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2015-08-21

Novartis International AG: Novartis acquires all remaining rights to GSK's Ofatumumab to develop treatments for MS and other autoimmune indications

Novartis International AG / Novartis acquires all remaining rights to GSK's
Ofatumumab to develop treatmentsfor MS and other autoimmune indications .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* Novartis strengthens multiple sclerosis focus with the addition of
Ofatumumab to leading MS portfolio which includes Gilenya and
investigational treatments BAF312 and CJM112
* Ofatumumab is a fully human monoclonal antibody for relapsing remitting
multiple sclerosis (RRMS) which targets CD20 and is administered by
subcutaneous injection
* The novel treatment works by inducing depletion of B cells in the lymphatic
tissues; B cells are known to play an important role in MS

Basel, August 21, 2015
-
Novartis announced today that it has entered into an agreement to acquire all
remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK). Ofatumumab, a
fully human monoclonal antibody which targets CD20, is being developed for
relapsing remitting multiple sclerosis (RRMS) and other autoimmune
indications. Novartis previously acquired the rights to Ofatumumab for
oncology indications and it is marketed under the brand name Arzerra®.

RRMS is thought to be associated with activation of B cells, a type of white
blood cell in the immune system. Ofatumumab works by binding to the CD20
molecule on the surface of B cells and depleting them in lymphatic tissues.
Positive phase IIa results for subcutaneous Ofatumumab demonstrated
significant reduction of up to 90% in the cumulative number of new brain
lesions in patients with MS between weeks 4-12 in the study. No unexpected
safety findings were reported in the study. Since this was a dose finding
trial, Ofatumumab is ready to begin phase III pivotal studies.

"Novartis is pleased to further reinforce our commitment to neuroscience and
to add an exciting new treatment to our strong MS portfolio," said David
Epstein, Head of Novartis Pharmaceuticals. "Our vision for patients with MS
is to develop treatments that improve on current standards of care, meeting
patients' needs at every stage of their disease with innovative and targeted
drugs."

Multiple sclerosis (MS) is a chronic disorder of the central nervous system
(CNS) that disrupts the normal functioning of the brain and spinal cord
through inflammation and tissue loss. More than 2.3 million people worldwide
are affected by MS, a disease that most often begins in early adulthood. The
typical evolution of MS results in progressive loss of both physical and
cognitive (e.g. memory) functions. People with MS can be diagnosed with
relapsing forms of MS (RMS), which include relapsing remitting MS (RRMS) and
secondary progressive MS (SPMS), or with primary progressive MS (PPMS).

Novartis will be responsible for the worldwide development, regulatory and
commercialization activities for Ofatumumab. Under the terms of the
agreement, Novartis will make an initial upfront payment of $300 million to
GSK for the acquisition of the compound and a further payment of $200 million
payable following the start of a phase III study in MS by Novartis. Upon
completion of pre-determined milestones, contingent payments of up to $534
million may be made. Novartis will also pay royalties of up to 12 per cent to
GSK on any future net sales of Ofatumumab in auto-immune conditions.

About Novartis in Multiple Sclerosis

The Novartis multiple sclerosis portfolio includes Gilenya®(fingolimod),
approved in the US for the first-line treatment of relapsing forms of MS in
adults and in the EU for adult patients with highly active
relapsing-remitting MS (RRMS) defined as either high disease activity despite
treatment with at least one DMT, or rapidly evolving severe RRMS. Gilenya® is
also being developed for pediatric MS and chronic inflammatory demyelinating
polyneuropathy (CIDP). Extavia®(interferon beta-1b for subcutaneous
injection) is approved in the US for the treatment of relapsing forms of MS.
In Europe Extavia is approved to treat people with relapsing remitting MS,
secondary progressive MS with active disease and people who have had a single
clinical event suggestive of MS.

Investigational compounds include BAF312, currently in phase III clinical
development and being investigated as an oral therapy for secondary
progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS
with CJM112.

Additionally, the Sandoz Division of Novartis markets Glatopa(TM), the first
generic version of Teva's Copaxone® 20mg.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "focus," "investigational," "being developed,"
"commitment," "exciting," "vision," "will," "being investigated,"
"exploring," or similar terms, or by express or implied discussions regarding
current and potential future development and commercialization of Ofatumumab
and the other products and investigational compounds in the Novartis multiple
sclerosis portfolio, potential future marketing submissions or approvals for
Ofatumumab and the other products and investigational compounds in the
Novartis multiple sclerosis portfolio, or regarding potential future revenues
from the products and investigational compounds in the Novartis multiple
sclerosis portfolio, including Ofatumumab, BAF312, CJM112, Gilenya and
Glatopa, and from Arzerra in oncology indications. You should not place undue
reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management regarding future events,
and are subject to significant known and unknown risks and uncertainties.
Should one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary materially
from those set forth in the forward-looking statements. There can be no
guarantee that Ofatumumab or any of the other investigational compounds in
the Novartis multiple sclerosis portfolio will be submitted or approved for
sale in any market, or at any particular time. Neither can there be any
guarantee that Ofatumumab or any of the other products and investigational
compounds in the Novartis multiple sclerosis portfolio will be submitted or
approved for any additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that Ofatumumab or any of the
other products and investigational compounds in the Novartis multiple
sclerosis portfolio, or Arzerra in oncology indications, will be commercially
successful in the future. In particular, management's expectations regarding
these products could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected clinical trial
results and additional analysis of existing clinical data; unexpected
regulatory actions or delays or government regulation generally; the
company's ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
safety issues; unexpected manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the US Securities
and Exchange Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.

Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2014, the Group
achieved net sales of USD 58.0 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 120,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

Novartis Media Relations

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Media release (PDF)
http://hugin.info/134323/R/1946843/706677.pdf

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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via Globenewswire

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