Biopharmaceutical Trends In 2012: Regulatory And Market Strides Paper Over Existential Dilemmas
The biopharma industry enjoyed regulatory success in 2012 that was recognized by investors. The stench from the carcasses of industry’s genericized blockbusters has begun to fade, but R&D productivity for the most part remains poor, expensive late-stage failures abound, and industry is still searching for sustainable business models.
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Eli Lilly has signed on as a risk-sharing partner with AstraZeneca to develop a BACE inhibitor for Alzheimer’s disease. The deal gives Lilly a mid-stage asset in the challenging field after two of its own candidates failed in late-stage trials.
Biopharma and diagnostic IPOs have been relatively quiet since before the U.S. presidential election, but companies are again starting on road shows and updating prospectuses in anticipation of recaptured momentum.
In 2012, FDA new drug approvals reached levels not seen since the peak years of the 1990s. FDA counts 39 NMEs; The RPM Report tracks a different metric—ICTs—and FDA topped 30 for the first time since 1999. The approval spike clearly reflects a regulatory agency operating at peak efficiency. Is there also (at last) a true bulge in innovative products making it through development?