Orexigen sees Light at the end of the tunnel

With positive results of Contrave’s cardiovascular outcomes study under its belt Orexigen Therapeutics should look forward to a reasonably quick US approval and an interesting advantage in Europe over its two obesity rivals, Arena Pharmaceuticals and Vivus.

So it is hardly surprising that Orexigen’s stock spiked 10% in early trade today. But the group now faces the harsh reality of a lukewarm market for weight loss drugs, and, given that the Light study’s design had biased the result in Contrave’s favour, what it has not disclosed is more interesting than what it has.

As it stands, all the company has said is that Light, a 10,000-patient study, had “clearly achieved” its first interim goal of ruling out a doubling of cardiovascular risk in patients taking Contrave. Orexigen said this met the FDA’s “firm commitment”, meaning Contrave would be re-filed within weeks, and should be approved by next June.

Roadblock

Light was a roadblock the US FDA had put in Contrave’s way after an advisory panel had recommended approval. In contrast, both Arena’s Belviq and Vivus’s Qsymia were eventually waved through, marking a regulatory shift in the weight loss space, though both have struggled to gain market traction.

As such investors were desperate for more information on the actual cardiovascular risk seen in Light versus placebo, and some had even hoped that Contrave might show a cardiovascular benefit. Such a result would have given it a huge advantage, but it was an extremely long shot.

Consensus for 2018 Contrave sales stood at $113m in September, but since then has risen to $308m, despite assumed aggressive initial discounting. The project’s NPV is now $1.4bn – a 47% rise from August, according to EvaluatePharma data (Event – Orexigen hopes study will show Contrave in a new Light, August 5, 2013).

The company refused to reveal any quantitative aspects of the Light analysis, citing the importance of maintaining the study blinding. Light will continue following patients, and a subsequent analysis will seek to rule out a 40% increase in risk of cardiovascular events with Contrave.

The scant amount of data might explain Orexigen stock’s fairly reserved rise, though there is also the fact that many investors have fallen out of love with obesity. At last week’s close Orexigen stood 28% off its 2013 high, reached in August.

Optimism?

Still, there are reasons to be optimistic. Orexigen’s US partner, Takeda, has marketing muscle in this area, having sold the diabetes drug Actos.

Qsymia is unpartnered, while Belviq is licensed to Eisai, a partner with limited experience. Moreover, Orexigen now stands as the only obesity company with a large cardiovascular trial under its belt.

This could help it make headway in Europe, where both Arena and Vivus have hit major problems, and neither will have cardiovascular data for years. Orexigen says it is confident that the Light analysis will answer the EU regulator’s 120-day questions to its October filing, positioning Contrave for possible approval there late next year.

This, in turn, could line up an ex-US deal, and Orexigen claims to have seen strong interest in rest-of-world rights to Contrave. It also has a phase II obesity project, Empatic, which contains the same dose of bupropion as Contrave, and which some also see as a partnering opportunity.

With Contrave Orexigen could be over the finish line at last. Now, as its rivals have found, the real battle begins.

Study Detail Trial ID
Light 4-year, 10,400-patient cardiovascular outcomes trial NCT01601704

To contact the writer of this story email Jacob Plieth in London at[email protected]or follow@JacobEPVantageon Twitter

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