Clinical Profiles

The transaction adds an innovative, fully owned, first-inclass therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. TZIELD (teplizumab-mzwv) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immunemediated diseases and diseasemodifying therapies in areas of high unmet need, and its expertise in diabetes. Sanofi will continue to utilize its capabilities in diabetes to maximize TZIELD’s potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year1. The purchase builds on an existing co-promotion agreement with Provention Bio that is already delivering TZIELD to patients in need of this immunemediated therapy.

Olivier Charmeil, Executive Vice President, General Medicines, Sanofi said, “The acquisition of Provention Bio builds on Sanofi’s mission to deliver best- and firstin-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people. By coupling Provention Bio’s transformative innovation with Sanofi’s expertise, we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes. Any additional indications, approvals and pipeline assets only serve to further our excitement. Given our existing partnership and complementary work in the diabetes and immunology spaces, we foresee a seamless integration and execution.”

TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to Stage 3 T1D eventually require insulin injections for life.

TZIELD is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for TZIELD include re-dosing and formulations as well as new therapeutic indications.

Provention Bio also brings certain pipeline assets in early development in immunemediated diseases.

Transaction Terms

Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in cash, reflecting a total equity value of approximately $2.9 billion.

The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023.

PJT Partners is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray LLP is acting as its legal counsel.

DUPIXENT® (DUPILUMAB) APPROVED BY EUROPEAN COMMISSION AS FIRST AND ONLY TARGETED MEDICINE FOR CHILDREN AS YOUNG AS SIX MONTHS OLD WITH SEVERE ATOPIC DERMATITIS

The European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S.

Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER) ays, “Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking. I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. Intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years.”

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. In a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

• 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a coprimary endpoint.

• 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.

• 55% average reduction in overall disease severity from baseline compared to 10% with placebo.

• 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain and healthrelated quality of life compared to placebo in both the overall and severe populations. Long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. The safety results of the 6 months to 5 years old trial were generally consistent with the known safety profile of Dupixent in its approved indications; in the trial, adverse events more commonly observed (≥5%) with Dupixent compared to placebo included eosinophilia and conjunctivitis. The long-term safety profile through 52 weeks was similar to the safety profile observed at 16 weeks, and consistent with what was observed in older patients with atopic dermatitis.

Gaps In Cardiovascular Care Contributing To Deaths

A report launched by the National Institute for Prevention and Cardiovascular Health (www. nipc.ie) and the National CVD Prevention Council has identified gaping holes in Ireland’s cardiovascular healthcare. The report outlines that cardiovascular disease (CVD) kills nearly 9,000 in people in Ireland every year, despite an estimated 80% of premature CVD being preventable. While there is a myriad of gaps in how the Irish healthcare system detects signs of CVD, notable issues include Ireland having the lowest rate of detection of high blood pressure in Western Europe. This is particularly worrying when considering that in 75% of those that had a heart attack between 2017-2020, the heart attack was the first manifestation of CVD. Likewise, more than 1,200 people that suffered an ischaemic stroke in 2020 were found to also have atrial fibrillation (AF), a common type of irregular, usually rapid, heartbeat. However, AF was not identified in 40% of patients until they suffered the stroke.

The report recommends a screening program for familial hypercholesterolaemia (FH), a genetic condition which causes dangerously high cholesterol levels from birth. FH affects around 1 in 200-250 people in Ireland however the majority of this goes undetected. Childhood FH screening programmes are commonplace throughout Europe. The report also details issues in the treatment and discharge of patients following the detection of CVD. These issues include long waiting times in public hospitals and the lack of tailored discharge plans for patients.

Minister Hildegarde Naughton, Minister of State at the Department of Health and at the Department of Children, Equality, Disability, Integration and Youth; Dr Angie Brown, Medical Director, Irish Heart Foundation; Consultant Cardiologist, Dublin; Professor J. William Mc Evoy, Research and Medical Director, National Institute for Prevention and Cardiovascular Health; Professor of Preventive Cardiology, University of Galway; Neil Johnson Acting Chief Executive, National Institute for Prevention and Cardiovascular Health and Chief Executive Croí.

Access to cardiac rehabilitation is paramount to the recovery of those post-cardiac events yet it has significantly declined. A 2017 study previously identified that there was national capacity to meet only 39% of the need for cardiac rehabilitation while in 2021 there was a waiting list of more than

Calling All Community Pharmacists

Inclusion of an Optional Business Management Elective into the Pharmacy Degree Program

My name is Deirbhle Joyce and I am a Supervising Pharmacist. I am working in Community Pharmacy and undertaking a part-time MBA at University of Galway. As part of my Applied Strategic Leadership Project in Year 2, I have identified an unmet need in the Pharmacy Degree Program. I am conducting research on the inclusion of a Business/Management module as an optional elective into the Pharmacy curriculum. The target audience is Community pharmacists registered with the PSI. Completion of this survey is voluntary. It consists of 10 questions, with an option to add additional comments. It should take no longer than 4 minutes to complete.

2,800 people, with 40% waiting at least three months following hospital discharge.

The issues in the management of patient discharges are particularly worrying when considering that in the absence of Irish data, the report references a Swedish study which reveals that nearly 20% of people that suffer a heart attack die from a cardiovascular cause or experience a repeat heart attack or stroke within a year.

In response to the urgent needs identified by the report, NIPC and the National CVD Prevention Council is calling on the Government to develop a national strategy to tackle cardiovascular disease (CVD). The previous national strategy expired in 2019 and has not been replaced.

The implementation of electronic health records is identified as a critically important key to integration of services required for effective prevention in clinical practice.

The report also outlines the requirement for investment in data collection and analysis to inform the strategy, the need to expand the role of nurses and allied health professionals and to increase access and care to disadvantaged groups.

Participants in this survey will be anonymous. Data will be used in aggregate form only and no individual persons will be identified in the reporting of the results. The data is collected for research purposes only. Full details of how your information is processed when it is collected with Microsoft Forms is documented in this privacy policy https://privacy.microsoft.com/en-US/privacystatement#mainnoticetoendusersmodule.

For further details, you can contact me at d.joyce11@nuigalway.ie.