A Medical Device Daily

Barr Pharmaceuticals (Woodcliff Lake, New Jersey) said that its subsidiary, Duramed Pharmaceuticals (also Woodcliff Lake), and Common Sense (Caesarea) have entered into a development, manufacturing and supply agreement for the Al-Sense detecting strip, a panty liner-like device that includes a polymer-coated polyester strip designed to detect amniotic fluid, which could indicate a potential problem with a pregnancy.

The parties intend to develop and seek approval to market the product as a medical device in the U.S. and Canada.

“Our partner, Common Sense, has developed a product that we believe physicians and women who have had, or may be at risk of having, amniotic fluid leakage during pregnancy will find very helpful,” said Bruce Downey, Barr's CEO and chairman. “The product is a self-administered test designed to identify and detect amniotic fluid leakage utilizing a proprietary polymer-coated polyester strip. 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.”

Common Sense said it expects to file a 510(k) application for the product in late 2006 and gain approval in early 2007, and Duramed will make a one-time payment to Common Sense following approval.

Common Sense will manufacture and package the product, which Duramed would then purchase and have responsibility for detailing to physicians and healthcare practitioners using its Duramed Specialty Sales Force. Barr will record net sales of the product and will pay Common Sense for product delivered.

Common Sense manufactures indicators utilizing common hygienic products such as panty-liners and diapers as a platform for “non-intrusive” diagnosis and health monitoring.

In other agreements news:

• Schering AG (Berlin) said it will collaborate with Avid Radiopharmaceuticals (Philadelphia) to develop diagnostic imaging agents for Alzheimer's disease.

The compounds made by Avid directly bind to the amyloid plaques in the brain thought to cause Alzheimer's disease. They can be used with a variety of imaging technologies such as positron emission tomography (PET) scanning. The potential of this compound class to accumulate preferentially in brain structures of Alzheimer's patients with high amyloid beta load already has been demonstrated in pilot human studies, The companies said.

Schering will have the option to assume exclusive rights for the development and commercialization of such compounds for use with PET technology.

• Aspyra (Calabasas, California), a global provider of clinical and diagnostic information solutions, entered into a distributor agreement with Merry X-Ray (MXR)/SourceOne Healthcare Technologies (Mentor, Ohio) for MXR to distribute Aspyra's AccessNET PACS and AccessMED Specialty PACS solutions nationwide.

MXR bills itself as the largest nationwide distributor in the X-ray and imaging industry. SourceOne Healthcare Technologies is an MXR subsidiary.

The three-year agreement enables MXR to be a single-point of contact to the imaging and orthopedic customer. “Providing a PACS solution to our customers, such as Aspyra's PACS, allows us to offer a comprehensive portfolio of electronic imaging solutions to our customers,” said Jeff Root, director of imaging for MXR.

In 1998, MXR created its Digital Imaging Division to respond to such current needs. MXR's electronic product portfolio includes vendor partners and solutions to meet any digital imaging need – from basic teleradiology to enterprise-wide PACS. MXR represents more than 8,000 products and has 38 branches nationwide.