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ELN » Topics » Our future success depends upon the successful development and commercialisation 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 6-K filed Mar 31, 2006. Our future success depends upon the
successful development and commercialisation 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 programmes in clinical development. The two programmes
are in the early stages of clinical development. Our future
success depends upon the successful commercialisation of
Tysabri and the development and the successful
commercialisation 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 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 commercialisation of
Tysabri and to the other products in our development
pipeline. We cannot assure you that these investments will be
successful.
160 Elan Corporation, plc 2005 Annual Report
Table of Contents
This excerpt taken from the ELN 6-K filed Apr 11, 2005. Our future success depends upon the successful development and Commercialisation of Tysabri and the successful development of additional Products. If Tysabri’s commercial potential remains substantially impaired, we will be materially and adversely affected. Excluding Tysabri, we only market three products and we have only one potential product in clinical development, and it is only in the early stages of clinical development. Our future success depends upon the successful commercialisation of Tysabri, the development and commercialisation of additional indications for Tysabri and the development and commercialisation 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 labeling changes that may be mandated by regulatory agencies, may substantially impair the commercial potential for Tysabri. We commit substantial resources to our 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 commercialisation 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 R&D pipeline, including Tysabri, and product candidates from our Alzheimer’s disease research programmes, will experience difficulties, delays or failures. A number of factors could affect our ability to successfully develop and commercialise products, including our ability to:
Risk Factors
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 commercialised. Our failure to successfully develop and commercialise Tysabri and other products would materially adversely affect us. | EXCERPTS ON THIS PAGE:
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