Another case in point occurred this past November, when the European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) issued a negative opinion on UCB's Cimzia as a treatment for Crohn's disease. The CHMP's opinion, which UCB
plans to appeal, cited issues relating to clinical efficacy, risk of bleeding, and quality control in manufacture of the active
ingredient. Crohn's is one of only several indications for which UCB is targeting Cimzia, with rheumatoid arthritis being
the biggest opportunity. While the clinical efficacy issues are specific to Crohn's, the bleeding and quality control issues
could have broader implications for other indications.
The CHMP's opinion could have a big impact on Lonza, which signed a six-year agreement with UCB in 2005 to supply the API
for Cimzia, a PEGylated antibody fragment. Under the agreement, Lonza is to dedicate to UCB half of the capacity of two 15,000-L
microbial fermentation bioreactors it has built at its site in Visp, Switzerland, at a cost of $165 million. Lonza is one
of the industry's savviest players and its contract probably has provisions that will protect at least some of its downside
risk. However, the uncertainty factor will probably weigh on the company for some time and make it difficult to arrange for
alternate uses of the capacity. (Lonza has not issued a statement on the Cimzia situation yet.)
The Committee for Medicinal Products for Human Use's decision shocked UCB and the biopharmaceutical industry, which has viewed
Cimzia's approval and market success as an almost foregone conclusion for several years. Not only did that perception jump
the gun on regulatory approval, it also overlooked the fact that Cimzia would be a late arrival in the anti-TNF market, where
existing candidates including Amgen's Enbrel, J&J's Remicade, and Abbott's Humira are duking it out and expanding their indications
across the autoimmune disease spectrum.
The reality of the contract manufacturing business model is that it shares a major characteristic of the proprietary product
model: CMOs must constantly renew their product portfolio, replacing late lifecycle products whose sales are declining with
new products that can be expected to grow. The odds are against the success of those new products, however, most of which
are signed up when they are still in clinical trials and have yet to gain regulatory approval, let alone commercial sales.
In an increasingly hostile regulatory and commercial environment, the continued success of contract manufacturing organizations
will require that they look beyond the biopharmaceutical industry hype and take careful measure of their clients' prospects
for success.
Jim Miller is president of PharmSource Information Services Inc. , Springfield, VA, 703.383.4903, jim.miller@pharmsource.com
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