Media Center

Sandoz launches first generic version of Taclonex® Ointment

Princeton, New Jersey, April 1, 2014

Sandoz today announced the US market introduction of its calcipotriene and betamethasone dipropionate ointment, the first generic version of Leo Pharma’s Taclonex® Ointment.

​Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and older.

Psoriasis affects approximately 2% of the US population. Plaque psoriasis is the most common form of the condition. [1]

"Sandoz is proud to be first-to-market with a generic version of this important therapy,” said Peter Goldschmidt, President of Sandoz US. “This launch further broadens our strong offering of differentiated generic dermatology products.”

Sandoz will market calcipotriene and betamethasone dipropionate through a partnership 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.

According to IMS Health, aggregate US sales for the branded version of calcipotriene and betamethasone dipropionate ointment were approximately USD 96 million for the 12 months ending December 2013. Sandoz is marketing calcipotriene and betamethasone dipropionate ointment in 60 gram and 100 gram tubes, the same strengths that are marketed as Taclonex® Ointment.

Important Safety Information

Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and above for up to 4 weeks. Calcipotriene and betamethasone dipropionate ointment should not be applied to the face, axillae or groin, or if skin atrophy is present at treatment site.

  • Hypercalcemia and hypercalciuria have been reported. If it occurs, discontinue treatment until parameters of calcium metabolism normalize
  • Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes
  • Systemic absorption may require evaluation for HPA axis suppression
  • Modify use should HPA axis suppression develop
  • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption
  • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids

For full safety information, please see the calcipotriene and betamethasone dipropionate ointment prescribing information, available in the Product Catalog at www.us.sandoz.com.

Disclaimer

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 calcipotriene and betamethasone dipropionate ointment 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 calcipotriene and betamethasone dipropionate ointment 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 calcipotriene and betamethasone dipropionate ointment; 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.

About Sandoz

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 sold 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).

Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.

# # #

For further information

Sandoz US Communications:

Chris Lewis
chris.lewis@sandoz.com

Sandoz Global Communications:

Neil Moorhouse
+49 8024 476 2597;
neil.moorhouse@sandoz.com