Sandoz leads the way with first generic version of 'gold standard' anti-thrombotic Lovenox®[1]
Novartis International AG / Sandoz leads the way with first generic version of 'gold standard' anti-thrombotic Lovenox®[1] processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Sandoz is the first company to receive US approval to market a more
affordable generic version of the leading hospital-based medication in the
US
* US 2009 sales of Lovenox® were USD 2.7 billion
* Enoxaparin launch demonstrates Sandoz focus on differentiated and complex
products, and underscores status as a global leader
Holzkirchen, July 23, 2010 - Sandoz today announced the introduction of
enoxaparin sodium injection, the first generic version of Lovenox®[1], in the
US. Product shipment began immediately following approval by the US Food and
Drug Administration (FDA).
According to IMS data enoxaparin sodium injection is the best-selling hospital
medicine in the US, and has been described as the 'gold standard' for
anti-thrombotic treatments.[2] Lovenox®, the reference product, recorded US
sales of USD 2.7 billion in 2009( )and has been used to treat an estimated 200
million patients worldwide since it was launched.[3]
"Sandoz is the first company to launch generic enoxaparin sodium in the US,
delivering on our strategy of being first-to-market with key products, and
underscoring our leadership in differentiated products," said Jeff George,
global head of Sandoz. "We welcome the FDA decision to approve our enoxaparin
application, and are now looking forward to significantly increasing patient and
payor access to this vital medicine, by providing a high-quality, more
affordable version."
The Sandoz product, developed in collaboration with Momenta Pharmaceuticals,
Inc., is indicated for use in prophylaxis and for treatment of deep vein
thrombosis, prophylaxis of ischemic complications of unstable angina and
non-Q-wave myocardial infarction, and the treatment of acute ST-segment
elevation myocardial infarction [STEMI]
Enoxaparin, a low molecular weight heparin (LMWH) is an anticoagulant that helps
to prevent thrombosis. Thrombosis is the formation of a blood clot in the blood
vessels in the absence of bleeding. Enoxaparin is made up of a complex blend of
low molecular weight substances (oligosaccharides) derived from heparins, and
therefore requires sophisticated analytical methods on the part of the
manufacturer to ensure accurate and reliable characterization, development and
production.
Collaborating since 2003, Sandoz and Momenta provided the FDA with substantial
data that demonstrated the equivalence of the Sandoz generic to Lovenox, and
addressed potential immunogenicity issues. The FDA also denied two related
Citizens' Petitions.
Sandoz specializes in the development, production and marketing of
differentiated products ranging from biosimilars to complex injectables and
inhalables. These products leverage complex ingredients, formulations, delivery
mechanisms or underlying technologies to add value for patients and payors by
going well beyond "standard" generics.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "strategy", "looking forward," "potential", or similar
expressions, or by express or implied discussions regarding potential future
sales of enoxaparin sodium injection. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current views of
the company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that enoxaparin sodium
injection will achieve any particular levels of revenue in the future. In
particular, management's expectations could be affected by, among other things,
unexpected inabilities to obtain or maintain exclusivity periods for developed
products; uncertainties regarding actual or potential legal proceedings,
including, among others, intellectual property disputes or other legal efforts
to prevent or limit Sandoz from selling enoxaparin sodium injection, and the
uncertain outcome of any such litigation; the particular prescribing preferences
of physicians and patients; competition in general; government, industry and
general public pricing pressures; unexpected manufacturing difficulties or
delays; unexpected regulatory actions or delays or government regulation
generally; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Sandoz 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 the Novartis group, is a global leader in the field of
generic pharmaceuticals, offering a wide array of high-quality, affordable
products that are no longer protected by patents. Sandoz has a portfolio of
approximately 1000 compounds and sells its products in more than 130 countries.
Key product groups include antibiotics, treatments for central nervous system
disorders, gastrointestinal medicines, cardiovascular treatments and hormone
therapies. Sandoz develops, produces and markets these medicines along with
pharmaceutical and biotechnological active substances and anti-infectives. In
addition to strong organic growth in recent years, Sandoz has made a series of
acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs
(US), EBEWE Pharma (Austria), and Oriel Therapeutics (US). In 2009, Sandoz
employed around 23,000 people worldwide and posted sales of USD 7.5 billion.
* * *
For further information
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Footnotes:
[1] Lovenox® is a registered trademark of Sanofi-Aventis
[2] 2009 Sanofi-Aventis Shareholder Letter
[3] 2008( )Sanofi-Aventis Annual Report
[HUG#1433879]
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