Sandoz launches Introvale®, a generic version of Seasonale®
Princeton, New Jersey; January 5, 2011 - Sandoz today announced the US Food and Drug Administration (FDA) approval and US launch of Introvale® (levonorgestrel and ethinyl estradiol tablets), a generic equivalent of Seasonale®.
Introvale is a levonorgestrel and ethinyl estradiol combined oral contraceptive indicated for use by women to prevent pregnancy.
According to IMS Health, US sales for branded and generic versions of Seasonale® were approximately USD 91 million for the 12 months ending November 2010. Sandoz is marketing Introvale in a dosage regimen consisting of 84 peach-colored active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and seven white inert tablets (without hormones). This dosage regimen is identical to that of Seasonale®.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," "launch," or similar expressions, or by express or implied discussions regarding potential future approvals of additional oral contraceptive products, or regarding potential future revenues from Introvale or such other 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 any additional oral contraceptive products will be submitted or approved by Sandoz for sale. Nor can there be any guarantee that Introvale or any such other 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 Introvale; unexpected product development difficulties; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; 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, 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 patents. Sandoz has a portfolio of about 1000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, 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 and anti-infectives. 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 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion.
* * *
For further information
Sandoz US Communications:
Ted Deutsch +1 609 627 5287
Sandoz Global Communications: Marija Mandic +49 8024 476 2597
Seasonale® is a registered trademark of Duramed.