US Food & Drug Administration (FDA) report, March 16, 2004

"The current medical product development path is becoming increasingly challenging, inefficient & costly."

"Pharmaceutical […] productivity appears to be declining at the
same time that the costs to develop a small number of treatments are
increasing."

"A new medicinal compound entering Phase 1 testing […] is
estimated to have only an 8 % chance of reaching the market. This
reflects a worsening outlook from the historical success rate of about
14 %."

"Similar trends have been observed at regulatory agencies worldwide."
Drug makers court small firms in push to fill thinning pipelines

"Big
drug companies are facing patent expirations on many blockbuster drugs
over the next five to 10 years. Meanwhile, there has been a steady
decline in the number of genuinely new drugs approved by the Food and
Drug Administration."

"Negotiations
are heating up in Cambridge, on the West Coast, and in Europe, as
pharmaceutical executives compete for the most promising molecules."

"They
are signing scores of cheaper pacts for the earliest discoveries,
looking to get a toehold on technology that may or may not succeed in
the future."