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Orexigen(R) Therapeutics to Discuss Two Advanced-Stage Obesity Products That Target the Brain's Critical Role in Regulating Body Weight

Posted on: Thursday, 12 June 2008, 09:01 CDT

Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system (CNS) disorders, including obesity, is scheduled to present an overview of its novel understanding of the current obesity epidemic. This understanding is the basis of new strategies that we believe have the potential to change the way obesity is treated and address co-morbidities associated with obesity such as diabetes, heart disease, and depression. Gary Tollefson, M.D., Ph.D., Orexigen President and CEO, will detail the Company's novel approaches during a panel discussion entitled "Confronting Obesity" at the 2008 BIO International Convention. The panel will take place on June 18 at 4:00 P.M. Pacific Time in room 30A of the San Diego Convention Center.

Research indicates that obesity is a CNS disorder in which specific brain pathways involved in appetite, energy expenditure, food preference and emotional eating behaviors contribute to excessive bodyweight. Orexigen scientists leverage this understanding to develop novel combination drug regimens designed to initiate and then sustain weight loss by mitigating compensatory mechanisms that result in an early weight loss plateau. Today, approximately 30% of the U.S. population is obese. The related morbidity and mortality costs the U.S. more than $100 billion a year, yet only a tiny fraction of those who are obese are treated, according to Frost & Sullivan.

"Developing products that not only target key brain pathways leading to obesity, but also those which thwart our efforts to sustain weight loss over time, represents an exciting new approach," said Dr. Tollefson. "Moreover, we are directing therapeutic actions toward the reward centers in the brain that we believe impair our ability to control what and how much we eat. The behavioral drivers of consumption, including stress, depression and food craving, lead many people to eat when they are not hungry. The resulting loss of control over food intake partly explains the current obesity epidemic. We are moving beyond the limited approach of diet, exercise and/or medical interventions to encompass the behaviors and neural mechanisms that we hope will make a real difference for patients."

Orexigen has two drug candidates in development for obesity. In a Phase IIb clinical trial the Company's lead product candidate, Contrave(R), demonstrated weight loss of 8.0% to 10.7% at 48 weeks, without significant diet or exercise intervention, in patients who completed the trial. Orexigen anticipates filing an NDA for Contrave with the FDA in late 2009. The Company's second product candidate, Empatic(TM), demonstrated weight loss of 11.0% to 15.1% at 48 weeks, also in patients who completed a Phase IIb clinical trial in the absence of a significant diet or exercise regimen. The Company anticipates initiation of a second Phase IIb clinical trial for Empatic in the third quarter of 2008.

Dr. Tollefson added: "In addition to weight loss, Contrave studies have shown an improvement in metabolic factors that can accompany obesity including improvements in insulin and blood sugar, lowering of triglycerides, and improvements in cholesterol. Moreover, we believe that Contrave may have a special role in also improving the mood for the one-in-four obese individuals who also experience depression. We are studying these and additional aspects in our Phase III clinical trials that are now underway."

The Orexigen product approach specifically targets the reward pathways in the brain that involve two processes relevant to eating: the endogenous opioid systems that make food tasty and pleasurable, and the dopamine systems underlying both the motivation and reinforcement for eating. These underlying mechanisms have been supported by recent government-sponsored studies including neuroimaging of the human brain that has demonstrated that pathways underlying decision making and choice are activated by select food cues. These findings are similar to other research findings in the field of addiction. They explain why obese people have problems gaining control over what and how much they eat and offer new strategies for treatment.

About Orexigen Therapeutics

Orexigen(R) Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, including obesity. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase III clinical trials, and Empatic(TM), which is in the later stages of Phase II clinical development. Both product candidates are designed to take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Further information about the company can be found at http://www.Orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes,""anticipates,""plans,""expects,""indicates,""will,""intends,""potential,""suggests,""assuming,""designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the enrollment, timing, execution and completion of clinical trials of Contrave or Empatic, the timing of an NDA submission for Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with Contrave or Empatic. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the progress and timing of the Company's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the ability for Contrave or Empatic to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Source: Business Wire

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