Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
Novartis International AG /
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three
times-a-week generic option for relapsing forms of multiple sclerosis
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The issuer is solely responsible for the content of this announcement.
* Glatopa() 40 mg/mL is a fully substitutable, AP-rated generic version of
Copaxone(*) (glatiramer acetate injection) 40 mg/mL
* Glatopa 40 mg/mL, along with Glatopa() 20 mg/mL, which was launched in the
US in June 2015, will offer patients a complete range of dosing options
* A full range of patient support services for Glatopa( )is available through
Holzkirchen, February13, 2018 - Sandoz, a Novartis division, today announced
the US FDA approval and launch of Glatopa() (glatiramer acetate injection) 40
Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-
substitutable, AP-rated generic version of Copaxone(*) (glatiramer acetate
injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple
sclerosis (MS). Glatopa was developed under a collaboration agreement between
Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.
"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in
delivering complex, differentiated generic products. We look forward to bringing
this product to patients and healthcare professionals and providing a full range
of patient support services for Glatopa through GlatopaCare()," said Richard
Francis, CEO, Sandoz.
Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms
of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer
patients a complete range of dosing options.Glatopa 20 mg/mL was made available
in the US in June 2015. Patients can expect the same patient services for
Glatopa 40 mg/mL as for Glatopa 20 mg/mL.
Sandoz GlatopaCare will offer a $0 co-pay support program to qualified patients.
To help increase patient confidence with administering injections, patients will
receive personalized injection training, 24-hour access to nurses for
Glatopa()-related questions and a free Starter Kit, which includes the
Glatopaject() injection device, designed to work with both Glatopa 20 mg/mL and
40 mg/mL prefilled syringes.
Glatopa() Indication and Important Safety Information
Glatopa() (glatiramer acetate injection) is indicated for the treatment of
patients with relapsing-forms of multiple sclerosis.
Important Safety Information
Glatopa() is contraindicated in patients with known hypersensitivity to
glatiramer acetate or mannitol.
Approximately 16% of glatiramer acetate injection 20mg/mL patients vs. 4% of
those on placebo, and approximately 2% of glatiramer acetate injection 40mg/mL
patients vs. none on placebo experienced a constellation of symptoms that may
occur within minutes after injection and included at least 2 of the following:
flushing, chest pain, palpitations, tachycardia, 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 care.
Transient chest pain was noted in 13% of glatiramer acetate injection 20mg/mL
patients vs. 6% of placebo patients, and approximately 2% of glatiramer acetate
injection 40mg/mL patients vs. 1% on placebo. 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
The most common adverse reactions with glatiramer acetate injection 20mg/mL 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%). The most common adverse reactions with glatiramer acetate
injection 40mg/mL vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to discontinuation of
glatiramer acetate injection. 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 or www.fda.gov/medwatch.
Please see full Prescribing Information for Glatopa.
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential launches, marketing approvals, new
indications or labeling for Glatopa 40 mg/mL, Glatopa 20 mg/mL and the other
products described in this press release, or regarding potential future revenues
from such products. You should not place undue reliance on these statements.
Such forward-looking statements are based on our current beliefs and
expectations 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 Glatopa 40 mg/mL, Glatopa 20 mg/mL or
the other products described in this press release will be launched, or
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Neither can there be any guarantee that,
if approved, such products will be approved for all indications included in the
reference product's label. Nor can there be any guarantee that such products
will be commercially successful in the future. In particular, our expectations
regarding such products could be affected by, among other things, regulatory
actions or delays or government regulation generally; the uncertainties inherent
in research and development, including clinical trial results and additional
analysis of existing clinical data; the particular prescribing preferences of
physicians and patients; competition in general, including potential approval of
additional competing versions of such products; global trends toward health care
cost containment, including government, payor and general public pricing and
reimbursement pressures; litigation outcomes, including intellectual property
disputes or other legal efforts to prevent or limit Sandoz from selling its
products; general political, economic and industry conditions; safety, quality
or manufacturing issues; potential or actual data security and data privacy
breaches, or disruptions of our information technology systems, 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.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a
division of the Novartis Group, our purpose is to discover new ways to improve
and extend people's lives. We contribute to society's ability to support growing
healthcare needs by pioneering novel approaches to help people around the world
access high-quality medicine. Our portfolio of approximately 1000 molecules,
covering all major therapeutic areas, accounted for 2017 sales of USD 10.1
billion. In 2017, our products reached well over 500 million patients and we
aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in
Germany's Greater Munich area.
Sandoz is on Twitter. Sign up to follow @Sandoz-global at
Follow our blog at www.sandoz.com/makingaccesshappen.
*Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
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Source: Novartis International AG via GlobeNewswire