Friday, September 10, 2010

Should Have Stayed at a Holiday Inn: Orexigen's "Tremendous" Advantage Going Third

The three obesity drugs—Vivus’ Qnexa, Arena’s Lorqess, and Orexigen’s Contrave—pending at FDA haven’t suffered from a lack of buzz in the investment community.

The trio of therapeutic candidates have the high-risk/high-reward profile that Wall Street typically flocks to.

In fact, the drugs are being so closely monitored by investors that two peripheral y relevant events—one that has happened and one that will happen—are garnering almost equal attention because of their impact on the three obesity drugs: the FDA advisory committee safety reviews of GlaxoSmithKline’s diabetes drug Avandia and Abbott Laboratories’ diet pill Meridia.

Qnexa was recently voted down by FDA’s Endocrinologic & Metabolic Drugs Advisory Committee due to concerns over the drug being used by large populations and a lack of long-term cardiovascular safety data (See “Weighing the Regulatory Climate,” The RPM Report, September 2010). In that instance, there was clearly an echo-effect from the prior two days of deliberations over the cardiovascular risks associated with Avandia.

Now investors are wondering if the case will be the same for Arena: Lorqess will be vetted by the Endocrinologic & Metabolic Drugs panel on September 16, the day after a joint committee review with the drug safety panel of Meridia to determine whether that drug should be taken off the market due to an increased risk of nonfatal myocardial infarction and stroke.

Orexigen’s Contrave is tentatively scheduled to go before an FDA panel on December 7.

Orexigen CEO Michael Narachi believes going third is an advantage, he explained during an interview with “The Pink Sheet” after announcing a partnership deal with Takeda.

“Being last up for review will provide tremendous learnings for our own regulatory review process. This will enable us to better understand the FDA's approach to evaluating the risk/benefit of obesity therapies, their perspective on potential post-marketing requirements and which of those may be broadly applicable versus drug specific.” (read coverage of Orexigen’s partnership deal with Takeda in “The Pink Sheet” by clicking here).

In other words, Orexigen is sitting back and watching—up close.

One detail that demonstrates just how important the regulatory lessons from Avandia, Qnexa et al. are to Orexigen was the company’s physical presence for the three-day advisory committee reviews of Avandia and Qnexa in July.

The July advisory committee meetings were held at the Hilton Hotel in Gaithersburg, Maryland, where FDA hosts more high-profile panel meetings due to more space.

We’re not sure Orexigen officials were there in person at the Hilton but the company showed up in force at the Holiday Inn just down the street.

We doubt Orexigen got lost. The firm had a pseudo-command center set up apparently to monitor the developments of the Avandia and Qnexa reviews as preparation for what may lie ahead in December.

That’s a smart strategy considering many of the themes from prior reviews, such as the need for long-term cardiovascular outcomes data beyond one year and an appropriate risk evaluation and mitigation strategies (REMS) program, will repeat themselves at the Contrave meeting.

Maybe Vivus should have stayed at a Holiday Inn too.

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