The Medicines Co. (MDCO) recently announced the voluntary recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion. During a routine annual inspection, the presence of visible particulate matter was observed in some vials.

However, The Medicines Co. stated that it has not yet received any product complaints or reports of adverse events associated with the issue. Physicians have, nevertheless, been warned to inspect the vials before using the product.

The Medicines Company received approval for Cleviprex in August 2008 for the short-term control of blood pressure in patients undergoing cardiac surgery. The product is an ultra-short acting calcium channel blocker (CCB) given intravenously when oral therapy is not feasible or desirable.

The drug acts by selectively relaxing the smooth muscle cells that line small arteries, resulting in widening of the artery and reduction of blood pressure with minimal effect on the heart rate. There are an estimated 300k cardiac surgery patients in the U.S that qualify for Cleviprex.

Although favorable results support the efficacy and safety of the product, Cleviprex has posted sales of only $2.5 million in the first nine months of 2009. We believe sales are being impacted by the presence of a generic version of nicardipine launched by Teva (TEVA) in the market. The presence of cheaper generic alternatives could lead to additional pricing pressure which would make it all the more difficult for the company to drive product sales.

We note that The Medicines Company has already reduced its 2009 sales guidance for Cleviprex to $5 – $10 million (previous guidance: $10 -$19 million). Cleviprex sales could be affected further by the product recall especially if the company recalls additional lots of the product.

The Medicines Company’s shares are down 3.7% on the product recall news. We currently have an Underperform recommendation on the stock.

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