Sanofi US News

* First biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

Results from the NIH-Sponsored "At-Risk" Study Published in The New England Journal of Medicine and Presented at the American Diabetes Association Annual Meeting

News Summary: * Isatuximab, an investigational anti-CD38 monoclonal antibody, added to pomalidomide and dexamethasone prolonged progression free survival by 5 months compared to pomalidomide and dexamethasone alone (11.53 vs. 6.47 months, p=0.001, HR 0.596) * Overall response rate significantly greater with isatuximab combination therapy compared to pomalidomide and dexamethasone (60% vs. 35%, p<0.0001) * First positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone presented at this year’s ASCO annual meeting * European Medicines Agency accepted for review the Marketing Authorization Application for isatuximab

- Pivotal Phase 3 data evaluated isatuximab (anti-CD38) in combination with pomalidomide/dexamethasone in prolonging progression-free survival in relapsed/refractory multiple myeloma

* New data at ASCO include more than double the patients previously reported; median overall survival still not reached with a median follow-up of up to 17 months

PROTECT Pivotal Phase 3 Clinical Study Initiated in Patients with Recent Onset Type 1 Diabetes

* Only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO)

* Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause

- Top-line Data Anticipated in the Fourth Quarter of 2019 -

* Sanofi continues its commitment to helping reduce cost burden for people living with diabetes with first-ever insulin savings program

Pivotal Study to Evaluate Potential of Anti-CD3 Monoclonal Antibody to Intercept Type 1 Diabetes

Strengthens Leadership Team with Appointment of Douglas Jacobstein, M.D. as V.P. of Clinical Development and Alex Rabiee as V.P. of Business Development

Dr. Bluestone is a World-renowned Expert and Academic Leader in Immune Tolerance Research

Plan to Initiate PROTECT Study for PRV-031 (teplizumab) in T1D Patients in Q2

* Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis

* Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes

Praluent® (alirocumab) continues to be available in the U.S.

* This is the latest step by the companies to help make Praluent more accessible and affordable for appropriate patients

- First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder

Provention is currently developing PRV-101 as a polyvalent vaccine for acute coxsackie virus infection and to potentially prevent the onset of T1D

- The 0.5 mL dose is now approved for use in children 6 months through 35 months of age

* First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the first vaccination to help protect against tetanus, diphtheria and pertussis, offering flexibility for health care providers to help manage their immunization schedules(2)

-HERCULES Phase 3 trial met its primary endpoint, demonstrating that treatment with Cablivi resulted in a significantly faster time to platelet count response in patients with acquired thrombotic thrombocytopenic purpura (aTTP) when administered in conjunction with plasma exchange and immunosuppression

Provention is currently developing PRV-101 as a vaccine for acute coxsackie infection and to potentially prevent the onset of T1D

* Mortality risk reduction greater in patients treated for at least 3 years or those with baseline LDL-C levels of at least 100 mg/dL

Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m., ET

* Praluent significantly reduced major adverse cardiovascular events by 15% (p<0.001)

- Top-line data from the "PULSE" clinical trial expected in the second quarter of 2019

-- Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype

- Dupixent significantly reduced nasal polyp size, nasal congestion severity, and need for systemic corticosteroids and/or surgery

* Libtayo is the third anti-PD-1 approved in the U.S.

* FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy

Industry executive adds considerable financial expertise as audit committee chairperson

- First therapeutic approved for the treatment of aTTP, a rare blood-clotting disorder

- Provention strengthens its strategic platform in type 1 diabetes (T1D) interception and prevention

Nearly 70 million doses to be manufactured this season

- Company invests €66 million in Chengdu, Sichuan province, China

- Toujeo (insulin glargine injection 300 Units/mL) met primary endpoint in lowering blood sugar levels and was non-inferior to insulin degludec in adults with type 2 diabetes not previously on insulin

-- Patients treated with cemiplimab experienced robust anti-tumor effects

* In steroid-sparing VENTURE trial, Dupixent-treated patients substantially reduced use of oral corticosteroids, yet had fewer exacerbations and improved lung function compared to placebo.

* U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018

-- Agreement provides Praluent at lower net price and enables streamlined patient access based on physician attestation

- If approved, health care professionals will be able to use the same 0.5 mL dose of Fluzone Quadrivalent vaccine with all patients ages 6 months and older for whom flu vaccination is recommended - which may provide more flexibility and convenience to immunizers.

* Max SoloStar holds more insulin than any other long-acting insulin pen

- Sanofi teams up with television personality Adam Savage and allergist Dr. Neeta Ogden to help dispel common allergy misconceptions with facts

* Precision medicine approach will focus efforts on high-risk patients, such as those who have had heart attacks or unstable angina and cannot reduce their LDL-C below 100 mg/dL despite maximally-tolerated statins

* ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who added Praluent® (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone

Companies also announce submission of dupilumab supplemental BLA for uncontrolled, persistent asthma

High and durable response rate in disease without any FDA-approved therapies

* First FDA-approved follow-on mealtime insulin

Phase 3 trials will evaluate isatuximab, an anti-CD38 antibody, in combination with other cancer treatments 

First head-to-head randomized clinical trial comparing the efficacy and safety of Toujeo (insulin glargine 300 Units/mL) versus insulin degludec

Two large real-world analyses compared adults with type 2 diabetes who were switched to Toujeo (insulin glargine injection 300 Units/mL) to those switched to insulin degludec

First study with a biologic to show benefit in severe steroid-dependent asthma population that enrolled patients regardless of blood eosinophil levels or any other Type 2 biomarkers at baseline

- Late-breaking oral abstract presented at the World Congress of Gastroenterology -

- Understand AD: A Day in the Life, Raises Awareness of Atopic Dermatitis by Sharing Real Stories from the AD Community, Driving Empathy and Understanding of this Unrelenting, Chronic Disease -

- Praluent continues to be available to patients in the U.S. -

- First targeted biologic in the European Union to receive marketing authorization for use in atopic dermatitis -

- In preclinical studies, trispecific antibodies show exceptional potency against diverse HIV viruses -

- Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo -

- Late-breaking oral abstract of Phase 3 CAFÉ study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress -

-- More adults reached HbA(1c) target at 8 and 12 weeks versus those receiving insulin glargine 100 Units/mL --

- Investigational dupilumab reduced severe asthma attacks and improved lung function -