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Novartis International AG: Sandoz receives FDA approval for GlatopaTM as the first generic competitor to MS therapy Copaxone® 20mg

Novartis International AG / Sandoz receives FDA approval for GlatopaTM as the
first generic competitor to MStherapy Copaxone® 20mg . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* Glatopa is the first FDA-approved, substitutable generic version of
Copaxone ® 20mg, a treatment for relapsing forms of multiple sclerosis
* Novartis and Sandoz are driving access to a full range of differentiated,
high-quality MS therapeutic options, complemented by a full range of
support services

Holzkirchen, Germany, April 16, 2015
- Sandoz, a Novartis company, today announced the US approval of GlatopaTM,
the first generic version of Teva's Copaxone®(glatiramer acetate injection)
20 mg/ml one-time-daily multiple sclerosis therapy.

"Sandoz, together with Momenta, is proud to be the first company to receive
FDA approval for a substitutable generic version of this important therapy,"
said Peter Goldschmidt, President of Sandoz US. "The approval of Glatopa
reinforces Sandoz leadership in complex, differentiated generic products and
further demonstrates our commitment to offer patients and payors a full range
of therapeutic options."

MS is a debilitating disease affecting about half a million individuals in the
US alone; only half of those diagnosed are currently treated.[1]

Glatopa, developed in collaboration with Momenta and produced entirely in the
US, is indicated for the treatment of patients with relapsing forms of MS,
including those who have experienced a first clinical episode and have
magnetic resonance imaging (MRI) features consistent with MS.

Sandoz is the global leader in complex differentiated generics, which
represent more than 40% of its global portfolio, and one of the top two
global generics companies by net sales.

Fighting MS, together with other CNS disorders, is central to the Novartis
mission, and Sandoz's Glatopa joins a broad MS portfolio including two
approved therapies and one late-stage development compound.

Important Safety Information

Glatiramer acetate is contraindicated in patients with known hypersensitivity
to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate patients vs. 4% of those on placebo
experienced a constellation of symptoms immediately after injection that
included at least 2 of the following: flushing, chest pain, palpitations,
anxiety, dyspnea, throat constriction, and urticaria. These symptoms
generally have their onset several months after the initiation of treatment,
although they may occur earlier, and a given patient may experience 1 or
several episodes of these symptoms. Typically, the symptoms were transient
and self-limited and did not require treatment; however, there have been
reports of patients with similar symptoms who received emergency medical

Transient chest pain was noted in 13% of glatiramer acetate patients vs. 6% of
placebo patients. While some episodes of chest pain occurred in the context
of the immediate post-injection reaction described above, many did not. The
temporal relationship of this chest pain to an injection was not always
known. The pain was transient, often unassociated with other symptoms, and
appeared to have no clinical sequelae. Some patients experienced more than 1
such episode, and episodes usually began at least 1 month after the
initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin
necrosis may occur. Lipoatrophy may occur at various times after treatment
onset (sometimes after several months) and is thought to be permanent. There
is no known therapy for lipoatrophy.

Because glatiramer acetate can modify immune response, it may interfere with
immune functions. For example, treatment with glatiramer acetate may
interfere with recognition of foreign antigens in a way that would undermine
the body's tumor surveillance and its defenses against infection. There is no
evidence that glatiramer acetate does this, but there has not been a
systematic evaluation of this risk.

The most common adverse reactions with glatiramer acetate vs placebo were
injection site reactions (ISRs), such as erythema (43% vs 10%);
vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest
pain (13% vs 6%). ISRs were one of the most common adverse reactions leading
to discontinuation of glatiramer acetate. ISRs, such as erythema, pain,
pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a
higher rate with glatiramer acetate than placebo.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747
or FDA at 1-800-FDA-1088

Please seefull Prescribing Informationfor glatiramer acetate.

This press release contains forward-looking statements that can be identified
by words such as "driving," "commitment," "offer," "mission," or similar
terms, or by express or implied discussions regarding potential future
marketing submissions or approvals for the development compounds in the
Novartis MS portfolio, or regarding potential future revenues from any or all
of the products and development compounds in the Novartis MS portfolio,
including Glatopa, or any other Sandoz products. 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 any of the development compounds in the Novartis MS portfolio
will be submitted or approved for sale in any market, or at any particular
time. Nor can there be any guarantee that any of the products and
development compounds in the Novartis MS portfolio, including Glatopa, or any
other Sandoz products, will be commercially successful in the future. In
particular, management's expectations regarding these products could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues; unexpected patent litigation
outcomes; the company's ability to obtain or maintain proprietary
intellectual property protection, 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.

About Sandoz

Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals,
driving sustainable access to high-quality healthcare. Sandoz employs more
than 26,000 people worldwide and supplies a broad range of affordable,
primarily off-patent products to patients and customers around the globe.

The Sandoz global portfolio comprises approximately 1,100 molecules, which
accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1
position in biosimilars as well as in generic anti-infectives, ophthalmics
and transplantation medicines. In addition, Sandoz holds leading global
positions in key therapeutic areas ranging from generic injectables,
dermatology and respiratory to cardiovascular, metabolism, central nervous
system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as
well as intermediary products including active pharmaceutical ingredients
(APIs) and biotechnological substances. Nearly half of Sandoz's portfolio is
in differentiated products - products that are scientifically more difficult
to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics
businesses under the Sandoz brand name in 2003, Sandoz has consistently
driven growth in selected geographies and differentiated product areas
through a series of targeted acquisitions, including Hexal (Germany), EBEWE
Pharma (Austria), and Fougera Pharmaceuticals (US).

Sandoz is on Twitter. Sign up to follow @Sandoz_global

# # #

For further information, contact:

Eric Althoff

Novartis Global Media Relations
+41 61 324 7999

Chris Lewis
Sandoz Global Media and External Relations
+49 8024 476 1906

Novartis Investor Relations

| Central phone: +41 61 324 7944 North America: |
| Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448 |
| Pierre-Michel Bringer +41 61 324 1065 Susan Donofrio +1 862 778 9257 |
| Thomas Hungerbuehler +41 61 324 8425 |
| Isabella Zinck +41 61 324 7188 |
| |
| |
Copaxone®is a registered trademark of Teva
---------------------------------------[1]National Multiple Sclerosis Society: "MS Prevalence -- National Multiple
Sclerosis Society." Accessed on March 12, 2014

Media release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
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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