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ELN » Topics » Our future success depends upon the successful development and commercialization of Tysabri and the successful development of additional products. If Tysabri is not commercially successful, we will be materially and adversely affected.This excerpt taken from the ELN 20-F filed Mar 30, 2006. Our
future success depends upon the successful development and
commercialization of Tysabri and the successful development of
additional products. If Tysabri is not commercially successful,
we will be materially and adversely affected.
Excluding Tysabri, we market three products and have two
potential programs in clinical development. The two programs are
in the early stages of clinical development. Our future success
depends upon the successful commercialization of Tysabri
and the development and the successful commercialization of
additional products.
Even if we can reintroduce Tysabri to the market,
uncertainty created by the serious adverse events that have
occurred or may occur, or restrictive labelling changes that may
be mandated by regulatory agencies, may significantly impair the
commercial potential for Tysabri.
We commit substantial resources to our research and development
(R&D) activities, including collaborations with third
parties such as Biogen Idec with respect to Tysabri. We
expect to commit significant cash resources to the development
and the commercialization of Tysabri and to the other
products in our development pipeline. We cannot assure you that
these investments will be successful.
In the pharmaceutical industry, the R&D process is lengthy
and involves a high degree of risk and uncertainty. This process
is conducted in various stages and, during each stage, there is
a substantial risk that products in our
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R&D pipeline, including Tysabri, and product
candidates from our Alzheimer’s disease research programs,
will experience difficulties, delays or failures. A number of
factors could affect our ability to successfully develop and
commercialize products, including our ability to:
Even if we obtain positive results from preclinical or clinical
trials, we may not achieve the same success in future trials.
Earlier stage trials are generally based on a limited number of
patients and may, upon review, be revised or negated by
authorities or by later stage clinical results. Historically,
the results from preclinical testing and early clinical trials
have often not been predictive of results obtained in later
clinical trials. A number of new drugs and biologics have shown
promising results in initial clinical trials, but subsequently
failed to establish sufficient safety and effectiveness data to
obtain necessary regulatory approvals. Data obtained from
preclinical and clinical activities are subject to varying
interpretations, which may delay, limit or prevent regulatory
approval. Clinical trials may not demonstrate statistically
sufficient safety and effectiveness to obtain the requisite
regulatory approvals for product candidates. In addition, as
happened with Tysabri, unexpected serious adverse events
can occur in patients taking a product after the product has
been commercialized.
Our failure to successfully develop and commercialize Tysabri
and other products would materially adversely affect us.
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