Sandoz launches generic version of Differin® Gel, 0.3%
Princeton, New Jersey, April 28, 2014
Sandoz today announced the US market introduction of its adapalene 0.3% gel, a generic version of Galderma Laboratories’ Differin® Gel, 0.3%.
Adapalene gel is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Acne vulgaris is a condition that affects nearly 85% of the US population at some point in their life.1
"Sandoz is proud to market a high-quality, affordable generic version of this important topical therapy,” said Peter Goldschmidt, President of Sandoz US. “This launch further broadens our strong offering of differentiated generic dermatology products in the US.”
Sandoz will market adapalene 0.3% gel through a collaboration with Tolmar Inc., which owns the Abbreviated New Drug Application for the product and was the first company to receive FDA approval for a generic version.
Sandoz will market adapalene 0.3% gel in 45 gram tubes, the same size and strength that is marketed by the brand. According to IMS Health, aggregate US sales for Differin® Gel, 0.3% in 45 gram tubes was approximately USD 87 million for the twelve months ending December 2013.
The foregoing release contains forward-looking statements that can be identified by terminology such as “launches,” “introduction,” “launch,” “mission,” or similar expressions, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from of adapalene 0.3% gel or any potential future products. 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 either of adapalene 0.3% gel or any potential new products 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 versions of of adapalene 0.3% gel; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; 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.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically 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 benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
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1American Academy of Dermatology. "Acne." Available from: http://www.aad.org/media-resources/stats-and-facts/conditions/acne. Accessed April 21, 2014.
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1 For full safety information, please see the adapalene 0.3% gel prescribing information, available in the Product Catalog at http://www.us.sandoz.com.
2 Differin® is a registered trademark of Galderma S.A.