Barr's Duramed unit to develop Al-Sense amniotic fluid detection product with Common Sense

By Lisa Kerner

Charlotte, N.C., July 14 - Barr Pharmaceuticals, Inc.'s subsidiary, Duramed Pharmaceuticals Inc., entered into a development, manufacturing and supply agreement with Common Sense Ltd. for the Al-Sense detecting strip.

The panty liner-like device with its proprietary polymer-coated polyester strip, detects amniotic fluid which could indicate a potential problem during pregnancy, according to a company news release.

Under the agreement, Common Sense is responsible for all regulatory filings, including a 510-K application planned for late 2006.

The company will also manufacture and package the Al-Sense product.

Duramed will purchase and sell the product using its specialty sales force.

In addition, Duramed will make a one-time payment to Common Sense following Food and Drug Administration approval.

Duramed and Common Sense plan to seek marketing approval for the Al-Sense detecting strip in the United States and Canada.

"If approved, this product would be available to women by prescription and would provide a significant advance in the treatment of female patients at risk for amniotic fluid leakage," Barr chairman and chief executive officer Bruce L. Downey said in the release.

Woodcliff Lake, N.J.-based Barr is a holding company whose Duramed subsidiary develops, manufactures and markets generic and proprietary pharmaceuticals.

Located in Caesarea, Israel, Common Sense develops and manufactures indicators using common hygienic products as a platform for non-intrusive diagnosis and health condition monitoring.

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