American Biogenetic Produces Single Isomer Version Of Epilepsy Drug ABS-103

American Biogenetic Sciences, Inc. (Copiague, NY) has produced a single-enantiomer version of its lead neurological compound, ABS-103. In predictive animal models, the single isomer was free of the potential for birth defects associated with valproic acid, one of the world's most commonly used epilepsy treatments. The R-ABS-103 isomer is a more refined version of ABS-103, which itself is a next-generation more potent derivative of valproic acid, a drug that generates annual worldwide revenues in excess of $1 billion.

Animal tests conducted by Heinz Nau of the University of Hanover, Germany, showed that R-103 had antiepileptic activity and potency equal to that of the racemic mixture ABS-103. In addition, while ABS-103 had virtually eliminated the teratogenic potential (tendency to produce birth defects) of valproic acid, tests found that the single isomer R-103 was even less toxic, and totally eliminated such risks in key animal models.

"We are very pleased with this development," said John S. North, president and CEO of ABS. "The FDA has strongly encouraged the pharmaceutical industry to take the development of new drugs to the final stage of isolating the proper isomer - the version of a compound that has maximum activity against disease, with minimum unwanted side-effects and toxicity. That is precisely what we have achieved with the development of R-103."

Optical isomers (enantiomers) are non-superimposable mirror images of the same compound. Although discovered by Louis Pasteur 150 years ago, only recently have pharmaceutical companies and regulatory agencies appreciated the value of single-isomer drugs. Their value lies in the fact that often one of the isomers is responsible for the therapeutic effect of a medicine, while the other isomer may be inactive or may cause unwanted side effects or toxicity. The isolation of single isomer drugs has proved particularly successful for pharmaceutical companies such as Sepracor (Marlborough, MA), which develops and patents single isomer versions of existing medicines.

"From this point forward, we will be proceeding with R-103," said North. "We have two issued patents and numerous pending for the compound in each of the world's largest pharmaceutical markets. Our priorities now for R-103 are to complete final preclinical testing currently underway, move the compound into Phase I clinical trials, and strike an agreement with a commercialization partner."

For more information: John North, CEO, American Biogenetic Sciences, 1375 Akron St., Copiague, NY 11726. Tel: 516-789-2600. Fax: 516-789-1661.