The U.S. Food and Drug Administration (FDA) is expected to render a final decision on Orexigen Therapeutics, Inc. 's ( OREX ) obesity candidate, NB32, by Jun 11. This is a binary event for the company.
It is likely that NB32 will be approved in the U.S. given the positive data from the Light Study. This will also help Orexigen to secure a lucrative partnership for NB32 outside North America this year.
We note that the company has a strong partner in North America in the form of Takeda Pharmaceutical Company Limited ( TKPYY ). Takeda has experience in the metabolic disorder market, which should be beneficial. The companies have started preparations to launch NB32 with approximately 900 sales representatives. Orexigen has rights to NB32 outside North America and is looking for a partner to commercialize NB32 in ex-North America territories.
Orexigen is also looking to get NB32 approved in Europe. A regulatory decision from the European Commission is expected later this year.
Apart from NB32, Orexigen's pipeline includes another obesity candidate, Empatic (phase II completed). The company is looking for a collaboration partner before initiating phase III studies.
We note that NB32, once launched, will enter a highly crowded obesity market with products like Qsymia and Belviq. Given the Light study data, expectations remain high that the candidate will be approved and will most likely be more successful than currently available obesity treatments.
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