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Sandoz launches an authorized generic version of Solaraze® Gel

Princeton, New Jersey, November 21, 2013 
Sandoz today announced the US launch of diclofenac 3% gel, an authorized generic version of PharmaDerm’s Solaraze® Gel.

Diclofenac 3% gel is indicated for the topical treatment of actinic keratosis (AK), a precancerous condition of thick, scaly, or crusty patches of skin1 that affects an estimated 58 million Americans.2

“As the global leader across a broad range of differentiated generic categories, Sandoz is pleased to offer a high-quality generic version of this important medicine to US patients,” said Peter Goldschmidt, President of Sandoz US. “This important launch further strengthens our US and global leadership in topical generic dermatology.”

Sandoz is marketing diclofenac gel in the 3% strength, which is the only strength marketed as Solaraze® Gel.

According to IMS Health, US sales for branded diclofenac 3% gel were USD 92 million for calendar year 2012.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “launch,” "launches," or similar expressions, or by express or implied discussions regarding potential future revenues from diclofenac 3% gel. 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 diclofenac 3% gel will achieve any particular levels of revenue in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including potential FDA approval of additional generic versions of diclofenac 3% gel; unexpected product manufacturing difficulties; competition in general; government, industry and general public pricing pressures; 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. 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, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz employs over 26,000 employees in more than 140 countries, offering broad range of over 1,000 high-quality, affordable products that are no longer protected by patents. With USD 8.7 billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology and antibiotics as well as strong positions in the 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. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003 , Sandoz has benefitted from strong growth of its acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), 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:
Chris Lewis
+1 609 627 5287; chris.lewis@sandoz.com

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

 

Solaraze® Gel is a registered trademark of PharmaDerm, part of Sandoz Inc.

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[1] For full safety information, please see the diclofenac 3% gel prescribing information, available in the Product Catalog at www.us.sandoz.com
[2] National Center for Biotechnology Information. Accessed on June 19, 2013 from: http://www.ncbi.nlm.nih.gov/pubmed/23556166