listing Company’s Science Collaborations and Partnerships in the U.S.

December06,2022: “Bayer announced the U.S. launch of the Bayer Science Collaboration Explorer (BSCE) as part of its ongoing efforts to enhance public trust in scientific innovations, processes, and R&D activities.

The Explorer is a publicly accessible database where Bayer shares information on its science collaborations and new contracts with universities, public research institutions, and individuals. 

Innovation is crucial to overcome the most pressing issues of our time, such as climate change, COVID-19, or the food crisis.

At Bayer, the company’s innovation ecosystem has produced breakthrough solutions to the world’s most complex challenges impacting humanity – and the company cannot do it alone.

Research collaborations are essential to develop and translate scientific findings, however partnerships between the public and private sector are sometimes regarded with skepticism.

In fact, only 29% of U.S. adults say they have a great deal of confidence in scientists to act in the best interests of the public, down from 39% in November 2020.

As science in general is facing eroding trust, Bayer is proactively addressing the desire for more transparency around corporate-funded research with clear, understandable, and accessible information for all stakeholders about the collaborations that are helping drive innovation for our society.

“Trust in science is essential for solving the major challenges humanity is facing and transparency is key to strengthening society’s trust in scientific innovations,” said Werner Baumann, CEO of Bayer AG.

“Launching the Bayer Science Collaboration Explorer in the United States demonstrates our commitment to transparency.

The publicly accessible database allows everyone to explore our external science collaborations. These partnerships are crucial to helping us achieve what matters to all of us and is anchored in Bayer’s vision ‘Health for All, Hunger for None.’”

Matthias Berninger, Executive Vice President of Public Affairs, Science & Sustainability at Bayer added: “Our commitment to transparency goes beyond just Bayer as a company – we want to drive this forward together with our industry, academic, and civil society partners.

We therefore see the launch of the Explorer as a game-changing tool to generate an important dialogue on trust in science.

As we lead this conversation, we welcome all stakeholders to join our work to enhance trust in the innovations that will address the biggest needs of our society.”

Specifically, the following core details will be published for new contracts: Name and country of the institution/person, collaboration type (e.g., research contract), subject of collaboration (e.g., oncology, digital farming), funding committed, effective date, participating Bayer division.

The Explorer is part of Bayer’s twelve transparency commitments. Complementing the Explorer, they provide open access to information from a variety of areas, including clinical trials and safety studies of Bayer’s crop protection products, or its political activities.”

https://www.bayer.com/media/en-us/bayer-launches-industry-first-public-database-listing-companys-science-collaborations-and-partnerships-in-the-us/

FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program

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FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program

December 06, 2022: “In July, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA).

The external evaluation External Link Disclaimer, conducted by an expert panel facilitated by the Reagan-Udall Foundation, was asked to assess the processes and procedures, resourcing, and organizational structure for the Foods Program. 

Today, the panel released its findings and recommendations to the agency. I want to thank the panel and the Reagan-Udall Foundation for their work and for all those, including FDA staff and external stakeholders, who provided important feedback for the panel to consider.

Although we have not yet had an opportunity to review the full report in depth, it does provide significant observations and options for the agency’s consideration, reflecting important and diverse perspectives, which will be carefully considered.

The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program.

The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures.

This new vision and structure will be built on the external evaluation being released today; the internal review of the agency’s infant formula supply chain response completed in September, which has already resulted in noticeable improvements in our operations across the Foods Program; and ongoing work that allows the agency to take advantage of emerging advances in food science, with a goal of designing a system that allows us to more quickly adapt to an ever- changing and evolving environment. 

I will be making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally.

To assist me in this effort, I am forming a group of agency leaders to advise me on how best to implement and operationalize these findings.

I expect this leadership group to be bold and focused on the transformative opportunities ahead for the FDA’s food program – by fully realizing the preventive vision laid out in the Food Safety Modernization Act, elevating the importance of nutrition given declining life expectancy in the U.S., due in large part to chronic diseases, strengthening our state partnerships, and embracing innovative food and agricultural technologies that will allow us to supply the nation – and the globe – with ample safe and nutritious food in the decades ahead.  

I will closely oversee the Human Foods Program until a determination is made on how we will strengthen and modernize the program.

I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American.  

The Human Foods Program is a top priority for the agency. America’s food supply is as safe as it’s ever been, and our Foods Program experts have significantly contributed to the availability of more safe and nutritious food options for consumers.

That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today. 

Each of these factors point to the need to evolve our existing Foods Program leadership and structure and identify new ways to fund these mission critical activities.

In addition, the agency’s inspectional activities, including those conducted in collaboration with our state and international partners, are critical in order to assure a safe and high-quality food supply.

And finally, the need to maintain upgraded digital technology systems that allow us to stay ahead of the vast and growing food system, are essential components of any future plan. 

I am fully committed to building a world-class Human Foods Program that works best for the public, our stakeholders and our employees – and that will allow us to effectively deliver on our mission.”

https://www.fda.gov/news-events/press-announcements/fda-provides-update-external-evaluation-strengthen-agencys-human-foods-program

EC approved Sanofi’s and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn® Beta

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EC approved Sanofi’s and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn® Beta

November 10, 2022: “After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older.

Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK’s pandemic adjuvant.

VidPrevtyn Beta is indicated as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements.

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“Today’s approval validates our research in developing a novel solution for the COVID-19 pandemic. 

As we’re ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19.”

Philip Dormitzer
Global Head of Research and Development Vaccines, GSK
“This EC approval is an important step in providing further vaccine solutions to Europe for the coming winter. Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further.”

In registration studies, carried out at times when Omicron strains were predominantly circulating, the vaccine induced a strong immune response against multiple variants.

Registration studies included a Phase 3 primary efficacy trial (VAT08 Stage 2) and two separate immunogenicity studies, including one comparative study with approved mRNA booster as comparator.

About VidPrevtyn Beta
VidPrevtyn Beta is a monovalent, recombinant-protein next-generation COVID-19 vaccine developed by Sanofi, modelled on the Beta variant and including GSK’s pandemic adjuvant. The same recombinant-protein technology is used in Sanofi’s approved seasonal flu vaccines. Next-generation COVID-19 vaccines are based on a variant-adapted approach, using a strain other than the parental strain of SARS-CoV-2 (D614 strain).

About COVIBOOST Immunogenicity & Safety Study
The independent COVIBOOST (VAT013) study conducted by the Assistance Publique – Hôpitaux de Paris (AP-HP) investigated VidPrevtyn Beta following primary vaccination with two doses of Pfizer-BioNTech’s Comirnaty vaccine (BNT162b2). VidPrevtyn Beta generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTech’s booster or the Sanofi-GSK first-generation booster, both of which target the original D614 parent strain.

In this study, which included 247 adult subjects (18-73 years-old), all three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate, one month after injection.

VidPrevtyn Beta also elicited around 2.5 times more neutralizing antibodies against Omicron BA.1 and, in an exploratory analysis, against BA.4 / BA.5 strains than mRNA COVID-19 booster comparator.

About the VAT02 Immunogenicity & Safety Study
Immunogenicity studies included VAT02 Cohort 2 and COVIBOOST which evaluated the booster formulation modelled on the Beta variant and including GSK’s pandemic adjuvant.

In the Phase 3 VAT02 Cohort 2 study, the vaccine induced (at day 15 following booster vaccination) a significant boost in antibody titers above baseline against multiple variants of concern (13-fold increase against D614 parent virus, 34-fold increase against the COVID-19 Beta strain) in 18-55 years-old adults previously primed with mRNA COVID-19 vaccines.

In the VAT02 cohort 2 study, reactions were mostly mild to moderate, transient and self resolutive.

About the VAT08 Stage 2 Efficacy & Safety Study
The VAT08 Phase 3 Stage 2 study is a randomized, double-blind, placebo-controlled trial investigating primary vaccination with a bivalent COVID-19 vaccine containing both parental (D614) and Beta strains.

The results showed a 64.7% efficacy against symptomatic SARS-CoV-2 infection in adults, regardless of their SARS-CoV-2 infection status prior to vaccination, and 75.1% efficacy in participants previously infected with SARS-CoV-2.

This study was the first ever to report efficacy data in an Omicron environment.

Across all the above-mentioned studies, the Sanofi-GSK bivalent next-generation vaccine candidate was well-tolerated, with an acceptable safety profile.

About BARDA support
Research and development for VidPrevtyn are supported by U.S. federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services under Contract # HHSO100201600005I, and in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002, and the National Institute of Allergy and Infectious Diseases (NIAID).”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-11-10-15-36-50-2553486

AstraZeneca expands global footprint in rare disease for patients in China

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AstraZeneca expands global footprint in rare disease for patients in China

November 11, 2022: “AstraZeneca announced the availability of the first rare disease therapy from Alexion, AstraZeneca’s Rare Disease group, in China.

The availability of Soliris (eculizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) in adults and children in China represents a significant expansion of the company’s global footprint in rare disease, following the acquisition of Alexion Pharmaceuticals, Inc. in 2021.

In addition to announcing the availability of Soliris, AstraZeneca announced that the National Medicine Products Administration of China (NMPA) has accepted its supplementary application for Soliris for the treatment of adults with refractory generalised myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive.

The NMPA has also granted AstraZeneca approval to start ongoing, global clinical trials in China for investigational therapies being evaluated for the treatment of lupus nephritis (LN), immunoglobulin A nephropathy (IgAN) and light chain (AL) amyloidosis.

Marc Dunoyer, Chief Executive Officer, Alexion, said: “These milestones represent significant progress against our commitment to expand access to our rare disease medicines globally, including the introduction of innovative rare disease therapies in China.

Expanding access to our medicines is possible because of the combined strength of Alexion’s rare disease expertise and AstraZeneca’s vast global footprint, and we look forward to continue bringing our therapies to people living with rare diseases around the world in the future.”

Leon Wang, Executive Vice President, International and China President of AstraZeneca, said: “This milestone reflects our ambition to bring transformative, rare disease medicines to the significant number of patients and families living with rare diseases in China who currently have limited treatment options or no available treatment at all.

We look forward to advancing our commitment in China and aim to bring additional, innovative therapies to even more rare disease patients across the country.”

As the first C5 complement inhibitor, Soliris works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. Soliris is approved for multiple indications in many countries around the world.

The availability of Soliris in China provides people living with PNH or aHUS with a new treatment option that can reduce disease symptoms and prevent the dysregulated complement system from causing further damage.

AstraZeneca established a rare disease business unit in China in September 2021.

In the future, the company aims to introduce more innovative medicines in China, targeting the complement system and beyond, for the treatment of rare diseases including PNH, aHUS, gMG, neuromyelitis optica spectrum disorder (NMOSD), hypophosphatasia, IgAN, LN and amyloidosis.”

https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-expands-global-footprint-in-rare-disease-with-availability-of-first-alexion-rare-disease-therapy-for-patients-in-china.html

Bayer completes sale of its Environmental Science Professional business to Cinven

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Bayer completes sale of its Environmental Science Professional business to Cinven

October05,2022: “Bayer has completed the sale of its Environmental Science Professional business to the international private equity firm Cinven, after the two companies had entered into a corresponding agreement in March.

The conditions for closing the transaction – including the receipt of regulatory approval – have now been met.

The purchase price for the business, which generated sales of approximately 600 million euros in 2021, amounts to 2.6 billion U.S. dollars (2.6 billion euros).

“We thank the employees of Environmental Science Professional for their many years of commitment and the associated success of Bayer.

In Cinven, we have found a strong new owner with a firm commitment to the long-term growth potential of the business and to its people,” said Rodrigo Santos, member of the Board of Management of Bayer AG and head of the Crop Science Division.

“At the same time, we can concentrate on our core agricultural business and the successful implementation of our growth strategy in the Crop Science Division.” Bayer will use the net proceeds from the transaction to reduce its net financial debt.

The divested business is set to operate as an independent company called Envu.

The business is a global leader offering solutions to control pests, disease and weeds in non-agricultural areas such as vector control, professional pest management, vegetation management, forestry, and turf and ornamentals.

It is headquartered in Cary, North Carolina, United States, and is active in over 100 countries. Nearly 900 employees in total will transfer from Bayer to Envu.

“Envu is a global leader in a highly attractive and critical industry.

We thank Bayer for the trust they have placed in Cinven and plan to build on the strong foundations established by Bayer by significantly investing in it,” said Pontus Pettersson, Partner at Cinven.

“Cinven is excited to build an independent, focused company and is well positioned to continue to drive innovation and accelerate growth, including the delivery of digital and data-enabled solutions, and to extend the product portfolio further by creating innovative and sustainable solutions for its customers.”

https://lifepronow.com/wp-admin/post.php?post=10096&action=edit

Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial

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Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial

October 04, 2022: “Pfizer Inc. announced positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations.

The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI.

The results of the primary endpoint exceeded the pre-specified hazard ratio of 0.696.Results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but these data are not yet mature.

Benefits were also observed in other secondary endpoints, including investigator assessed rPFS, prostate specific antigen (PSA) response, time to PSA progression, and overall response rate. Other secondary endpoints are being analyzed.

At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicine.

“XTANDI is a global standard of care, with overall survival demonstrated in mCRPC, non-metastatic CRPC, and metastatic castration-sensitive prostate cancer (mCSPC),” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

“We are very pleased with the strong findings from TALAPRO-2, and although no definitive conclusions can be made across trials, the rPFS appears to be the longest observed in a randomized trial in this setting.

These data highlight the potential for TALZENNA in combination with XTANDI, if approved, to become a new standard of care for mCRPC, irrespective of HRR gene mutation status. We look forward to discussing these data with global health authorities.”

“These exciting results from TALAPRO-2 underscore our long-standing commitment to men living with prostate cancer and delivering the next scientific breakthroughs,” said Suneet Varma, Global Oncology and U.S. President, Pfizer.

“Based on these compelling combination data with XTANDI, we believe TALZENNA in prostate cancer may become the next potential blockbuster opportunity in our leading Pfizer Oncology portfolio, subject to regulatory approval.”

Detailed results from TALAPRO-2 will be submitted for presentation at a near-term medical congress. These data will also be shared with global regulatory authorities to potentially support a regulatory filing.

TALZENNA or the combination of TALZENNA plus XTANDI have not been approved by any regulatory agency for the treatment of mCRPC.

In addition to the TALAPRO-2 trial, the combination of TALZENNA plus XTANDI is being investigated in the TALAPRO-3 trial (NCT04821622), a global, randomized, double-blind, placebo-controlled Phase 3 study in men with HRR-deficient mCSPC.

About Metastatic Castration-Resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC) is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone.

Approximately 10%–20% of prostate cancer patients develop mCRPC within 5−7 years of diagnosis,1 and in the U.S., in 2020, approximately 60-90 thousand cases of the three million prostate cancer cases were mCRPC.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-results-phase-3-talapro-2

CHMP recommends approval of Enjaymo™ for hemolytic anemia in adult patients with cold agglutinin disease

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CHMP recommends approval of Enjaymo™ for hemolytic anemia in adult patients with cold agglutinin disease

September 16, 2022: “The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Enjaymo™ (sutimlimab), recommending that the C1 protein (C1s) inhibitor be approved in EU for treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD).

CAD is a rare, serious, and chronic autoimmune hemolytic anemia.

The positive CHMP opinion is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion.

In the CADENZA trial, eligible patients were randomized 1:1 to receive a fixed weight-based dose (6.5g or 7.5g) of sutimlimab or placebo via intravenous infusion on Day 0, Day 7 and then once every other week up to Week 26.

The positive results of the study were presented at the European Hematology Association (EHA) 2021 Congress.

The open-label Part B of the study assessed long-term safety as well as durability of response to sutimlimab in patients with CAD.

In the CARDINAL trial, patients received a fixed weight-based dose (6.5g or 7.5g) of sutimlimab via intravenous infusion on Day 0, Day 7 and then once every other week up to Week 26.

The positive results were presented at the Late-Breaking Abstracts Session of the 61st Annual Meeting of the American Society of Hematology in 2019.

Part B of the study evaluated the long-term safety as well as durability of response to sutimlimab in patients with CAD over a 2-year follow up and the positive results were presented at EHA 2022.

The European Commission will review the CHMP recommendation, and Sanofi expects a decision by the end of 2022.

Enjaymo was approved by the U.S. FDA in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD.

About Enjaymo™ (sutimlimab)
Enjaymo is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system.

By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways.

About cold agglutinin disease
Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia, where part of the body’s immune system mistakenly destroys healthy red blood cells (hemolysis).

CAD impacts the lives of an estimated 12,000 people in the U.S., Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-09-16-15-18-01-2517753

Sandoz announces further progress on its biosimilar pipeline

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Sandoz announces further progress on its biosimilar pipeline

 September 19, 2022: “Sandoz, a global leader in off-patent (generic and biosimilar) medicines announces further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab.

“Biosimilars have the opportunity to create a substantial positive impact on patient access and healthcare systems sustainability,” said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals.

“Therefore, this important milestone means that we are one step closer to giving individuals living with osteoporosis access to a more affordable, biosimilar version of this critical medicine, which may help to change the course of their disease.”

Denosumab is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, and giant cell tumor of the bon.

The results from the integrated Phase I/III study confirm the biosimilar matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in the respective indications; and contributes to demonstration of similarity, which is the basis for use in all indications.

Approximately 500 million men and women worldwide may be affected by osteoporosis, which causes 8.9 million fractures annually – or one fracture every three seconds.

By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 1990.

The results come soon after Sandoz confirmed acceptance of license applications for two other proposed biosimilars.

In July 2022, the application for the first-of-a-kind multiple sclerosis proposed biosimilar natalizumab was accepted for review by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

In June 2022, the EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar adalimumab.

Sandoz biosimilars help patients, in areas including immunology, oncology, nephrology, supportive care and endocrinology, access critical and potentially life-changing medicines sustainably and affordably.

Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development.

About ROSALIA
In ROSALIA, 527 postmenopausal women with osteoporosis were randomized to receive either biosimilar denosumab or the reference medicine for up to 78 weeks of treatment.

Objectives were to demonstrate similar efficacy in terms of change in lumbar spine bone mineral density, as well as similar pharmacokinetics and pharmacodynamics.

The global clinical program for biosimilar denosumab was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory approval.

About denosumab
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).

By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.

https://www.novartis.com/news/media-releases/sandoz-announces-further-progress-its-biosimilar-pipeline-release-positive-results-denosumab-integrated-phase-iiii-clinical-trial

WHO responds to The Lancet COVID-19 Commission

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WHO responds to The Lancet COVID-19 Commission

September 15, 2022: “WHO welcomes the overarching recommendations of The Lancet COVID-19 Commission’s report on “Lessons for the future from the COVID-19 pandemic,” which align with our commitment to stronger global, regional and national pandemic preparedness, prevention, readiness and response.

At the same time, there are several key omissions and misinterpretations in the report, not least regarding the public health emergency of international concern (PHEIC) and the speed and scope of WHO’s actions.   

WHO welcomes the Commission’s endorsement of a pandemic agreement, strengthening the International Health Regulations (IHR), and enhancing financing.

These issues are core to the vision of WHO Director-General, Dr Tedros Adhanom Ghebreyesus, as distilled in the five priorities for his second term.

WHO and its Member States are already enacting these recommendations.

The World Health Assembly agreed a historic decision in May 2022 to sustainably finance WHO.

This year will see two rounds of public hearings for a pandemic accord take place.

The Commission strongly endorses WHO’s central role in global health, arguing that “WHO should be strengthened” and that reforms “should include a substantial increase of its core budget.”

WHO echoes the Commission’s conclusions that COVID-19 exposed major global challenges, such as chronic under financing of the UN, rigid intellectual property regimes, a lack of sustainable financing for low- and middle-income countries, and “excessive nationalism,” which drove vaccine inequity.

The Organization also agrees with the focus on biosafety, as shown by the formalization of our Technical Advisory Group on biosafety, the publication of our Laboratory biosafety manual – now in its 4th edition – and the publication on 13 September this year of a life sciences framework to help mitigate bio risks and safely govern dual-use research.

WHO places similar emphasis on the importance of multilateralism, solidarity and cooperation when facing pandemics. We also welcome the recognition of the key role that countries themselves play.  

Many of the Commission’s recommendations align with those received over the past two years from review bodies set up by WHO itself, such as the Independent Panel for Pandemic Preparedness and Response (IPPPR), the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC) and the IHR Review Committee, as well as assessments from other entities.

As we are a learning organization, we established a dashboard of recommendations from these initiatives and others to track their implementation by WHO and others.

WHO’s rapid response

The Commission does not, however, convey the full arc of WHO’s immediate, multi-year, life-saving response, detailed below:  

  • On 30 December 2019, WHO received the first alerts of cases of pneumonia of unknown cause in Wuhan, China, and notified the IHR focal point, seeking further information from Chinese health authorities the next day.
  • On 1 January 2020, WHO activated its Incident Management System to manage daily action.

    The team, which includes focal points on clinical care, infection prevention and control, diagnostics, logistics, communications and more, met daily throughout 2020, into 2021 and continues to meet this year.  
  • On 5 January 2020, WHO issued a global alert to all Member States through a formal IHR system – the Event Information System – based on our initial risk assessment of the situation in China.

    This alerted Member States and advised them to take measures to identify cases, care for patients, and prevent infection and onward human-to-human transmission for acute respiratory pathogens with epidemic and pandemic potential.

    This was WHO’s first global warning to take concrete measures for an unknown respiratory disease.

    WHO has consistently driven knowledge-sharing through dedicated briefings for countries, during which the critical experiences of early-affected countries were shared and the elements of WHO’s comprehensive response were outlined.
  • On 9 January 2020, WHO convened the first of many teleconferences with established global expert networks, to discuss all available information on the cluster reported from China.
    These networks enabled the real-time exchange of direct knowledge, experience and early study findings, which fed directly into WHO’s early advice and recommendations.
  • Between 10 and 12 January 2020, WHO published a comprehensive package of technical guidance for countries.
    This package covered how to test for a high threat respiratory coronavirus, treat patients for severe acute respiratory infection, inform the public to prevent infection and human- to-human transmission, and to prepare health systems to deal with more cases.
  • On 13 January 2020, WHO published the first protocol to develop PCR tests to identify cases based on the release of the full genome sequence two days earlier. By 2 February 2020, WHO began shipping validated PCR assays to countries around the world.
  • On 22 and 23 January 2020, when there were nine cases and no deaths reported outside China, the Director-General convened the Emergency Committee (EC) under the IHR to meet, and advise whether the event constituted a public health emergency of international concern (PHEIC). 

    The Committee advised that it did not. The Director-General said publicly: “Make no mistake.

    This is an emergency in China, but it has not yet become a global health emergency. It may yet become one”.
  • From 27 to 28 January, following the EC, the Director-General and senior staff travelled to China to meet with top government officials, gather information about the outbreak and seek cooperation.
  • On 30 January 2020, when there were 98 reported cases (and no deaths) in 18 countries outside China, the Director-General reconvened the Emergency Committee.

    It advised that the outbreak constituted a PHEIC. The DG took their advice and declared a PHEIC, issuing temporary recommendations for how countries could further prepare and respond.
  • On 4 February 2020, WHO’s Strategic Preparedness and Response Plan (SPRP) was published.

    It outlined comprehensive measures all countries needed to take to suppress transmission and save lives, using a package of interventions including early identification and isolation and care of cases, contact tracing and supported quarantine, use of medical masks, distancing, ventilation, infection prevention and control in health facilities, taking a risk-based approach to small and large gatherings, and for travel.
  • Following regular media briefings held in January, daily briefings began on 5 February 2020.
    Media briefings continue on a weekly basis, alongside regular live social media conversations with senior WHO experts, demonstrating the priority placed on communicating with leaders and the public.
  • From 11 to 12 February 2020, WHO led a Global Research and Innovation Forum on the new virus, convening nearly 900 experts and funders from more than 40 countries, to take stock of what was known about the novel coronavirus and to set the agenda going forward.

    A follow-up achievement was WHO’s Solidarity trial, which became one of the largest clinical trials for COVID-19 therapeutics, involving more than 30 countries, over 14 000 patients and nearly 500 hospitals at its peak.

A comprehensive and detailed list of actions taken by WHO during the COVID-19 response can be viewed in our interactive timeline.

From day one and to this day, WHO, together with our global expert networks and guideline development groups, regularly updates our guidance and strategies with the latest knowledge about the virus, including updates to the SPRP and the COVID-19 global vaccination strategy, and to the 11th version of WHO’s living guideline on COVID-19 therapeutics, which was published in July 2022.

WHO played, and continues to play, a vital role in getting COVID-19 tools to countries in need, not least through joint endeavours such as the ACT-Accelerator, Pandemic Supply Chain Network (PSCN) and UN COVID-19 Supply Chain Task Force.

Lab testing capability in African nations rose dramatically over six months, thanks to support from WHO. Only two countries on the African continent had COVID-19 testing capacities at the start of 2020; by mid-year, all 54 countries had them.

WHO has supported 18 countries globally to set up plants for medical oxygen.

Throughout the pandemic, the Director-General has repeatedly called for leaders to take actions to protect people and share tools equitably when addressing the world’s most important fora, such as the February Munich Security Conference; the extraordinary G20 Leaders Summit of March 2020; the G7 Summit of June 2021, where the 70% vaccination target was announced; and Global COVID-19 Summits co-hosted by the Biden Administration in September 2021 and May 2022.

Regarding the areas of WHO’s response focused on by the Commission, WHO would like also to highlight the many day-to-day steps, including the following:   

  • WHO repeatedly warned of the potential of asymptomatic human-to-human transmission, particularly pre-symptomatic transmission, including in late January in updated surveillance guidance, in protocols for enhanced surveillance on 29 January (defining a contact as someone with exposure 1 day before symptom onset of a case) and 4 February (changing a contact to someone with exposure up to 4 days before symptom onset of a case), at its Executive Board on 4 February, in guidance documents from 23 and 28 February 2020, in its China mission report and media briefings.
  • WHO issued guidance and enhanced surveillance protocols early in the pandemic to identify contacts among people prior to the development of symptoms.
  • The IHR recognize the sovereign rights of State Parties to introduce restrictions on travel. From the very beginning of the COVID-19 response, WHO recommended many measures countries should take, including screening at entry points.
  • At the beginning of the pandemic, dramatic global supply constraints saw health workers around the world scrambling to find basic supplies to protect themselves.

    WHO’s early priority was getting access to masks for those most at-risk around the world; we initially recommended the use of medical masks for anyone with symptoms, anyone caring for someone sick, and frontline health workers.

    Our logisticians and other UN partners were central in activating the pandemic supply chain and increasing global supplies.
  • WHO guidance published on 10 January 2020, outlined respiratory precautions – including airborne precautions – in health-care settings.

    WHO guidance addressing many forms of transmission including zoonotic, droplet, airborne, short- and long-range aerosol, fomite, and vertical transmission, along with specific recommendations to prevent such transmission in different settings (such as health facilities, schools, workplaces), was updated and expanded regularly throughout the pandemic based on emerging evidence.

    WHO is leading and coordinating a multi-agency, multidisciplinary, international technical consultation process to discuss and reach a consensus on pathogens that transmit through the air, with a wide range of global experts and international and national agencies. 

Looking ahead

The pandemic is not over, though the end is in sight, and WHO continues its response, while laying a stronger foundation for the future:

  • Daily meetings of experts continue in order to update and streamline strategies and guidance. WHO-supported research continues. Helping countries access vaccines continues. Setting up oxygen plants continues.
  • At the World Health Assembly in May 2022, the Director-General presented WHO’s proposals, developed in consultation with Member States and other stakeholders – taking into consideration the over 300 recommendations from review bodies and panels – to strengthen the architecture for Health Emergency Preparedness, Response and Resilience.
  • In early September 2022, the financial intermediary fund for pandemic prevention, preparedness, and response was officially launched.

    This will provide long-term financing to strengthen these capabilities in low- and middle-income countries and address critical gaps.
  • Through the Intergovernmental Negotiating Body to draft and negotiate a WHO international instrument on pandemic preparedness and response, WHO is hosting public hearings, the first since those that fed into the WHO Framework Convention on Tobacco Control (which entered into force in 2005).
  • WHO continues to actively pursue the search for the origins of SARS-CoV-2, with July 2021 marking the establishment of a permanent international Scientific Advisory Group for Origins of Novel Pathogens, or SAGO, which covers both SARS-CoV-2 and future new pathogens.”

https://www.who.int/news/item/15-09-2022-who-responds-to-the-lancet-covid-19-commission

DA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

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DA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

September 14, 2022: “The U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases.

The FDA and NIH have selected the Critical Path Institute External Link Disclaimer (C-Path) as the convener of this partnership.

“There is a crucial need to develop new treatments that can improve and extend the lives of people diagnosed with rare neurodegenerative diseases, including ALS. Collaboration across public and private sectors can accelerate the progress to address this urgent need,” said FDA Chief Medical Officer, Hilary Marston, M.D., M.P.H.

“The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases.

We look forward to working with NIH, C-Path, and other public and private partners to carry out this important effort.”

“This public-private partnership will convene the entire ALS community to develop novel strategies and approaches to therapy development and clinical testing with the goal to finally produce a treatment that stops the tragic progression of ALS,” said Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH. 

C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities.

The direction and priorities for the effort will be determined with input from the partners. Areas of focus will include patient-focused drug development, and utilization of the FDA-funded Rare Disease Cures Accelerator-Data and Analytics PlatformExternal Link Disclaimer (RDCA-DAP) to bring together scientific data on rare neurodegenerative diseases to facilitate the characterization of neurodegenerative diseases and their natural history, the identification of molecular targets for neurodegenerative disease, and increased efficiency, predictability, and productivity of clinical development of therapies.

Building on and leveraging the shared expertise of the participants, the goal of this partnership is to generate actionable solutions that can tangibly accelerate drug development for rare neurodegenerative diseases. 

The Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (Act for ALS) was signed into law on December 23, 2021 by President Biden and requires HHS, through FDA and NIH, to establish and implement a public-private partnership not later than one year after enactment.

This partnership is a key component of the FDA’s  Action Plan announced in June.”

https://www.fda.gov/news-events/press-announcements/fda-and-nih-launch-public-private-partnership-rare-neurodegenerative-diseases

CHMP recommendation based on favorable data from Omicron-adapted vaccines

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CHMP recommendation based on favorable data from Omicron-adapted vaccines

September 12, 2022: “Pfizer Inc. and BioNTech SE announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the EMA Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

The Omicron BA.4/BA.5-adapted bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.

Apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.

“This recommendation marks another major milestone in the ongoing global fight against COVID-19, bolstering our defenses as we prepare for fall and winter with potential increased exposure to the virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will have our bivalent booster options, pending authorization, to facilitate flexible vaccination strategies for maximal coverage across the region.”

“If the European Commission follows today’s recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

“The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant.

They aim to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern.”

Today’s recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance bivalent vaccine candidates, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible.

The CHMP recommendation concerning the Omicron BA.4/BA.5 bivalent COVID-19 vaccine is based on data from Pfizer’s and BioNTech’s Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted bivalent vaccine. 

Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ current COVID-19 vaccine, with a favorable safety profile.

Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus, while retaining a favorable safety profile.

If an authorization is granted, the Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination campaigns. Local supply may vary based on individual country government requests.

In early September, Pfizer and BioNTech were granted a conditional marketing authorization for an Omicron BA.1-adapted bivalent COVID-19 vaccine in the EU.

An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was also authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022.

The companies are also planning to file the data with other regulatory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an application for an Omicron-adapted bivalent vaccine in children younger than 12 years of age.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized underEmergency Use Authorization (EUA) for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:

  • completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
  • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-0

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