Grace and Formac Pharmaceuticals Announce Successful Clinical Trial
Demonstrating the Novel Use of Silica for Drug Delivery
COLUMBIA, Md., Apr 23, 2012 (BUSINESS WIRE) --W. R. Grace & Co. (NYSE: GRA), 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.
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.
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.
W. R. Grace & Co.
Greg Euston, +1
Mark Sutherland, +1 410-531-4590