Albany Molecular Research, Inc. Adds Metabolic Screening and Metabolite Production Technologies.

Business Editors

BOSTON--(BUSINESS WIRE)--Aug. 6, 2002

Albany Molecular Research, Inc. (Nasdaq: AMRI):

Technologies for Evaluating the Rate and Products of

Drug Metabolism and Potential for Drug-Drug Interactions

Integrated with AMRI's Medicinal Chemistry 

Albany Molecular Research, Inc. (Nasdaq: AMRI) today announced that it has added drug metabolism assay and metabolite production capabilities to its integrated drug discovery and development technologies.

AMRI's new high throughput metabolic screening system provides valuable information about the metabolic properties and enzyme interactions of compounds. This information, when obtained early in the lead optimization process, can be used to select compounds with maximum metabolic stability and minimize the potential for drug-drug interactions. Increased metabolic stability correlates with a need for less frequent dosing intervals.

AMRI's metabolic screening technologies use the same high throughput, robotic platform as the company's proprietary combinatorial biocatalysis technology, which broadly applies enzyme-catalyzed reactions to pharmaceutical chemistry, providing a seamless transition to structural modification of lead compounds or re-synthesis of medicinally interesting metabolites. This platform is ideally suited for scale-up synthesis of metabolites in significant quantities.

"The integration of new metabolism capabilities with our existing drug discovery technologies provides enhanced lead optimization and preclinical support opportunities," said AMRI Chairman and Chief Executive Officer Thomas E. D'Ambra, Ph.D. "Synergies with medicinal chemistry enable the optimization of the metabolic behavior of a candidate series at the same time that its therapeutic activity and other parameters are being optimized, reducing the likelihood of late-stage failures. Our metabolic screening and metabolite production capabilities can improve the quality of optimized drug candidates, and help reduce drug development time, preclinical drop-outs and cost."

AMRI's newly developed technologies include primary metabolic studies of potential drug candidates, including metabolic stability assays, metabolite profiling assays, and evaluation of the interactions of drug candidates with cytochrome P-450 isoforms. Metabolite scale-up can be accomplished using AMRI's biocatalysis platform.

- Metabolic Stability Assays

AMRI's metabolic stability assays evaluate the expected "first pass" stability of a lead compound using timed incubation with liver microsomes and hepatocytes from human and animal species. The assays help predict primary metabolism in the liver, enabling researchers to identify early in the drug discovery process whether a compound is stable in a natural environment, metabolized too fast or at a pharmacologically acceptable rate, and assess important elements of the compound's likely toxicity and side effect profile--all characteristics that can be considered in a lead optimization program.

- Metabolic Profiling Assays & Metabolite Production

AMRI's metabolic profiling assays identify metabolites produced from the interaction of a potential drug compound with metabolic enzymes identical to those produced in the body. AMRI's testing protocol includes incubation of the lead compound with liver microsomes, hepatocytes and isolated human cytochrome P-450 isoforms to determine the relative quantities of observed metabolites, followed by multiple analyses to identify, quantify and structurally characterize those metabolites. AMRI's extensive and established expertise with enzymology and parallel, high throughput synthetic biocatalysis enables the company to rapidly assess the impact of many classes and sources of metabolic enzymes affecting drug clearance and pharmacokinetics on drug candidates, and rapidly and thoroughly identify metabolites.

Once observed metabolites have been identified and characterized through metabolic profiling, AMRI can then scale-up metabolites of interest using traditional chemical synthesis or biocatalysis. AMRI has an extensive collection of enzyme catalysts that can be evaluated to determine suitability for the large scale production of specific metabolites. Thus, pure metabolites may then be studied for biological activity, toxicity, side effects, structural confirmation, or further modified through medicinal chemistry and/or biocatalysis.

- Cytochrome P-450 Isoform Analysis

Cytochrome P-450 (CYP-450) isoforms are a particularly important class of metabolic enzymes that act on chemical compounds as they enter the human body, particularly in the liver. In order to identify specific CYP-450 isoform interactions with a test compound, AMRI utilizes liver fractions and recombinant versions of individual CYP-450 isoforms. The analysis uncovers possible drug-drug interactions, along with the metabolic path of the compound, the involvement of CYP-450 isoforms in generating specific metabolites, and provides guiding information for further studies of kinetics, clinically relevant polymorphisms, and related information.

- Cytochrome P-450 Inhibition Assays

Test drug compounds may inhibit the activity of a specific CYP-450 isoform, causing changes to the metabolism of co-administered drugs or the body's metabolism that can produce adverse interactions or unwanted side effects. AMRI evaluates lead compounds using several different human CYP-450 isoforms to anticipate these potential side effects. Using IC50 values and Ki values for inhibition of CYP isoforms, AMRI measures, respectively, the potential that a test compound will significantly inhibit a particular CYP-450 isoform, and the concentration at which the compound is likely to inhibit a CYP-450 isoform.

"Information on the pharmacological properties of early-stage lead compounds is crucial for sharpening drug development efforts," added Peter C. Michels, Ph.D. senior director at AMRI's Mount Prospect Research Center. "AMRI's goal is to provide improved knowledge of the metabolism of pharmaceutical lead compounds, resulting in earlier prioritization of lead compounds and more focused medicinal chemistry efforts."

The announcement of AMRI's new drug metabolism technologies was made in conjunction with the 7th Annual Drug Discovery Technology(TM) World Congress in Boston, MA.

Albany Molecular Research, Inc. is a leading chemistry research, drug discovery and development company focusing on applications for the life sciences industries. The company performs comprehensive research, development or manufacture for many of the leading pharmaceutical and biotechnology companies and for its own internal drug discovery and development.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements may be identified by forward-looking words such as "may," "could," "should," "would," "will," "intend," "expect," "anticipate," "believe" and "continue" or similar words. Readers should not place undue reliance on our forward-looking statements. The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control. Factors that could cause such differences include, but are not limited to (a) the company's ability to attract and retain experienced scientists, (b) trends in pharmaceutical and biotechnology companies outsourcing chemical research and development, (c) the company's ability to take advantage of proprietary technology and expand the scientific tools available to it, (d) the company's ability to integrate its metabolic screening and metabolite production technologies with its existing drug discovery technologies, (e) the company's ability to optimize the metabolic behavior of a candidate series at the same time that its therapeutic activity and other parameters are being optimized, (f) the company's ability to improve the quality of optimized drug candidates, help reduce drug development 0time, preclinical drop outs and cost, as well as those factors discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2001 as filed with the Securities and Exchange Commission on April 1, 2002 and the company's other SEC filings. The company does not undertake any duty to and does not intend to update any forward-looking statements contained in this press release after the date of this press release.