Merck to Showcase New Data Across MS Portfolio at EAN 2019

Darmstadt (Germany) June 24th 2019 (PROTEXT/PRNewswire)

Not intended for UK or U.S. based media

- Company to present 16 abstracts on MAVENCLAD® (cladribine tablets), Rebif® ( interferon beta-1a) and investigational evobrutinib at the 5th Congress of the European Academy of Neurology

- Presentations include new data on the long-term efficacy and safety of MAVENCLAD®, new safety data for Rebif® and the 48-week analysis from the Phase 2 clinical study with evobrutinib

- Merck-initiative MS in the 21st Century to present findings from Patient Perceptions Initiative

Merck, a leading science and technology company, today announced that data from across its multiple sclerosis (MS) portfolio will be presented at the 5th Congress of the European Academy of Neurology (EAN), 29 June - 2 July 2019 in Oslo, Norway. Merck will present a total of 16 abstracts (12 posters and 4 presentations) on MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and the investigational therapy evobrutinib (an oral, highly selective Bruton's Tyrosine Kinase [BTK] inhibitor). The company will also present findings from the Patient Perceptions Initiative by MS in the 21st Century.

"The wealth of new data that we are presenting at EAN 2019, from both our approved medicines and our pipeline in MS, highlight our commitment to making further advances for people living with this chronic disease," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck.

Key MAVENCLAD® data will include:

- Post-hoc analysis of the CLARITY Extension study to examine the long-term efficacy in high-disease activity patients treated with cladribine tablets 3.5 mg/kg

- Updated safety analysis of cladribine tablets 3.5 mg/kg in patients with relapsing multiple sclerosis (RMS)

Key Rebif® data will include:

- Results from the Nordic registry regarding the risk of spontaneous abortion and ectopic pregnancy in patients using interferons

- Results from the UK Multiple Sclerosis Risk Sharing Scheme on treatment with subcutaneous interferon beta-1a

Key evobrutinib data will include:

- Results of analysis of the efficacy and safety of evobrutinib in patients with RMS over 48 Weeks: a randomized, placebo-controlled, phase 2 study

In addition, Merck will be presenting results from a global mapping study supported by the MS in the 21st Century initiative. The results will outline the availability of educational resources in MS across several themes including 'MS stages and progression'. The initiative, led by a steering group of international MS specialists, aims to gain insight into patient opinions on unmet needs in MS management.

Below is a selection of abstracts that have been accepted for presentation at EAN 2019:

MAVENCLAD ® (cladribine tablets)

TitleLead AuthorPosterPresentation / Session
NEDA-3 durability in CLARITY Extension in patients with relapsing multiple sclerosis receiving Cladribine TabletsGiovannoni GEPO1244"MS and related disorders 3" Saturday, 29 June 2019 12:30 to 13:15 Screen B12
Variations of uric acid levels and their clinical correlates during cladribine treatmentMoccia MEPO2218"MS and related disorders 5" Sunday 30 June 2019 12:30 to 13:15 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 baselineVermersch PEPO3211"MS and related disorders 8" Monday, 01 July 2019 12:30 to 13:15 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 TabletsBoyko APOD026"Poster on Display Saturday 29 June-Monday 1 July
Incidence and risk of any malignancies in multiple sclerosis (MS) from the Netherlands (NL) and Denmark (DK)Kuiper JEPO2202"MS and Related Disorders 4" Sunday 30 June 2019 12:30 to 13:15 Screen B10
Incidence and risk of malignancies by type, in multiple sclerosis (MS) patients, compared from the Netherlands (NL) and Denmark (DK)Norgaard MEPO2226"MS and related disorders 6" Sunday, 30 June 2019 12:30 -13:15Screen B12
Severity and frequency of relapses in patients with relapsing-remitting MS treated with Cladribine Tablets in CLARITY and placebo in CLARITY ExtensionSchippling SEPO3196"MS and related disorders 7" Monday, 01 July 2019 12:30 to 13:15 Screen B10
CLARITY/CLARITY Extension: Lymphopenia rates are consistent in patients with and without high disease activity at baselineCook SPOD049Poster on Display Saturday 29 June-Monday 1 July
Treatment of patients with Multiple Sclerosis: An updated safety analysis of Cladribine TabletsCook SPOD050Poster on Display Saturday 29 June-Monday 1 July
Efficacy of Cladribine Tablets 3.5 mg/kg in Patients with Relapsing Multiple SclerosisAged Above and Below 45 Years; CLARITY and CLARITY ExtensionGiovannoni GEPO1243"MS and related disorders 3" Saturday, 29 June 2019 12:30 to 13:15 Scree

Evobrutinib

Bruton's Tyrosine Kinase Inhibitor Evobrutinib (M2951) in Patients with Relapsing Multiple Sclerosis: a Randomised, Placebo-Controlled, Phase 2 StudyMontalban XOral presentation - O1205"MS and related disorders" Saturday, 29 June 2019 17:30

Rebif® (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 MSJuuti REPR2074ePresentation Sunday, June 30 13:30 to 14:15Screen A6
Subcutaneous Interferon ß-1a: 10 years of the UK Multiple Sclerosis Risk Sharing SchemeHarty GEPR1089ePresentation Saturday 29 June 13:30 to 14:15Screen A7
A systematic review of relapse rates in patients with relapsing multiple sclerosis during pregnancy and breastfeedingSabidó MEPO3194ePoster Monday 1 July 12:30 to 13:15Screen B10
Rapid reduction of lesion accumulation in specific white matter tracts as assessed by lesion mapping in RR-MS patients treated with IFN beta-1aDe Stefano NEPR1086ePresentation Saturday 29 June 13:30 to 14:15Screen A7
Dynamics of Pseudo-Atrophy in RRMS Patients Treated with Interferon beta-1a as Assessed by Monthly Brain MRIDe Stefano NEPO1234ePoster Saturday 29 June 12:30 to 13:15Screen B11

MS in the 21st Century

A sub-analysis of global mapping data on the availability of online educational resources for multiple sclerosis patientsVermersch PEPO1148ePoster Saturday, 29 June 2019 12:30 to 13:15Screen 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 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 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 ß 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 RebiSlideTM. 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 € 14.8 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

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