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Sandoz launches generic version of INTUNIV® extended release tablets in the US

Princeton, New Jersey, June 4, 2015 – Sandoz today announced the US market introduction of guanfacine hydrochloride extended release tablets, a generic version of INTUNIV®, which is currently marketed by Shire Pharmaceuticals.

Guanfacine hydrochloride extended release is a central alpha2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. Guanfacine is not a central nervous system (CNS) stimulant. The mechanism of action of guanfacine in ADHD is not known.

“Attention Deficit Hyperactivity Disorder is one of the most commonneurodevelopmental disorders of childhood, according to the Centers for Disease Control and Prevention,” said Peter Goldschmidt, President of Sandoz Inc. “Sandoz is pleased to add guanfacine hydrochloride extended release tablets to our portfolio of high-quality medicines for the central nervous system.”

According to IMS Health, US sales for the branded version of guanfacine hydrochloride extended release tablets were approximately USD $800 million for the 12 months ending in March 2015. Sandoz will market guanfacine hydrochloride extended release in 1mg, 2mg, 3mg and 4mg strength tablets, the same strengths as the branded Intuniv.

Important Safety Information
See full prescribing information, available at DailyMed.NLM.NIH.gov.

Contraindication
Guanfacine hydrochloride extended release tablet is contraindicated in patients with a history of a hypersensitivity reaction to INTUNIV or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported.

Adverse Reaction(s)
The following serious adverse reactions are described elsewhere in the labelling:

  • Hypotension, bradycardia, and syncope [see Warnings and Precautions ]
  • Sedation and somnolence [see Warnings and Precautions]
  • Cardiac conduction abnormalities [see Warnings and Precautions]

Warnings and Precautions

Hypotension, Bradycardia, and Syncope
Treatment with guanfacine extended release tablets can cause dose-dependent decreases in blood pressure and heart rate. Decreases were less pronounced over time of treatment. Orthostatic hypotension and syncope have been reported.

Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate guanfacine extended release tablets slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated. Monitor blood pressure and heart rate, and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope.

Sedation and Somnolence
Somnolence and sedation were commonly reported adverse reactions in clinical studies. Before using guanfacine extended release tablets with other centrally active depressants, consider the potential for additive sedative effects. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with guanfacine extended release tablets. Advise patients to avoid use with alcohol.

Cardiac Conduction Abnormalities
The sympatholytic action of guanfacine extended release tablets may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate guanfacine extended release tablets slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “will,” or similar terms, or by express or implied discussions regarding potential revenues from guanfacine extended release tablets. 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 guanfacine extended release tabletswill be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of guanfacine extended release tablets; national trends toward health care cost containment, including ongoing pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, 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 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. Sandoz also 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 the Sandoz portfolio is in differentiated products – medicines 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 at http://twitter.com/Sandoz_Global.

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For further information:

Sandoz US Communications
Leslie Pott
+1 609-627-5287
leslie.pott@sandoz.com

Sandoz Global Communications
Neil Moorhouse
+49 8024 476 2597
neil.moorhouse@sandoz.com

Footnotes:
1 For full safety information, please see guanfacine hydrochloride extended release tablets prescribing information, available in the Product Catalog at www.us.sandoz.com.
2 INTUNIV is a registered trademark of Shire Pharmaceuticals.