>Orphan Drug status is designed to facilitate the development and commercialization of drugs to treat rare diseases.
>According to a recent research report by Thomson Reuters, orphan drugs are replacing the blockbuster drugs of previous decades and have the economic potential to generate as much lifetime revenue as drugs used for more common health conditions.
>In recent years, large pharmaceutical companies have begun to focus their attention on orphan drug development and, in some cases have established business units dedicated to rare diseases.
>Although orphan drugs are developed to treat a small number of patients, these therapies can generate significant amounts of revenue. For example, Gleevec® (Novartis Oncology), which has multiple orphan indications, had sales of $2.4 billion in 2010. The world’s second most profitable drug, Rituxan® (Genentech), which was granted orphan status for the treatment of B-cell Non-Hodgkin’s lymphoma, had sales of $5.24 billion in 2010, with expanded use in other types of cancer, as well as rheumatoid arthritis.7
>The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation.
>Once a compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%)
>Orphan drugs also experience significant competitive advantage in being first to market. Recent research suggests that the higher pricing, increased market share, lower marketing costs, longer exclusivity period and faster uptake of orphan drugs offset the smaller patient pool.
>Orphan drug development shows great potential for commercialization and is an important part of the future of the global biopharmaceutical industry.
All GOOD NEWS.
PAB Price at posting:
4.9¢ Sentiment: Buy Disclosure: Held
