Orphan Drug Trends 2011 – With the industry’s ongoing transition toward more niche high-value therapies, a growing number of companies are expanding into the orphan drugs arena, fuelled by the incentives offered by national regulatory authorities, the high price point orphan drugs can achieve, and the limited competition they face.

Features and benefits

An overview of orphan drug designation policies in the major pharmaceutical markets
Insight into pricing and reimbursement challenges faced by orphan drug manufacturers
Review of orphan drug market R&D, designation, and approval trends in the US market
Orphan drug deal trend and case study analysis

Highlights
• With the growing number of orphan drugs entering the market, products are facing tougher scrutiny from payers, with pricing and reimbursement remaining the most significant hurdle to market access, leading to the use of risk-sharing agreements by a number of manufacturers.
• Pharma’s shift toward niche markets is occurring either by gradually undertaking several bolt-on deals with specialist players, as exemplified by GlaxoSmithKline and Pfizer, or opting for a large scale merger or acquisition to rapidly access the target company’s orphan drug portfolio, as illustrated by Sanofi’s purchase of Genzyme.
• The majority of orphan drug candidates targeted by pharma are in Phase III clinical trials, and are accessed primarily through licensing deals. Nevertheless, pharma is also keen to access orphan drugs during pre-clinical development. Often these deals involve smaller up-front fees, with greater emphasis on commercial milestone and royalty payments.

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