Grace and Formac Pharmaceuticals Announce Successful Clinical Trial Demonstrating the Novel Use of Silica for Drug Delivery

COLUMBIA, Md., Apr 23, 2012-- W. R. Grace & Co., in partnership with Formac Pharmaceuticals NV, a research and development pharmaceutical company, announced today positive data from initial human studies enabled by the companies' unique mesoporous silica-based drug delivery technology. This novel technology opens up a viable new avenue for the development of poorly soluble compounds.

This was the first-ever clinical study to demonstrate the bioavailability enhancing properties of silica in humans. Improved bioavailability enables active pharmaceutical ingredients (API's) to more effectively absorb into the body. In this study, the bioavailability profile of fenofibrate formulated with silica was compared to the marketed micronized formulation (Lipanthyl(R)). The study results show a 54 percent higher bioavailability for the silica formulation than the marketed formulation.

The study confirmed the numerous promising findings obtained in preclinical models and exemplifies that the Grace and Formac Pharmaceuticals partnership can provide a fully integrated, cost effective and innovative solution, from early phases to commercial production, for the development of poorly soluble compounds.

"We are excited about the study results proving the effectiveness of the silica-based drug delivery technology in humans," said George Young, Vice President of New Business Development at Grace. "The successful completion of this study marks an important milestone for our strategic partnership with Formac as we embark on the development and commercialization of this novel approach for improved drug delivery."

Grace and Formac partnered in 2011 to optimize and commercialize the silica based technology that Formac created. Grace is leveraging its silica R&D and manufacturing expertise to develop a portfolio of silicas that can give pharmaceutical companies an optimized and tailored drug delivery solution for their drug.

For more information, please visit www.SilicaDrugDelivery.com .

About Grace

Grace is a leading global supplier of catalysts; engineered and packaging materials; and, specialty construction chemicals and building materials. The company's three industry-leading business segments--Grace Catalysts Technologies, Grace Materials Technologies and Grace Construction Products--provide innovative products, technologies and services that enhance the quality of life. Grace employs approximately 6,000 people in over 40 countries and had 2011 net sales of $3.2 billion. More information about Grace is available at www.grace.com .

About Formac

Formac Pharmaceuticals serves the pharmaceutical industry with a powerful, innovative tool to improve the oral bioavailability of poorly soluble active pharmaceutical ingredients (API's). Using its tailor-made mesoporous silica materials, Formac has created an innovative solution for bioavailability enhancement that relies on the generation of intestinal supersaturation. Formac's formulation platform provides solid dosage forms with excellent physical and chemical stability and is easily implementable and upscalable in established manufacturing units. More information about Formac is available at www.formacpharma.com .

SOURCE: W. R. Grace & Co.

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