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

Darmstadt, Germany (ots/PRNewswire) -

Not intended for U.K./U.S. based media

- First treatment in relapsing-remitting multiple sclerosis (RRMS) to
show sustained clinical efficacy for up to 4 years with a maximum
of 20 days of oral treatment over 2 years
- Updated registration follows recent approval of Mavenclad in Europe
and Canada

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.

(Logo: https://mma.prnewswire.com/media/472778/Merck_Logo.jpg )

"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 < 60
mL/min), during pregnancy and breastfeeding. Precautions:
Haematological monitoring is required prior to and during therapy.
Lymphopenia; Infections; Malignancies; Switching to and from
MAVENCLAD treatment; Renal impairment; Hepatic impairment; Fructose
intolerance; Effects on fertility (incl. male patients), Use in
pregnancy (Category D) and lactation; Use in Paediatric or Elderly;
Carcinogenicity, Genotoxicity. Interactions: 3 hours interval
required for administration of other oral medicines. Concomitant
treatment with immunosuppressive or myelosuppressive agents is
contraindicated; must not be initiated within 4 to 6 weeks after
vaccination with live/live-attenuated vaccines. Recommendations to
avoid co-administration with potent ENT1, CNT3 and ABCG2 transporter
inhibitors. Adverse reactions: Very Common:Lymphopenia (may be
severe, Grade 3 or 4). Common: Rash, alopecia, oral herpes,
dermatomal herpes zoster, decrease in neutrophil count. Dosage and
administration:Haematological and infections screening criteria for
starting and continuing therapy have to be met before initiating
MAVENCLAD therapy or administering any subsequent treatment course.
The recommended cumulative dose of MAVENCLAD is 3.5 mg/kg body weight
over 2 years, administered as 1 treatment course of 1.75 mg/kg per
year. Each treatment course consists of 2 treatment weeks, one at the
beginning of the first month and one at the beginning of the second
month of the respective year. Each treatment week consists of 4 or 5
days on which a patient receives 10 mg or 20 mg (one or two tablets)
as a single daily dose, depending on body weight. Patients should
receive no more than 2 treatment courses over two consecutive years.
The recommended dose should not be exceeded. Following completion of
the 2 treatment courses, no further cladribine treatment is required
in year 3 and year 4. Re-initiation of therapy after year 4 has not
been studied.

Based on approved PI dated 5 December 2017

About MAVENCLAD®

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.

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.

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 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 EUR 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(TM) Product Monograph. November 2017

[6]. https://www.msaustralia.org.au/what-ms

ots Originaltext: Merck KGaA
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Erin-Marie Beals
+49-151-1454-2694

Original-Content von: Merck KGaA, übermittelt durch news aktuell