PharmExec Blog

A Lead Drug on the Way? All Eyes on FDA

For NeurogesX, a small biopharma company based in San Mateo, CA, time does not stand still. Every day preceding November 16 brings its flagship drug, Qutenza, one step closer to approval. Until then, the company has turned its energies to finalizing its US commercialization strategy. (NeurogesX previously entered into a commercialization agreement with Astellas Pharma for EU sales/marketing in June 2009.) An approval would not only validate the NeurogesX strategy, but would also transform the company into a commercial-stage, revenue-generating entity.

“The difference is that I think smaller companies take more risks in Phase I and II,” said Anthony DiTonno, CEO of NeurogesX. “They make mistakes like big ones, but in our case, we were lucky enough to have a package of Phase III trials approved in Europe, where authorities view neuropathic pain differently than the US does. One of the interesting things is the difference between the regulatory pathways.”

Since neuropathic pain is very different than acute traumatic pain, it’s not something primary physicians see often. Thus, the sales team will target a very specialized group of physicians who treat nerve signal disorders. “Our approach is to capture roughly the 15,000 to 25,000 physicians out there who spend their day treating this, which includes calling on physicians in pain centers and hospitals,” said DiTonno.

Initially, the company plans to put 30 to 35 people in the field, and ramp that number up based on sales. The plan basically overlays physicians’ prescriptions by zip code. For example, in zip code 00000 there are X amount of prescriptions generated for Product A by a specific type of physician. DiTonno notes that by doing it this way, “you get to more intelligently deploy your sales force.”

So what happens if NeurogesX doesn’t receive get approved? According to DiTonno, that depends on the audience. He cautions, however, that one thing is most important for small pharma to remember: Put yourself in a position to be successful by doing all the planning you can while being extremely conservative with resources.

“Be really strict as you can be in deploying your human and financial resources. In early 2007, we decided that any activity not directly related to approval didn’t begin. We didn’t start any new clinical developments.”

In light of the economic meltdown, and the tough times that all of pharma has experienced, DiTonno emphasized that cash is king, and a kingmaker must manage it efficiently. “It’s a balance between planning for success while making sure that in the event there is a delay or a hiccup, you have the cash available to get you through whatever that hiccup may be.”

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