FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies

– There are currently no FDA-approved treatments that help prevent
severe reactions due to food allergies –

– As many as 15 million Americans have food allergies – including
approximately 6 million children – and the incidence is increasing –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation for Xolair®
(omalizumab) for the prevention of severe allergic reactions following
accidental exposure to one or more foods in people with allergies.
Breakthrough Therapy Designation is designed to expedite the development
and review of medicines intended to treat serious or life-threatening
diseases, and to help ensure people have access to them through FDA
approval as soon as possible. This is the 23rd Breakthrough Therapy
Designation for Genentech’s portfolio of medicines.

“Food allergies can have a significant impact on the lives of children
and adults, and they are a growing public health concern for which there
are currently no FDA-approved treatments,” said Sandra Horning, M.D.,
chief medical officer and head of Global Product Development. “We are
committed to helping address this high unmet medical need and look
forward to working with leaders in the field to further develop Xolair
as a potential medicine to help people with this condition that can be

Food allergies can be life-threatening, and result in an estimated
200,000 emergency room visits each year. Up to 8 percent of children and
4 percent of adults in the U.S. are affected by food allergies, and the
incidence is increasing.

Breakthrough Therapy Designation was granted on the basis of data from
seven clinical studies over the last decade assessing the efficacy and
safety of Xolair against a range of food allergens including peanut,
milk, egg and others. These studies of Xolair, as monotherapy or in
combination with oral immunotherapy (OIT), were supported by Genentech
and independent sponsors including the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health

Genentech and Novartis Pharmaceuticals Corporation are working closely
with NIAID and the Consortium of Food Allergy Research (CoFAR) to
initiate a potentially pivotal study evaluating the efficacy and safety
of Xolair in multiple food allergies and will disclose details at a
later date.

In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation
work together to develop and co-promote Xolair. Genentech is a leading
biotechnology company that discovers, develops, manufacturers and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. Novartis Pharmaceuticals
Corporation is an affiliate of Novartis which provides innovative
healthcare solutions that address the evolving needs of patients and

About Xolair

Xolair for subcutaneous use is an injectable prescription medicine
approved by the FDA to treat:

  • Moderate to severe persistent asthma in patients six years of age or
    older whose asthma symptoms are not controlled by asthma medicines
    called inhaled corticosteroids. A skin or blood test is performed to
    see if a patient has allergies to year-round allergens.
  • Chronic idiopathic urticaria (CIU; chronic hives without a known
    cause) in patients 12 years of age and older who continue to have
    hives that are not controlled by H1 antihistamine treatment.

Xolair is not used to treat other allergic conditions, other forms of
urticaria, acute bronchospasm or status asthmaticus.

Important Safety Information

The most important information patients should know about XOLAIR is
that a severe allergic reaction called anaphylaxis can happen
when a patient receives Xolair. The reaction can occur after the first
dose, or after many doses. It may also occur right after a Xolair
injection or days later. Anaphylaxis is a life-threatening condition and
can lead to death. Patients must go to the nearest emergency room right
away if they have any of these symptoms of an allergic reaction:

  • 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

The patient’s healthcare provider will monitor the patient closely for
symptoms of an allergic reaction while they are receiving Xolair and for
a period of time after the patient’s injection. The patient’s healthcare
provider should talk to the patient about getting medical treatment if
they have symptoms of an allergic reaction after leaving the healthcare
provider’s office or treatment center.

Patients must not receive Xolair if they are allergic to
omalizumab or any of the ingredients in Xolair.

Before receiving Xolair, patients must tell their healthcare provider
about all of their medical conditions, including if they:

  • have any other allergies (such as food allergy or seasonal allergies)
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if Xolair may
    harm a patient’s unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Xolair
    passes into breast milk. Talk with your healthcare provider about the
    best way to feed your baby while you receive Xolair.

Patients must tell their healthcare provider about all the medicines
they take, including prescription and over-the-counter medicines,
vitamins or herbal supplements.

Receiving Xolair

  • Xolair should be given by a healthcare provider, in a
    healthcare setting.
  • Xolair is given in one or more injections under the skin
    (subcutaneous), 1 time every two or four weeks.
  • In asthma patients, a blood test for a substance called IgE must be
    performed prior to starting Xolair to determine the appropriate
    dose and dosing frequency.
  • In patients with chronic hives, a blood test is not necessary to
    determine the dose or dosing frequency.
  • Patients must not decrease or stop taking any of their other asthma or
    hive medicine unless their healthcare providers tell them to.
  • Patients may not see improvement in their symptoms right away after
    Xolair treatment.

Possible Side Effects of Xolair

Xolair may cause serious side effects, including:

  • See, “What is the most important information I should know about
    in the Xolair Medication Guide at http://www.xolair.com
    regarding the risk of anaphylaxis.
  • Cancer. Cases of cancer were observed in some people who
    received Xolair.
  • Inflammation of your blood vessels. Rarely, this can happen in
    people with asthma who receive Xolair. This usually, but not always,
    happens in people who also take a steroid medicine by mouth that is
    being stopped or the dose is being lowered. It is not known whether
    this is caused by Xolair. Tell your healthcare provider right away if
    you have rash; chest pain; shortness of breath; or a feeling of pins
    and needles or numbness of your arms or legs.
  • Fever, muscle aches, and rash. Some people who take Xolair get
    these symptoms one to five days after receiving a Xolair injection. If
    a patient has any of these symptoms, they must tell their healthcare
  • Parasitic infection. Some people who are at a high risk for
    parasite (worm) infections, get a parasite infection after receiving
    Xolair. The patient’s healthcare provider can test the patient’s stool
    to check if they have a parasite infection.
  • Heart and circulation problems. Some people who receive Xolair
    have had chest pain, heart attack, blood clots in the lungs or
    legs, or temporary symptoms of weakness on one side of the body,
    slurred speech, or altered vision. It is not known whether this is
    caused by Xolair.

The most common side effects of Xolair:

  • In adults and children 12 years of age and older with asthma:
    pain especially in the arms and legs, dizziness, feeling tired, skin
    rash, bone fractures and pain or discomfort of the ears.
  • In children 6 to less than 12 years of age with asthma: common
    cold symptoms, headache, fever, sore throat, pain or discomfort of
    your ear, abdominal pain, nausea, vomiting and nose bleeds.
  • In people with chronic idiopathic urticaria: nausea, headaches,
    swelling of the inside of the nose, throat or sinuses, cough, joint
    pain and upper respiratory tract infection.

These are not all the possible side effects of Xolair. Patients should
call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555 or Novartis
Pharmaceuticals Corporation at 888-669-6682.

Please see full Prescribing Information, including Medication Guide
for additional Important Safety Information.

About Genentech

Founded more than 40 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 http://www.gene.com.


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Karl Mahler, 011 41 61 687