Merck to Showcase New Data Across MS Portfolio at EAN 2019 (2)

MAVENCLAD (R) (cladribine tablets) --- Title Lead Author Poster Presentation / Session --- --- NEDA-3 durability in CLARITY Extension in patients with relapsing multiple sclerosis receiving Cladribine Tablets Giovannoni G EPO1244 Session: "MS and related disorders 3" Date: Saturday, 29 June 2019 Time: 12:30 to 13:15 Location: Screen B12 --- --- Variations of uric acid levels and their clinical correlates during cladribine treatment Moccia M EPO2218 Session: "MS and related disorders 5" Date: Sunday 30 June 2019 Time: 12:30 to 13:15 Location: Screen B11 --- --- CLARITY Extension: Sustained efficacy in relapsing remitting multiple sclerosis following switch from Cladribine Tablets to placebo in patients with high disease activity at baseline Vermersch P EPO3211 Session: "MS and related disorders 8" Date: Monday, 01 July 2019 Time: 12:30 to 13:15 Location: Screen B11 --- --- Rationale, design and feasibility assessment of the phase IV CLASSIC-MS study evaluating long-term efficacy outcomes for patients with multiple sclerosis treated with Cladribine Tablets Boyko A POD026 Session: "Poster on Display Date: Saturday 29 June-Monday 1 July --- --- Incidence and risk of any malignancies in multiple sclerosis (MS) from the Netherlands (NL) and Denmark (DK) Kuiper J EPO2202 Session: "MS and Related Disorders 4" Date: Sunday 30 June 2019 Time: 12:30 to 13:15 Location: Screen B10 --- --- Incidence and risk of malignancies by type, in multiple sclerosis (MS) patients, compared from the Netherlands (NL) and Denmark (DK) Nrgaard M EPO2226 Session: "MS and related disorders 6" Date: Sunday, 30 June 2019 Time: 12:30 -13:15 Location: Screen B12 --- --- Severity and frequency of relapses in patients with relapsing-remitting MS treated with Cladribine Tablets in CLARITY and placebo in CLARITY Extension Schippling S EPO3196 Session: "MS and related disorders 7" Date: Monday, 01 July 2019 Time: 12:30 to 13:15 Location: Screen B10 --- --- CLARITY/CLARITY Extension: Lymphopenia rates are consistent in patients with and without high disease activity at baseline Cook S POD049 Poster on Display Date: Saturday 29 June-Monday 1 July --- --- Treatment of patients with Multiple Sclerosis: An updated safety analysis of Cladribine Tablets Cook S POD050 Poster on Display Date: Saturday 29 June-Monday 1 July --- --- Efficacy of Cladribine Tablets 3.5 mg/kg in Patients with Relapsing Multiple Sclerosis Giovannoni G EPO1243 Session: "MS and related disorders 3" Aged Above and Below 45 Years; CLARITY and CLARITY Extension Date: Saturday, 29 June 2019 Time: 12:30 to 13:15 Location: Screen B12 --- --- Evobrutinib --- Bruton's Tyrosine Kinase Inhibitor Evobrutinib (M2951) in Patients with Relapsing Multiple Sclerosis: a Randomised, Placebo-Controlled, Phase 2 Study Montalban X Oral presentation -O1205 Session: "MS and related disorders" Date: Saturday, 29 June 2019 Time: 17:30 --- --- Rebif(R) (interferon beta-1a) --- No increased risk of spontaneous abortion and ectopic pregnancy after exposure to interferon- beta prior to or during pregnancy: Results from register-based Nordic study among women with MS Juuti R EPR2074 Session: ePresentation Date: Sunday, June 30 Time: 13:30 to 14:15 Screen A6 --- --- Subcutaneous Interferon -1a: 10 years of the UK Multiple Sclerosis Risk Sharing Scheme Harty G EPR1089 Session: ePresentation Date: Saturday 29 June Time: 13:30 to 14:15 Screen A7 --- --- A systematic review of relapse rates in patients with relapsing multiple sclerosis during pregnancy and breastfeeding Sabidó M EPO3194 Session: ePoster Date: Monday 1 July Time: 12:30 to 13:15 Screen B10 --- --- Rapid reduction of lesion accumulation in specific white matter tracts as assessed by lesion mapping in RR-MS patients treated with IFN beta-1a De Stefano N EPR1086 Session: ePresentation Date: Saturday 29 June Time: 13:30 to 14:15 Screen A7 --- --- Dynamics of Pseudo-Atrophy in RRMS Patients Treated with Interferon beta-1a as Assessed by Monthly Brain MRI De Stefano N EPO1234 Session: ePoster Date: Saturday 29 June Time: 12:30 to 13:15 Screen B11 --- --- MS in the 21st Century --- A sub-analysis of global mapping data on the availability of online educational resources for multiple sclerosis patients Vermersch P EPO1148 Session: ePoster Date: Saturday, 29 June 2019 Time: 12:30 to 13:15 Screen A5 --- ---

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe [https://www.merckgroup.com/en/company/press/press-release-su...] to register online, change your selection or discontinue this service.

About MAVENCLAD()

MAVENCLAD() is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD() for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD() has since then been approved in more than 50 countries, including Canada and Australia and most recently in the U.S. in March 2019.

Visit www.MAVENCLAD.com [http://www.mavenclad.com/] for more information.

The clinical development program for cladribine tablets includes:

-- The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS. -- The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4. -- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). -- The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy. -- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

About Rebif()

Rebif() (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif() in chronic progressive MS has not been established. Interferon is thought to help reduce inflammation. The exact mechanism is unknown.

Rebif(), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif() has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.

Rebif() can be administrated with the RebiSmart() electronic auto-injection device (not approved in the US), or with the RebiDose() single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif() can also be administered with the autoinjector Rebiject II() or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif() in early multiple sclerosis. The extension of the indication of Rebif() has not been submitted in the United States.

Rebif() should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif() with their doctors.

*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

Rebif() (interferon beta-1a) is approved in the United States for relapsing forms of MS.

About Evobrutinib

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2018, Merck generated sales of EUR 14.8 billion in 66 countries.

(CONTINUA)