PAREXEL CONSULTING AND GULF PHARMACEUTICAL INDUSTRIES SIGN AGREEMENT FOR HUMAN RECOMBINANT INSULIN REGULATORY DEVELOPMENT PROJECT
Boston, MA, U.S. and Ras Al Khaimah, UAE, February 2, 2011— PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global consultancy serving the biopharmaceutical and medical device industries, today announced that it has signed an agreement with Gulf Pharmaceutical Industries (Julphar), a pharmaceutical manufacturing company based in the United Arab Emirates, to support a key development project. PAREXEL Consulting’s experts will assist Julphar in shaping a product regulatory development plan for a human recombinant insulin project, as well as defining and executing the most efficient path to regulatory approval according to EMA guidelines.
“Julphar is pleased to work with PAREXEL Consulting’s global experts to assist us in our leading efforts to manufacture our products according to European Union and EMA standards,” said Dr. Ayman Sahli General Manager, Julphar. “PAREXEL’s consulting expertise will support Julphar in its goals to set high benchmarks for the regional pharmaceutical industry in the Arab Gulf States, and continue to introduce critical and innovative products for the community.”
“PAREXEL Consulting looks forward to providing our expertise and experience to help Julphar formulate a sound product strategy that assists in maximizing the company’s product results and optimizing the benefit to patients,” said Gadi Saarony, Corporate Vice President, and Head of PAREXEL Consulting. “We are bringing together our regulatory, product development, and market access experts for Julphar to create a tailored comprehensive, effective and efficient program focused on development, regulatory approval, and commercialization.”
As a leader in global development services, PAREXEL Consulting executes hundreds of clinical trial applications (CTAs), new drug applications (NDAs), and global Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) audits per year. Focused on speeding time to market and promoting long-term product and portfolio viability, PAREXEL Consulting provides integrated product development consulting services. Expertise provided by PAREXEL Consulting includes strategic regulatory partnering, product globalization, development optimization, reimbursement and market access, and strategic compliance. PAREXEL Consulting experts also provide capabilities in development of leading edge products such as follow-on biologics, therapeutic vaccines, and combination products. For information regarding PAREXEL Consulting’s services visithttp://www.parexel.com/services-and-capabilities/consulting http://www.parexel.com/services-and-capabilities/consulting.
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Gulf Pharmaceutical Industries (Julphar) is committed to ensuring good health for the community at large. Julphar has the distinction of being not only the first pharmaceutical manufacturing company in Arab Gulf States, but also the only pharmaceutical producer of its scale and size in the United Arab Emirates (UAE). It is also one of the largest in the entire Middle East region. Julphar is a public shareholding company based in the Emirate of Ras Al Khaimah, UAE. It is engaged in the manufacture of pharmaceutical products that address a range of therapeutic segments. It was established in the year 1980 under the able guidance of H H Sheikh Saqr Bin Mohammed Al Qasimi, the Ruler of Ras Al Khaimah. His Highness etched his everlasting legacy when he envisioned a pharmaceutical company that will make UAE self-sufficient in all of its therapeutic needs, providing quality medicine at affordable prices. True to his vision, Julphar has, since its inception, grown into a world class, state-of-the-art pharmaceutical manufacturing company of the Arab World. Starting with its first plant in 1984, Julphar has rapidly evolved into a true multinational organization with a worldwide marketing network. With nine production facilities located in UAE and its products being marketed across the globe in over 45 countries and 5 continents today, Julphar has truly become a representative of UAE’s entrepreneurial capabilities. For information regarding Julphar visit www.julphar.net
About PAREXEL Consulting
PAREXEL Consulting, a division of PAREXEL International, provides integrated product development services with the goal of helping biopharmaceutical and medical device companies get their products to the market, and keep them on the market. Through a unique fusion of scientific, regulatory, and business expertise PAREXEL Consulting helps clients worldwide manage risk and maximize product and portfolio value at every milestone and during each phase of development.
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 10,380 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 as filed with the SEC on November 9, 2010, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.