A steady stream of FDA approvals drive most pharmaceutical companies. Any break in the flow interrupts the organic flow of the company. Baring any eureka moments, all that a company can do is wait.

Penwest Pharmaceuticals Inc., a pharmaceutical development company, is primarily engaged in development and marketing of neurological drugs. Its strategic partner in the sale of its products is Chadds Ford, Pa based ENDO Pharmaceuticals Inc. The company’s current pipeline of products is back end loaded with two products heading for phase IIa/III or orphan phase 1/1a safety approval by the FDA in 2008. Estimated phase III and Phase IIa efficacy are expected in 2009. Additionally, two drugs should be reaching Phase II in 2009 relating to Parkinson’s disease and epilepsy.

As might be expected, with a product approvals pipeline such as it is, the company’s balance sheet is not dominated by astounding returns. The company’s strategic partner, ENDO Pharmaceuticals has expressed a desire to use its large sales force to bolster its pain/neurological drugs sectors but is apparently waiting for product. This company, however, has a stable full of brand products such as Percocet to keep its sales force moving.

The products that Penwest Pharmaceuticals has in its stable are available but appear to be doing little for the company. A patent infringement case against a recent FDA filing from a Florida company wanting to manufacture a generic form of the company’s Opana product has been instigated. The lawsuits effect on the company is likely minimal considering that the drug in question, Opana® ER, an opiate with addiction issues, has a “black box” warning and is not likely to impact the company’s sales to any real extent.

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