ViroPharma Drug Gets a 2nd Shot at Approval: Pleconaril



John George

Exton-based ViroPharma Inc., which shelved its experimental treatment for the common cold after it was rejected by Food and Drug Administration early last year, has entered into a new deal for Pleconaril with Schering-Plough Corp. of Kenilworth, N.J.

The two companies entered into an option agreement that could result in Schering-Plough receiving a license for ViroPharma’s intranasal formulation of its antiviral compound Pleconaril as a treatment of the common cold in the United States and Canada.

Under terms of the agreement, Schering-Plough will pay ViroPharma an up-front option fee of $3 million. ViroPharma will then conduct a series of clinical studies designed to evaluate the antiviral activity, safety and other performance characteristics of the intranasal Pleconaril formulation.

Results from the studies are expected to be available in mid-2004.

Based on its assessment of the product’s performance in the characterization studies, Schering-Plough will then have the option to trigger a full license agreement with ViroPharma, under which it would assume responsibility for all future development and commercialization of intranasal Pleconaril domestically and in Canada.

If Schering-Plough exercises its option, ViroPharma will receive an initial license fee of $10 million and Schering-Plough will buy ViroPharma’s existing inventory of bulk drug substance for Pleconaril for an additional undisclosed fee. ViroPharma also would be eligible to receive additional milestone payments if it achieves certain targeted, but unspecified, events as well as royalties on Schering-Plough’s sales of intranasal Pleconaril in the licensed territories.

“We are delighted that we’ve entered into this agreement with Schering-Plough,” said Mark McKinlay, ViroPharma’s vice president of research and development. “We hope to demonstrate that this formulation can deliver significantly more drug to the site of active common cold infections than the oral formulation, while limiting its systemic exposure and minimizing the risk of drug interactions.”

The FDA rejected a tablet formulation of Pleconaril in March 2002 citing safety concerns tied to the drug’s potential adverse interactions with other drugs, such as birth control pills and AIDS medicine. An FDA advisory committee also said it was concerned the widespread use of Pleconaril had the potential to yield new drug-resistant viruses.

Source: Philadelphia Business Journal.

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