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XARENO study revealed Xarelto™ was associated with net clinical benefit and a reduced risk of kidney failure

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XARENO study revealed Xarelto™ was associated with net clinical benefit and a reduced risk of kidney failure

 April 4, 2022: “In the XARENO study, after a minimum follow up period of one year, Xarelto (rivaroxaban) was associated with a greater net clinical benefit (lower event rates for stroke and other thromboembolic events, major bleeding and all-cause mortality) and a reduced risk of kidney failure in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD) compared to vitamin K antagonists.

The study findings were presented at the American Congress of Cardiology’s 71st Annual Scientific Session (ACC.22).

“Chronic kidney disease is a common and potentially deadly condition that is widely underrecognized, despite the fact it can severely impact patients’ quality of life,” said Reinhold Kreutz, Professor of Clinical Pharmacology, Charité University – Medicine Berlin.

“The XARENO study findings provide important evidence that can help physicians in the management of patients with atrial fibrillation and chronic kidney disease and help reduce patients’ risk of progressing to kidney failure.”

XARENO is the first prospective observational study to evaluate the effectiveness and safety of Xarelto versus VKAs or no oral anticoagulation (at the discretion of attending physicians) in treating patients with NVAF and advanced CKD.

The prevention of worsening renal function is an important additional therapeutic target beyond stroke prevention when it comes to the selection of an oral anticoagulant in patients with atrial fibrillation (AF).

The XARENO study was undertaken to investigate the real-world effectiveness and safety of Xarelto compared with VKAs in this vulnerable patient group with AF and advanced CKD.

The study adds to the evidence obtained in the randomized controlled ROCKET-AF study and supports the use of Xarelto in this patient group including patients with CKD stage 4.

In agreement with previous data demonstrating various benefits of rivaroxaban over VKAs on kidney outcomes, XARENO also suggests a potential reduction in kidney failure of Xarelto vs VKA.

With XARENO and previous studies like ANTENNA Xarelto provides the broadest evidence on preservation of renal function compared to all other NOACs.

“Previous trials evaluating stroke prevention in atrial fibrillation have excluded patients with advanced chronic kidney disease. Consequently, the clinical impact of NOACs versus VKAs in this patient population was unknown,” said Dr. Mike Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance for the Pharmaceuticals Division at Bayer. “The XARENO study provides crucial new insights into how we can help to prevent disease progression and improve clinical outcomes in people with atrial fibrillation and chronic kidney disease.”

About atrial fibrillation (AF) and chronic kidney disease (CKD)

AF is the most common sustained cardiac rhythm disorder. In AF, the upper chambers of the heart (atria) contract irregularly.

As a result, blood does not flow properly, potentially allowing blood clots to form. These blood clots can break loose and travel to the brain, resulting in a stroke.

Patients with AF can have a up to 5 times higher risk of stroke than those without AF. AF is frequently associated with comorbidities, including CKD.

It’s estimated that 15–20% of people with AF also have CKD. CKD is a common and potentially deadly condition that is widely underrecognized.

The disease progresses silently and unpredictably, with many symptoms not appearing until CKD is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.

Previous studies have found that patients with both AF and renal impairment are at higher risk for bleeding and stroke. They are also more likely to be undertreated with oral anticoagulation such as warfarin than those with normal renal function.

About XARENO

The XA inhibition in RENal patients with non-valvular atrial fibrillation Observational registry (XARENO) was a prospective, non-interventional, international multicenter study recruiting AF patients with CKD in five European countries.

The results build on findings from a retrospective database analysis which indicated that Xarelto may be associated with lower risks of adverse renal outcomes in patients with CKD and NVAF, compared with VKA.

Between April 2016 and January 2020, 1,550 patients were enrolled in the study. Patients treated with Xarelto or VKA having estimated glomerular filtration rates (eGFR) between 15 and 49 mL/min per 1.73 m2 were eligible for inclusion.

Patients without anticoagulation at the discretion of the attending physicians were also enrolled for explorative analysis.

The study population comprised 766 patients in the Xarelto group, 695 in the VKA group, and 89 in the group without anticoagulation and 85 patients not eligible/with missing information.

Patients were treated with either Xarelto or VKA at the discretion of the attending physicians. Pre-specified follow-up was at least 12 months with a planned extended data collection period for one up to two additional years.

Primary outcomes, as determined by blinded adjudication, included progression of CKD and net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality).

Propensity score matched analysis (PSMA) was used to compare the Xarelto and VKA groups.

After one year follow up, the study found that in PSMA, baseline eGFR was similar in both groups and numerically higher in the rivaroxaban group after follow-up (difference 1.0 mL/min per 1.73 m2, 95% confidence interval [CI] -0.48 to 2.51, p=0.18).

The frequency of net-clinical benefit events was 12.9% (51/397) in the rivaroxaban and 18.3% (75/410) in the VKA group (incidence rate ratio [IRR] 0.68, 95% CI 0.47 to 0.96, p=0.03).

The incidence risk ratio (IRR) for progression to CKD stage 5 was 0.40 (CI 0.22 to 0.71) and the IRR for in the initiation of chronic renal replacement therapy was 0.08 (CI 0.01 to 0.63).

About Rivaroxaban (Xarelto™)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:

· The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
· The treatment of pulmonary embolism (PE) in adults
· The treatment of deep vein thrombosis (DVT) in adults
· The prevention of recurrent PE and/or DVT in adults
· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
· The prevention of VTE in adult patients undergoing elective knee replacement surgery
· The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
· The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events when co-administered with acetylsalicylic acid (ASA)
· Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
· Thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure

Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications may differ from country to country. Since launch in 2008, more than 100 million patients have been treated.

Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).

Anticoagulant medicines are therapies used to prevent or treat serious illnesses and potentially life-threatening conditions.

Before initiating treatment with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.”

https://media.bayer.com/baynews/baynews.nsf/id/XARENO-study-revealed-XareltoTM-associated-clinical-benefit-a-reduced-kidney-failure-compared?Open&parent=news-overview-category-search-en&ccm=020

AZ’s Self-administered SC monthly dose with a potential best-in-class efficacy profile

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AZ’s Self-administered SC monthly dose with a potential best-in-class efficacy profile

April 04, 2022: “Positive results from the ETESIAN Phase IIb trial showed AZD8233 (an investigational antisense oligonucleotide [ASO], also known as ION449) met the primary endpoint at 50 mg with 73% (95% confidence interval [CI]: -77%, -68%) reduction in low-density lipoprotein cholesterol (LDL-C) levels, from baseline.

The trial also met the secondary endpoints, including significantly reducing proprotein convertase subtilisin/kexin type 9 (PCSK9) levels by 89% (95% CI: -91%, -86%), with sustained reductions maintained over the dosing intervals, and through to week 14 (6 weeks after last dose) at 50 mg dose.

Reduction of PCSK9 levels leads to increases in LDL receptor levels, which results in lower LDL-C levels in the bloodstream and reduces the risk of developing coronary heart disease.

AZD8233 was generally well-tolerated during the treatment duration.

Three dose levels of AZD8233 were evaluated (15mg, 50mg, 90mg), given monthly by subcutaneous injection over the 12 week dosing period.

All active arms demonstrated reductions in LDL-C and PCSK9 levels at week 12 compared to placebo.

The trial was conducted in patients with high-risk hypercholesterolemia on a high-dose statin.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today, we are pleased to announce that ETESIAN Phase IIb for AZD8233 demonstrated a clear dose-response for both PCSK9 and LDL-C levels.

The results underscore AZD8233’s potential best-in-class efficacy profile, and supports its further development as a next generation PCSK9 inhibitor that is easily self-administered monthly.”

Brett Monia, CEO, Ionis Pharmaceuticals said: “The positive results of the ETESIAN study, along with the clinical studies to date, reinforces our confidence that ION449 (AZD8233) is a potential new treatment option that may be able to change the current standard of care for patients affected by hypercholesterolemia who have cardiovascular disease.”

More than half of patients with cardiovascular disease at high-risk of a major secondary event do not meet their LDL-C goals, despite taking a high-intensity statin.1-3 Elevated LDL-C is a key risk factor for cardiovascular disease, resulting in approximately 2.6 million deaths worldwide every year.4

AZD8233 is a next generation PCSK9 inhibitor with a unique mode of action and is the only PCSK9 ASO, which acts upstream of current PCSK9 inhibitors, targeting gene expression in the nucleus. It is designed to reduce blood cholesterol levels in patients with hypercholesterolemia by targeting PCSK9, an important regulator of LDL-C.

Results from the ETESIAN Phase IIb trial were presented on 4 April 2022 at the American College of Cardiology’s 71st Annual Scientific Session.

Results from the SOLANO Phase IIb trial assessing the safety, efficacy and tolerability of AZD8233 in patients with hypercholesterolemia is anticipated later in 2022.

Notes

Hypercholesterolemia
Hypercholesterolemia, or elevated LDL-C levels in the blood, is an important risk factor for cardiovascular disease, the leading cause of death worldwide.

There is a significant unmet medical need for stronger LDL-C lowering therapies in secondary prevention patients with approximately 50% who are not meeting their treatment goals despite taking a high-intensity statin.

One in six patients with LDL-C >100mg/dL will suffer a second major adverse cardiovascular event over approximately three years.

AZD8233
AZD8233 (also known as ION 449), dosed once monthly via subcutaneous administration, is a novel, investigational ASO therapy designed to reduce blood cholesterol levels in patients with hypercholesterolemia by inhibiting PCSK9 expression in the nucleus.

By reducing PCSK9 levels, AZD8233 is expected to increase the number of LDL receptors available to clear LDL from the blood, thereby lowering LDL-C levels.

ETESIAN
ETESIAN was a randomised, parallel-group, double-blind, placebo-controlled, dose-ranging Phase IIb study of AZD8233 in patients with hypercholesterolemia on a background of high-dose statin.

The primary endpoint was to assess the efficacy of AZD8233 across different dose levels versus placebo in reducing serum LDL-C levels.

Secondary endpoints included change in PCSK9 levels and the assessment of safety and tolerability of AZD8233.

The reduction from baseline to week 12 in LDL-C at the 15 mg and 90 mg monthly dose was 39% (95% CI: -48%, -29%) and 79% (95% CI: -83%, -76%), respectively.

The reduction from baseline to week 12 in PCSK9 levels at the 15 mg and 90 mg monthly dose was 58% (95% CI: -66, -48) and -94% (95% CI: -95, -92) respectively.

In the AZD8233 90 mg group, transient, moderate treatment-emergent elevations in liver enzyme levels occurred in some patients.

AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s three disease areas and is a key growth driver for the Company.

By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improving outcomes by slowing disease progression, reducing risks and tackling co-morbidities.

The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/azd8233-reduced-low-density-lipoprotein-cholesterol-levels-73-patients-high-risk-hypercholesterolemia-etesian-phase-iib-trial.html

Sanofi launches first-in-pharma Diversity, Equity & Inclusion Board

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Sanofi launches first-in-pharma Diversity, Equity & Inclusion Board

April 4, 2022: “Sanofi launches its Diversity, Equity & Inclusion (DE&I) Board, the first-of-its-kind in the pharmaceutical industry to feature outside advisors.

Sanofi’s DE&I Board will include three of the most influential voices in the DE&I space as Board members appointed for 3 years: organizational psychologist & best-selling author John Amaechi, award-winning social entrepreneur Caroline Casey, and DE&I pioneer and renowned thought-leader Dr. Rohini Anand.

Sanofi’s DE&I strategy was revamped in June 2021 with set objectives toward 2025, built around three key pillars: building representative leadership, creating a work environment where employees can bring their whole selves and engaging with the company’s diverse communities.

The DE&I Board’s role is to ensure Sanofi’s DE&I strategy is rightly executed, to monitor progress on the company’s 2025 targets and to advise on how to accelerate the company’s impact in this space.

Together with the DE&I Board, Sanofi is launching a global Employee Resource Group (ERG) framework and five global focused ERGs: Gender+, Generations+, Pride+, Ability+ and Culture and Origins+, which will allow already existing local ERGs to scale and grow. ERGs are voluntary, employee-led groups that help create a diverse and inclusive workplace.

Critical in supporting their members’ professional and personal growth and in cultivating a sense of belonging, they ensure the company reflects, values and listens to its diverse employees’ communities.

Paul Hudson
CEO of Sanofi
“We’re committed to driving diversity, equity and inclusion in Sanofi and beyond. These new initiatives will help us bring the outside in, so we can hear, listen and learn faster, and grow stronger as we continue our DE&I journey.”

The DE&I Board is composed of eleven members, including seven members from Sanofi’s leadership – Paul Hudson, Chief Executive Officer, Natalie Bickford, Chief People Officer, Olivier Charmeil, Head of General Medicines, Roy Papatheodorou, General Counsel & Head of Legal, Ethics & Business Integrity, John Reed, Head of Research & Development, Thomas Triomphe, Head of Vaccines, and Raj Verma, Chief Diversity, Culture & Experience Officer.

Raj Verma will chair the DE&I Board. One member will be one of the company’s five global Employee Resource Group Leads, with rotation among all global ERG Leads on an annual basis.

The DE&I Board will meet 3 times per year and progress on the 2025 targets will continue to be communicated on a quarterly basis.

John Amaechi
“I am always excited to support organizations looking to ensure that whether for colleagues, stakeholders or consumers – they stand for fairness, equity and the preservation of human dignity. 

I am a scientist first and bring an understanding of what can work to performance through improving inclusion and equity in the context of a large, complex multinational company with a strong history and tradition. It’s clear there are many strong advocates within the company, and I am delighted to add my insights and expertise to those already present within Sanofi.”

Dr. Rohini Anand
“I am thrilled to join Sanofi’s DE&I Board as it affords me an opportunity to influence the critical need to address health care disparities globally.

With my experience in leading global DE&I transformations I am motivated to support Sanofi as it seeks to foster an equitable and inclusive culture that enables breakthrough innovations because it is the desired destination for diverse talent. 

I am impressed by the authenticity and humility with which the leadership approaches DE&I and its willingness and openness to learn from external thought leaders.”

Caroline Casey
“It’s a real honour to be joining the Sanofi DE&I Board which will support the strategic evolution of Business Inclusion focusing on the complex intersectional nature of diversity, equity, and inclusion.

As a supporter of removing the decisive siloed approach which has and continues to create exclusion and mistrust, I am proud to bring the voice of disability business inclusion front and centre of Sanofi’s strategy both as a person with lived experience and as the founder of The Valuable 500.”

Sanofi’s DE&I Board external members

John Amaechi is an organizational psychologist, best-selling author, Chartered Scientist (CSci), elected Fellow of the Royal Society for Public Health, Research Fellow at the University of East London, and Founder of APS Intelligence.

A former NBA sportsman, John Amaechi serves as a mentor to many, a teacher to some, and always uses his deep psychological insight combined with real life experience to provide a touchstone for people and companies who want to thrive, achieve and align their beliefs, values and ethics.

Dr. Rohini Anand, is a strategic business leader, Board member and author. With expertise that spans executive leadership, human capital, global corporate responsibility, wellness and diversity equity and inclusion, Rohini brings a unique perspective on the critical alignment of the business culture and the triple bottom line (People, Planet, Profit) to drive exceptional performance.

Most recently Rohini was Senior Vice-President Corporate Responsibility and Global Chief Diversity Officer for Sodexo.

Caroline Casey is a businesswoman and activist, founder of The Valuable 500, the world’s largest CEO collective and business move for disability inclusion.

Recently appointed President of the International Agency for the Prevention of Blindness (IAPB), Caroline also sits on several Diversity and Inclusion Boards to include L’Oréal and Sky.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-04-04-12-00-00-2415480

ViiV Healthcare announces FDA approval of Triumeq PD for HIV

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ViiV Healthcare announces FDA approval of Triumeq PD for HIV

 March 30, 2022: “ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi B.V. as shareholders, has announced that the U.S. Food and Drug Administration has approved a NDA for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1).

In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs.

According to UNAIDS, approximately 1.7 million children globally were living with HIV in 2020, with most AIDS-related deaths among this population occurring during the first five years of life.

Therefore, the availability of age-appropriate treatment options is critical in ensuring young children can access optimal care.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option.

Developing paediatric formulations of anti-retroviral treatments is a priority for ViiV Healthcare because we want to ensure that no one living with HIV is left behind and this approval means that we are one step closer to closing the gap between HIV treatment options available for adults and children.”

Today’s FDA approval is an important step in fulfilling ViiV Healthcare’s commitment to bring optimised paediatric formulations containing dolutegravir to children.

In addition to today’s regulatory milestones, an application to approve the new dispersible tablet of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients with human immunodeficiency virus type 1 (HIV-1) and to extend the current approved Marketing Authorisation of Triumeq tablets to include a paediatric indication for children is currently under review by the European Medicines Agency (EMA).

Chip Lyons, President and CEO of the Elizabeth Glaser Paediatric AIDS Foundation (EGPAF), said: “Children are still disproportionality impacted by the HIV epidemic with only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need and even fewer still reaching viral suppression.

An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste and this presents a real challenge to many caregivers’ ability to administer life-saving medicine.

Today’s approval of a child-friendly formulation of a single tablet regimen will help meet the urgent needs of this vulnerable population.”

Through its paediatric voluntary licences, ViiV Healthcare enables generic versions of dolutegravir to be manufactured and sold royalty-free for the treatment of children living with HIV in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries.

In order to ensure licensees expedite the development and introduction of optimised paediatric formulations containing dolutegravir to help the children most affected by HIV, the majority of whom reside in sub-Saharan Africa, ViiV Healthcare works with the Clinton Health Access Initiative (CHAI) and Unitaid in a public-private partnership.

About Triumeq

Two essential steps in the HIV life cycle are replication – when the virus turns its RNA copy into DNA – and integration – the moment when viral DNA becomes part of the host cell’s DNA.

These processes require two enzymes called reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information (ISI) for TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine) tablets“

https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-triumeq-pd-the-first-dispersible-single-tablet-regimen-containing-dolutegravir-a-once-daily-treatment-for-children-living-with-hiv/

Bayer set to drive breakthrough innovations in the Life Sciences

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Bayer set to drive breakthrough innovations in the Life Sciences

April 1, 2022: “Bayer held its first ever Breakthrough Innovation Forum, focusing on longer-term opportunities for health and agriculture leveraging emerging technologies.

The event followed Bayer’s recent short- and mid-term pipeline updates for its Pharma and Crop Science Divisions and shared further insights on Bayer’s ongoing progress to drive long-term breakthrough innovations in the Life Sciences.

Renowned experts and Bayer executives illustrated how a forthcoming wave of innovations will open new opportunities in next-generation healthcare and in providing farming solutions to make agriculture more sustainable and less resource intensive.

In conjunction with the event, Bayer announced that it is accelerating its investment in its Leaps by Bayer impact investment unit with more than 1.3 billion euros funding until end of 2024.

“We stand at the dawn of a new age of innovation in the Life Sciences,” said Werner Baumann, Chairman of the Board of Management of Bayer AG. “Our ability to tackle some of the greatest challenges is increasing rapidly.

From providing answers for incurable diseases, equipping people with preventive tools to live healthier, better and longer lives, to producing more agricultural output whilst significantly reducing inputs and respecting the planetary boundaries.

This ability is particularly driven by the accelerating confluence of biology, chemistry, advanced computing, data analytics and artificial intelligence.

As a leader in health and nutrition, Bayer is further stepping up its efforts to be a driver of this new era of innovation. Ultimately, better innovation is the engine that drives superior business results and outperformance.”

Tackling humanity’s biggest challenges with Leaps by Bayer

Leaps by Bayer follows a unique approach aimed at tackling ten of humanity’s biggest challenges such as curing cancer or reducing the environmental impact of agriculture.

“Over the past seven years, we have invested more than 1.3 billion euros across a portfolio comprising more than 50 companies – all geared towards shifting core paradigms in the sectors of Health and Agriculture,” said Jürgen Eckhardt, Head of Leaps by Bayer.

“With Bayer stepping up its investment in Leaps over the coming years, we will be able to continue on our successful path and provide funding for the brightest minds working on solutions that truly make a difference for people and the planet.”

Leaps has embarked on numerous joint ventures – such as JoynBio or the former portfolio company BlueRock Therapeutics which is now fully owned by Bayer – and successfully led several investment rounds.

One example is Recursion, an AI-focused company working to find new drug treatments for lung fibrosis and other fibrotic diseases, which successfully went public in April 2021.

The Breakthrough Innovation Forum features CEOs of Leaps’ portfolio companies Cellino, Andes and Ukko to share insights on their missions and technologies in health and agriculture.

Driving breakthrough innovations in health and agriculture

The event also provided tangible examples of Bayer’s ongoing work to change the paradigms in Life Sciences.

In health, the prospects of this new era of innovation are expected to significantly enlarge the toolbox of technologies and enable scientists around the world to address areas of high unmet medical need.

“The convergence of biology, chemistry and data is opening up fundamentally new ways to understand and treat disease. Breakthrough innovation, powered by new technologies, enables us to not only treat symptoms, but to potentially stop or reverse progression of a disease – and offers the promise of treatment options that are truly transformative for patients,” said Stefan Oelrich, Member of the Board of Bayer AG and President of the Pharmaceuticals division.

Bayer is investing strongly in new areas of biomedical innovation, especially in the fields of cell and gene therapies. Over the past three years, Bayer has invested more than 2.5 billion euros to build up a Cell & Gene Therapy Platform, including the acquisitions of BlueRock Therapeutics and Asklepios BioPharmaceutical (AskBio).

In addition, Bayer is driving innovation in strategic collaborations with partners such as Mammoth Biosciences to leverage the collaborative advantages of partnerships.

Already today, the company’s strong preclinical and clinical cell and gene therapy portfolio is benefitting its pipeline, with eight projects in various stages of clinical development.

These cover therapeutic areas with a high unmet medical need, with leading programs in Parkinson’s disease, Pompe disease and congestive heart failure.

Bayer has also significantly strengthened its drug discovery capabilities through its acquisition of Vividion Therapeutics, a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics.

Moreover, the company is tapping into the potential of precision health in consumer healthcare.

With its majority ownership of Care/of, a personalized nutrition company originally invested in by Bayer’s Leaps arm, Bayer is positioned to tap into the growth and future potential of the personalized supplements market.

Further, the company has secured innovation partnerships in the field of healthy aging, which use novel biological insights to inform how the right nutrition and lifestyle choices can improve cellular health and promote healthy aging.

These efforts complement the company`s portfolio of science-based nutritional supplements and preventive health products, which have seen double-digit year-over-year growth in each of the past two years.

“The pandemic has heightened the importance of everyday health,” said Heiko Schipper, Member of the Board of Management of Bayer AG and President of the Consumer Health division.

“Advancing innovation-driven solutions in self-care will enable individuals to take more proactive, personalized care of their everyday health.”

In agriculture, Bayer is building on the power of emerging new technologies to create a sustainable and resilient food system and help growers around the world produce more with fewer resources while reducing emissions and removing carbon from the atmosphere.

“Bayer’s R&D investment of 2 billion euros annually in our Crop Science division is unparalleled in the industry, leading to a robust innovation pipeline spanning seeds and trait technologies, crop protection and digital solutions valued at up to 30 billion euros peak sales potential over the next two decades – with approximately half accounting for incremental growth,” said Rodrigo Santos, Member of the Board of Bayer AG and President of the Crop Science division.

On the basis of RNAi technology, Bayer recently launched the first-ever biotech defence against corn rootworm, enabling farmers to control a pest that costs around 1 billion euros annually in crop damage while reducing the need for crop protection.

With its short-stature corn, planned to launch as part of Bayer’s newly introduced Smart Corn System in 2023, Bayer is going to bring a more weather resistant plant to the market.

Short-stature corn is able to withstand extreme conditions emerging from climate change, thus reducing the risk of crop loss and contributing to food security.

Leveraging its unparalleled digital farming platform, Bayer is a leading force in the decarbonization of agriculture.

The Bayer Carbon Initiative incentivizes farmers to embrace the use of climate smart practices such as no-till or cover crops.

In addition, it uses next-generation technology to quantify and track the impact of these practices, underlining Bayer’s pioneering role and its unique position in advancing digital capabilities for the food, feed, fuel, and fiber value chain.”

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-set-to-drive-breakthrough-innovations-in-the-Life-Sciences?Open&parent=news-overview-category-search-en&ccm=020

Novartis announces EU approval of Beovu® for diabetic macular edema

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Novartis announces EU approval of Beovu® for diabetic macular edema

March 31, 2022: “Novartis announced that the European Commission has approved Beovu® (brolucizumab) 6 mg for the treatment of visual impairment due to diabetic macular edema (DME).

Today’s approval in DME represents the second indication for Beovu granted by the EC, which was first approved for the treatment of wet age-related macular degeneration in 2020.

The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway and Liechtenstein.

The EC approval was based on year one data from the Phase III, randomized, double-masked KESTREL and KITE* studies, which met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one.

In both trials, following the loading phase, over half of patients (55.1% in KESTREL and 50.3% in KITE) in the Beovu 6 mg arm remained on a 12-week dosing interval through year one.

Aflibercept dosing was aligned to the approved EU label in year one of treatment.

In aggregate, a numerically lower proportion of patient eyes treated with Beovu had intraretinal fluid, subretinal fluid or both at week 52 versus eyes treated with aflibercept (in KESTREL 60.3% in Beovu arm versus 73.3% in aflibercept arm; in KITE 54.2% versus 72.9%, respectively; testing for statistical significance was not performed).

Per the approved prescribing information, following the loading phase of five doses injected six weeks apart, physicians may individualize treatment for DME patients based on their disease activity, as assessed by vision and fluid-related parameters.

In patients without disease activity, physicians should consider 12-week intervals between Beovu treatments; in patients with disease activity, physicians should consider eight-week intervals between treatments.

“This approval marks a significant milestone for DME patients, many of whom are of working age and struggle with adherence due to the need to manage multiple comorbidities related to diabetes,” said Jill Hopkins, SVP and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals.

“KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one.*

The EC approval of Beovu in DME may thus help address unmet needs.”

The most common ocular and non-ocular adverse events (≥5%) at year one in KESTREL and KITE were conjunctival hemorrhage, nasopharyngitis and hypertension.

Intraocular inflammation (IOI) rates in KESTREL were 4.7% for brolucizumab 3 mg (including 1.6% retinal vasculitis), 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis), and 0.5% for aflibercept 2 mg.

IOI rates in KITE were equivalent (1.7%) between the Beovu 6 mg and aflibercept 2 mg arms with no retinal vasculitis reported.

Retinal vascular occlusion was reported in KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for brolucizumab and aflibercept (0.6% each).

The majority of these events were manageable and resolved with routine clinical care.

In KESTREL, the percentage of patients who experienced ≥15 letter loss from baseline at year one was 1.6% for brolucizumab 3 mg, 0% for Beovu 6 mg and 0.5% for aflibercept.

In KITE, the percentage of patients who experienced ≥15 letter loss from baseline at year one was 1.1% for Beovu 6 mg and 1.7% for aflibercept.

Brolucizumab 6 mg is the commercialized dose of Beovu. 

Novartis remains committed to bringing Beovu to the patients who may benefit from this important medicine.

Regulatory applications for Beovu in DME are under review by the U.S. Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Discussions with additional health authorities regarding Beovu are ongoing.

*Aflibercept dosing was aligned to the approved EU label in year one of treatment

About the KESTREL and KITE clinical trials
KESTREL and KITE are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of Beovu and aflibercept in the treatment of patients with visual impairment due to DME.

KESTREL and KITE involved 926 total patients in 36 countries.

In the loading phase of both trials, patients in the Beovu arms were treated every six weeks for a total of five doses; patients in the aflibercept arms were treated every four weeks for a total of five doses, in line with its label.

In the first year of the study, following the loading phase, patients in the Beovu arms were subsequently treated every 12 weeks, with those demonstrating disease activity moved to dosing every eight weeks.

After the loading phase, patients in the aflibercept arms were treated every eight weeks.

About diabetic macular edema (DME)
DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness.

DME is a leading cause of blindness in adults in developed countries, affecting 12% of patients with type 1 diabetes and 28% of those with type 2 diabetes.

Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid.

This damage leads to an excess of vascular endothelial growth factor (VEGF).

VEGF is a protein that stimulates the growth of blood vessels.

At elevated levels in DME, VEGF stimulates the growth of abnormal, leaky blood vessels1,7. The resulting accumulation of fluid (known as edema) in the macula is a key marker of disease activity and can lead to vision loss.

The macula is the area of the retina responsible for sharp, central vision.

Early symptoms of DME include blurry or wavy central vision and distorted color perception, although the disease can also progress without symptoms at early stages

About Beovu (brolucizumab) 6 mg
Beovu (brolucizumab, also known as RTH258) 6 mg is approved for the treatment of wet age-related macular degeneration (AMD) in more than 70 countries, including in the US, EU, UK, Japan, Canada and Australia.

In March 2022, Beovu was also approved by the European Commission (EC) to treat diabetic macular edema (DME), applying to all 27 European Union member states as well as Iceland, Norway and Liechtenstein.

Additional trials, which study the effects of brolucizumab in patients with wet AMD, diabetic macular edema (DME), and proliferative diabetic retinopathy (PDR), are currently ongoing.”

https://www.novartis.com/news/media-releases/novartis-announces-european-commission-approval-beovu-people-living-diabetic-macular-edema

EUROAPI listing on Euronext Paris expected on May 6, 2022

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EUROAPI listing on Euronext Paris expected on May 6, 2022

April 1, 2022. Sanofi announced that the French Autorité des marchés financiers (AMF) has approved the listing prospectus prepared by EUROAPI in connection with the intended listing of its shares on the regulated market of Euronext Paris.

On March 17th, 2022, Sanofi’s Board of Directors unanimously decided to submit for approval to its shareholders the proposed distribution in kind (the “Distribution”) of EUROAPI shares, via an additional extraordinary dividend, exclusively in kind, in addition to the previously proposed €3.33 cash dividend per Sanofi share.

The Distribution relates to circa 58% of the share capital and voting rights of EUROAPI.

In connection with the proposed Distribution, EPIC Bpifrance has agreed to purchase 12% of EUROAPI shares from Sanofi, which confirmed its intention to hold circa 30% of the share capital and voting rights of the company after the Distribution.

The Distribution by Sanofi to its shareholders of EUROAPI shares in the form of an additional extraordinary dividend, exclusively in kind, is subject to the shareholders’ approval at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting.

Subject to certain customary exceptions, the following lock-up periods have been agreed:

  • 2 years for Sanofi and EPIC Bpifrance following the settlement and delivery of the EUROAPI shares to be sold to EPIC Bpifrance; and
  • 1 year for L’Oréal, Sanofi’s largest shareholder and for Karl Rotthier, CEO of the Company, following the settlement of the Distribution.

Main features of the Distribution are as follows:

  • The Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi shares.

No fractional EUROAPI shares will be issued. Any right to receive a fractional share will not be tradable or transferable.

Consequently, when the amount of the Distribution to which a Sanofi shareholder is entitled does not correspond to a whole number of EUROAPI shares (i.e., less than twenty three (23) or a multiple of twenty three (23) Sanofi shares), the shareholder will receive the immediately lower number of EUROAPI shares, plus a cash payment for the whole of the balance arising from the price at which EUROAPI shares corresponding to fractional shares were sold.

Each financial intermediary will sell the shares corresponding to the fractional shares of its entitled clients.

As a result, the amount of the cash balance may vary depending on the shareholder’s financial intermediary;

  • The technical reference price of EUROAPI shares is expected to be announced on May 5, 2022 by Euronext Paris after market close;
  • The admission to trading of the EUROAPI shares and the ex-date (détachement) of the Distribution will occur at 9.00 am (CET) on May 6, 2022;
  • The record date (the date on which positions are closed) for Sanofi shares to be eligible to the Distribution is scheduled on May 9, 2022;
  • Payment of the Distribution (delivery and book-entry of the allocated EUROAPI shares) will take place on May 10, 2022.

Following the Distribution and the purchase of 12% of EUROAPI shares by EPIC Bpifrance, the Sanofi group will no longer control EUROAPI, resulting in a slightly accretive impact on Sanofi 2022 business operating income (BOI) margin2.

Documents related to Sanofi shareholders’ meeting will be made available on April 11, 2022 on the Sanofi dedicated web page.

Investors are invited to read EUROAPI’s press release, issued concurrently and available on EUROAPI’s website announcing the AMF’s approval of its prospectus, and the listing prospectus in order to fully understand the potential risks and rewards associated with any decision to invest in EUROAPI shares.

EUROAPI draws attention to the risk factors contained in Chapter 3 and Section 22.2 of the listing prospectus.

The occurrence of one or more of these risks may have a significant adverse effect on the business, reputation, financial condition, results of operations or prospects of EUROAPI, as well as on the market price of EUROAPI’s shares.

For information on the tax treatment of the Distribution, shareholders are invited to read Paragraph 22.1.6 of the listing prospectus.

Copies of the French-language listing prospectus, approved by the AMF on March 31, 2022 under number 22-076, are available free of charge and on request from EUROAPI at EUROAPI’s registered office, 15 rue Traversière, 75012 Paris, France, as well as on the websites of the AMF (https://www.amf-france.org), Sanofi (https://www.sanofi.com) and EUROAPI (listing.euroapi.com).

An English-language information document for non-French resident shareholders of Sanofi is also available on Sanofi’s and EUROAPI’s website.

BNP Paribas, BofA Securities Europe SA, and J.P. Morgan SE are acting as Lead ECM Advisors to EUROAPI and Sanofi and Crédit Agricole Corporate and Investment Bank, Deutsche Bank, Natixis SA and Société Générale are acting as Other ECM Advisors in the contemplated listing. Rothschild & Co. is acting as independent financial adviser to Sanofi and EUROAPI. Jones Day is acting as a legal advisor to EUROAPI and Sanofi in connection with the Distribution, and White & Case as legal advisor to the Lead ECM Advisors.

Capital Markets Day details

Today, Sanofi will host a EUROAPI-dedicated Capital Markets Day at 1:30 pm CET and will cover the following topics:

  • Execution of the Play to Win strategy with the spin-off of EUROAPI
  • Main features of the Distribution
  • Sanofi’s long-term commitment to EUROAPI: strong business relationship and future ownership structure alongside with EPIC Bpifrance
  • EUROAPI’s deconsolidation impact for Sanofi
  • Presentation of EUROAPI, including its business model, strategy and guidance.

For background slides and webcast information, please refer to the following link on Sanofi website:https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/Capital-Markets-Day-on-Euroapi-Webinar-2022.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives.

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.

We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-04-01-07-30-00-2414527

Mission Therapeutics authorised first clinical trial for kidney disease

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Mission Therapeutics authorised first clinical trial for kidney disease

March 31, 2022 – “Mission Therapeutics (“Mission”), a drug discovery and development company focused on protein homeostasis by selectively inhibiting deubiquitylating enzymes (DUBs) announced it has been granted approval to take its lead USP30 DUB inhibitor, MTX652, into clinical study.

Mitochondria are essential for energy production and cellular health. When they become damaged or stop working properly, they are labelled with ubiquitin, marking them for degradation.

The mitochondrial-associated DUB, USP30, removes this ubiquitin and thereby inhibits the degradation, which can affect cell health. 

Mission has developed MTX652 to inhibit USP30 with the aim to enable appropriate degradation of dysfunctional mitochondria to preserve and improve cellular health.

Specific kidney cells are rich in mitochondria and highly vulnerable to injury if those mitochondria are not working correctly. Mitochondrial dysfunction is strongly implicated in kidney injury and chronic kidney disease (CKD). In addition to kidney diseases, mitochondrial quality is implicated in a range of other poorly treated conditions such as idiopathic pulmonary fibrosis, muscular dystrophy and primary mitochondrial disease. Mission is also investigating the potential of USP30 inhibitors to treat these diseases.

Following candidate nomination last year, MTX652 has successfully advanced through preclinical regulatory toxicology studies and is ready to be progressed into the clinic.

The planned initial clinical trial will evaluate the safety, tolerability and pharmacokinetics of MTX652 in over 60 participants given either a single or multiple doses.

The trial is due to start in April 2022.

Dr Suhail Nurbhai, CMO of Mission Therapeutics, commented: “We are delighted that our lead programme is entering the clinic.

Mission has built a groundbreaking platform for the discovery and development of first-in-class small molecule drugs that selectively target DUBs.

MTX652 entering the clinic is a major milestone for the Company and a tremendous achievement. We are excited to be taking this important next step.”

Kidney diseases are a major global health problem and are reported by the US CDC as a leading cause of death in the US.

CKD affects an estimated 780 million people around the world.

The attributable UK NHS costs in 2009/10 were around £1.5 billion and the estimated US Medicare costs for CKD are greater than US$87 billion.

Acute kidney injury (AKI) and CKD are increasingly viewed as a continuum of kidney disease and increase risk to patients of damage to non-renal organs, cardiovascular disease, and early death. Preventing these conditions is therefore an important unmet medical need.”

https://missiontherapeutics.com/mission-therapeutics-authorised-to-initiate-first-clinical-trial-for-lead-dub-program-mtx652-in-kidney-disease/

WHO urges quality care for women and newborns in critical first weeks after childbirth

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WHO urges quality care for women and newborns in critical first weeks after childbirth

 March 30, 2022: “The World Health Organization launched its first ever global guidelines to support women and newborns in the postnatal period – the first six weeks after birth.

This is a critical time for ensuring newborn and maternal survival and for supporting healthy development of the baby as well as  the mother’s overall mental and physical recovery and wellbeing.

Worldwide, more than 3 in 10 women and babies do not currently receive postnatal care in the first days after birth – the  period  when most maternal and infant deaths occur.

Meanwhile the physical and emotional consequences of childbirth – from injuries to recurring pain and trauma – can be debilitating if unmanaged, but are often highly treatable when the right care is given at the right time.

“The need for quality maternity and newborn care does not stop once a baby is born,” said Dr Anshu Banerjee, Director of Maternal, Newborn, Child and Adolescent Health and Ageing at WHO. 

“Indeed, the birth of a baby is a life-changing moment, one that is bound by love, hope and excitement, but it can also cause unprecedented stress and anxiety.

Parents need strong health care and support systems, especially women, whose needs are too often neglected when the baby comes.”

In addition to addressing immediate health concerns, these first weeks after birth are crucial for building relationships and establishing behaviours that affect long-term infant development and health.

The guidelines include recommendations for breastfeeding counselling – to aid attachment and positioning as breastfeeding is established – and to support parents in providing responsive care for their newborns.

Over 60 recommendations that help shape a positive postnatal experience for women, babies and families.

These include:

  • High quality care in health facilities for all women and babies for at least 24 hours after birth, with a minimum of three additional postnatal checkups in the first six weeks.
  • These additional contacts should include home visits if feasible, so that the health worker can support the transition to care in the home. In the case of a home birth, the first postnatal contact should occur as early as possible, and no later than 24 hours after birth
  • Steps to identify and respond to danger signs needing urgent medical attention in either the woman or the baby;
  • Treatment, support and advice to aid recovery and manage common problems that women can experience after childbirth, such as perineal pain and breast engorgement ;
  • Screening of all newborns for eye abnormalities and hearing impairment, as well as vaccination at birth;
  • Support to help families interact and respond to babies’ signals, providing them with close contact, warmth and comfort;
  • Exclusive breastfeeding counselling, access to postnatal contraception and health promotion, including for physical activity;
  • Encouragement of partner involvement, by being part of checkups, for instance, as well as providing support to the woman and attending to the newborn;
  • Screening for postnatal maternal depression and anxiety, with referral and management services where needed.

The recommendations detail the minimum length of hospital stay after birth and provide guidance on discharge criteria, but note that the time needed will depend on individual women and babies, social context, birth experience, and any health concerns.

Additional postnatal contacts are recommended for healthy women and newborns between 48 and 72 hours, between seven and 14 days, and during week six after birth.

If health risks are identified, more contacts will likely be required, with treatment needed potentially well beyond the first six weeks.

Evidence shows that women and their families want and need a positive ostnatal experience that helps them navigate the immense physical and emotional challenges that occur after their babies are born, while building their confidence as parents,” said Dr Mercedes Bonet, Medical Officer with WHO’s Department of Sexual and Reproductive Health and Research and the UN Special Programme, HRP.

“Dedicated postnatal services should provide vital physical and mental health support, while helping caregivers thrive in providing the right care for their newborns.”

These recommendations complete a trilogy of guidelines from WHO for quality maternity care through pregnancy and during and after childbirth, centred on meeting the needs of all those who give birth and their babies.

These uphold the rights to a positive healthcare experience, where people are treated with dignity and respect and can participate actively in healthcare decisions.”

https://www.who.int/news/item/30-03-2022-who-urges-quality-care-for-women-and-newborns-in-critical-first-weeks-after-childbirth

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

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Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

March 29, 2022: “Ondexxya (andexanet alfa)has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the  ANNEXA-4  Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.

Ondexxya is the first approved medicine in Japan to specifically reverse the anticoagulant effect of FXa inhibitors apixaban, rivaroxaban or edoxaban in patients experiencing a life-threatening or uncontrolled bleed. 

Japan is also the first country to provide full regulatory approval of Ondexxya for use with all three of the FXa inhibitors currently available. 

FXa inhibitors are increasingly used for the prevention and treatment of thrombotic events, including deep vein thrombosis and pulmonary embolism, or in patients at high risk of a stroke due to an irregular heart rate (atrial fibrillation).

While they prevent unwanted clots from forming, they can also increase the risk of major bleeding, which can be life-threatening.

Masahiro Yasaka, MD, PhD, National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan, said: “FXa inhibitors are essential medicines for people prone to developing blood clots, but they can also present a risk of uncontrolled bleeding and related complications, which can be fatal if left untreated. 

Ondexxya’s rapid reversal of the anticoagulating effects of apixaban, rivaroxaban and edoxaban effectively reduces the bleeding and is a major advancement in patient care.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With the approval of Ondexxya in Japan, we are working to make this important medicine available as quickly as possible for the small proportion of patients with life-threatening or uncontrolled bleeding who are on FXa inhibitors and who have not previously had an approved reversal agent treatment option.”

Ondexxya received approval by the US Food and Drug Administration under the accelerated approval pathway in May 2018 and conditional approval by the European Commission in April 2019for adults treated with FXa inhibitors apixaban and rivaroxaban. In the US, Ondexxya is marketed under the trade name Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo].

Notes

Life-threatening bleeding
There is an urgent need for a specific reversal agent for patients treated with FXa inhibitors hospitalised with a major bleed. Millions of patients worldwide depend on FXa inhibitors every day to prevent harmful blood clots from forming; however, these agents increase the risk of major bleeding.

Major bleeding can be very serious and life-threatening, and can happen inside the body and may not be visible. As prescriptions for FXa inhibitors increase, the potential for serious bleeding hospital admissions grows.

ANNEXA-4
The approval of Ondexxya is supported by data from the ANNEXA-4 Phase III trial, which evaluated the haemostatic efficacy  and safety of Ondexxya in patients receiving a FXa inhibitor who were experiencing an acute major bleed.

In the trial, Ondexxya markedly reversed anti-FXa activity within minutes, with 80% of patients having excellent or good haemostatic efficacy sustained at 12 hours following administration. 

During the trial, 10.4% of patients experienced at least one thrombotic event, the majority of which occurred in patients who delayed or did not restart anticoagulation during the follow-up period.

Consistent with previous trial results in patients who are at increased risk of thrombosis, 15.7% of patients died during the trial.

Ondexxya
Ondexxya (andexanet alfa)is a recombinant protein specifically designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effect. 

Ondexxya is a modified form of the human FXa molecule, an enzyme that helps blood clot. Ondexxya works by acting as a decoy for oral and injectable FXa inhibitors, which target and bind to FXa, allowing them to exert their anticoagulant effect.

When Ondexxya is given through an intravenous infusion to a patient with FXa inhibitor-related bleeding, it binds with high affinity to the FXa inhibitor, prevents it from inhibiting the activity of FXa and reverses the anticoagulant effects of the inhibitor. 

AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s three disease areas and is a key growth driver for the Company.

By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improving outcomes by slowing disease progression, reducing risks and tackling co-morbidities.

The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/ondexxya-approved-in-japan-for-fxai-reversal.html

FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and immunocompromised Individuals

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FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and immunocompromised Individuals

March 29, 2022: “The U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.

Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.

The agency amended the emergency use authorizations as follows: 

  • A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
  • A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

    These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
  • A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals.

Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

Today’s action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged.

The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups. 

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s).

Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).

Information to Support Authorization of a Second COVID-19 Booster Dose

The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations.

The evidence considered for authorization of a second booster dose following primary vaccination and first booster dose included safety and immune response information provided to the agency as well as additional information on effectiveness submitted by the companies. 

A summary of safety surveillance data provided to the FDA by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 4 months after the third dose in adults 18 years of age and older (approximately 600,000 of whom were 60 years of age or older) revealed no new safety concerns. 

The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech COVID-19 Vaccine and safety information reported from an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior.

No new safety concerns were reported during up to three weeks of follow up after the second booster dose.

Immunogenicity data from an ongoing, open-label, non-randomized clinical study in healthcare workers at a single center in Israel were reported in a publication provided to the FDA.

In this study, individuals 18 years of age and older who had received primary vaccination and a first booster dose with Pfizer-BioNTech COVID-19 Vaccine were administered a second booster dose of Pfizer-BioNTech COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120 individuals) at least four months after the first booster dose.

Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose.

The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and

Sanofi and IGM Biosciences Collaborates for Oncology, Immunology and Inflammation Targets

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Sanofi and IGM Biosciences Collaborates for Oncology, Immunology and Inflammation Targets

March 29, 2022 – Sanofi and IGM Biosciences, Inc. announced the signing of an exclusive worldwide collaboration agreement to create, develop, manufacture, and commercialize IgM antibody agonists against three oncology targets and three immunology/inflammation targets.

Engineered IgM antibodies represent a new class of potential therapeutics that combine the multi-valency of IgM antibodies possessing 10 binding sites compared to conventional IgG antibodies having only 2 target binding sites.

John Reed, M.D., Ph.D.
Global Head of Research and Development, Sanofi
“We look forward to this collaboration with IGM Biosciences, a pioneer in a new class of antibody medicines for the treatment of cancer, immunology, and inflammatory diseases.

The IGM Biosciences technology platform offers an exciting approach to developing high-avidity IgM antibodies that can efficiently bind and stimulate the activity of cell surface receptors.

This unique platform has the potential to overcome historical limitations of conventional IgG antibodies when seeking agonists of some classes of receptors.”

Fred Schwarzer
Chief Executive Officer of IGM Biosciences
“Sanofi is a global leader in the development and commercialization of innovative therapies, and we welcome the addition of their extensive expertise and resources in expanding and accelerating the development of our IgM antibody platform across multiple areas of high unmet need. 

This partnership builds on an existing research collaboration with Sanofi and is a key step towards our goal of unlocking the full breadth of potential for this important new class of therapeutics.

We are pleased to share this vision with Sanofi and look forward to working together on these six potentially first- and best-in-class programs.”

Terms of the Collaboration
Under the terms of the agreement, IGM will receive a $ 150 million upfront payment. Sanofi has also expressed an interest in purchasing up to $100M of IGM non-voting common stock in a public financing.

For each oncology target collaboration program, IGM will lead research and development activities, and assume related costs, through approval of the first biologics license application (BLA) for a product directed to that oncology target by the FDA or EMA in exchange for up to $940 million in development and regulatory milestones per oncology target.

After receipt of the first marketing approval for a product directed to an oncology target, Sanofi will lead all subsequent development and commercialization activities for that oncology target.

For each oncology target, the companies will share profits 50:50 in certain major markets, and IGM will be eligible to receive tiered royalties on net sales in the rest of world.

For each immunology/inflammation target collaboration program, IGM will lead research and development activities, and assume related costs, through the completion of Phase 1 clinical trial for up to two constructs directed to each immunology/inflammation target, after which Sanofi will be responsible for all future development and related costs, in exchange for up to $1,065 million in aggregate development and regulatory and commercial milestones per immunology/inflammation target.

Following the completion of Phase 1 clinical trial for each immunology/inflammation target, Sanofi will be responsible for subsequent development activities, commercialization efforts, and related costs.

IGM is eligible to receive tiered high single-digit to low-teen royalties on global net sales.

Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and customary closing conditions.

About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.

Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies.

Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-29-07-00-00-2411497

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