GenInv – Health and Wellness

Opportunities in Orphan Drugs: Strategies for developing maximum returns from niche indications
 
 The US government introduced the Orphan Drugs Act (ODA) in 1983 as a means to provide incentives to drug developers so that they would develop treatments for diseases for which incidence is so low that that normal market forces are unable to deliver effective medication for these conditions. A 1984 modification to the ODA defined an Orphan Disease as any condition affecting fewer than 20

0,000 people in the US. The US was followed by both Japan and the EU which have also introduced their own orphan drug legislation in 1993 and 2000 respectively.  ( http://www.bharatbook.com/detail.asp?id=132643&rt=Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications.html )
 
 Industry has responded to this call for action and the FDA has approved over 270 orphan drugs in the US whilst there are another 583 listed in the Medtrack database as being in o

ngoing development. This has been motivated by the special incentives provided by the FDA and the EU including enhanced market exclusivity, research grants and tax incentives.
 
 Orphan drugs present opportunities to pharma companies looking to move into more niche indications and away from mass market indications that have very low levels of clinical unmet need. Although there are many successful orphan drugs that have made large profits for their developers (Gleevec, NovoSeven etc) the deve

lopment of these products must be approached carefully. This report uses a mixture of case studies and data from secondary sources to elucidate the key issues in the development of orphan drugs and ways to navigate them.
 
 Key features of this report
 
 • Overview of orphan drugs legislation in the US, EU, Japan and Australia including details of key incentives for developers and history of orphan designations and approvals.
 • Evaluation of clinical trial and approval strategies including data on current clinical trial designs and strategies to maximize the chances of clinical trial success through the use of adaptive clinical trials.
 • Overview of orphan drug reimbursement issues in both the US and the EU including details of the importance of the UK’s NICE and the development of novel risk sharing agreements.
 • Examination of the role being played in orphan drug development by leading players in the pharmaceutical and biotech industry and the motivations behind this.
 
 Scope of this report
 
 • Gain an understanding of key orphan drugs legislation and the incentives available to the developers of drugs which successfully gain orphan designation.
 • Get a quick overview of the overall orphan drug development pipeline in the EU and US.
 • Gain strategic insight into the key differences between the development of orphan drugs and non-orphan drugs including the importance of patient advocacy groups.
 • Discover key strategies to maximize revenues from orphan drugs through gaining market access and broadening the product label.
 
 To know more and to buy a copy of your report feel free to visit : http://www.bharatbook.com/detail.asp?id=132643&rt=Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications.html
 
 Or
 
 Contact us at :
 
 Bharat Book Bureau
 Tel: +91 22 27578668
 Fax: +91 22 27579131
 Email: info@bharatbook.com
 Website: www.bharatbook.com
 Blog: http://bharatbookresearch.blogspot.com
 Follow us on twitter: http://twitter.com/3bbharatbook