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.”
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.”
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.
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 strategieswith 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.”
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.”
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.”
September11,2022: “New results from the Phase III ARASENS trial evaluating quality of life (QoL) and patient-relevant endpoints for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) show that, in addition to extending overall survival (OS), darolutamide has a strong tolerability profile and ability to maintain patient QoL with control of disease-related physical symptoms and pain.
The full results were presented during the ESMO Congress 2022.
“For those diagnosed with advanced prostate cancer, it is crucial to find a treatment that is not only effective but allows them to safely preserve their quality of life,” said Bertrand Tombal, M.D., Ph.D., Professor of Urology, Université catholique de Louvain (UCL), Cliniques universitaires, Saint-Luc, Brussels, Belgium.
“These additional findings from the ARASENS trial further reinforce darolutamide’s potential for patients with mHSPC in this critical phase of their life.”
Additionally, treatment with darolutamide plus ADT and docetaxel showed a trend toward delaying time to worsening of disease-related physical symptoms and pain in patients with moderate or severe baseline pain and improvement across patient-relevant endpoints compared to ADT plus docetaxel, supporting early treatment intensification with addition of darolutamide.
Results from the Phase III ARASENS trial have demonstrated a 32.5% reduction in risk of death and improvement across all patient-relevant endpoints for patients with early treatment intensification compared to ADT plus docetaxel.
At baseline, most patients in Phase III ARASENS trial had high QoL scores, and no pain or only mild pain (81%).
Data from the study showed that darolutamide in combination with ADT and docetaxel maintained QoL with similar time to worsening (TTW) of disease-related physical symptoms and pain as ADT and docetaxel.
Treatment with darolutamide in combination with ADT and docetaxel also led to fewer all-cause deaths (35.1% versus 46.8%) and prostate cancer-related deaths (26.1% versus 36.0%) compared to ADT and docetaxel.
Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months). Incidence of AEs of special interest was generally low and similar across both arms.
Bayer recently received U.S. Food and Drug Administration (FDA) approval for darolutamide in combination with docetaxel in mHSPC patients and has submitted applications in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labour and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE).
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish Pharmaceutical company.
About the ARASENS Trial
The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in metastatic hormone-sensitive prostate cancer (mHSPC).
A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.
The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all evaluated at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.
Results from this trial were published in the New England Journal of Medicine.
The ARASENS trial demonstrated that darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel.
Improvements in the secondary endpoints supported the OS benefit observed in the trial’s primary endpoint.
About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.
Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the docetaxel chemotherapy and ADT.
Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.
About Nubeqa™ (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.
The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans.
This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.
The product is approved under the brand name Nubeqa™ in more than 70 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
For the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), the product has recently been granted U.S. Food and Drug Administration (FDA) approval and is currently being reviewed by other health authorities around the globe with further filings underway.
Darolutamide is also being investigated in further studies across various stages of prostate cancer, including in the Phase III ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC, ARASEC trial (darolutamide plus ADT) in the U.S. for mHSPC, as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.”
September 13, 2022: “CDC announced that polioviruses found in New York, both from the case of paralytic polio in an unvaccinated adult in Rockland County and in several wastewater samples from communities near the patient’s residence, meet the WHO’s criteria for circulating vaccine-derived poliovirus (cVDPV) – meaning that poliovirus continues to be transmitted in Rockland County, NY, and surrounding areas.
CDC is working closely with WHO, the Pan American Health Organization (PAHO), and other international public health partner organizations.
As previously reported, the virus’ genetic sequences from the patient from Rockland County, NY, and wastewater specimens collected in New York have been linked to wastewater samples in Jerusalem, Israel, and London, UK, indicating community transmission.
The viral sequences from the patient and from three wastewater specimens had enough genetic changes to meet the definition of a vaccine-derived poliovirus (VDPV).
These two things – one individual with VDPV and at least one detection of a related VDPV in an environmental sample – meet WHO’s definition of cVDPV, and CDC submitted this data to WHO for inclusion on its list of countries with cVDPV.
There are global recommendations for countries with cVDPV2 outbreaks to protect people from polio, and the United States is taking all appropriate actions to prevent new cases of paralysis.
The United States now joins a list of about 30 other countries where cVDPVs have been identified. Circulating vaccine-derived poliovirus occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine.
As the virus circulates and more genetic changes occur, the virus can regain its ability to infect the central nervous system and cause paralysis.
It’s important to note that cVDPVs are not caused by a child receiving the polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries.
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, Director of CDC’s National Center for Immunization and Respiratory Diseases.
“We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”
It’s important to note that no additional cases of polio have been reported in the United States at this time, and today’s update does not impact the current CDC recommendations for polio vaccination for children or adults.
CDC continues to support New York State Department of Health’s investigation through ongoing testing of wastewater to better understand the possible spread of the virus and through supporting vaccination efforts in the affected communities.
Last week, the New York State Governor issued an Executive Order declaring a State Disaster Emergency. While no additional polio cases have been found, this action helps the state expand vaccination efforts and surveillance.
Improving vaccination coverage is the key to preventing additional cases of paralytic polio in the United States.”
September 13, 2022: “WHO issued the Global guidance framework for the responsible use of the life sciences.
The Framework calls on leaders and other stakeholders to mitigate biorisks and safely govern dual-use research, which has a clear benefit but can be misused to harm humans, other animals, agriculture and the environment.
This is the first global, technical and normative framework for informing the development of national frameworks and approaches for mitigating biorisks and governing dual-use research.
It aims to safely unlock the great promise for new and improved ways to improve global health offered by life sciences and related technologies.
The Framework addresses the decades-long challenges of preventing the accidental and deliberate misuse of biology and other life sciences, as well as how to manage governance and oversight to both accelerate and spread innovation, while mitigating negative impacts.
The life sciences are increasingly crossing over with other fields, such as chemistry, artificial intelligence and nanotechnology, which changes the landscape of risks, with those that span multiple sectors and disciplines more likely to be missed.
“Life sciences and technologies offer many opportunities to improve our health, our societies and our environment” said Dr Soumya Swaminathan, WHO Chief Scientist.
“However, developments and advances in life sciences and associated technologies could pose risks caused by accidents during experiments, inadvertent and deliberate misuse.”
Looking at how to manage the increasing pace of advances in the life sciences, the Framework outlines the need for anticipatory and responsive governance mechanisms, including foresight approaches, which are participatory and multi-disciplinary ways of exploring trends, emerging changes, systemic impacts and alternative futures.
To help manage risks, it covers issues such as preventing misinformation and disinformation, as well as managing large health data sets.
Other topics include: increasing awareness and capacities for biorisk management, navigating the particular challenges around research on infectious diseases and preventing the misuse of research and technologies through collaboration among different actors and sectors.
The Framework is intended as the go-to starting point for the development and strengthening of biorisk management, which relies on three core pillars: biosafety, laboratory biosecurity and the oversight of dual-use research.
Accounting for different contexts, resources and priorities, the Framework is designed to be adapted by Member States and other stakeholders, depending on their needs and perspectives.
Ministries of health are called upon to work with other ministries, including of science and technology, education, agriculture, environment and defense, along with other key stakeholders, to assess the risks posed by life sciences locally and nationally, and identify appropriate risk mitigation measures to strengthen governance for biorisks and dual-use research.
The document aims to raise awareness about the importance of biorisk management in the context of the One Health approach to optimize the health of people, animals and ecosystems; provide a set of values and principles to guide decision-making; and identify tools and mechanisms for biorisk management.
Practically focused, it also sets out a six-step approach for implementation; checklists for various stakeholders; and scenarios and case studies to illustrate issues and options in the governance of biorisks and dual-use research.
Recognising that awareness and resources will be limited in low- and middle-income countries (LMICs), the Framework calls for providing these countries with technical and financial support and empowering their scientists through opportunities to pursue and govern life sciences.
It also highlights the importance of developing more context-specific materials for awareness raising, education, capacity-building and training.
The life sciences include all sciences that deal with living organisms, including humans, nonhuman animals, plants and agriculture, and the environment, or products of living organisms or that incorporate components derived directly or synthetically from living organisms; the life sciences include but are not limited to biology, biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research and technologies.
WHO activities to support the Framework’s worldwide implementation include:
Leveraging existing efforts and initiatives, including those on laboratory biosafety, biosecurity and ethics;
Maintaining different stakeholders and local champions to monitor and evaluate the measures developed and implemented at local, national, regional and global levels;
Conducting awareness-raising activities, including regional and global dialogues, to support the sharing of experiences, lessons learned and best practices;
Developing trainings and tools to evaluate progress.
While governance of biorisks cannot be under the sole responsibility of one international body, WHO, through its leadership, aims to harness the developments of the life sciences to improve global health while anticipating and mitigating risks posed by such developments.
Implementing the Framework will be done at country and local levels, with efforts supported by WHO regional offices and other partners.”
Sept 12, 2022: “Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics.
Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.
“Across the industry, biotherapeutics account for almost one-half of all recent new drug approvals and have enormous potential to address unmet need across a wide range of diseases,” said Reto Fischer, Head of Technical Research Division, Global Drug Development (GDD), Novartis.
“We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless, and rapid fashion. In doing so, we are supporting our broader ambition to enable faster development and focused prioritization across our global portfolio.”
The Novartis early-stage biologics portfolio has grown significantly in the last 15 years.
It has also expanded beyond conventional monoclonal antibodies into a wide range of novel development candidates with potential to be first-in-class, best-in-class, or both, including antibody-drug conjugates and therapeutic proteins.
This investment is intended to position Novartis at the forefront of biotherapeutic development, by supporting the company’s increasingly sophisticated pipeline with the most advanced technical infrastructure, alongside the highest level of capabilities.
It will create seamless, end-to-end development and manufacturing environments by embedding biologics development within existing Novartis commercial manufacturing facilities in Slovenia and Austria as well as by establishing a biologic’s hub on the Basel St. Johann Campus in Switzerland alongside the NIBR biologics center fostering scientific innovation, technology leadership and talent attraction.
Collectively these commitments will enhance development processes targeting faster transition times from pre-clinical to first in human studies.
Specifically, the investment will:
Strengthen the Novartis St. Johann campus in Basel by investing USD 100M to establish a biologics hub to complement the existing NIBR Biologics Center;
Create a biocampus in Mengeš, Slovenia with an investment of USD 110M in clinical manufacturing capabilities (non cGMP and cGMP) and technical development capabilities in proximity of development operations; and
Amplify synergies and strategic proximity at the Schaftenau campus in Austria with a USD 60M USD investment in development manufacturing capacity and capabilities.
“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Jonathan Novak, Global Head for Biologics, Technical Research Division, GDD at Novartis.
“We look forward to amplifying the knowledge and experience of our associates to ensure that biologics development is an exhilarating and rewarding process for our current and future colleagues – and that is ultimately a source of profoundly innovative new therapies for patients worldwide.”
September 12, 2022: “Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced biliary tract cancer (BTC).
These results from TOPAZ-1, the first Phase III trial to show improved OS with an immunotherapy combination in this setting, will be presented today at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris (abstract #56P).
The updated results for Imfinzi plus chemotherapy (gemcitabine plus cisplatin) showed enhanced clinical efficacy after an additional 6.5 months of follow-up, demonstrating a 24% reduction in the risk of death versus chemotherapy alone (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI], 0.64–0.91).
Updated median OS was 12.9 months versus 11.3 with chemotherapy. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Results were seen across all prespecified subgroups, regardless of disease status, tumour location or PD-L1 expression.
In addition, OS benefit was observed in patients whose tumours stayed the same size (stable disease) as well as in patients whose tumours got smaller or disappeared (responders).
The safety profile of Imfinzi plus chemotherapy continued to be well-tolerated, with no new safety signals observed with longer follow-up.
Grade 3 or 4 treatment-related AEs were experienced by 60.9% of patients treated with Imfinzi and chemotherapy, and by 63.5% of patients receiving chemotherapy alone.
Imfinzi plus chemotherapy did not increase the discontinuation rate due to adverse events (AEs) compared to chemotherapy alone (8.9% for the Imfinzi combination versus 11.4% for chemotherapy).
Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 Phase III trial, said: “It’s exciting to see the improved overall survival delivered by durvalumab plus chemotherapy over the current standard of care for patients with advanced biliary tract cancer after a median follow-up of nearly two years.
With limited treatment advances over the past decade, these patients have long faced a dismal prognosis. For the first time, an immunotherapy-based combination has shown the ability to alter the course of treatment for this disease and should become the new standard of care.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These longer-term data reinforce the survival benefit and well-tolerated safety profile of Imfinzi added to standard-of-care chemotherapy for patients with advanced biliary tract cancer.
With these results, the exploratory data from the HIMALAYA trial and the recent FDA approval based on the TOPAZ-1 trial, we are continuing to advance our commitment to extend survival for patients with gastrointestinal tumours who desperately need new treatment options.”
Summary of updated results: TOPAZ-1
Imfinzi + chemotherapy (N=341)
Chemotherapy (n=344)
OSi,ii
Median OS (95% CI) (in months)
12.9
11.3
HR (95% CI)iii
0.76 (0.64, 0.91)
OS rate at 12 months (95% CI) (%)iv
54.3
47.1
OS rate at 24 months (95% CI) (%)
23.6
11.5
OS by BoRv,vi
Median OS (95% CI), responders, months
19.5
15.7
HR (95% CI) respondersiii
0.69 (0.46, 1.04)
Median OS (95% CI), stable disease (SD), months
13.6
11.5
HR (95% CI) SDiii
0.77 (0.62, 0.96)
12-month OS rate in responders (95% CI) (%)iv
75.8
75.0
12-month OS rate in SD (95% CI) (%)iv
57.5
48.0
24-month OS rate in responders (95% CI) (%)iv
40.6
20.5
24-month OS rate in SD (95% CI) (%)iv
20.7
10.6
OS, overall survival; HR, hazard ratio; CI, confidence interval; BoR, best overall response; SD, stable disease
i. 6.5 months of additional follow-up (data cut-off: 25 February 2022) after the primary analysis, with 76.9% overall OS event maturity
ii. At data cut-off for this analysis, median (95% CI) follow-up time (calculated using the inverse Kaplan-Meier techniques with the censoring indicator of OS reversed) was 23.4 (20.6–25.2) months for Imfinzi plus chemotherapy and 22.4 (21.4–23.8) months for chemotherapy
iii. HRs were calculated using a Cox proportional hazards model
iv. OS rates calculated using Kaplan-Meier techniques
v. To avoid immortal time bias, only participants surviving ≥ 3 months were included in this OS by best objective response analysis
vi. BoR was assessed by the investigator per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 in all randomised participants with measurable disease at baseline and defined as response (complete response or partial response), SD or progressive disease (PD); BoR was determined based on the IA data cut-off (11 August 2021)
Earlier this month, Imfinzi in combination with chemotherapy was granted approval in the US as a treatment for adults with locally advanced or metastatic BTC based on results from TOPAZ-1. Regulatory applications are also currently under review in Europe, Japan and several other countries based on the TOPAZ-1 results.
In October 2021, the TOPAZ-1 trial met the OS primary endpoint at a predefined interim analysis, reducing the risk of death by 20% versus chemotherapy (based on a HR of 0.80; 95% CI, 0.66-0.97; 2-sided p=0.021).
HIMALAYA Phase III trial exploratory analysis by aetiology in unresectable hepatocellular carcinoma at ESMO Also at ESMO, an exploratory analysis from the HIMALAYA Phase III trial evaluated the impact of disease causes on outcomes for patients with unresectable hepatocellular carcinoma (abstract #714P).
Data from HIMALAYA suggest a trend for OS benefit over sorafenib with the STRIDE regimen regardless of the underlying disease cause (hepatitis B virus [HBV], hepatitis C virus [HCV] or nonviral). Similar trends were observed with Imfinzi versus sorafenib across subsets.
In 2021, positive results from the HIMALAYA Phase III trial showed a single priming dose of tremelimumab, an anti-CTLA4 antibody, added to Imfinzi (STRIDE regimen) demonstrated a statistically significant and clinically meaningful improvement in OS versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment.
Patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a HR of 0.78, 96.02% CI 0.65-0.93; p=0.0035). Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.
When subsets were adjusted for prognostic factor imbalances, patients with HBV treated with the STRIDE regimen experienced a 36% reduction in the risk of death versus sorafenib (based on a HR of 0.64, 95% CI 0.47-0.86).
Median duration of response was 25.69 months versus 17.00 months for sorafenib. Patients with HCV treated with the STRIDE regimen experienced an 11% reduction in the risk of death versus sorafenib (based on a HR of 0.89; 95% CI 0.63-1.25). Median duration of response was 13.5 months versus 15.7 months for sorafenib.
Nonviral patients treated with the STRIDE regimen experienced a 23% reduction in the risk of death versus sorafenib (based on a HR of 0.77; 95% CI 0.59-1.00). Median duration of response was 13.21 months versus 6.01 months for sorafenib.
The safety profiles of STRIDE and durvalumab were consistent across aetiology subgroups.
In the past, viral HCC (disease associated with cirrhosis related to chronic hepatitis B or hepatitis C) has been the primary aetiology of the disease.
Over the last two decades, the prevalence of non-viral HCC (disease associated with non-viral factors including liver disease, obesity and diabetes) has significantly increased.
HIMALAYA is the only Phase III trial to demonstrate a survival benefit for immunotherapy in participants with non-viral HCC.
The STRIDE regimen is under review by global regulatory authorities in unresectable HCC based on the results of the HIMALAYA trial.”
Sept 12, 2022: “Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics.
Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.
“Across the industry, biotherapeutics account for almost one-half of all recent new drug approvals and have enormous potential to address unmet need across a wide range of diseases,” said Reto Fischer, Head of Technical Research Division, Global Drug Development (GDD), Novartis.
“We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless, and rapid fashion.
In doing so, we are supporting our broader ambition to enable faster development and focused prioritization across our global portfolio.”
The Novartis early-stage biologics portfolio has grown significantly in the last 15 years.
It has also expanded beyond conventional monoclonal antibodies into a wide range of novel development candidates with potential to be first-in-class, best-in-class, or both, including antibody-drug conjugates and therapeutic proteins.
This investment is intended to position Novartis at the forefront of biotherapeutic development, by supporting the company’s increasingly sophisticated pipeline with the most advanced technical infrastructure, alongside the highest level of capabilities.
It will create seamless, end-to-end development and manufacturing environments by embedding biologics development within existing Novartis commercial manufacturing facilities in Slovenia and Austria as well as by establishing a biologic’s hub on the Basel St. Johann Campus in Switzerland alongside the NIBR biologics center fostering scientific innovation, technology leadership and talent attraction.
Collectively these commitments will enhance development processes targeting faster transition times from pre-clinical to first in human studies.
Specifically, the investment will:
Strengthen the Novartis St. Johann campus in Basel by investing USD 100M to establish a biologics hub to complement the existing NIBR Biologics Center;
Create a biocampus in Mengeš, Slovenia with an investment of USD 110M in clinical manufacturing capabilities (non cGMP and cGMP) and technical development capabilities in proximity of development operations; and
Amplify synergies and strategic proximity at the Schaftenau campus in Austria with a USD 60M USD investment in development manufacturing capacity and capabilities.
“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Jonathan Novak, Global Head for Biologics, Technical Research Division, GDD at Novartis.
“We look forward to amplifying the knowledge and experience of our associates to ensure that biologics development is an exhilarating and rewarding process for our current and future colleagues – and that is ultimately a source of profoundly innovative new therapies for patients worldwide.”
