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Aetion and Cegedim Health Data Announce Real-World Evidence Research

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Aetion and Cegedim Health Data Announce Real-World Evidence Research

July 12, 2021: “Aetion and Cegedim Health Data announced an expanded, 3-year partnership that facilitates access to Cegedim Health Data’s anonymized real-world data through the Aetion Evidence Platform® (AEP).

Cegedim Health Data’s The Health Improvement Network® (THIN®) database currently covers the United Kingdom, France, Spain, Italy, Belgium, and Romania, with plans to add data from Germany.

Following their first year of partnership, Aetion and Cegedim Health Data have committed to further collaboration, enabling customers to monitor the utilization, safety, and effectiveness of medical products at scale across Europe.

Building on their collaboration announced in 2020, the offering employs leading trans-Atlantic real-world data to power regulatory-grade analytics for biopharma companies, regulatory agencies, health technology assessment
(HTA) bodies, and public payers.

With THIN® data — which covers large populations of over 69 million patients within Europe — loaded into the AEP, customers can analyze the utilization, safety, and effectiveness of treatments in nearn real time, which is especially important for reviewing COVID-19 vaccines and therapeutics.

“The Aetion-Cegedim Health Data partnership advances access to pan-European data sources for real-world evidence research, and enables us to help our customers navigate data privacy regulations and the heterogeneity of data across countries,” said Carolyn Magill, CEO of Aetion.

“Combining Cegedim Health Data’s THIN® database with the AEP is critical as manufacturers, regulators, and HTAs work to assess the utilization, safety, and effectiveness of interventions, as well as the long-term impact of COVID-19.”

Gilles Paubert, Global Head of Cegedim Health Data, comments: “The COVID-19 pandemic has highlighted the relevance of real-world patient data and has changed health sector attitudes on the importance of recent, regularly updated data to help monitor patient symptom trends, as well as the safety and efficacy of new treatments for the benefit of public health.

Paired with Aetion’s platform, our clinically rich data captured through THIN® will help deliver efficacious treatments to patients more rapidly as we continue to battle COVID-19, and as we look to the broader future for drug development.”

Aetion is a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) designated research center, and contributes to the ENCePP Working Group 3, whose focus is to inventory EU data sources and define methodological approaches for multi-source studies.

In addition, Aetion is engaged in a research collaboration with the U.S. FDA to advance the agency’s understanding of and response to COVID-19.

Global regulatory agencies and HTAs are increasingly adopting real-world evidence, especially as they respond to the COVID-19 pandemic.

The Aetion-Cegedim Health Data partnership expansion will grow the capacity for these bodies across Europe to use real-world data to urgently answer questions on treatment utilization, safety, and
effectiveness.”

https://www.cegedim.com/Communique/FINAL_Aetion-Cegedim%20Expansion_PR_ENG.pdf

Quidel Receives CE Mark For Savanna® Multiplex Molecular Analyzer And Respiratory Viral Panel

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Quidel Receives CE Mark For Savanna® Multiplex Molecular Analyzer And Respiratory Viral Panel

July 12, 2021: “Quidel Corporation, a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that the company has received the CE Mark for its innovative Savanna® multiplex molecular analyzer and Savanna® RVP4 Assay (Respiratory Viral Panel-4).

The CE Mark allows Quidel to market and sell the Savanna system in Europe, as well as other countries that accept the CE Mark.

Savanna is Quidel’s revolutionary multiplex molecular platform that enables professional customers to analyze up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes.

The Savanna system is a fully integrated, sample-to-result automated in-vitro diagnostic platform that performs real-time Polymerization Chain Reaction (PCR) tests by using the Savanna instrument and Savanna assay cartridges.

After inserting the assay cartridge, the instrument performs sample and reagent preparation, nucleic acid extraction and amplification, real-time detection of RNA or DNA target sequence, and qualitative or quantitative result interpretation from a variety of sample types.

The Savanna system is intended to aid in the diagnosis of the related diseases.

Quidel’s initial Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed nucleic acid test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection.

This in vitro diagnostic test is intended to aid in the differential diagnosis of infections with these viruses. The Savanna RVP4 Assay comes in a fully integrated cartridge that is stable at room temperature.

“Receipt of the CE Mark is an important step forward on our path to commercialize Savanna’s powerful but simple-to-use molecular diagnostic technology,” said Douglas Bryant, president and CEO of Quidel Corporation.

“The Savanna system’s small footprint features integrated sample prep combined with rapid real-time PCR amplification and detection technologies, making it a perfect fit for syndromic testing in hospitals and moderate-complexity labs, with the goal of eventually accessing physician offices, urgent care clinics and other point-of-care locations.

We expect to deploy our first batch of instruments to select international customers and the performance data generated will support our longer-term commercialization efforts as we build instrument inventory that we anticipate will be required for our planned broad-scale launch in the U.S.”

About the CE Mark

The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985.

The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives.

These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA.

This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.

About Quidel Corporation

Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe.

An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.

Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.” 

https://ir.quidel.com/news/news-release-details/2021/Quidel-Receives-CE-Mark-for-Savanna-Multiplex-Molecular-Analyzer-and-Respiratory-Viral-Panel/default.aspx

Sanofi streamlines Consumer Healthcare portfolio in Latin America with divestiture of eight brands to Hypera Pharma

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Sanofi streamlines Consumer Healthcare portfolio in Latin America with divestiture of eight brands to Hypera Pharma

July 13 2021: “As part of Sanofi’s ongoing efforts to simplify its Consumer Healthcare portfolio and accelerate its growth trajectory, the company has signed an agreement with HYPERA S.A. (“Hypera Pharma”) for the divestiture of eight products commercialized in Latin America.

The agreement also includes four prescription products from the General Medicine portfolio.

“As discussed during our Capital Markets Day in February, simplifying the CHC product portfolio is an important part of our strategy to focus our resources and efforts where we can bring the most value, especially to consumers.

We are pleased these products will continue to be available for consumers as we focus on becoming a fully integrated standalone business” said Julie Van Ongevalle, Executive Vice-President, Sanofi and Head of Sanofi Consumer Healthcare.

Sanofi does not anticipate any impact of this divestiture to its Latin American-based workforce.

The transaction is expected to close at the end of 2021, subject to approval of relevant regulatory authorities and other customary closing conditions.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-13-08-00-00-2261594

AZ receives final regulatory clearance for proposed acquisition of Alexion from UK’s Competition and Markets Authority

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AZ receives final regulatory clearance for proposed acquisition of Alexion from UK’s Competition and Markets Authority

July 14, 2021: “The UK Competition and Markets Authority has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion). As a result, the acquisition is expected to close on 21 July 2021.

Following closing, the new AstraZeneca shares issued to Alexion shareholders will be admitted to listing on the premium listing segment of the official list of the UK Financial Conduct Authority (FCA) and to the secondary listing on Nasdaq Stockholm.

In addition, the new AstraZeneca American Depositary Shares (ADSs) will be admitted on the Nasdaq Stock Market.

Trading on the London Stock Exchange’s main market for listed securities, Nasdaq Stockholm and the Nasdaq Stock Market, is expected to commence on 22 July 2021.

In addition, the Alexion shares will be de‐listed from the Nasdaq Stock Market. They will be deregistered under the Exchange Act as soon as practicable following completion of the acquisition.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: “We are very pleased to have secured this critical final clearance from the UK Competition and Markets Authority for the acquisition of Alexion.

We look forward to the imminent closing of the transaction so that we may pursue our shared ambition to bring more innovative medicines to patients worldwide and begin AstraZeneca’s next chapter of growth.”

The proposed acquisition, first announced in December 2020, will enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platforms and robust pipeline.

Rare diseases represent a high-growth opportunity with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly voted in support of the transaction on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Financial considerations
AstraZeneca anticipates providing updated 2021 financial guidance for the new, combined entity in due course.

Consolidation of Alexion will start from the closing of the transaction and the first quarter of consolidated financial reporting is expected to be the third quarter of 2021 due for announcement on Wednesday 10 November 2021.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.

Demand in medicines for rare diseases is forecasted to grow by a low double-digit percentage in the future.

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 with the SEC on 12 April 2021 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus), Alexion filed a proxy statement with the SEC (the proxy statement) on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC.

Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available, because they will contain important information.

Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

These documents may also be obtained free of charge on AstraZeneca’s website at http://www.astrazeneca.com under the tab “Investors”.

The documents filed by Alexion with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

These documents may also be obtained free of charge on Alexion’s internet website at http://www.alexion.com under the tab, “Investors” and under the heading “SEC Filings” or by contacting Alexion’s Investor Relations Department at [email protected].

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement.

Neither Evercore nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise.

Apart from the responsibilities and liabilities, if any, which may be imposed on Evercore by the Financial Services and Markets Act 2000 (FSMA), or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Evercore nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future.

To the fullest extent permitted by applicable law, each of Evercore and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.

Centerview Partners UK LLP (Centerview Partners), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement.

Neither Centerview Partners nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise.

from the responsibilities and liabilities, if any, which may be imposed on Centerview Partners by the FSMA, or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Centerview Partners nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in this announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future.

To the fullest extent permitted by applicable law, each of Centerview Partners and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement, or any statement contained in this announcement.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-alexion-transaction-cleared-in-the-uk.html

Valneva Awarded FDA Breakthrough Designation for its Single-Shot Chikungunya Vaccine Candidate

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Valneva Awarded FDA Breakthrough Designation for its Single-Shot Chikungunya Vaccine Candidate

July 7, 2021: “Valneva, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need announced that it has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration (FDA).

Breakthrough Therapy Designation intends to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates that the drug may have substantial improvement for at least one endpoint over available therapies.

This new U.S. milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency (EMA)’s PRIME designation which the Company received in December 2018 and in October 2020, respectively.

Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “We are extremely pleased with FDA’s recognition of VLA1553 as a Breakthrough program. Chikungunya is a major, growing public health threat and VLA1553 targets long lasting protection against the chikungunya virus with a single shot.

We will continue to work closely with the FDA to bring a preventative solution to the market as soon as possible.”

Valneva announced recruitment completion for its pivotal Phase 3 trial, VLA1553-301, in April 2021 and expects to report topline data this summer.

The primary objective of the trial is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunization.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.

Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia.

Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.

The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia.

As of September 2020, there were more than 3 million reported cases in the Americas and the economic impact is considered to be significant.

The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically.

There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

About VLA1553
VLA1553 targets the chikungunya virus, which has spread to more than 100 countries. VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease.

It has been designed by deleting a part of the chikungunya virus genome.

To Valneva’s knowledge, VLA1553 is currently the only chikungunya vaccine candidate in Phase 3 clinical trials that targets long-term protection following the administration of a single dose.

In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. Antibody titers were sustained after 12 months.

Based on these results and Valneva’s discussions with regulators, VLA1553 has advanced directly into Phase 3 clinical development.

The Company has also received confirmation for its proposal to seek licensure under the accelerated approval pathway from the FDA.

Under this pathway, Valneva plans to seek licensure of the vaccine based on a surrogate of protection agreed with the FDA that is reasonably likely to predict protection from chikungunya infection.

VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations.

The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032.

To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing and marketing of VLA1553.

The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI) signed in July 2019, which provides funding of up to $23.4 million, with support from the European Union’s (EU’s) Horizon 2020 programme.

About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options.

We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases.

We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.”

https://valneva.com/press-release/valneva-awarded-fda-breakthrough-designation-for-its-single-shot-chikungunya-vaccine-candidate/

Joint CDC and FDA Statement on Vaccine Boosters

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Joint CDC and FDA Statement on Vaccine Boosters

July 08, 2021: “The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up.

People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta.

People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.

We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community.

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.

This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.

We continue to review any new data as it becomes available and will keep the public informed.

We are prepared for booster doses if and when the science demonstrates that they are needed.”

https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-vaccine-boosters

Sanofi’s MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers

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Sanofi’s MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers

July 10, 2021: “Results from a head-to-head Phase 3 study, evaluating the immune response of MenQuadfi® to serogroup C, one of the main serogroups of invasive meningococcal disease (IMD), compared to Nimenrix® (quadrivalent ACWY vaccine) and NeisVac-C® (monovalent C vaccine) in healthy toddlers, were presented in an oral session at the 2021 European Congress of Clinical Microbiology and Infectious Disease.

The Phase 3 study met all primary and secondary endpoints, demonstrating that MenQuadfi induced superior immune responses to serogroup C based on geometric mean antibody titers (GMTs*) compared to NeisVac-C – a standard-of-care vaccine – in healthy toddlers. The study shows that a switch from monovalent C to MenQuadfi in toddlers can be achieved without compromising serogroup C protection.

The data also showed superior immune responses to serogroup C based on seroprotection rates and GMTs compared to Nimenrix in this population.

The safety profiles were comparable between all three vaccines.

“In the last decade there has been an increase in the incidence of invasive meningococcal disease due to serogroups W & Y in Europe, demonstrating a need for routine MenACWY vaccination.” said Prof. Markus Knuf, Head of Department for Pediatric and Adolescent Medicine, Worms Clinic, Worms, Germany, “Now that we know that we can help protect against A,C,W and Y serogroups with no compromise on C serogroup protection, I have great hope that routine ACWY vaccination will soon become the standard helping to protect European children from this potentially devastating disease.”

Children under five and adolescents are most at risk from IMD, a rare but potentially deadly disease which can have devastating consequences.

Up to 20% of survivors of IMD suffer from serious complications such as brain damage or loss of limbs.

Data has shown IMD has an unpredictable and evolving epidemiology.

Recent trends in Europe suggest a decreasing incidence of IMD cases caused by serogroup B and an increase in serogroups Y and W.

There has also been a significant increase in the incidence of IMD caused by hypervirulent serogroup W, with a case fatality rate more than twice that of IMD caused by other serogroups.

“The results of our head-to-head Phase 3 study are clear and add to our robust evidence demonstrating the strong profile of MenQuadfi against meningococcal disease caused by serogroups A, C, W and Y from toddlers to adults,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur.

“These data represent an important public health milestone in our efforts to advance protection against meningococcal meningitis and in support of the World Health Organization’s ambition to defeat this disease by 2030.”

About the Phase 3 study

MEQ00065 is a head-to-head comparative, multi-center, Phase 3 study conducted in Germany, Finland and Denmark to compare the immune response against meningococcal serogroup C and describe the safety following a single dose of MenQuadfi in healthy meningococcal vaccine-naïve toddlers 12 to 23 months of age compared to Nimenrix or NeisVac-C.

The full results of the Phase 3 MEQ00065 data will be submitted for publication in a peer-reviewed journal Q4 2021.

About MenQuadfi

MenQuadfi benefits from Sanofi’s latest advancements in chemical design and delivers optimized stability while maintaining the vaccine in a convenient, fully liquid presentation.


The vaccine can be administered as a single injection, supporting primary and booster vaccination to a wide age group, ranging from 12-month-old toddlers to children, adolescents, adults, and the elderly.

It can also be co-administered with multiple routine pediatric and adolescent vaccines.

MenQuadfi is approved by the European Commission, Iceland, Liechtenstein, Norway, Australia, Canada, UK, Brazil and Argentina for use as a single dose in individuals 12 months of age and older for the prevention of invasive meningococcal ACWY disease and is currently under review by several health authorities across the world to help meet local immunization efforts.

It is licensed by the Food and Drug Administration in the United States for the prevention of invasive meningococcal disease in individuals 2 years of age and older.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-10-19-30-00-2260818

Amgens Tezepelumab Granted Priority Review By U.S. FDA

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Amgens Tezepelumab Granted Priority Review By U.S. FDA

July 7, 2021: Amgen announced that the U.S.FDA has accepted a BLA and granted Priority Review for tezepelumab in the treatment of asthma.

Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022.

Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.2-5 Patients with severe, uncontrolled asthma experience frequent exacerbations, significant limitations on lung function and a reduced quality of life.2,6,7

“Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are proud to advance an innovative, first-in-class monoclonal antibody that targets the top of the inflammatory cascade and represents a potentially transformative treatment option for a broad population of patients with severe asthma. We look forward to bringing tezepelumab to patients as quickly as possible.” 

The BLA was based on results from the PATHFINDER clinical trial program, including results from the pivotal NAVIGATOR Phase 3 trial in which tezepelumab demonstrated superiority across every primary and key secondary endpoint compared to placebo in a broad population of patients with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.

The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection and headache.

Results from the NAVIGATOR Phase 3 trial were published in the New England Journal of Medicinein May 2021.

Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018.”

https://www.amgen.com/newsroom/press-releases/2021/07/tezepelumab-granted-priority-review-by-u-s–fda

New study highlights unacceptably high global prevalence of syphilis among men who have sex with men

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New study highlights unacceptably high global prevalence of syphilis among men who have sex with men

July 09, 2020 : “A new study, Prevalence of syphilis among men who have sex with men: A global systematic review and meta-analysis from 2000 to 2020, released today highlights the unacceptably high global prevalence of syphilis among men who have sex with men and underscores the need to advance stalled progress toward eliminating syphilis as a public health threat by 2030.  

Syphilis, a sexually transmitted infection (STI), is caused by the bacteria Treponema pallidum. 

The study lead by the London School of Hygiene and Tropical Medicine, London, UK and published in the Lancet Global Health presents the first global syphilis prevalence estimate among men who have sex with men. 

Findings from this global review show that men who have sex with men have high burden of syphilis infection, with significant variation across countries and regions.

The global pooled prevalence of syphilis among men who have sex with men was 7.5% during 2000-2020 (95% CI: 7.0-8.0), as compared to the most recent estimate of syphilis among men in the general population in 2016, 0.5% (95% UI: 0.4-0.6).

The proportion of men who have sex with men with syphilis was highest in settings where HIV prevalence was greater than 5% and in low and -middle income countries (LMIC).

Sub-analysis showed that pooled prevalence estimates were higher between 2015-2020 compared to the prior 5 years in half of the global regions assessed and several countries are reporting a high and sustained increase in syphilis infection among men who have sex with men.

Globally, there were an estimated 7 million new syphilis infections in 2020. WHO has set ambitious targets to reduce incidence of syphilis by 90% by 2030, but the global response has been slow.

While there have been modest reductions in congenital syphilis as a result of the scale-up of interventions in antenatal care, such as syphilis screening and treatment for pregnant women, there is an urgent need to galvanize momentum and better serve other priority populations disproportionally impacted by the disease. 

Syphilis is preventable and curable, with cost-effective and, in certain contexts, cost-saving interventions.

Easy to use and inexpensive point-of-care tests include blood-based rapid tests that produce results in less than 20 minutes, and products that test syphilis and HIV using a single platform.

Treatment with injectable benzathine penicillin is simple to administer and inexpensive.

A major challenge is that populations at higher risk for syphilis, particularly in LMIC, are often not able to access services due to structural barriers, including criminalization, policy and legal barriers, discrimination and violence. As recommended by WHO, governments should address these structural barriers as a priority.

“This first review of global syphilis prevalence among men who have sex with men highlights the urgent need to improve access to syphilis testing, treatment and prevention services,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes.

“Stakeholders must address structural barriers, like discrimination and violence; improve sexuality education, and expand access and delivery of syphilis testing and immediate treatment for all populations at higher risk of infection.”

https://www.who.int/news/item/09-07-2030-new-study-highlights-unacceptably-high-global-prevalence-of-syphilis-among-men-who-have-sex-with-men

FDA Approves Merck’s KEYTRUDA® in Locally Advanced Cutaneous Squamous Cell Carcinoma

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FDA Approves Merck’s KEYTRUDA® in Locally Advanced Cutaneous Squamous Cell Carcinoma

July 6, 2021: Merck known as MSD outside the United States and Canada announced that the U.S.FDA has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.

Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer.

In June 2020, KEYTRUDA was granted its first indication in cSCC, as monotherapy for the treatment of patients with recurrent or metastatic disease that is not curable by surgery or radiation.

“This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

“This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation.

Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA.

Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.

KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

Data Supporting the Approval

The approval was based on data from KEYNOTE-629 (ClinicalTrials.gov, NCT03284424), a multicenter, multi-cohort, non-randomized, open-label trial that enrolled patients with recurrent or metastatic cSCC or locally advanced cSCC.

The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression.

Patients received KEYTRUDA 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months.

Patients with initial radiographic disease progression could receive additional doses of KEYTRUDA during confirmation of progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status.

Assessment of tumor status was performed every six weeks during the first year and every nine weeks during the second year.

The major efficacy outcome measures were ORR and DOR as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Among the 54 patients with locally advanced cSCC treated, the study population characteristics were: median age of 76 years (range, 35 to 95), 80% age 65 or older; 72% male; 83% white, 13% race unknown; 41% Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 and 59% ECOG PS of 1.

Twenty-two percent received one or more prior lines of therapy; 63% received prior radiation therapy.

The ORR was 50% (95% CI, 36-64), including a complete response rate of 17% and a partial response rate of 33%, for patients treated with KEYTRUDA.

After a median follow-up of 13.4 months, the median DOR had not yet been reached (range, 1.0+ to 17.2+ months).

Among the 27 responding patients, 81% had a DOR of six months or longer, and 37% had a DOR of 12 months or longer.

Among the 159 patients with advanced cSCC (recurrent or metastatic or locally advanced disease) enrolled in KEYNOTE-629, the median duration of exposure to KEYTRUDA was 6.9 months (range, 1 day to 28.9 months).

Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with KEYTRUDA as a single agent.

Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence included lymphopenia (10%) and decreased sodium (10%).

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program.

There are currently more than 1,500 trials studying KEYTRUDA across a wide variety of cancers and treatment settings.

The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.”

https://www.merck.com/news/fda-approves-expanded-indication-for-mercks-keytruda-pembrolizumab-in-locally-advanced-cutaneous-squamous-cell-carcinoma-cscc/

AstraZeneca receives clearance from EU for proposed acquisition of Alexion

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AstraZeneca receives clearance from EU for proposed acquisition of Alexion

July 06, 2021: AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, (Alexion) has achieved an important step towards completion by having cleared the European Commission review.

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: “We are pleased to have secured clearance from the European Commission for the proposed acquisition of Alexion, a pioneer in the discovery and development of medicines for rare diseases.

We are now another step closer to closing the acquisition and combining the two companies to create a leader in immunology and precision medicines. We continue to progress towards the completion of the acquisition during this quarter.”

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platform and an extensive pipeline.

Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly supported the acquisition by their votes on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.

Demand in medicines for rare diseases is forecasted to grow by a low double-digit percentage in the future.

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 with the SEC on 12 April 2021 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus), Alexion filed a proxy statement with the SEC (the proxy statement) on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC.

Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available, because they will contain important information.

Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. “

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-alexion-transaction-cleared-in-the-eu.html

AZ’s Tezepelumab regulatory submission accepted in US for treatment of asthma

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AZ’s Tezepelumab regulatory submission accepted in US for treatment of asthma

July 08, 2021: “AstraZeneca’s BLA for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US FDA.

Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.

Patients with severe, uncontrolled asthma experience frequent exacerbations, significant limitations on lung function and a reduced quality of life.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This decision brings us a step closer to delivering a much-needed, first-in-class medicine for asthma patients, many of whom remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines.

Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status and fractional exhaled nitric oxide, and has the potential to transform treatment for a broad population of severe asthma patients.”

The BLA was based on results from the PATHFINDER clinical trials programme, including results from the pivotal NAVIGATOR Phase III trial.

In NAVIGATOR, tezepelumab demonstrated superiority across every primary and key secondary endpoint, compared to placebo, in a broad population of patients with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medicine with or without oral corticosteroids (OCS).

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.

The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection and headache.

Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicinein May 2021.

Tezepelumab received Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype in September 2018.

Severe asthma
Asthma is a heterogeneous disease affecting an estimated 339 million people worldwide.

Approximately 10% of asthma patients have severe asthma.

Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled.

Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.

Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.

Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalisations.

There is also a significant socio-economic burden, with these patients accounting for 50% of asthma-related costs.

Clinical trials
Building on the Phase IIb PATHWAY trial, the Phase III PATHFINDER programme included two trials, NAVIGATOR and SOURCE.

The programme includes additional planned mechanistic and long-term safety trials.

NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC).

SoC was treatment with medium- or high-dose ICS plus at least one additional controller medicine with or without OCS.

The trial population included approximately equal proportions of patients with high (≥ 300 cells/µL) and low (< 300 cells/µL) blood eosinophil counts.

The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period.

All patients received their prescribed controller medicines without change throughout the trial.

The primary efficacy endpoint was the annualised asthma exacerbation rate (AAER) during the 52-week treatment period. Key secondary endpoints included the effect of tezepelumab on lung function, asthma control and health-related quality of life.8

As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, fractional exhaled nitric oxide (FeNO) level, serum specific immunoglobin E (IgE) status (perennial allergen sensitivity positive or negative).

These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analysing a patient’s blood (eosinophils/IgE) and exhaled air (FeNO).

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.

The most frequently reported adverse events for tezepelumab were nasopharyngitis, upper respiratory tract infection and headache.

NAVIGATOR is the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP).

These results support the US Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

SOURCE is a Phase III multicentre, randomised, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists, and chronic treatment with maintenance OCS therapy.

The primary endpoint is the categorised percentage reduction from baseline in the daily OCS dose, while not losing asthma control.

Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase III extension trial assessing long-term safety and efficacy.

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