Arena Eagerly Awaits Answer to $1 Billion Question: Does It Have a Big-Time Obesity Drug?

9/8/09Follow @xconomy

San Diego-based Arena Pharmaceuticals has spent a dozen years, and raised almost $1 billion from investors and partners, to create a new drug that helps millions of people lose weight. This month, the company will find out whether the time and money was well spent.

Arena (NASDAQ: ARNA) plans to unveil results of a 4,008-patient clinical trial in September that will answer vital questions about its experimental pill, lorcaserin. The study, called Blossom, is designed to see whether a high or low dose of the treatment can help patients lose weight over a full year compared to a placebo. The study will also look at whether the Arena drug helps with many ailments that stem from obesity—high blood pressure, cholesterol, high blood sugar, and inflammation, to name a few.

If this clinical trial confirms the findings of another major trial from earlier this year, Arena will bundle the data together and ship it to the FDA by the end of this year for approval to start selling lorcaserin in the U.S. Arena will have a very busy fall, as the results are scheduled for a full presentation at The Obesity Society’s scientific meeting in October. If the results withstand all that public scrutiny, the company hopes to entice a Big Pharma company with the muscle to put together a mass marketing campaign aimed at the roughly two-thirds of people in the U.S. who are considered overweight or obese.

“It’s an exciting time,” says Arena CEO Jack Lief. “It’s been a long time. I can’t wait.”

Any drug for obesity has to have a squeaky clean safety profile because it would potentially be taken by millions of people without an imminently life-threatening condition like cancer.
While the bar is high, obesity represents a potentially gigantic market. The leading treatment on the market is a four-decade old generic amphetamine, called phentermine, that most people avoid because it causes insomnia and high blood pressure.

Arena really has not taken any interim peeks at the clinical trial results while the study is ongoing, so it will have a motherlode of raw data to sift through for the first time. When I spoke with Lief and Arena’s chief scientific officer, Dominic Behan, last week, they were optimistic as usual that this study would confirm the safety and effectiveness they saw earlier this year in the 3,182-patient clinical trial known as Bloom. “We don’t expect any bad stuff to come out, because Bloom was so robust,” Lief says.

Based on those results, and assuming that Blossom provides the added confirmation the FDA wants to see, Arena has clearly been sharpening up its marketing strategy and competitive position against rival treatments from San Diego-based Orexigen Therapeutics (NASDAQ: OREX) and Mountain View, CA-based Vivus (NASDAQ: VVUS).

Both Arena and Orexigen underwhelmed investors … Next Page »

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  • http://www.liv.ac.uk/obesity Jason Halford

    The findings of this trial will be very interesting. However, a number of centrally acting drugs are under development, and a whole class of them – the endocannabinoids antagonists, failed in 2008. What is interesting is that all these drugs target similar appetite regulator centres in the brain. However, surprisingly it remains unclear how this or any of the drugs currently under development actually alters human appetite. If leading drug companies had measured the behavioural effects of the endocannabinoids in far more detail in early human trials they may have also uncovered the reported psychological side effects. In clinical trials, companies move increasingly quickly from determining potentially safe and effective doses in small groups of volunteers (phase 1) to examining weight loss and cardio-metabolic indicators in large scale patient studies (phase 2 and 3). Unfortunately, as currently conducted, neither type of clinical trial is sufficiently sensitive to detect drug-induced psychological effects (on mood or cognition).
    The onus is on regulatory authorities to demand that behavioural specificity of all drugs targeting human eating behaviour should be assessed in early phase clinical trials. This is particularly important for drugs acting on the Central Nervous System – CNS (anti-obesity or otherwise) where specific neuro-chemical systems are often involved in many differing psychological functions; in the case of rimonabant this relates to both the motivation to eat and experience of mood. When drugs are used to target human behaviour knowing exactly how they work, and how behaviourally specific they are, is very important. Determining this sufficiently in humans should precede any assessment of clinical efficacy. Until regulatory authorities appreciate this, then although this may sound like a cliché, history may well repeat itself, and not just for anti-obesity drugs but other medications targeting the brain to alter behaviour. Investors be warned.

    Dr Jason C.G. Halford Ph.D. C.Psychol. (Health)

    Reader in Appetite and Obesity
    University of Liverpool,

  • Jim Stevens

    Dr. Halford:

    Recommend you go to Arena’s website and review the presentation that Jack Lief gave at the BMO conference. In that presentation, you will see that Arena has had an “abuse” profile done on Lorcaserin and has come up with a clean bill of health on that front.

    So before you warn investors, do a bit more due diligence as this long time Arena investor has done and you will see that Lorcaserin indeed does have the safety and tolerability profile needed to be a very effective weight loss drug.

    Respectfully,

    Jim Stevens
    Carlsbad CA 92011
    Very Knowledgeable Investor

  • Jason

    Hi Jim.

    I have studied CNS anti-obesity drugs and 5-HT receptor agonists in particular for 20 years, and published plenty on them. It is actually a target I favour. I can send you copies of the papers if you would like. I also regularly check all the company websites. However, sorry to have upset you.

    Hopefully, the selectivity of the drug will make its side effect profile lower. However, as recent history demonstrates not all unwanted behaviour effects are detected in clinicals trial process. As an investors such issues are ones you should be aware of. This is more selective so it should be better but there is insufficient data.

    Yours diligantly.

    J

  • brigitte metzger

    bought orex because drug looks very promising….i only invest in things that i would use myself and it really doesnt have all the side effects that a lot of other drugs do or did…..especially when you have health factors that may stop you from using other drugs……
    sincerely yours
    B

  • Gloria Johnson

    Luke, thanks for another extremely informative article, this time on Arena. As an Arena shareholder, I’m anxiously awaiting the results of Blossom. The Bloom data released in March underwhelmed analysts but mainly due to their misunderstanding of what the FDA is looking for. You nailed it by stating that, “Those readings of effectiveness meet one of the important criteria the FDA has said it wants to see from any new obesity drug.” Lorcaserin is approvalable by the FDA. The market is big enough for more than one drug, but Arena is the one I’m betting on. The safety data for lorcaserin beats it’s competition and safety is even more important than total weight loss. Thanks again for the excellent coverage.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Gloria–thanks for the comment. I’m going to watch for the Phase III results from Vivus tomorrow morning to see how they might alter the competitive landscape for companies I cover in San Diego—Arena and Orexigen. If you or other investors have some immediate reaction to the Vivus data, please send it my way.

    Luke

  • Tony

    Nice article Mr. Timmerman. September will certainly be an interesting month for VVUS and ARNA. My money is on ARNA.