Shareholders punish Orexigen for failing to enter disappointing market

Yesterday two were supposed to become three with the widely expected US approval of Orexigen Therapeutic’s obesity project NB32, formerly known as Contrave. Unfortunately the FDA had other ideas and delayed NB32's PDUFA date by three months, saying it needed more clarity on the post-marketing requirements relating to cardiovascular outcomes.

The news sent Orexigen’s shares down by 15%, but, given the lacklustre sales NB32’s rivals have chalked up since their launches, if there is money to be made in the obesity market a delay until September 11 will not change this opportunity for NB32. Indeed, if Orexigen can get positive cardiovascular outcomes data on the label for NB32 then the delay might well have been worth it.

Safety blanket

Being able to comfort patients that NB32 poses no increased risk of heart attack or other adverse cardiovascular events would put the obesity drug ahead of Vivus’s Qsymia and Arena Pharmaceuticals’ Belviq, which have yet to report any cardiovascular data.

However, the limited findings from Orexigen’s 8,900-patient Light trial have come at a price. The group is thought to have spent $100m on the study, which at an interim analysis ruled out doubling of cardiovascular risk in patients taking NB32 (Orexigen sees Light at the end of the tunnel, November 25, 2013).

But the fact that NB32 has produced some positive data might make payers want to do what they have not done with Qsymia and Belviq and open their wallets.

Cleaning up in the market

Hopes for the promised multi-billion dollar market for obesity pills have long faded, and even the $660m and $527m that have been forecast for Qsymia and Belviq respectively in 2020, according to EvaluatePharma, look excessively generous given that in the first quarter of this year they achieved sales of just $9m and $8m.

Sales for NB32 are forecast to reach $574m in 2020, according to EvaluatePharma, positioning it in the middle of the field, but what might help Orexigen eventually drum up more sales than its rivals is the commitment from its big pharma partner, Takeda.

Qsymia is unpartnered, while Belviq has tied itself to the relatively inexperienced Eisai. In contrast, Takeda can boast a long history in diabetes and has also promised to commit a 900-strong sales force to the launch of NB32 – 300 more than Belviq.

There is also Europe, where the Light study should allow NB32 to make more headway than its rivals, which have failed to get approval owing to the lack of cardiovascular data. NB32 has been filed in Europe, using interim data from Light, and Orexigen is hoping for an approval by the end of the year, which could in turn trigger ex-US partnering discussions for the project.

But while this might give NB32 the edge in a weak field, given the lukewarm response to obesity pills perhaps the real potential for NB32 lies in combination with either a DPP-IV or sodium-glucose co-transporter 2 (SGLT2) inhibitors.

To contact the writer of this story email Lisa Urquhart in London at [email protected] or follow @LisaEPVantage on Twitter

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