This excerpt taken from the NVS 6-K filed Apr 27, 2006.
Elidel in treating mild-to-moderate eczema, but recommended that products in this class should be used with greater caution. Novartis remains confident in the safety and efficacy of
This excerpt taken from the NVS 6-K filed Jan 20, 2006.
Elidel, which is one of the most thoroughly researched dermatology products in the world and continues to be supported with significant ongoing clinical trials.
This excerpt taken from the NVS 6-K filed Nov 2, 2005.
Elidel has been shown to be an effective treatment for the management of mild to moderate eczema, with a favorable safety profile. It is the only non-steroid prescription cream approved for the short-term and intermittent long-term treatment of mild to moderate eczema in patients as young as two years old, who do not respond well to, or may have side effects from, conventional treatments.
Novartis is in product labeling discussions with the FDA and a number of other health authorities, after an FDA Advisory Committee in February 2005 recommended the inclusion of a boxed warning for Elidel and Protopic® (Astellas) relating to a theoretical risk of lymphoma. Novartis and many independent medical experts do not agree that such an action would be justified. Novartis remains confident in the safety and efficacy of Elidel in its approved indications.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as long-term, supports a paradigm shift, is in product labeling discussions, remains confident, or similar expressions, or by express or implied discussions regarding Novartis product labeling discussions with the FDA and other health authorities, or any potential revenues from Elidel. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Elidel to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee regarding the outcome of Novartis product labeling discussions with the FDA and other health authorities, or that Elidel will reach any particular sales levels. In particular, managements expectations regarding commercialization of Elidel could be affected by, among other things, uncertainties relating to clinical trials; new clinical data; additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally, including the outcome of Novartis product labeling discussions with the FDA and other health authorities; the companys ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; as well as other risks and factors referred to in the Companys 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.