FDA Approves ACTEMRA® for Children Living with a Rare Form of Arthritis

  FDA Approves ACTEMRA® for Children Living with a Rare Form of Arthritis

   Medicine Offers a New Option for the Treatment of Polyarticular Juvenile
                         Idiopathic Arthritis (PJIA)

Business Wire

SOUTH SAN FRANCISCO, Calif. -- April 30, 2013

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that the U.S. Food and Drug Administration (FDA) has approved
ACTEMRA^® (tocilizumab) for the treatment of polyarticular juvenile idiopathic
arthritis (PJIA). The medicine can be used in children two years of age and
older with active disease. ACTEMRA can be given alone or in combination with
methotrexate (MTX) in people with PJIA.

PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile
rheumatoid arthritis, a chronic disease of childhood.^1 JIA affects
approximately 100 in every 100,000 children^2 of which PJIA accounts for
around 30 percent.^3 PJIA is characterized by inflammation in five or more
joints within the first six months of the disease and most commonly affects
the small joints in the body such as the hands and feet.^3

“Polyarticular juvenile idiopathic arthritisis a rare, debilitating condition
in children that worsens over time,” said Hal Barron, M.D., chief medical
officer and head, Global Product Development. “We are pleased to offer ACTEMRA
to doctors and parents of children aged two or older as an important medicine
to help improve the signs and symptoms of this often painful disease.”

This FDA approval marks the second ACTEMRA indication in children and is the
first FDA approval for the treatment of PJIA in approximately five years.

About the CHERISH Study

The expanded indication for ACTEMRA was based on positive data from the Phase
III CHERISH study in children with PJIA, which had an open label phase,
followed by a randomized double-blind placebo-controlled withdrawal phase. The
study demonstrated that patients treated with ACTEMRA experienced clinically
meaningful improvement in signs and symptoms of PJIA. A total of 91 percent of
patients taking ACTEMRA plus MTX and 83 percent of patients taking ACTEMRA
alone achieved an ACR 30 response at week 16 compared to baseline. In the
randomized double-blind placebo-controlled withdrawal phase of the trial,
ACTEMRA-treated patients experienced significantly fewer disease flares
compared to placebo-treated patients (26 percent [21/82] vs. 48 percent
[39/81]).

The safety data collected to date for ACTEMRA in PJIA patients is consistent
with that observed in previous studies in ACTEMRA-treated patients.^4 In the
CHERISH study, infections were the most common adverse events (AEs) and
serious adverse events (SAEs) over 40 weeks. Laboratory abnormalities known to
occur with ACTEMRA were also observed in this study, includingdecreases in
white blood cell counts and platelet counts, and elevation in ALT and AST
liver enzyme levels.

About JIA ACR 30, 50, 70

The JIA American College of Rheumatology (ACR) response was derived from the
following six variables:

  *Parents/Patients Global Assessment of Overall Well-Being
  *Physicians Global Assessment of Disease Activity
  *Number of joints with active arthritis
  *Number of joints with limitation of movement
  *Acute phase reactant (erythrocyte sedimentation rate (ESR))
  *Functional ability determined by Childhood Health Assessment Questionnaire
    (C-HAQ) disability index (~xr30i)

About ACTEMRA^®(tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor antagonist
approved for the treatment of adult patients with moderately to severely
active rheumatoid arthritis (RA) who have had an inadequate response to one or
more disease-modifying antirheumatic drugs (DMARDs). The extensive ACTEMRA RA
clinical development program included five Phase III clinical studies and
enrolled more than 4,000 people with RA in 41 countries, including the United
States. In addition, ACTEMRA is also approved for the treatment of active
systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile
idiopathic arthritis (PJIA) in patients two years of age and older.

Important Safety Information

Some people developed serious infections while taking ACTEMRA, including
tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that
can spread throughout the body. Some people have died from these infections.

Other serious side effects of ACTEMRA include tears (perforation) of the
stomach and intestines, changes in blood test results (including low white
blood cell count, low platelet count, increase in certain liver function
tests, and increase in blood cholesterol levels), hepatitis B infection
becoming an active infection again, and nervous system problems.

ACTEMRA affects the immune system and may increase a patient's risk of certain
cancers.

Serious allergic reactions, including death, can happen with ACTEMRA. These
reactions may happen with any infusion of ACTEMRA, even if they did not occur
with an earlier infusion. Patients must tell their doctor if they have had a
previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are
allergic to it or any of its ingredients.

Common side effects with ACTEMRA in patients with RA include upper respiratory
tract infections (common cold, sinus infections), headache, and increased
blood pressure (hypertension).

Common side effects with ACTEMRA in patients with PJIA or SJIA include upper
respiratory tract infections (common cold, sinus infections), headache, and
diarrhea.

Patients must tell their healthcare providers if they plan to become pregnant
or are pregnant. It is not known if ACTEMRA will harm an unborn baby.
Genentech has a registry for pregnant women who take ACTEMRA. Patients who are
pregnant or become pregnant while taking ACTEMRA must contact the registry at
1-877-311-8972 and talk to their healthcare provider.

Patients must call their healthcare provider for medical advice about any side
effects.

Report side effects to the FDA at 1-800-FDA-1088 or
http://www.FDA.gov/medwatch. Patients and caregivers may also report side
effects to Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information,
including Boxed Warning and Medication Guide, for additional Important Safety
Information or call 1-800-ACTEMRA (228-3672).

ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co.
and has been approved in Japan since June 2005. ACTEMRA is approved in the
European Union, where it is known as RoACTEMRA, and several other countries,
including China, India, Brazil, Switzerland and Australia.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco, Calif. For
additional information about the company, please visithttp://www.gene.com.

References

1. Beukelman, T et al. 2011 American College of Rheumatology Recommendations
for the Treatment of Juvenile Idiopathic Arthritis: Initiation and Safety
Monitoring of Therapeutic Agents for the Treatment of Arthritis and Systemic
Features. Arthritis Care & Research. 2011.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222233/. Accessed April 2, 2013.

2. Woo, P. Systemic Juvenile Rheumatoid Arthritis: Diagnosis, Management, and
Outcome. Nature Clinical Practice: Rheumatology. 2006. 2:1.

3. Macaubas, Claudia et al. Oligoarticular and Polyarticular JIA: Epidemiology
and Pathogenesis. Nature Reviews. 2009 vl 5.

4. De Benedetti F, et al. Ann Rheum Dis 2011; 70 (Suppl. 3):67.

Contact:

Genentech
Media:
Joe St. Martin, 650-467-6800
or
Investors:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 85 03
 
Press spacebar to pause and continue. Press esc to stop.