Merger Creates World-Class CRO With Decades of Clinical Trials Support; Strengths in Oncology, Dermatology, Nephrology, and Medical Device Trials
BOSTON, MA and SAN DIEGO, CA Jul 6, 2006, IT&E International Group, Inc. (OTC BB:ITER.OB), a life sciences service organization and full-service clinical research organization (“CRO”), today announced that it has entered into an Agreement and Plan of Merger with privately held Averion Inc., a Massachusetts corporation (“Averion”) and CRO, for the purpose of forming a world-class CRO. The transaction will combine two groups — IT&E and Millennix, the IT&E division providing comprehensive clinical research services, and Averion — to form a clinical research organization with unique therapeutic areas of expertise.
Under the terms of the Agreement, Averion will be acquired for $25 million in stock, cash, and notes. It is expected that the newly combined company will have approximately $40 million in combined annual revenue, and maintain leadership positions in oncology, dermatology, nephrology and medical device development.
Averion’s founder and Chief Executive Officer, Dr. Philip T. Lavin, will become Chief Executive Officer of the new company, overseeing the integration of the companies and directing the combined operations. Dr. Lavin founded Averion in 1983 and has over 20 years of continuous industry experience. He will continue to be active with clients and the FDA in strategic planning and product presentation. Gene Resnick, M.D., President and founder of Millennix, will work with Dr. Lavin. Dr. Resnick has over 25 years experience in oncology clinical practice, large pharmaceutical portfolio management and specialized CRO leadership. The combined company workforce will exceed 250 employees with offices located in the Boston, New York, San Francisco and San Diego metropolitan areas, and Darmstadt, Germany. The combined companies have helped clients achieve over 45 FDA approvals including 20 PMA approvals. Due to current and expected outsourcing project demand from the two combined client bases, staffing levels are expected to increase across the company.
“This transaction is a significant step in expanding our CRO business,” said Alastair McEwan, Interim Chief Executive Officer of IT&E International. “We are especially pleased to have the talents of Phil Lavin and the organization he has built. Combining these two businesses brings our clients superior track records, decades of clinical and statistical experience at the senior levels, greater geographic reach with minimal client overlap, and a complementary set of processes and audits. In particular, we will leverage our depth in oncology and medical devices. We expect to make additional acquisitions as we address the needs of the estimated $10 billion clinical outsourcing market.”
“We aim to create the CRO partner of choice,” said Philip T. Lavin, Chief Executive Officer / President and Founder of Averion Inc. “We’re excited to join IT&E and its Millennix division, a company with a track record like Averion’s, and one that shares our core values. With our combined international reach, we believe we can address unmet needs in the areas of metrics and customer service that will enable Averion to better serve U.S. clients seeking extended validation and compliance services through the product life cycle. By combining, we also believe we can extend clinical support expertise to IT&E customers, and deliver strong customer service and state-of-the-art solutions.”
Dr. Gene Resnick, Senior Vice President of IT&E and President of IT&E’s Millennix division, through which IT&E provides comprehensive clinical research services, said, “This merger will give Millennix expanded access to clinical research systems, monitors, and other support personnel in the US and in Europe. We expect our clients to be enthusiastic at our ability to conduct larger and more demanding studies with a global scope. The fit is ideal.”
“We’re very pleased that Averion will be joining us as we continue to execute our life science strategy,” stated Kelly Alberts, President and founder of IT&E International. “Averion has a demonstrated record of providing superior services, and we look forward to combining the organizations to give our clients a high quality, total product lifecycle solution.”
The transaction, which is subject to certain closing conditions, is expected to close during July.
IT&E International’s largest shareholder, The ComVest Group’s private equity fund, ComVest Investment Partners II LLC, has committed to exercise its option to invest an additional $5 million in IT&E simultaneous with the closing of the merger.
About The ComVest Group
The ComVest Group is a Leading Private Equity Firm focused on investing in middle-market companies. Since 1988 ComVest has invested more than $2 billion of equity capital in over 200 public and private companies world wide. Through the firm’s extensive financial resources and broad network of industry experts, the firm is able to offer its portfolio companies total financial sponsorship, critical strategic support, and business development assistance. The firm has offices in West Palm Beach, Florida and New York City, New York. (https://comvest.com)
About Averion Inc.
Headquartered in Southboro, Massachusetts, Averion Inc., and its European division located in Darmstadt, Germany, is a full-service CRO in business for 23 years with a therapeutic focus in dermatology, medical devices, nephrology, and oncology and core competence in FDA and product registration support, site selection, project management, medical and site monitoring, data management, biometrics, pharmacovigilance, medical writing, and full clinical trial management services throughout the clinical trials lifecycle. The company has supported over 40 FDA approvals to date with no refusals among submissions accepted for filing; in addition, the company has helped achieve approvals for six oncology-related product approvals. (http://www.averioninc.com)
About IT&E International Group, Inc.
Headquartered in San Diego, IT&E International and its Millennix division in Rye Brook, NY, is a full-service CRO that provides pharmaceutical and biotechnology companies with FDA and global regulatory compliance and validation services as well as full-service CRO support with an oncology focus throughout the product development lifecycle. The company’s team of industry veterans utilizes the latest tools and procedures to help its clients move quickly and effectively from drug development through the FDA approval process. Consulting services throughout the product development lifecycle cycle include regulatory planning, providing skilled personnel for development operations, enterprise software and training to manage data and ensure FDA compliance and validation of new pharmaceutical manufacturing facilities. Oncology CRO services support Phase I – IV trials, and include regulatory and strategic planning, study design and implementation, site identification and management, safety reporting, data management and biotmetrics and reporting. (http://www.iteinternational.com) (www.millennix-inc.com)
Included in this release are “forward-looking statements.” Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to have been correct. The Company’s actual results could differ materially from those anticipated in the forward-looking statements. The Company refers you to the cautionary statements and risk factors set forth in the documents it files with the Securities and Exchange Commission, including its most recent 10-KSB. The Company is not under any obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.