From Promise to Payoff

Dec 01, 2009

After five years of in-licensing drugs and buying biotech companies outright, Big Pharma's shopping spree may be finally moving from promise to payoff. The new drug applications (NDAs) submitted by the Pfizers and Mercks of the world are increasingly for out-of-house discoveries to which the world's biggest drugmakers biggest contribution is bankrolling, designing, and executing late-stage clinical trials.

This trend is nowhere more dramatic than in oncology. Major companies are poised to profit from Cougar Biotechnology's albiraterone, a promising therapy for hormone-refractory prostate cancer, Medarex's ipilimumab, a potential blockbuster in hard-to-treat malignant melanoma, and PARP inhibitors by BiPar and KuDOS Pharmaceuticals.

"There hasn't been much to show for the last five years," said Barbara Ryan, managing director and pharma analyst at Deutsche Bank. "It's time to look for the fruits of those collaborations. There is a glimmer of hope that the payoffs may now become apparent."

On the whole, buying promising pipeline candidates has yet to result in more—or more successful—NDAs. IMS Health, a healthcare information and consulting company that charts NDAs, does not expect the number of new launches to begin climbing back toward 50 a year. (It peaked at 49 in 1997.) "We believe the range for 2010 will stay the same as it is for 2009," said Anthony Riggio, a spokesperson for IMS. The company sees 25 to 30 launches in 2010. Only 25 new drugs were launched in 2008.

That said, the 2010 pipeline promises therapeutic advances and, here and there, a potential blockbuster. Of the 44 Phase II and III compounds, several merit special mention. Denosumab, Amgen's versatile monoclonal antibody, offers hope for metastatic cancer patients as well as people combating bone disease. Four late-stage Factor Xa inhibitors are racing to replace the blood thinner warfarin, one of the oldest and most widely prescribed medications in the world. And multiple sclerosis patients can see an oral therapy on the horizon.

The most notable absence is in the CNS diseases, a.k.a. the "black box" of drug R&D. As the current disarray in the Alzheimer's pipeline illustrates, neuroscience has a great deal left to learn about the fundamental workings of the brain before truly disease-modifying drugs are developed.

Our 2009 Pipeline Report take-home? It may not be an age of bounty in the pharmaceutical industry—but it is a time of hope.

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