Merck Receives Approval (Updated Registration) for Mavenclad (Cladribine Tablets) in Australia

Darmstadt, Germany, December 7, 2017/PRNewswire/ - Merck, a leading science and technology company, today announced that the Therapeutic Goods Administration (TGA) has updated the registration including the indication, dosing and safety information of MAVENCLAD® (cladribine tablets) for the treatment of relapsing-remitting multiple sclerosis (RRMS) in Australia. As a result, MAVENCLAD® is now approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of 2 courses of treatment, no further treatment is required in years 3 and 4. The changes bring the Product Information (1) in line with the latest clinical trial evidence supporting MAVENCLAD®. MAVENCLAD® is the first and only oral short-course treatment to provide efficacy across key measures of disease activity in patients with RRMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity.

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"Multiple sclerosis is a debilitating disease where new treatments are needed," said Professor Bill Carroll, Clinical Professor of Neurology at the University of Western Australia and the Perron Institute, and a consultant neurologist at the Sir Charles Gairdner Hospital as well as President-elect of the World Federation of Neurology. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS. As an oral therapy taken in two short courses over a 2-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional".

"We are pleased the Therapeutic Goods Administration has updated the Product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, Chief Operating Officer at the biopharma business of Merck. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible".

MAVENCLAD® has been subject to a comprehensive clinical development program in multiple sclerosis (MS), that includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial programs,(2) and up to 10 years of observation in some patients.

MAVENCLAD® is a selective immune reconstitution therapy (3), (4) which simplifies treatment administration, by giving patients just 2 short annual courses of tablets with a maximum of 20 days of treatment over 2 years providing a lasting treatment benefit of at least 4 years. MAVENCLAD® works by selectively targeting B&T lymphocytes followed by a distinct pattern of lymphocyte reconstitution, without continuous suppression of the immune system (5).

This registration update for MAVENCLAD® in Australia follows the recent approval of MAVENCLAD® in Europe and in Canada. MS affects more than 23,000 Australians with most people diagnosed between the ages of 20-40 (6). Merck plans additional filings for regulatory approval in other countries, including the United States.

MAVENCLAD® Minimum Product Information: Indications: MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied. Contraindications: Patients with hypersensitivity to cladribine or to any of the tablet excipients, infected with the human immunodeficiency virus (HIV), active chronic infections (tuberculosis, hepatitis), immunocompromised patients, including patients receiving immunosuppressive or myelosuppressive therapy, moderate or severe renal impairment (creatinine clearance

Based on approved PI dated 5 December 2017

AMAVENCLAD®

MAVENCLAD® (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis (RMS). MAVENCLAD® is approved in Canada and Australia for the treatment of relapsing-remitting multiple sclerosis (RRMS). MAVENCLAD® is a short-course oral therapy that selectively 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 cladribine tablets 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® is currently under clinical investigation and not yet approved for the treatment for any use in the United States.

The clinical development program for MAVENCLAD® 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 MAVENCLAD® as a monotherapy in patients with RRMS;

- The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of MAVENCLAD® over an extended administration for four years;

- 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 MAVENCLAD® 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 MAVENCLAD®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 Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of MAVENCLAD®.

The clinical development program of Cladribine in MS comprises more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.

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.

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Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

(1) Approved MAVENCLAD® Product Information (2017)

(2) Merck data on file

(3). Giovannoni G. Personalized medicine in multiple sclerosis. 2017 Neurodegenerative Disease Management; 7 (6s) 13-17

(4) Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple Sclerosis. Neurotherapeutics. November 2017; DOI 10.1007/s13311-017-0573-4

(5) MAVENCLAD™ Product Monograph. November 2017

(6) https://www.msaustralia.org.au/what-ms

Source: Merck

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