Genentech’s Gazyva Helped People with One of the Most Common Forms of Blood Cancer Live Significantly Longer without Their

  Genentech’s Gazyva Helped People with One of the Most Common Forms of Blood
  Cancer Live Significantly Longer without Their Disease Worsening Compared to
  Rituxan in Phase III CLL11 Study

  *Second stage of CLL11 study showed Gazyva plus chlorambucil significantly
    reduced the risk of disease worsening or death by 61 percent compared to
    Rituxan plus chlorambucil for people with previously untreated chronic
    lymphocytic leukemia
  *Updated data from Stage 1a of CLL11 showed Gazyva plus chlorambucil
    improved overall survival compared to chlorambucil alone
  *Full CLL11 study results to be presented during the Plenary Scientific
    Session of the 55th Annual Meeting of the American Society of Hematology
    (ASH)

Business Wire

SOUTH SAN FRANCISCO, Calif. -- November 7, 2013

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced new, positive data from the second stage of the CLL11 study. This
Phase III study, conducted in cooperation with the German CLL Study Group,
compared Gazyva™ (obinutuzumab), also known as GA101, in combination with
chlorambucil to Rituxan^® (rituximab) in combination with chlorambucil for
people with previously untreated chronic lymphocytic leukemia (CLL) and
co-existing medical conditions. The data showed that people treated in the
Gazyva arm lived nearly a year longer without their disease worsening
(progression-free survival, or PFS).

For patients in the Gazyva arm, median PFS was 26.7 months compared with 15.2
months for those in the Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.0001). No new
safety signals were observed for either Gazyva or Rituxan. The data have been
accepted for presentation during the Plenary Scientific Session of the 55th
Annual Meeting of American Society of Hematology (Abstract #6).

“Gazyva is the result of years of research for patients with chronic
lymphocytic leukemia,” said Hal Barron, M.D., chief medical officer and head
of Global Product Development. “These new data are important because they
showed for the first time that Gazyva significantly extended progression-free
survival when directly compared against Rituxan.”

Additional data comparing the Gazyva and Rituxan treatment arms showed higher
complete response rates (21 percent compared with 7 percent) and a ten-fold
increase in the percentage of people achieving minimal residual disease (MRD)
negativity (29.4 percent compared with 2.5 percent), which was defined as no
detectable disease in the blood at the end of the treatment course.

In addition to the Stage 2 data being presented at ASH, an updated analysis
from the first stage (Stage 1a) of the CLL11 study, which compared Gazyva in
combination with chlorambucil to chlorambucil alone, will also be presented.
This analysis showed that people treated with Gazyva in combination with
chlorambucil lived longer (overall survival, or OS) compared to chlorambucil
alone (HR 0.41, 95 percent CI 0.23-0.74, p=0.002). Given the median
observation time of 23 months, median overall survival has not yet been
reached in any of the study arms.

On November 1, 2013, Gazyva in combination with chlorambucil became the first
medicine with Breakthrough Therapy Designation to receive U.S. Food and Drug
Administration (FDA) approval. Roche has also submitted Marketing
Authorization Applications to other regulatory authorities around the world,
including the European Medicines Agency (EMA).

The following data related to Gazyva will be also presented during the ASH
annual meeting:

  *Safety and Efficacy of Obinutuzumab (GA101) with
    Fludarabine/Cyclophosphamide (G-FC) or Bendamustine (G-B) in the Initial
    Therapy of Patients with Chronic Lymphocytic Leukemia (CLL): Results from
    the Phase Ib GALTON Trial (GAO4779g) (Abstract #523)
  *Safety and Efficacy Of Obinutuzumab (GA101) Plus CHOP Chemotherapy In
    First-Line Advanced Diffuse Large B-Cell Lymphoma: Results From The Phase
    II GATHER Study (GAO4915g) (Abstract #1820)
  *Obinutuzumab (GA101) Plus CHOP or FC in Relapsed/Refractory Follicular
    Lymphoma: Final Data From the Maintenance phase of the Phase Ib GAUDI
    Study (BO21000) (Abstract #1814)

About The CLL11 Study

CLL11 is a Phase III, multicenter, open-label, randomized three-arm study
investigating the efficacy and safety profile of Gazyva plus chlorambucil,
Rituxan plus chlorambucil and chlorambucil alone in 781 previously untreated
people with CLL and co-existing medical conditions who are in need of therapy.
Stage 1 (n=589) compared Gazyva plus chlorambucil to chlorambucil alone and
Rituxan plus chlorambucil to chlorambucil alone. Stage 2 (n=663) compared
Gazyva plus chlorambucil directly with Rituxan plus chlorambucil.

The primary endpoint of the study was PFS with secondary endpoints including
overall response rate (ORR), overall survival (OS), disease free survival
(DFS), minimal residual disease (MRD) and safety profile.

Stage 2 results (investigator assessed)          Gazyva plus      Rituxan plus
                                                chlorambucil    chlorambucil
Total N = 663
                                                 N=333            N=330
Overall response rate (ORR), %*                 78              65
Complete response (CR), %*                      21              7
Median PFS, months                               26.7^#          15.2

Hazard Ratio, 95 percent Cl, p-value log rank   0.39, 0.31-0.49, p<0.0001
test
Median OS, months                                NR              NR

HR, Cl, p                                       0.66, 0.41-1.06, p=0.09
Minimal residual disease                        63/214 [29.4%]  6/243 [2.5%]
Grade 3-5 Adverse events, %**                    66               47
Grade 3-5 Infusion-related reactions, %***       20               4
Grade 3-5 Neutropenia (low count of certain      33               27
white blood cells), %***
Grade 3-5 Infections, %                          7                7
                                                              

*    At end-of-treatment
**    During treatment
***   No deaths (grade 5 AE) in these categories
#     Still immature
NR   Not reached

About Chronic Lymphocytic Leukemia (CLL)

CLL is one of the most common forms of blood cancer and in 2013, it is
expected that there will be nearly 5,000 deaths from CLL in the United States.
Most cases of CLL (95 percent) start in white blood cells called B-cells that
have a protein called CD20 on their surface.

About Gazyva

Gazyva is a new monoclonal antibody designed to attach to CD20, a protein
found only on B-cells. It attacks targeted cells both directly and together
with the body's immune system.

Gazyva was discovered by Roche Glycart AG, a wholly owned, independent
research unit of Roche. In the United States, Gazyva is part of a
collaboration between Genentech and Biogen Idec.

Gazyva is now approved in combination with chlorambucil for people with
previously untreated chronic lymphocytic leukemia and is additionally being
investigated in a large clinical program, including multiple head-to-head
Phase III studies compared to Rituxan in indolent non-Hodgkin’s lymphoma (NHL)
and diffuse large B-cell lymphoma (DLBCL).

About The German CLL Study Group (GCLLSG)

Founded in 1996 and headed by Professor Michael Hallek, the GCLLSG has been
running various Phase I, II and III trials with the goal providing optimal
treatment to patients suffering from CLL. This included landmark trials like
CLL8, which led to the current standard of care in CLL. For many years, GCLLSG
has been aiming to improve not just the treatment of younger and physically
fit patients, but also that of elderly and less fit patients. These patients
are generally underrepresented in clinical trials although they constitute the
majority of CLL patients treated by doctors in daily practice. The GCLLSG is
an independent non-profit research organization supported by German Cancer Aid
(Deutsche Krebshilfe).

Gazyva Indication Statement

Gazyva is a prescription medicine used with the chemotherapy chlorambucil, to
treat chronic lymphocytic leukemia (CLL) in adults who have not had previous
CLL treatment.

Important Safety Information

Patients must tell their doctor right away about any side effects they
experience. Gazyva can cause side effects that can become serious or
life-threatening including:

Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems
including liver failure and death. If patients have had hepatitis B or are
carriers of HBV, receiving Gazyva could cause the virus to become an active
infection again. Patients should not receive Gazyva if they have active HBV
liver disease. A patient’s doctor will do blood tests to check for HBV
infection prior to treatment and will monitor the patient during and for
several months following their treatment.

Progressive Multifocal Leukoencephalopathy (PML): a serious brain infection
that can lead to severe disability and death and for which there is no known
prevention, treatment, or cure. Symptoms can include difficulty thinking, loss
of balance, changes in speech or walking, weakness on one side of the body, or
blurred or lost vision.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effects they
experience. Gazyva can cause side effects that may become severe or
life-threatening, including:

  *Infusion Reactions: may occur during or within 24 hours of the
    infusion.The patient’s doctor should give the patient medicines before
    their treatment that may help to reduce the risk of an infusion
    reaction.Symptoms can include hives, rash, itching, facial or oral
    swelling, sudden cough, shortness of breath, difficulty breathing,
    weakness, dizziness, feeling faint, racing heart or chest pain.
  *Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer
    cells. TLS may cause an abnormal heartbeat or kidney failure requiring the
    need for dialysis treatment. The patient’s doctor may do blood tests to
    check the patient for TLS and give the patient medicines before their
    treatment to help prevent TLS. Symptoms of TLS may include nausea,
    vomiting, diarrhea and tiredness.
  *Infections: Serious bacterial, fungal and viral infections can occur
    during and following Gazyva therapy.Symptoms may include fever and cough.
  *Low blood cell counts: The patient’s blood cell counts may be monitored
    during treatment.

Most common side effects of Gazyva

The most common side effects of Gazyva are infusion reactions, low white blood
cellcounts, low platelet counts, low red blood cell counts, fever, cough and
muscle and joint pain.

Before receiving Gazyva, patients should talk to their doctor about:

Immunizations: Before receiving Gazyva therapy, patients must tell their
healthcare provider if they have recently received or are scheduled to receive
a vaccine. People who are treated with Gazyva should not receive live
vaccines.

Pregnancy: Patients must tell their doctor if they are pregnant or planning to
become pregnant or are breastfeeding.It is not known if Gazyva may harm the
patient’s unborn baby or pass into the patient’s breast milk. Women should use
birth control while using Gazyva and for 12 months after treatment.

Patients must tell their doctor about any side effect that bothers them or
that does not go away.

These are not all of the possible side effects of Gazyva.For more
information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

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.

Please visit http://www.gazyva.com for the full Prescribing Information,
including Boxed WARNINGS, for additional Important Safety Information.

Rituxan Indications

Rituxan is indicated for the treatment of patients with:

  *Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL
    as a single agent
  *Previously untreated follicular, CD20-positive, B-cell NHL in combination
    with first-line chemotherapy and, in patients achieving a complete or
    partial response to Rituxan in combination with chemotherapy, as
    single-agent maintenance therapy
  *Non-progressing (including stable disease), low-grade, CD20-positive,
    B-cell NHL, as a single agent, after first-line CVP chemotherapy
  *Previously untreated diffuse large B-cell, CD20-positive NHL in
    combination with CHOP or other anthracycline-based chemotherapy regimens
  *Previously untreated and previously treated CD20-positive CLL in
    combination with fludarabine and cyclophosphamide (FC)

Rituxan is not recommended for use in patients with severe, active infections.

Important Safety Information:

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

  *Infusion Reactions: may occur during or within 24 hours of the infusion.
    The patient’s doctor should give the patient medicines before their
    treatment. Symptoms can include hives, rash, itching, facial or oral
    swelling, sudden cough, shortness of breath, difficulty breathing,
    weakness, dizziness, feeling faint, racing heart or chest pain
  *Severe Skin and Mouth Reactions: symptoms can include  painful sores,
    ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or
    pustules
  *Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems
    including liver failure and death. If patients have had hepatitis B or are
    carriers of HBV, receiving Rituxan could cause the virus to become an
    active infection again. Patient should not receive Rituxan if they have
    active HBV liver disease. The patient’s doctor will do blood tests to
    check for HBV infection prior to treatment and will monitor the patient
    during and for several months following their treatment
  *Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain
    infection that can lead to severe disability and death and for which there
    is no known prevention, treatment or cure. Symptoms can include difficulty
    thinking, loss of balance, changes in speech or walking, weakness on one
    side of the body or blurred or lost vision

What are the additional possible serious side effects of Rituxan?

Patients must tell their doctor right away about any side effects they
experience. Rituxan can cause serious side effects that can lead to death,
including:

  *Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for
    dialysis treatment, abnormal heart rhythm and can lead to death. The
    patient’s doctor may give the patient medicines before their treatment to
    help prevent TLS
  *Serious Infections: can happen during and after treatment and can lead to
    death. These infections may be bacterial, fungal or viral. Symptoms can
    include fever; cold or flu symptoms; earache or headache; pain during
    urination; white patches in the mouth or throat; cuts or scrapes that are
    red, warm, swollen or painful
  *Heart Problems: symptoms can include chest pain and irregular heartbeats
    that may require treatment. The patient’s doctor may need to stop their
    treatment
  *Kidney Problems: the patient’s doctor should do blood tests to check how
    well the patient’s kidneys are working
  *Stomach and Serious Bowel Problems: can include blockage or tears in the
    bowel that can lead to death. Stomach area pain during treatment can be a
    symptom
  *Low Blood Cell Counts: the patient’s blood cell counts may be  monitored
    during treatment

The most common side effects of Rituxan are infusion reactions, chills,
infections, body aches, tiredness and low white blood cells.

Patients must tell their doctor if they are pregnant, plan to become pregnant
or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn
baby or pass into the patient’s breast milk. Women should use birth control
while using Rituxan and for 12 months after treatment.

Patients must tell their doctor about any side effect that bothers them or
that does not go away.

These are not all of the possible side effects of Rituxan. For more
information, patients should ask their doctor or pharmacist.

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.

Please see the Rituxan full Prescribing Information, including Most Serious
Side Effects, for additional important safety information at
http://www.Rituxan.com.

About Genentech In Hematology

For more than 20 years, Genentech has been developing medicines with the goal
to redefine treatment in hematology. Today, we’re investing more than ever in
our effort to bring innovative treatment options to people with cancers of the
blood.

In addition to Gazyva, Genentech’s pipeline of potential hematology medicines
includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22
[RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration
with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).

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
http://www.gene.com.

Contact:

Genentech
Media Contact:
Emmy Wang, 650-467-6800
Advocacy Contact:
Jen Mills, 650-467-6722
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
 
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