Sandoz introduces authorized generic version of Clobex® Shampoo, 0.05%
Princeton, New Jersey, January 3, 2011 - Sandoz today announced the introduction of clobetasol propionate shampoo, 0.05%, an authorized generic version of Clobex® Shampoo, 0.05%, in the US.
Clobetasol propionate shampoo, 0.05% is indicated for the treatment of moderate to severe forms of scalp psoriasis in patients 18 years of age or older.1 Psoriasis is a common skin condition that affects up to 7.5 million people in the US.2
According to IMS Health, US sales for branded and generic versions of clobetasol propionate shampoo, 0.05% were approximately USD 54.9 million for the 12 months ending in October 2011. Sandoz will market clobetasol propionate shampoo, 0.05% in 4 fluid ounce (118 mL) bottles.
The foregoing release contains forward-looking statements that can be identified by terminology such as "introduces," "introduction," "will," or similar expressions, or by express or implied discussions regarding potential future revenues from clobetasol propionate shampoo, 0.05%. 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 clobetasol propionate shampoo, 0.05% 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 clobetasol propionate shampoo, 0.05%; 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
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 valid and enforceable third-party patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in about 130 countries. Key product groups include cardiovascular medicines, anti-infectives, treatments for
central nervous system and alimentary tract disorders, oncology and respiratory therapies, as well as medications for blood and blood forming organ disorders. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances. 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 2010, Sandoz employed more than 23,000 people (full-time equivalents) worldwide and achieved net sales of USD 8.5 billion for the full year.
1 Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment with clobetasol propionate shampoo, 0.05% should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results. Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression. In Galderma's clinical study on Clobex®, Shampoo, 0.05%, there were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety. For full safety information, please see the clobetasol propionate shampoo, 0.05% prescribing information, available in the product catalogue at www.us.sandoz.com.
2 National Psoriasis Foundation. About Psoriasis. Available from: http://www.psoriasis.org/about-psoriasis. Accessed: December 19,
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For further information
Sandoz US Communications:
Sandoz Global Communications:
+49 8024 476 2597
Clobex® Shampoo, 0.05% is a registered trademark of Galderma Laboratories.