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Orexigen Provides Update on Its NB32 European Marketing Authorization Application

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SOURCE Orexigen Therapeutics, Inc.

Orexigen received CHMP Day 120 List of Questions and expects to submit a timely response; Company continues to have high conviction for a positive CHMP opinion

SAN DIEGO, Feb. 25, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company received the Day 120 List of Questions (LoQs) regarding its NB32 Marketing Authorization Application (MAA) from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA reviewers' questions are consistent with issues raised by the United States Food and Drug Administration during the course of NB32 development and the initial review of the New Drug Application, such as manufacturing and quality, non-clinical studies, dosing regimen, and, most significantly, cardiovascular safety. The NB32 MAA is being reviewed by EMA regulators for the first time, and the LoQs represent the first formal interaction with the regulators since the MAA was filed in October. Orexigen is confident that it can successfully address all of the questions posed.

"The day 120 questions reflect a thorough initial review of the NB32 MAA and do not raise any surprising new concerns," said Michael Narachi, CEO of Orexigen. "We believe data from the Light Study clearly address cardiovascular safety concerns, and we are confident we will be able to respond to the remaining questions in a timely manner. We remain highly confident that NB32 will receive a positive opinion from the CHMP at the conclusion of its review."

About NB32
NB32 (naltrexone sustained release (SR)/bupropion SR) is an investigational medication being evaluated for weight loss and maintenance of weight loss. Prior to initiation of the ongoing Light Study cardiovascular outcomes trial, NB32 was studied in clinical trials enrolling more than 4,500 people. In these clinical trials, 53 percent of study participants taking NB32 and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Many patients saw improvements in cholesterol levels and blood sugar control. Those who combined NB32 with intensive diet and exercise experienced the most reduction in body weight. There is no guarantee that NB32 will help patients lose weight.

In the NB32 Phase 3 clinical development program, the most frequent adverse events in patients on NB32 were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity.

In November 2013, Orexigen announced successful results of the interim analysis of the Light Study, an ongoing cardiovascular outcomes trial with approximately 8,900 randomized patients, stating that it met the prespecified criteria to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving NB32 as compared to placebo.

In addition to the Marketing Authorization Application currently being reviewed in Europe, Orexigen has resubmitted the New Drug Application to the United States Food and Drug Administration which has assigned a Prescription Drug User Fee Act goal date of June 10, 2014 for the conclusion of its review.

Orexigen has licensed North American NB32 rights to Takeda Pharmaceuticals. Orexigen owns NB32 rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize NB32 in those territories.

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is NB32. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen's strategy for NB32 is to pursue approvals worldwide and pharmaceutical partnerships for global commercialization. The Company has submitted applications for marketing authorization in the United States and Europe, with potential approvals in 2014. If approved, North American partner Takeda Pharmaceuticals will commercialize NB32 in the United States. The Company's other product candidate, Empatic, has completed Phase 2 clinical trials. Further information about the Company can be found at 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," "should," "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 receipt of a positive opinion from the CHMP, the ability to timely respond to the Day 120 LoQs; the ability to successfully respond to the questions; the timing of potential approval of the NDA for NB32 in the U.S. and the MAA for NB32 by the European Medicines Agency (EMA); the benefit risk profile for NB32; and the potential to obtain a partner to commercialize NB32 in certain territories. 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 materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the Company is not able to successfully answer the Day 120 LoQs; the results from the interim analysis may not be sufficient to respond to the questions raised regarding cardiovascular safety of Contrave; the possibility that the CHMP requests additional or new data to be provided; the potential for the FDA to not approve NB32 even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis of the Light Study would later be deemed to jeopardize the integrity of the Light Study potentially resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study; the potential for early termination of Orexigen's North American collaboration agreement with Takeda; even if the NDA is approved by the FDA, the final results of the Light Study may not support continued approval of NB32; the therapeutic and commercial value of NB32; and other risks described in Orexigen'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. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Current Report on Form 8-K filed with the Securities and Exchange Commission December 2, 2013 and its other reports, which are available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading "Investor Relations." 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.

Orexigen Contact:

Media Contact:

McDavid Stilwell

Denise Powell

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(510) 703-9491

 

 

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