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Press Release: FDA approves Xolair(R) (omalizumab) for adults with nasal polyps

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Xolair is the first biologic for the treatment of nasal polyps that
targets and blocks immunoglobulin E (IgE), a key driver of inflammation

Xolair is now FDA-approved across three diseases and in two formulations,
continuing to build on the medicine's 17 years of patient experience
since its initial approval for allergic asthma



Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced that the U.S. Food and Drug Administration (FDA) has approved
the company's supplemental Biologics License Application (sBLA) for
Xolair(R) (omalizumab) for the add-on maintenance treatment of nasal
polyps in adult patients 18 years of age and older with inadequate
response to nasal corticosteroids.(1) Nasal polyps can lead to a loss of
smell and nasal congestion, and frequently co-occur with other
respiratory conditions, such as allergies and asthma. With this approval,
Xolair is now the first biologic for the treatment of nasal polyps that
targets and blocks immunoglobulin E (IgE), a key driver of inflammation.




"With Xolair, we observed significantly reduced nasal polyps and
congestion symptoms in adults who had nasal polyps in two pivotal Phase
III studies," said Joseph Han, M.D., Chief of the Division of Rhinology
and the Division of Allergy at Eastern Virginia Medical School and study
investigator of the POLYP 1 and POLYP 2 trials. "Xolair provides a new
option for treating these patients, who often have other respiratory and
allergic conditions that may further worsen symptoms."



The FDA's approval is based on results from the Phase III POLYP 1 and
POLYP 2 trials. Both trials showed that adult patients with nasal polyps
who had an inadequate response to nasal corticosteroids and received
Xolair had statistically significant greater improvement from baseline
at Week 24 in Nasal Polyp Score (NPS) and weekly average Nasal
Congestion Score (NCS) than patients who received placebo.(1) The
greater improvements in NPS and NCS in the Xolair group compared to the
placebo group were observed as early as the first assessment at Week 4
in both studies. All patients received background nasal mometasone
therapy during both the treatment period and a five-week run-in period.
The safety profile in POLYP 1 and POLYP 2 was consistent with the
established safety profile for Xolair.



"With today's approval, people living with nasal polyps now have a
treatment option that targets IgE, an underlying driver of various
allergic conditions," said Levi Garraway, M.D., Ph.D., Roche's Chief
Medical Officer and Head of Global Product Development. "We are
committed to understanding the full potential of Xolair across the
spectrum of allergic diseases and are excited to provide this important
treatment for people living with nasal polyps."



Xolair is an injectable biologic medicine that is also FDA-approved for
the treatment of moderate to severe persistent allergic asthma in people
6 years of age or older whose asthma symptoms are not controlled by
inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in
people 12 years of age and older who continue to have hives that are not
controlled by H1 antihistamines. Approximately 460,000 patients have
been treated in the U.S. with Xolair since its initial approval for
allergic asthma in 2003.(2) In the U.S., Genentech and Novartis
Pharmaceuticals Corporation work together to develop and co-promote
Xolair.



About Nasal Polyps

Nasal polyps is a commonly occurring and potentially debilitating
condition in adults, impacting 13 million people in the U.S.(3,4)
Currently, there are limited treatment options available and many
patients opt for nasal surgery or systemic steroids. However, polyps may
regrow over time. Nasal polyps present as noncancerous lesions on the
lining of the nasal sinuses or nasal cavity associated with irritation
and inflammation, which can block normal airflow.(5) Nasal polyps may
co-occur with other respiratory conditions, such as allergies and
asthma.



About POLYP 1 and POLYP 2

In POLYP 1 and POLYP 2, the mean change from baseline at Week 24 for
Xolair compared to placebo were: NPS, -1.1 versus 0.1 (95% CI: -1.6,
-0.7) and -0.9 versus -0.3 (95% CI: -1.1, -0.1); NCS, -0.9 versus -0. 4
(95% CI: -0.8, -0.3) and -0.7 versus -0.2 (95% CI: -0.8, -0.2).1 POLYP 1
and POLYP 2 are the ninth and tenth Phase III trials for Xolair,
respectively. Results from POLYP 1 and POLYP 2 were recently published
in the Journal of Allergy and Clinical Immunology. No new or unexpected
safety signals were identified in patients treated with Xolair, with
over 95% of patients completing each safety arm of POLYP 1 and POLYP
2(.6) The most common adverse reactions (>=3% of patients) included
headache, injection site reaction, arthralgia, upper abdominal pain and
dizziness.



POLYP 1 and POLYP 2 are replicate Phase III pivotal studies designed to
determine the efficacy and safety of Xolair compared with placebo in
adult patients with nasal polyps who had an inadequate response to nasal
corticosteroids. Both trials were randomized, multicenter, double-blind
and placebo-controlled. POLYP 1 involved 138 patients, and POLYP 2
involved 127 patients. The co-primary outcomes for both trials were
change from baseline to Week 24 in average daily Nasal Congestion Score
and Nasal Polyp Score. Patients in the studies were administered either
Xolair or placebo by subcutaneous injection every two to four weeks in
addition to background nasal mometasone therapy during both the
treatment period and a five-week run-in period.(1)



About Xolair

Xolair is the only approved antibody designed to target and block
immunoglobulin E (IgE). By reducing free IgE, down-regulating
high-affinity IgE receptors and limiting mast cell degranulation, Xolair
minimizes the release of mediators throughout the allergic inflammatory
cascade.



About Roche in Immunology

The Roche Group's immunology medicines include: Actemra(R)/RoActemra(R)
(tocilizumab) for rheumatoid arthritis, polyarticular juvenile
idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis
(sJIA) and giant cell arteritis (GCA) and for the treatment of severe or
life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine
release syndrome (CRS); Rituxan(R)/MabThera(R) (rituximab) for
rheumatoid arthritis granulomatosis with polyangiitis and microscopic
polyangiitis and for pemphigus vulgaris (PV); Xolair(R) (omalizumab) for
allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme(R)
(dornase alfa) for cystic fibrosis; and Esbriet(R) (pirfenidone) for
idiopathic pulmonary fibrosis (IPF). Roche has more than 15
investigational medicines in clinical development for immunological
diseases that include asthma, autoimmune diseases, rheumatoid arthritis,
ulcerative colitis and Crohn's disease.



About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics under one roof have made Roche the
leader in personalised healthcare a strategy that aims to fit the
right treatment to each patient in the best way possible.



Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology
and diseases of the central nervous system. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics, and
a frontrunner in diabetes management.



Founded in 1896, Roche continues to search for better ways to prevent,
diagnose and treat diseases and make a sustainable contribution to
society. The company also aims to improve patient access to medical
innovations by working with all relevant stakeholders. More than thirty
medicines developed by Roche are included in the World Health
Organization Model Lists of Essential Medicines, among them life-saving
antibiotics, antimalarials and cancer medicines. Moreover, for the
twelfth consecutive year, Roche has been recognised as one of the most
sustainable companies in the Pharmaceuticals Industry by the Dow Jones
Sustainability Indices (DJSI).



The Roche Group, headquartered in Basel, Switzerland, is active in over
100 countries and in 2019 employed about 98,000 people worldwide. In
2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF
61.5 billion. Genentech, in the United States, is a wholly owned member
of the Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan. For more information, please visit
https://www.globenewswire.com/Tracker?data=ke_79vGB4Ufxh2Ww2Gijd0Z1LAQ7dUNLSVnXOfLd8AFQKqYcS7dl6qQr5LYQsBS7QT_NnCyrqvLGe4rpfJR0_Q
www.roche.com.



All trademarks used or mentioned in this release are protected by law.



References

[1] Xolair(R) Full Prescribing Information. Genentech, Inc.; November
2020.

[2] Data on file. Genentech, Inc.

[3] United States Census Bureau. QuickFacts. Census Bureau population
estimates (2018). Accessed October 2020.
https://www.census.gov/quickfacts/fact/table/US/PST045218

[4] Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal
polyps. J Allergy Clin Immunol Pract. 2016;4(4):565572.

[5] Mayo Clinic. Nasal polyps. Accessed October 2020.
https://www.mayoclinic.org/diseases-conditions/nasal-polyps/symptoms-causes/syc-20351888.


[6] Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of
omalizumab in nasal polyposis: two randomized phase III trials. J
Allergy and Clin Immunol. 2020; 146(3):595-605. doi:
10.1016/j.jaci.2020.05.032



Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail:
https://www.globenewswire.com/Tracker?data=w_CMkA2fxb3vW2wWKuc29r1b0R0oT3gF8n3IYFfN1I_YTgCGlGRyxYfScU9ft6c3k7DZTqKc253b2Aip8Neww7-bgE_mqCGLhecMXQBXLigpqiz0MBzoFKLz3lxxfTmz
media.relations@roche.com









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December 01, 2020 12:07 ET ( 17:07 GMT)
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