From the Pharmalot, we have some interesting statistics regarding activity in the orphan drug arena. As we know, The Orphan Drug Act encourages development of drugs for diseases with small markets. It gives drugmakers seven years in which to sell a product without competition and sometimes tax incentives, too.
Orphan Drugs: More Designations, Fewer Approvals // Pharmalot.
With the advent of patent cliffs and revamping R&D groups in Big Pharma, as well as directional changes away from chasing so-called "blockbuster models", orphan and rare disease markets have become more in vogue. Several large pharma companies have launched specific initiatives in this sphere including Pfizer, GSK and Sanofi.
Now let's review the recent stats. Last year, 323 requests went to the FDA for orphan status and 192 were awarded with that designation. There are now 2308 drugs designated as orphans. Designated n development and approved for sale are two different things it seems. The FDA approved 14 orphan meds in 2010, 17 in 2009, which ar eboth below the peak year of 25 in 1996.
Based on the stats, a given Company's reach may exceed its grasp when pursing orphan drugs -- but the opportunity to get a lock on a market for several years is apparently irresistable at a time when FDA scrutiny of new drugs is particularly high and drug development is so expensive. Of course, when everyone pursues the same strategy some are destined to be disappointed as well - and the stats would seem to reveal that news.
Posted by Bruce Lehr Feb 1st 2011.
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