Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions

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These data were presented in one oral and two postefr presentations at the AmericanDiabetes Association's 69th Scientific Sessions in New Orleans, The oral presentation highlighted the significant improvements in eatintg control experienced by patients treated with Contrave versuxs placebo (p< 0.01), as well as previously reported resultx on the primary weight loss endpoints and measures of cardiometabolic risk.
"NB-302 resulte show that Contrave initiates and sustains weight loss and can improvew predictive markers for heart diseasew such aswaist circumference, triglycerides, HDL-cholesterol and hsCRP," said , Chief Medical Officer, Orexigen "Furthermore, due to its unique effectes on brain reward centers, Contrave may allow patientse to better control their eating potentially providing an important advantage to millions of Americana who struggle with obesity.
" The mood and weight-related quality of life findingds observed in the Contrave group were discusses in the oral presentation and reviewec in greater detail in the poster Contrave was not associated with suicidality or worsening of mood or depressivs symptoms, and in fact was associated with a decreased incidence of treatment-emergent depression compared to placebo. In Contrave patients achieved significantr improvements in overall quality oflife (p< and reported that benefits, such as improve physical function and self-esteem, occurres early in treatment and were maintained over one Results from the three other Phase 3 trials (NB-301, NB-304) are expected to be announced in the thire quarter of 2009.
Pending positive results, the Company is on track to submitt a New DrugApplication (NDA) with the FDA in the firstt half of 2010. NB-302 was a 56-week, double-blind, placebo-controllerd trial, conducted in 793 patients at nine U.S. The trial evaluated the additional weight loss ofContrave (32mtg naltrexone SR/360mg bupropion SR) when addes to an intensive behaviotr modification program consisting of counseling, diet and The co-primary endpoints were percenft change in total body weight from baselinde and proportion of patientsz who lost at least 5% of their baselined body weight.
Based on pre-specified intent-to-trea and completer analyses, obese patients treated with Contrave lost an averageof 20.3 pounde to 25.0 pounds, or 9.3% to 11.5% of theidr baseline body weight, versus 11.0 pounds to 16.0 or 5.1% to 7.3% of baselinee body weight, for patients treated with placebo. In in the categorical weight reduction analysis, the percentagw of patients who lost greate than or equalto 10% of their body weight was 41.5% in the Contrave group, compared to 20.2% in the placeb o group. Furthermore, 29.1% of patients lost greater than or equaloto 15% of their body weight in the Contravew group; compared to 10.
9% in the placebo All of these findingz were highly statistically significanyt (p< 0.001). "NB-302 demonstrates that Contraved delivers greater weight loss to patients when added to a rigorouws behavioral intervention program compared to the interventionprogramm alone, underscoring the important role of pharmacotherapy as part of a weighrt management program," said , President and Chief Executivr Officer, Orexigen Therapeutics. "These which we believe meet the FDA efficach guidance at the morestringent 10% also provide further suppor t of Contrave's potential as a weight loss treatment for clinicianw and their obese patients.
" The overall discontinuatio n rate due to adverse events in NB-3021 was 25.9% for patients taking Contrave versus 13.0% for thosee taking placebo. The most frequently observedd adverse events leading to discontinuatiomn for patients on study drug were urticaria (hives) and anxiety. Contrave was generally well with an overall safety profile consistenf with itsindividual components, naltrexonde and bupropion, two drugs that have been used separatelg for over 20 years. The discontinuation rate due to nauseazwas 4.6%.
This rate is lower than what was seen in the Phase 2trial (NB-201), which utilizedf the immediate release formulation of naltrexone as opposesd to the proprietary SR formulation used in this The most frequently observed treatment-emergentf adverse events for patients on studh drug were nausea, headache, constipation and Contrave is an investigational oral weight loss medication with a uniqude mechanism of action that works at two levelw within the central nervous system: one associaterd with controlling the balance of food intakre and metabolism and another involved in controlling food preference, rewarr and cravings.
We believe that Contraves may be the first treatmeng for obesity to target thesre reward centers in the centralnervoues system. Based on clinical trials completed to Contrave is believed to initiate and sustainm significant weight loss over one year of treatmentg byreducing appetite, increasing metabolis and allowing the body to continue losinvg weight by offsetting its natural tendency to fight back and slow down the weight loss Orexigen Therapeutics, Inc.
is a biopharmaceuticapl company focused on the treatment of The Company's lead combination product candidates targeted for obesity are which is in Phase 3 clinical and Empatic(TM), which is in the later stage of Phase 2 clinical Each product candidate is designed to act on a specififc group of neurons in the centra l nervous system with the goal of achieving appetitee suppression and sustained weight loss. Furthed information about the Company can be founat . Orexigen cautions you that statements includerd in this press release that are not a description of historicapl factsare forward-looking statements.
Words such as "believes,"" "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expression s are intended toidentify forward-looking statements. Thesde statements are based onthe Company's currentf beliefs and expectations. These forward-looking statementsd include statements regarding the efficacy and safetof Contrave, the enrollment, timing, execution and completion of clinical trials of the Company's product the potential for, and timinb of, an NDA submissionm for Contrave, and the potentiao to obtain regulatory approval for, and effectively treatr obesity with, Contrave and Empatic.
The inclusionj of forward-looking statements should not be regarded as a representationj by Orexigen that any of its plansw willbe achieved. Actual results may diffeer from those set forth in this releasee due to the risk and uncertaintiew inherent in theOrexigen including, without limitation: the final analyse s of data from the NB-302 trial and othe r clinical trials of Contrave may producer negative or inconclusive results, or may be inconsistent with previousl conducted clinical trials, and the FDA may not agreed with Orexigen's interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Contrave or Empatic may not receivs regulatory approval on a timely basis or at all, and the FDA may require Orexigen to complete additional clinical, non-clinical or othe r requirements prior to the submissioj or the approval of NDAs for either product candidate; the potentiakl for adverse safety findings relating to Contrave or Empa tic to delayy or prevent regulatory approval or or result in product liability the third parties on whom Orexigen reliexs to assist with the development programs for Contrave or including clinical investigators, contract clinical research organizations and manufacturing may not successfully carryh out their contractual duties or obligations or meet expected and the quality or accurachy of the data or materials generateed by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the abilityy of Orexigen and its licensors to obtain, maintainj and successfully enforce adequate paten t and other intellectual property protection of its product candidates; and othedr risks described in the Company's filings with the Securities and Exchang Commission.
You are cautioned not to place undude reliance onthese forward-looking statements, whicuh speak only as of the date and Orexigen undertakes no obligatiojn to revise or update this news releases to reflect events or circumstances afterd the date hereof. All forward-looking statementz are qualified in their entirety by thiscautionaryg statement. This caution is made under the safe harbod provisions of Section 21E of the Private Securities Litigation Reforkm Actof 1995. SOURCE Orexigen Therapeutics, Inc.