Market Overview

FDA Approves Genentech's Rituxan (rituximab) For Pemphigus Vulgaris

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  • Rituxan is the first FDA-approved treatment for moderate to severe
    pemphigus vulgaris (PV) in more than 60 years
  • FDA previously granted Priority Review, Breakthrough Therapy
    Designation and Orphan Drug Designation to Rituxan for the treatment
    of PV
  • Rituxan is now FDA-approved to treat four autoimmune diseases

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 Rituxan® (rituximab) for the treatment of adults
with moderate to severe pemphigus vulgaris (PV), a rare, serious,
potentially life-threatening condition characterized by progressive
painful blistering of the skin and mucous membranes.1

Rituxan is the first biologic therapy approved by the FDA for PV and the
first major advancement in the treatment of the disease in more than 60
years. The FDA previously granted Priority Review, Breakthrough Therapy
Designation and Orphan Drug Designation to Rituxan for the treatment of
PV. With today's FDA decision, Rituxan is now approved to treat four
autoimmune diseases.

"Today's decision by the FDA provides the first approved treatment
option in more than 60 years for patients with pemphigus vulgaris, a
potentially life-threatening disease," said Sandra Horning, M.D., chief
medical officer and head of Global Product Development. "We are pleased
to offer Rituxan as a new and effective therapy to patients with this
serious condition."

The FDA approval is based on data from the Ritux 3 trial, a
Roche-supported, randomized, controlled trial conducted in France that
used Roche-manufactured, European Union (EU)-approved rituximab product
as the clinical trial material. The study compared the Ritux 3 regimen
(EU-approved rituximab product plus short-term corticosteroids [CS]) to
CS alone as a first-line treatment in patients with newly diagnosed
moderate to severe pemphigus. The primary endpoint of the study was
complete remission* at month 24 without the use of steroids for two or
more months. Results of the study showed that 90 percent of PV patients
treated with the Ritux 3 regimen met the endpoint, compared to 28
percent of PV patients treated with CS alone. These results supported
the efficacy of Rituxan in treating patients with moderate to severe PV,
while tapering off of CS therapy. These results were published in The
Lancet
in March 2017.2

Recently an international panel of experts, the International Bullous
Disease Consensus Group, provided new recommendations on the diagnosis
and management of pemphigus in the Journal of the American Academy of
Dermatology
.3 Based on existing European treatment
guidelines, a Delphi survey process was used to help achieve
international expert consensus. The consensus includes the
recommendation to use an anti-CD20 monoclonal antibody (Rituxan) and
corticosteroids as first line therapy options for moderate to severe
pemphigus.

About Pemphigus Vulgaris

Pemphigus vulgaris is an autoimmune blistering disease affecting the
skin and mucous membranes.1 This rare, potentially
life-threatening condition accounts for up to 80% of cases of pemphigus,
a group of autoimmune disorders which affect 30,000 to 40,000 people in
the United States.4

*Complete remission defined as complete epithelialization and absence
of new and/or established lesions.

What autoimmune diseases does Rituxan treat?

Rheumatoid arthritis (RA): with another prescription medicine called
methotrexate, to reduce the signs and symptoms of moderate to severe
active RA in adults, after treatment with at least one other medicine
called a tumor necrosis factor (TNF) antagonist has been used and did
not work well enough.

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and
Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and
MPA.

Pemphigus vulgaris (PV): to treat adults with moderate to severe
PV.

It is not known if Rituxan is safe or effective in children.

Important Side Effect Information

What is the most important information patients should know about
Rituxan?

Rituxan can cause serious side effects that can lead to death,
including:

  • Infusion Reactions: Infusion reactions
    are the most common side effect of Rituxan treatment. Serious infusion
    reactions can happen during an infusion or within 24 hours after an
    infusion
  • Severe Skin and Mouth Reactions: painful
    sores or ulcers on skin, lips, or in the mouth; blisters, peeling
    skin, rash, or pustules
  • Hepatitis B Virus (HBV) Reactivation: If
    a patient has had hepatitis B or is a carrier of hepatitis B virus,
    receiving Rituxan could cause the virus to become an active infection
    again
  • Progressive Multifocal Leukoencephalopathy (PML):
    a rare, serious brain infection caused by the JC virus

Before receiving Rituxan, patients should tell their healthcare
provider if they:

  • have had a severe infusion reaction to Rituxan in the past
  • currently have or have a history of other medical conditions,
    especially heart disease
  • have had a severe infection, currently have an infection, or have a
    weakened immune system
  • have had a recent vaccination or are scheduled to receive vaccinations
  • have taken Rituxan in the past
  • are pregnant or planning to become pregnant. Females who are able to
    become pregnant should use effective birth control (contraception)
    during treatment with Rituxan and for 12 months after the last
    dose of Rituxan
  • are breastfeeding or plan to breastfeed. Patients should not
    breastfeed during treatment and for at least 6 months after the
    last dose of Rituxan
  • are taking any medications, including prescription and
    over-the-counter medicines, vitamins, and herbal supplements

What are the possible side effects of Rituxan?

Rituxan can cause serious and life‐threatening side effects, including:

  • Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of
    cancer cells. TLS can cause kidney failure and the need for dialysis
    treatment or may cause an abnormal heart rhythm
  • Serious Infections: Serious infections can happen during and after
    treatment with Rituxan and can lead to death
  • Heart Problems: Rituxan may cause chest pain and irregular heartbeats,
    which may need treatment, or a patient's doctor may decide to stop
    treatment with Rituxan
  • Kidney Problems: especially if a patient is receiving Rituxan for
    non-Hodgkin's lymphoma (NHL). Doctors should do blood tests to check
    how well a patient's kidneys are working
  • Stomach and Serious Bowel Problems That Can Sometimes Lead to Death:
    Patients should inform their doctor right away if they have any
    stomach area pain during treatment with Rituxan
  • Low Blood Cell Counts: A doctor may do blood tests during treatment
    with Rituxan to check a patient's blood cell counts

What are the most common side effects during treatment with Rituxan?

  • Infusion reactions
  • Infections (may include fever, chills)
  • Body aches
  • Tiredness
  • Nausea

Other side effects include:

  • Aching joints during or within hours of receiving an infusion
  • More frequent upper respiratory tract infections

These are not all of the possible side effects with Rituxan. For more
information, ask a doctor or pharmacist.

Contact a doctor for medical advice about side effects. Report side
effects to the FDA at (800) FDA‐1088 or
http://www.fda.gov/medwatch.
Patients may also report side effects to Genentech at (888) 835‐2555.

Please see the Rituxan Prescribing Information and Medication Guide
including Most Serious Side Effects for additional Important Side Effect
Information at
 http://www.rituxan.com.

Genentech and Biogen collaborate on Rituxan in the United States, and
Roche markets MabThera in the rest of the world, except Japan, where
Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

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 and 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.

References

1. Medscape. Pemphigus Vulgaris. Available at: http://emedicine.medscape.com/article/1064187-overview.
[Last accessed: May 15, 2018]

2. Joly P, et al. First-Line Rituximab Combined with Short-Term
Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux
3): A Prospective, Multicentre, Parallel-Group, Open-Label Randomised
Trial. The Lancet. March 22, 2017

3. Murrell DF, et al. Diagnosis and Management of Pemphigus:
recommendations by an International Panel of Experts, Journal of the
American Academy of Dermatology,
2018 https://doi.org/10.1016/j.jaad.2018.02.021
[Article in Press]

4. International Pemphigus & Pemphigoid Foundation. Pemphigus. Available
at: http://www.pemphigus.org/research/clinically-speaking/pemphigus/.
[Last accessed: May 15, 2018]

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