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

By: Tony

Tony — Wed, 09 Sep 2009 01:08:39 +0000

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

By: Luke Timmerman

Luke Timmerman — Tue, 08 Sep 2009 23:22:15 +0000

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

By: Gloria Johnson

Gloria Johnson — Tue, 08 Sep 2009 23:03:22 +0000

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.

By: brigitte metzger

brigitte metzger — Tue, 08 Sep 2009 22:06:58 +0000

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

By: Jason

Jason — Tue, 08 Sep 2009 18:47:53 +0000

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.

By: Jim Stevens

Jim Stevens — Tue, 08 Sep 2009 18:26:17 +0000

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

By: Jason Halford

Jason Halford — Tue, 08 Sep 2009 08:50:07 +0000

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,