Chiltern has fully integrated its two early Phase units into a single operation branded as Chiltern Early Phase. This follows the acquisition of Drug Development Solutions (DDS) in February.
   
Chiltern Early Phase provides early phase services for the pharmaceutical industry through its two units in Slough (just outside of London) and Dundee, Scotland. Chiltern Early Phase has a total of 72 beds, 42 of which are based at Ninewells Hospital in Dundee and can cover all therapeutic areas and all types of clinical pharmacology studies, with specialization in first in man, drug photosensitivity, drug-drug interaction, Japanese bridging and vaccine studies.
   
Glenn Kerkhof, Chiltern's chief executive officer, said, "When we created Chiltern Early Phase, our vision was to develop a brand that would be synonymous with quality and service excellence. We now have the team, organization and facilities to deliver on this vision and provide a truly expert Early Phase service at reasonable cost."
   
Dr. Brian Sanderson, medical director of Chiltern Early Phase commented, "I am delighted to see the integration completed so thoroughly and ahead of schedule. We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialization such as diabetes and cardiovascular medicine. We are also looking forward to forging academic links to provide specialist studies involving new biomarkers."

Timothy C. Tyson has been appointed executive chairman and acting chief executive officer of Aptuit, Inc. Michael A. Griffith, the company’s founder and chief executive officer since 2005, has resigned to pursue other opportunities.
    
“The board wishes to thank Mike for his outstanding success in creating a world-class organization that is a trusted partner to hundreds of innovative clients throughout the world,” said Tony Ecock, outgoing chairman of Aptuit’s board of managers. “With 2,700 employees working with more than 800 clients throughout the world, Aptuit has established a solid foundation for continued growth and success.”
   
Tim Tyson is the former chief operating officer, president and chief executive officer of Valeant Pharmaceuticals International, where he served from 2002-2008. Prior to Valeant, Mr. Tyson spent 14 years at GlaxoSmithKline, where he was president of global manufacturing and supply and ran Glaxo Dermatology and Cerenex Pharmaceuticals. He managed all sales and marketing for GlaxoWellcome’s U.S. operations. Mr. Tyson has also held executive positions at Bristol-Myers in commercial and technical operations and R&D. Previously he was a manufacturing manager for Procter & Gamble.

Bristol-Myers Squibb and Pfizer reported that an interim analysis of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement indicate that the primary endpoint of this study was not met.
   
The Phase III VTE prevention study known as ADVANCE-1 compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to the FDA-approved dose of Sanofi-Aventis' enoxaparin, 30 mg given twice daily. The primary efficacy outcome was the total of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause. The rate of the primary efficacy endpoint on apixaban was similar to enoxaparin (9.0% vs. 8.9%), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin, which was expected to be 16%, based on previous trials.
   
The companies are considering further studies with different protocols in preventing VTE in knee surgery and will not submit the U.S. filing for VTE prevention in 2009 as planned. Programs directed towards VTE prevention including EMEA registrational studies, treatment of VTE, and the prevention of stroke in atrial fibrillation continue as planned.
   
Full results of the ADVANCE-1 trial will be presented in December. Also, new Phase II data of apixaban in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC).
   
“Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban,” said Jack Lawrence, vice president, R&D, Bristol-Myers Squibb. “[The companies] anticipate that the results of APPRAISE-1 being presented at ESC will provide important insight into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary syndrome, which affects an estimated 2.7 million people around the world every year.”

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