Media releases
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`Media releases
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`November 06, 2007 07:15 CET
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`Back to all media releases
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`New Galvus® clinical data reinforces efficacy profile; safety update provided to
`regulatory agencies
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`New data accepted for publication show Galvus 50 mg twice-daily dose as effective as a
`thiazolidinedione (TZD), well tolerated and not causing weight gain
`Novartis proposes improving Galvus risk/benefit profile through use of approved 50 mg
`once-daily and twice-daily doses instead of approved 100 mg once-daily
`
`Basel, November 6, 2007 - New clinical data involving Galvus® (vildagliptin) has been accepted for
`publication in the journal Diabetes, Obesity and Metabolism showing this new oral medicine was as
`effective as one of the leading oral type 2 diabetes treatments and well tolerated.
`
`Separately, Novartis provided on November 6 a safety update to European regulators of pooled data
`showing numerically less frequent liver enzyme elevations in patients who took either 50 mg per day or
`50 mg twice daily of Galvus compared to 100 mg once-daily. As a result, Novartis has proposed changes
`to European prescribing information recommending use of the already-approved 50 mg once-daily and
`twice-daily doses instead of the 100 mg once-daily dose. Novartis will discuss the data and
`recommendations with other regulators.
`
`New clinical data reaffirms effectiveness against a TZD
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`The results of a new clinical study further confirmed the efficacy of Galvus in combination with metformin,
`a long-standing oral type 2 diabetes treatment. This trial showed Galvus was as effective as pioglitazone,
`a member of the thiazolidinedione (TZD) class of diabetes medicines, when each was combined with
`metformin. Galvus was well tolerated and did not cause the weight gain that often occurs in patients
`taking a TZD.
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`In the 24-week study of 576 patients with type 2 diabetes, all of whom had inadequately controlled
`diabetes despite taking the oral medicine metformin, the addition of a 50 mg twice-daily dose of Galvus
`to metformin treatment reduced blood sugar levels as effectively as adding a 30 mg once-daily dose of
`pioglitazone to metformin.
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`Galvus was shown to be weight neutral, while the addition of the TZD was associated with weight gain
`(up to 1.9 kg after 24 weeks of treatment).
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`Novartis provides safety update to regulatory agencies
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`An updated analysis of pooled clinical trial data involving more than 8,000 patients treated with Galvus
`was finalized following the European Union approval on September 26 and included recently completed
`studies.
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`Novartis will discuss these data with the Committee for Medicinal Products for Human Use (CHMP), which
`is responsible for the review of medicines in Europe, and will seek a revision of prescribing information
`before Galvus is launched for sale in European markets.
`
`The recent analysis further characterized a known imbalance in liver enzyme levels, which now appears
`more visibly in the higher Galvus once-daily dosing regimen. The results showed 0.86% of Galvus
`patients taking the 100 mg once-daily dose, 0.34% of those taking the 50 mg twice-daily dose and
`0.21% of those taking the 50 mg once-daily dose had elevations of the liver enzymes aspartate
`aminotransferase (AST) and alanine aminotransferase (ALT) of greater than three times the upper limit of
`normal (3xULN).
`
`At a 50 mg daily dosage, the incidence rate was comparable to the 0.20% in the pooled comparator
`group of about 4,400 patients taking metformin, a TZD, a sulfonylurea or a placebo. The placebo rate was
`0.40%, and this was numerically higher than the Galvus 50 mg twice-daily dose. Elevated levels of these
`enzymes can indicate liver cell damage.
`
`Novartis will continue working with the CHMP and other agencies to review these results and to revise
`prescribing information for Galvus, which is a member of a new drug class known as DPP-4 inhibitors. The
`currently approved European information recommends a 50 mg once-daily dose for use in combination
`
`AstraZeneca Exhibit 2081
`Mylan v. AstraZeneca
`IPR2015-01340
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`Media releases
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`with a sulfonylurea as well as a SO mg twice-daily or 100 mg once-daily dose for combination use with
`either metformin or a TZD.
`
`Galvus is currently available in Brazil and Mexico as both a SO mg and 100 mg daily dose. In February
`2007, Novartis received an "approvable letter" from the US Food and Drug Administration (FDA) and is in
`discussions with the agency.
`
`Disclaimer
`
`The foregoing release contains forward -looking statements that can be identified by terminology such as
`"proposes", "will", "approvable", or similar expressions, or by express or implied discussions regarding
`the potential launch of Galvus for sale in European markets, potential future approvals of Galvus in other
`countries, including the US, and potential future revenues from Galvus. 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 with Galvus to be materially different from
`any future results, performance or achievements expressed or implied by such statements. There can be
`no guarantees that Galvus will be launched for sale in any European market, or that Galvus will be
`approved in the US or in any other markets. Nor can there be any guarantee that Galvus will achieve any
`particular levels of revenue. I n particular, management's expectations regarding Galvus could be affected
`by, among other things, unexpected regulatory actions or delays or government regulation generally;
`unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis
`of existing clinical data; competition in general; government, industry and general public pricing
`pressures; the company's ability to obtain or maintain patent or other 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 . 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 . 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 Novartis
`
`Novartis AG (NYSE : NVS) is a world leader in offering medicines to protect health, cure disease and
`improve well-being . Our goal is to discover, develop and successfully market innovative products to treat
`patients, ease suffering and enhance the quality of life . We are strengthening our medicine-based
`portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high(cid:173)
`quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the
`only company with leadership positions in these areas. In 2006, the Group's businesses achieved net
`sales of USD 37 .0 billion and net income of USD 7.2 billion. Approximately USD S.4 billion was invested in
`R&D . Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000
`associates and operate in over 140 countries around the world . For more information, please visit
`htt p: //www.novartis.com .
`
`###
`
`Novartis Me dia Relations
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`John Gilardi
`Novartis Global Media Relations
`+41 61 324 3018 (direct)
`+41 79 S96 1408 (mobile)
`john.gilardi@novartis.com
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`e-mail: media .relat ions@novartis.com
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`Novartis Investor Relations
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`International
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`Ruth Metzler-Arnold
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`Katharina Ambuehl
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`Navjot Rai
`Novartis Pharma Communications
`+41 61 324 6498 (direct)
`+41 79 777 6400 (mobile)
`navjot .rai@novartis.com
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`North America
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`Ronen Tamir + 1 212 830 2433
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`Jill Pozarek + 1 212 830 244S
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`Media releases
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`Page 3 of 3
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`Nafida Bendali
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`Pierre- Michel Bringer
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`Jason Hannon
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`Thomas Hungerbuehler
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`Richard Jarvis
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`Edwin Valeriano +1 212 830 2456
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`Central phone no: +41 61 324 7944
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`e-mail : invest or.relations@novartis.com
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`e-mail : investor.relations@novartis .com
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