Kendle International Strengthens Regulatory Consulting Expertise Through Key Appointments

CINCINNATI, June 15 /PRNewswire-FirstCall/ -- Kendle , a leading, global full-service clinical research organization, today announced the appointments of Paul Roney, PhD, DABT, and Lisa Jenkins, PhD, as Senior Regulatory Consultants. These appointments strengthen the company's global regulatory affairs and quality consulting team and will help drive continued growth in its regulatory business worldwide by providing strengthened regulatory consulting expertise to advise customers on their regulatory strategies from early stage through registration.

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Dr. Roney will provide strategic advice and expertise on all matters dealing with nonclinical toxicology, including strategic planning, preparation of the nonclinical section of Investigational New Drugs (INDs) and New Drug Applications (NDAs), helping customers to prepare and meet with the FDA and construction of Expert Reports and other regulatory documents. He will be based at the company's office in Rockville, Md. Dr. Jenkins, who will be based out of the company's Cincinnati office, will be responsible for regulatory submission projects, including INDs and NDAs. She will provide guidance to the company's biopharmaceutical customers for Prescription Drug User Fee Act milestone meetings and related briefing documents, as well as strategic advice on clinical and regulatory development plans.

"The addition of Paul will be a great attraction to our regulatory customers that want advice from an ex-FDA toxicologist," said Melanie A. Bruno, PhD, Vice President, Global Regulatory Affairs and Quality. "Lisa will provide an excellent resource to those clients who need to develop global regulatory submissions."

Prior to joining Kendle, Dr. Roney was a toxicology reviewer in the Division of Neurology Products at the U.S. Food and Drug Administration. In this position, he wrote the primary review of the nonclinical sections of INDs and NDAs for drugs in development to treat neurological and psychiatric diseases. He worked closely with other members of the review team to produce integrated assessments of the risks associated with these drugs and frequently met with industry representatives to offer guidance on the nonclinical issues associated with all phases of drug development.

Dr. Roney earned his doctorate and master's degrees in environmental sciences from the University of Texas Health Science Center in Houston and a bachelor's degree in microbiology from the University of Notre Dame. He has been a Diplomate of the American Board of Toxicology (DABT) since 1991. While at the FDA, he was a member of the Inactive Ingredients Subcommittee and the Phospholipidosis Working Group. He is a member of the Society of Toxicology and the American College of Toxicology. He was past president of the Association of Government Toxicologists.

Dr. Jenkins comes to Kendle from Wyeth Pharmaceuticals, Inc. where she served most recently as Senior Manager, Worldwide Regulatory Affairs with responsibility for providing strategic and functional regulatory support for several global eCTD, IND and NDA filings. Dr. Jenkins also served as a principal statistician at Wyeth and was actively involved in the planning, execution and reporting of Phase I-III CNS trials. She earned her doctorate in experimental psychology from Syracuse University (New York) and completed her post-doctoral research fellowship at Washington University in St. Louis, Missouri.

The recipient of numerous industry and academic awards, Dr. Jenkins has published more than 15 articles and presented at more than 30 national conferences. In addition, she is a member of the Drug Information Association and Regulatory Affairs Professional Society.

Forward-Looking Statements

This release contains information about management's view of Kendle's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, those set forth in the "Risk Factors" section of the Company's latest Form 10-K and other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point, the Company specifically disclaims any obligation to do so other than as required by federal securities laws. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

About Kendle

Kendle International Inc. is among the world's leading global clinical research organizations and is the fourth-largest provider of Phase II-IV clinical development services worldwide. We deliver innovative and robust clinical development solutions - from first-in-human studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share.

Our global clinical development business is focused on five regions - North America, Europe, Asia/Pacific, Latin America and Africa - to meet customer needs. With the expertise of our more than 3,000 associates worldwide, Kendle has conducted clinical trials and provided regulatory and pharmacovigilance services in more than 80 countries.

Additional information and investor kits are available upon request from Kendle, 441 Vine Street, Suite 1200, Cincinnati, OH 45202 or from the Company's Web site at http://www.kendle.com.

CONTACT: Investors, Patty Frank, +1-513-763-1992, or Media, Lori Dorer,+1-513-345-1685, both of Kendle International Inc.

Web site: http://www.kendle.com//