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Optivia Launches Comprehensive Assay Suite to Assess Transporter-Related Drug-Drug Interactions and Improve Drug Safety.

OptiDDI(TM) Suite Meets New FDA Advisory Committee and International Transporter Consortium Recommendations

MENLO PARK, Calif. -- Optivia Biotechnology Inc., a leading provider of in vitro transporter assay services, today announced the launch of the OptiDDI(TM) Suite, a novel assay panel that assesses the most clinically significant transporter-related drug-drug interactions (DDIs), as identified by the International Transporter Consortium (ITC) in its report "Membrane Transporters in Drug Development" (Nature Reviews-Drug Discovery, March 2010). The FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology also recently voted that new molecular entities (NMEs) be routinely evaluated during drug development for the transporter-mediated DDIs identified by the ITC.

Optivia Biotechnology is the only company that offers a polarized mammalian cell assay panel for all seven transporters cited by the ITC and the FDA as the most clinically relevant to transporter-related DDIs. Membrane transporters, which facilitate the movement of substances into and out of cells, play a vital role in drug response; they can cause toxicity and can dramatically impact the pharmacokinetics, efficacy and safety profiles of drugs, especially interactions with other drugs. The seven identified transporters are: the efflux transporters P-glycoprotein (P-gp, MDR1, ABCB1) and BCRP (ABCG2); organic cation transporter OCT2 (SLC22A2); organic anion transporters OAT1 (SLC22A6) and OAT3 (SLC22A8); and organic anion-transporting polypeptides OATP1B1 (SLCO1B1) and OATP1B3 (SLCO1B3).

Unlike other transporter assays that are based on frog or insect biology, Optivia assays are modeled on human biology. Consequently, these assays better represent human transporter structure, topology and function, and are most likely to predict results in humans. Another advantage is that all Optivia assays are always performed in polarized mammalian cell monolayers, resulting in fewer false positives and fewer false negatives than other models.

"Drug-drug interactions are particularly important in the growing aging populations in many countries, given the number of different drugs older people may be taking. These interactions can result in reduced medication efficacy, or worse, increased toxicity," said Leslie Z. Benet, Ph.D., Professor and Chairman Emeritus, Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco. "Our rapidly evolving knowledge of transporter biology gives us the opportunity to make these serious adverse drug reactions more predictable, manageable and preventable."

New Tool Optimizes Drug Development

The OptiDDI(TM) Suite provides rapid and reliable in vitro results from a single comprehensive panel that has been designed specifically to satisfy the ITC and FDA Advisory Committee recommendations for transporter-related studies. Results are delivered in an FDA-ready report. Alternatively, clients may select individual transporters for study from a range of transporters offered by Optivia Biotechnology. The assays can help researchers identify DDIs in the early stages of drug development, in support of the clinical development and filing of new drug applications, and finally, in the regulatory review process, providing better information for evaluating the benefits and risks of new chemical entities (NCEs).

"The Optivia assays provide a quantitative tool that will help to evaluate the potential for drug interactions with respect to the transporters identified by the ITC. Earlier identification of DDIs can make drug development more efficient and reduce adverse drug reactions, with the potential to achieve considerable cost savings for the U.S. health care system," Dr. Benet added. Dr. Benet, a leading pioneer in pharmacokinetics/ pharmacodynamics, transporter and metabolic pathways, is a member of the ITC and also serves on the Optivia Scientific Advisory Board.

Notable Drug Failures Linked to DDIs

The need to identify DDIs in the drug development process has become increasingly critical. Over the past decade, there have been several cases of widely prescribed drugs being removed from the U.S. and world markets for safety reasons as a result of serious drug interactions. One of the most recognized was the removal of Baycol([R]) (cerivastatin), a statin drug to lower cholesterol that was implicated in a fatal DDI when concomitantly administered with gemfibrozil, another type of cholesterol-lowering agent. Cerivastatin was linked to 52 fatalities from rhabdomyolysis, a serious muscle myopathy that led to death. The transporter OATP1B1, one of the seven transporters identified in the ITC/FDA recommendations, was implicated in the DDI. Today there is a growing body of evidence linking some commonly prescribed statins with myopathy related to the same transporter.

"We applaud the FDA for recognizing the significance of transporters in drug safety and efficacy and supporting the development of guidance for in vitro DDI studies as part of its Critical Path Initiative to address the most pressing drug development issues," said Yong Huang, Ph.D., President and CEO, Optivia Biotechnology. "Applying in vitro assay systems to understand transporter biology will allow for more accurate prediction of drug behavior in humans, thereby improving the success rate of new drug development and speeding up the approval process. As importantly, transporter assays could prevent a risky compound from harming patients by enabling more accurate labeling to prevent DDIs," he added.

Optivia Biotechnology has developed a Road Map to the ITC Transporter White Paper for Drug Development to support the efforts of the FDA, industry and academia in the application of preclinical and clinical transporter DDI studies to make medications safer and more effective.

About Transporters

Transporters are proteins that act as nature's gatekeeper for cellular entry and exit by facilitating the movement of substances (drugs and endogenous compounds such as hormones and neurotransmitters) across cell and organ membranes. Inhibition or activation of a transporter that serves a role in the absorption, disposition, metabolism, elimination (ADME) and toxicity of a drug can have profound clinical effects ranging from lowering drug efficacy to compromising safety, including DDIs. There are more than 400 currently known unique human transporters, and the body of evidence is growing rapidly for their role in DDI, ADME/Tox and early drug discovery. Approximately 70% of new drug R&D spending is wasted on failed compounds, with ADME/Tox as the number one bottleneck leading to about 86% failure of pipeline compounds and about 40% of clinical failures.

About Optivia Biotechnology Based in Menlo Park, CA, Optivia Biotechnology, Inc. is a leader in developing and providing comprehensive in vitro transporter assay services to help in the discovery and development of drugs with improved safety and efficacy. Optivia uses its proprietary Opti-Expression(TM) technology to create transporter assays that more closely model human biology, and is the only company to conduct all its assays in polarized mammalian cells as opposed to frog or insect-based models or non-polarized models. Optivia's clients and collaborators include pharmaceutical and biotechnology companies, academic groups and research institutions. A pioneer in the field of transporter biology, Optivia is committed to leading the development of clinically relevant assays in support of the FDA's goals to improve drug efficacy and safety. For more information about Optivia Biotechnology, its technologies and services, visit www.optiviabio.com

Baycol[R] is a registered trademark of Bayer Corporation.
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Date:May 11, 2010
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