Pullan Consulting
Biotech Business Development Consulting
www.pullanconsulting.com and www.lindapullan.com
email: lpullan@msn.com 805-558-0361
Issue #21
Pullan's Pieces
Commentary on Science & Business of Drug Development
For Business Development & Others
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The FDA may start missing its review deadlines
The WSJ (http://blogs.wsj.com/health/2008/03/05/fda-decisions-on-drug-approval-could-start-slipping/trackback) reports that FDA staffers have unofficial permission to start missing the PDUFA-imposed deadlines on reviews for drug approvals. PDUFA provided greater industry fees to provide staffers for prompt review. The news of expected slippage in review times comes after an increase in rejections of filings, more approvable letters (requiring more work before approval), and a greater emphasis on safety. Delays in time to market will have ripples all the way down to the valuation of early licensing deals.
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Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook – Good source of industry averages
The CRO Parexel regularly publishes a collection of statistics for our industry compiled from many sources. I find it very useful for unbiased estimates of numbers used in modeling market potential or deal values, such as Phase 1 clinical trial costs and durations or attrition rates by stage of development The citations for each original source are included. Back issues (with slightly dated statistics) are available for less. http://www.barnettinternational.com/edu-pubs1.cfm
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Companies are expanding their antibody pipelines
The antibody field is still young and growing. There are only 50 launched or registered therapeutic antibodies in the analyzed companies. Genentech has launched the most therapeutic antibodies (6), with J&J in second place with 5. But AstraZeneca may overtake those leaders with its strong pipeline of 37 antibodies in preclinical to pre-registration. AstraZeneca may launch the most antibodies in the future, with its pipeline power of 11.5, obtained by multiplying the industry probability of launch at each stage of development by the number of molecules at that stage and summing all the probability adjusted numbers, in an approximation of how many molecules the pipeline can be expected to deliver to market. Medarex, with no launched antibodies, has the 2nd highest pipeline power and Genentech and Glaxo are in 3rd and 4th place.
In the top half of pipeline power and in the top half of number of launched drugs are the “Committed” leaders in antibodies, Genentech, J&J, AstraZeneca, Roche, Biogen Idec, Novartis and GSK. In the bottom half of pipeline power but in the top half of launched drugs, are Merck KGaA, Sanofi-Aventis, Daiichi Sankyo, Abbott, BMS, and Bayer. But in contrast to last month’s analysis of anti-infectives (see www.pullanconsulting.com for back issues), this group may not be so clearly falling behind in replacement power in antibodies. Merck KGaA has the potential to replace its launched antibodies from its pipeline, with pipeline power almost equal to its number of launched antibodies. Medarex, Amgen, PDL and Pfizer are growing their antibody franchises, with pipeline power in the top half of the analyzed group; with Pfizer in the top half of pipeline power from zero launched antibodies. Smaller players, with zero or 1 launched antibody and with pipeline power in the bottom half, include ImClone, Eisai, Wyeth, Takeda, Genzyme, Elan, Merck, and Astellas. Astellas and Bayer have only 2 antibodies in their pipeline.
The replacement power (pipeline power/number of launched antibodies), an estimate of the ability to replace the existing launched products. for the entire group of these companies is 1.8. This is dramatically stronger than the 0.16 for anti-infectives, suggesting that the number of launched antibodies in the future will be more than enough to replace the current collection of launched antibodies. It is a growing field.
What does all this mean for the small companies working in antibodies? Growth in antibodies will not just come from these bigger players. The pipeline power of the rest of the industry (beyond those analyzed above) is almost the same as for the leaders, with most (322) of the remaining antibodies in preclinical. It seems that companies with low replacement power, such as Bayer, Sanofi-Aventis, Daiichi-Sankyo, BMS and Abbott might be interested in licensing new antibodies, and there is pipeline power available to license!
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Pullan Consulting
Linda M. Pullan, Ph.D.
Biotech Business Development
www.pullanconsulting.com and www.lindapullan.com
e-mail: lpullan@msn.com
805-558-0361
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