MedDRA Terminology Now Available for License.

RESTON, Va.--(BUSINESS WIRE)--April 13, 1999--

TRW (NYSE: TRW) today announced the availability of MedDRA 2.1, the Medical Dictionary for Regulatory Activities (MedDRA) terminology created under the auspices of the International Conference on Harmonisation (ICH) and owned by the International Federation of Pharmaceutical Manufacturers Association (IFPMA) acting as trustee of the ICH steering committee.

TRW, together with partners Quintiles, Inc., Stellar Systems LLC, and Cyntergy operate the MedDRA Maintenance and Support Services Organization (MSSO), the sole authorized source of MedDRA licenses and core services which includes the MedDRA maintenance, distribution and updates, as well as basic help desk and user group membership. Ernst and Young has been retained to provide knowledge management services. The MSSO has sub-licensed the terminology to the Japanese Maintenance Organization (JMO) to maintain and distribute the Japanese translation of MedDRA.

"MedDRA 2.1 provides a common platform and communications link for the rapid exchange of clinical data throughout the international biopharmaceutical industry and between industry and its regulatory bodies, thereby facilitating efforts to bring new drugs to market, safely, and quickly," says Kathryn Huntley, MSSO program manager, who notes that use of the terminology is open to any organization worldwide. "Today, there are a number of terminologies used throughout the industry," Huntley explains, "complicating the exchange of clinical information and research and safety monitoring and needlessly delaying the regulatory approval process. A great benefit to the medical community and unique to MedDRA is that it is capable of serving a large international user base with varied linguistic and cultural difference," Huntley adds. Huntley and others view MedDRA as an imperative solution and one that will be adopted by regulators in the U.S., Europe, and Japan. The U.S. Food and Drug Administration (FDA) has already implemented MedDRA within its new Adverse Event Reporting System (AERS).

The need to address the growing communications issues between international drug manufacturers and regulators prompted the creation of MedDRA by the International Conference on Harmonisation (ICH) in 1994. The ICH is a committee comprised of international regulators and members of the pharmaceutical industry. The terminology is the intellectual property of the IFPMA, which awarded a 5-year, sole-source contract to TRW in November 1998 to license MedDRA terminology.

The MSSO has begun distributing the newest version of MedDRA (2.1), which replaces all earlier versions of the terminology, on a subscription basis. MedDRA 2.1 was designed to simplify data entry, retrieval, analysis, and display of clinical information without compromising data integrity. "MedDRA 2.1 substantially expands the capabilities of MedDRA and its value to drug manufacturers, others in the biopharmaceutical world, and the bodies that regulate drug registration and safety," says Huntley.

The MSSO will also offer expanded services bringing their extensive expertise in information systems and safety data management to assist MedDRA subscribers with training, assessment, and implementation.

MedDRA MSSO is supported by TRW's Healthcare Solutions unit of the Reston, Va.-based TRW Systems & Information Technology Group. Healthcare Solutions provides advanced solutions to global healthcare data management by integrating complex, disparate computer system and databases in secure environments. TRW Systems & Information Technology Group is one of the world's 10 largest global IT providers. Parent company, TRW Inc., is a worldwide provider of advanced technology products and services with sales in 1998 of $12 billion.

Quintiles is the market leader in providing a full range of integrated product development and commercialization services to the pharmaceutical, biotechnology and medical device industries.