BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Dec 21 2012

Blue Chip Patient Recruitment (BCPR), a division of Blue Chip Marketing Worldwide, a full-service integrated marketing agency, has successfully partnered with Orexigen® Therapeutics (Nasdaq: OREX) to accelerate patient enrollment of The Light Study, Orexigen's cardiovascular outcomes trial evaluating Contrave® (naltrexone sustained release (SR)/bupropion SR). Approximately 9,000 patients will be randomized in the study within the next few weeks, nearly 14 months ahead of original forecasts. Contrave is an investigational medication being evaluated for the treatment of obesity.

“Working with a forward-thinking company like Orexigen gave us the opportunity to innovate and push the traditional boundaries of patient recruitment marketing and communications”

The Light Study (www.lightstudy.com) is a randomized, double-blind, placebo-controlled cardiovascular outcomes trial evaluating the occurrence of major adverse cardiovascular events (MACE) in patients participating in the study. The study, which began enrolling study participants in June 2012, was originally projected to achieve its enrollment goal within 18-20 months of the study launch.

According to the Center for Information & Study on Clinical Research Participation, delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial. Each day a drug is delayed from reaching the market could cost sponsors up to $8 million in missed revenue. Six percent of clinical trials are completed on time, and 72% of trials run over schedule by more than one month. Currently about six cents of each health dollar spent in the United States is spent on medical health and research.

Orexigen formed a strategic partnership with BCPR to consult and help with clinical trial enrollment execution. BCPR conducted extensive market research that led to the development of The Light Study brand and an integrated communications platform. BCPR also deployed a team of Clinical Enrollment Specialists, a first of its kind, field-based team of former study coordinators whose sole responsibility was to serve as a positive, supportive enrollment resource for study sites. These Clinical Enrollment Specialists conducted site visits and regular telephone consultations to enhance in-practice recruitment efforts and facilitate ad leads. In addition, BCPR helped enhance the site selection process by identifying geographic considerations that helped improve the effectiveness of the advertising campaigns.

"From the beginning of this study, Orexigen needed a different type of strategic partner, one who would rethink study startup and enrollment," said Michael Narachi, CEO of Orexigen. "Blue Chip Patient Recruitment truly moved beyond a traditional marketing partner. They customized innovative tactics to find, understand and engage with the targeted patient. We believe that the approach we experienced with BCPR will be seen as an industry benchmark for future patient enrollment projects."

"Working with a forward-thinking company like Orexigen gave us the opportunity to innovate and push the traditional boundaries of patient recruitment marketing and communications," says Neil Weisman, executive vice president and general manager of Blue Chip Healthcare Marketing. "Through open communication and a commitment to collaboration between BCPR, Orexigen, CROs and other partners, we were able to create an effective, holistic marketing plan, validated with data and market research that exceeded all forecasted expectations and accelerated enrollment."

As soon as The Light Study enrollment is officially completed, BCPR will continue to support patients through a specific and tailored retention plan for Orexigen.

Contrave is an investigational medication being evaluated for the treatment of obesity and has been studied to date in clinical trials enrolling more than 4,500 people. Contrave was developed by Orexigen to help to reduce appetite, increase metabolism and control cravings and over- eating behaviors. Contrave has been shown to help people lose weight and keep it off for up to one year and to improve certain measures of health and well being including losing inches from their waistlines, improving their cholesterol numbers, and making significant improvements in their blood sugar levels.

According to some estimates, over 1.5 billion adults world-wide are overweight or obese. According to the Centers for Disease Control and Prevention (CDC), 35.7% of U.S. adults are obese. CDC estimates that in 2008, medical costs associated with obesity were $147 billion. Some of the leading causes of death are obesity related, including certain types of cancer, heart disease, stroke, and type 2 diabetes.