FDA Files Genentech’s Supplemental Biologics License Application of Xolair® (omalizumab) for Chronic Idiopathic Urticaria

  FDA Files Genentech’s Supplemental Biologics License Application of Xolair®
  (omalizumab) for Chronic Idiopathic Urticaria (CIU)

  *CIU is a skin condition characterized by red, swollen, itchy hives
  *Currently, H[1]-antihistamines are the only approved therapy for patients
    suffering from CIU, also known as chronic spontaneous urticaria (CSU)
  *FDA Decision on sBLA expected during second quarter of 2014

Business Wire

SOUTH SAN FRANCISCO, Calif. -- October 11, 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 accepted and
filed the company’s supplemental Biologics License Application (sBLA) for
subcutaneous use of Xolair^® (omalizumab) in people with Chronic Idiopathic
Urticaria (CIU) who remained symptomatic despite treatment with
H[1]-antihistamine therapy at approved doses. Xolair is jointly developed by
Genentech and Novartis Pharma AG and is co-marketed in the United States with
Novartis Pharmaceuticals Corporation. The FDA action date is second quarter of

CIU, also known as chronic spontaneous urticaria (CSU), is a skin condition
characterized by red, swollen, itchy hives.^1,3 It is diagnosed when hives
spontaneously present without an identifiable cause and reoccur for more than
six weeks.^1 Some 30-50 percent of CIU patients also have angioedema, where
swelling occurs under the skin instead of on the surface. The prevalence of
CIU is approximately 0.5 to 1 percent of the worldwide population.^2
Currently, H[1]-antihistamines are the only approved therapy for patients
suffering from CIU.

“We are pleased that the FDA has filed our application for Xolair for chronic
idiopathic urticaria,” said Hal Barron, M.D., chief medical officer and head,
Global Product Development. “We hope we can soon bring our medicine to people
with this chronic form of hives.”

Development Program

The sBLA was primarily based on two, global, multi-center, randomized,
double-blind, placebo-controlled Phase III studies (ASTERIA I and ASTERIA II)
in a total of 642 (319 and 323, respectively) patients with moderate-to-severe
CIU who remained symptomatic despite treatment with H[1]-antihistamine therapy
at approved doses. A third study (GLACIAL) was a global Phase III,
multicenter, randomized, double-blind, placebo-controlled, parallel-group
study in 336 patients to primarily evaluate the safety profile of Xolair as an
add-on therapy in CIU patients who remained symptomatic despite other
treatments with antihistamines.


XOLAIR^® (omalizumab) for subcutaneous use is an injectable, prescription
medicine for patients 12 years of age and older. It is for patients with
moderate to severe persistent allergic asthma caused by year-round allergens
in the air. A skin or blood test is done to see if you have allergic asthma.
XOLAIR is for patients who are not controlled by asthma medicines called
inhaled steroids.

XOLAIR helps reduce the number of asthma attacks in people with allergic
asthma who still have asthma symptoms even though they are taking inhaled

  *XOLAIR has not been proven to work in other allergic conditions.
  *XOLAIR is not a rescue medicine and should not be used to treat sudden
    asthma attacks.
  *XOLAIR should not be used in children under 12 years of age.

XOLAIR should always be injected in a doctor’s office. Patients should read
the Medication Guide before starting XOLAIR treatment and before each and
every treatment.

A severe allergic reaction called anaphylaxis has happened in some patients
after they received XOLAIR. Anaphylaxis is a life-threatening condition and
can lead to death. Patients must seek emergency medical treatment right away
if symptoms occur.

Signs and symptoms of anaphylaxis include:

  *wheezing, shortness of breath, cough, chest tightness, or trouble
  *low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety,
    or feeling of "impending doom"
  *flushing, itching, hives, or feeling warm

  *swelling of the throat or tongue, throat tightness, hoarse voice, or
    trouble swallowing

Anaphylaxis from XOLAIR can happen:

  *right after receiving a XOLAIR injection or hours later
  *after any XOLAIR injection. Anaphylaxis has occurred after the first
    XOLAIR injection or after many XOLAIR injections

A patient’s healthcare provider should watch the patient for some time in the
office for signs or symptoms of anaphylaxis after injecting XOLAIR. If
patients have signs or symptoms of anaphylaxis, they must tell their
healthcare provider right away.

Patients must not receive XOLAIR if they have ever had an allergic reaction to
a XOLAIR injection. Patients should not use XOLAIR if they are allergic to any
of its ingredients.

In clinical studies, a variety of cancer types, including breast, skin,
prostate, and parotid (a type of salivary gland), were reported in more
patients who received XOLAIR than in patients who did not receive XOLAIR.

XOLAIR is not a rescue medicine and should not be used to treat sudden asthma

XOLAIR is not a substitute for the medicines patients are already taking.
Patients must not change or stop taking any of their other asthma medicines
unless their doctor tells them to do so.

Some patients on XOLAIR may have an abnormal increase in eosinophils (a type
of white blood cell) in the blood or tissues, sometimes causing an
inflammation of blood vessels, which can lead to rash, worsening of
respiratory symptoms, heart trouble, and/or nerve pain and weakness.

Joint inflammation or pain, rash, fever, and swollen lymph nodes have been
seen in some patients taking XOLAIR after the first or subsequent injections.
Patients should talk to their doctor if they have experienced any of these
signs and symptoms.

The most commonly seen side effects occurring more frequently in patients
receiving XOLAIR than in patients who received placebo (an injection with no
active medicine) were joint pain, pain (general), leg pain, tiredness
(fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin,
and earache.

In asthma studies, the most common side effects in patients, who either needed
to stop XOLAIR or needed medical attention, were injection site reaction,
viral infections, upper respiratory tract infection, sinusitis, headache, and
sore throat. These side effects were seen at similar rates in XOLAIR-treated
patients as in patients that did not receive XOLAIR.

There are other possible side effects with XOLAIR. Patients should talk to
their doctor for more information and if they have any questions about their

XOLAIR has not been studied in pregnant women. Pregnant women exposed to
XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry.
Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or
by speaking with their doctor.

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

Please visit http://www.xolair.com for the full Prescribing Information,
including Boxed WARNINGS and Medication Guide for additional important safety

About Genentech

Founded more than 35 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,
California. For additional information about the company, please visit


^1 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria
(Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed
August 6, 2013.

^2 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66:

^3 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin
Allergy Overview.”
Accessed August 6, 2013.


Media Contact:
Chris Vancheri, 650-467-6800
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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