Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of diet drug developer Arena Pharmaceuticals (Nasdaq: ARNA ) caught a tailwind today, rising as much as 14% in intraday trading after an encouraging announcement from a competitor.
So what: Getting a prescription diet pill approved in the U.S. has been a tough slog for the companies that have set out to do it. Orexigen (Nasdaq: OREX ) has already pulled itself from the fight, announcing in June that it would halt work on its obesity drug after it thought the Food and Drug Administration put an unnecessarily large hurdle between its treatment and potential approval. Arena and Vivus (Nasdaq: VVUS ) , meanwhile, have pushed on. And perhaps the dedication could pay off -- in a press release yesterday, Vivus said that the FDA will reconsider its Qnexa drug early next year.
Now what: So here's the thing when it comes to Arena. First, from Captain Obvious' desk, the FDA reached the agreement with Vivus, not Arena. Second, the FDA has promised to reconsider, not approve Vivus' drug -- they could very easily get the new application and say "You know what? We were right the first time. Rejected!" And finally, the consideration of approval will only be for obese patients that are unable to have children. The obesity market is huge (no pun intended), but you significantly cut down your addressable market when you put on a qualifier like "unable to bear children."
Obesity is a real problem, particularly here in the U.S., but the FDA is making it very clear that companies that want to sell diet pills are going to have to fight tooth and nail to get them approved for use by anyone. Like it or not, the FDA is the gatekeeper here, and so as long as it keeps that attitude I'd have trouble getting excited about any of these companies.
Want to keep up to date on these companies?
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- Add Orexigen to your watchlist.
- Add Vivus to your watchlist.
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Report this Comment On September 17, 2011, at 12:11 AM, Blindnomore wrote:
I swear you Arena bashers have NOT done ANY due dilligence. You guys harangue and pontificate about that and yet example after example not only on this sites reviews but elsewhere too never even go further than their own personal opinion for the basis of their opinion. I am not going to do it for you but suffice it to say the information is there, and it is good for Arena. I don't know about Vivus or Orexigen other than what is in this again very limited opinion of just another hedge fund lackey. Really I'm surprised there wasn't more lies about the "rat tumors". Why not? Did you finally learn the truth? That the tumor data was a huge ruse done by dr. alavi to give his company of favor an upper hand in the review process. The first part of his lies worked and the second part backfired in Orex's review when the panel denied them passage too. Or was that Vivus he was all roses and acting like their drug was the greatest thing since sliced bread? What shows he is totally paid for is the fact that Vivus' drug combo does have known birth defect issues and phentermine does increase heart rate and blood pressure. How many known birth defects and heart issues does Arena's drug have? Zero. Not a single one. All tumors have been proven to be caused by no one thing over another. Thus the reason can not be blamed upon Arena's drug. Do some real due dilligence for a change and research this stuff for yourself.
Report this Comment On September 17, 2011, at 12:31 AM, PhillyDan wrote:
Captain Obvious needs to go back to School"
Numb er one lesson, the Dr. Alavi analysis was crapola and this was proven by the WPG (Working Pathology Group) selected by both Arena and the FDA to re-adudicate the female rat slide. The results were that their is not SS risk of cancer to humans or to rats. Yes the dosage of 82x was greater than control, but 82x of anything will kill most rats and humans.
There are no heart related issues with Lorcaserin. None, zippo, nada, zilch, zero, etc. You get the picture. In the study with all T2DM patients, A1C and FG levels dropped by 0.9% and 27%. What that mean, it means a reduction of type II diabetics and pre-diabetics.
No HR or BP increase with Lorcaserin! In addition, you and other alleged experts on obesity and medications to treat obesity have not heard that the FDA has launched an Obesity Project in conjunction with George Washington University.
The purpose of this project is for GWU to interview obesity patients, medical doctors that treat obesity, obesity groups, etc. Part of the their objective is to determine what risk patients are willing to take to lose weight that will benefit their overall health.
What the above means, if you Captain Obvious have been paying attention is that the FDA is getting serious about obesity and the environment is changing just in time for Arena's resubmission.
Unfortunately, Captain Obvious will have to look for a new line of work. I see pooper-scooper in the future.
Regards
Jim Stevens
Carllsbad, CA 92011
Report this Comment On September 17, 2011, at 7:31 PM, hatch23 wrote:
Great response Jim and Blindnomore. There have been numerous companies that failed to get approved the first go round by the FDA, only to get approved once they addressed everything the FDA wanted. The rise in ARNA started before VVUS resubmitted. ARNA is getting close to resubmitting also. Just like what dndn went thru, I expect Arena's drug to get approved the 2nd time around. What an opportunity with the number of overweight people in America. Big Pharma does not want this drug approved because it will cause a drop in sales for so many of their own drugs, high blood pressure, etc.
Go ARNA! Fron what I read it is Much safer than VVUS drug.
Report this Comment On September 17, 2011, at 7:32 PM, hatch23 wrote:
James,
Miss you on NWI.
Report this Comment On September 17, 2011, at 8:25 PM, hatch23 wrote:
Nice article on ARNA:
Clinical Trial Confirms: Experimental Weight Loss Drug Lorcaserin Works
by Dr. Sunita Khatri / Weight Loss
Log in to vote: [ 2 voters ]
COMMENTS WRITE ABOUT LORCASERIN SHARE THIS USING
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Lorcaserin can Help You Lose Weight without Adversely Affecting Your Heart
Various drugs have been introduced from time to time to help you in shedding those extra pounds. However, all of these old generation medicines have been associated with certain side effects, the most noticeable among them being heart problems. However, a new drug Lorcaserin, which is still in its experimental stage, has been found to help you lose weight without adversely affecting your heart.
In what could be heartening news to all the obese people around the world, a new study, which has been published in the Journal of Clinical Endocrinology and Metabolism, has found lorcaserin to be effective in shedding some extra pounds. The study, conducted by Meredith C Fidler et al, was aimed at evaluating the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients. 4008 patients, aged 18–65 years, with a body mass index higher than normal, received lorcaserin for a year along with diet and exercise counseling. More than 40 percent participants lost at least five percent of their initial weight as compared to just 25% who received placebos.
The patients receiving lorcaserin were divided into two groups. While the first group received lorcaserin 10 mg twice daily (BID), the second group received lorcaserin 10 mg once daily (QD). The patients who received the twice daily dose lost more weight (47.2%) as compared to those who received only one dose of lorcaserin daily (40.2%).
The Food and Drug Administration (FDA) has not approved Lorcaserin as yet
The results of the latest study support the results of an earlier study published last year in the New England Journal of Medicine, in which 47.5% of the 1,600 participants lost 5% of their body weight after taking lorcaserin for at least a year. 68% of the participants managed to keep their weight under control for a second year.
Though lorcaserin has been found effective in shedding weight, The Food and Drug Administration (FDA) has not approved the drug as yet. This is because research in rats has suggested that it could be a cancer risk. Arena Pharmaceuticals Inc., the drug company that has made lorcaserin, has promised to conduct further research into the potential cancer risk in human beings. If further researches prove that lorcaserin does not increase to the cancer risk, it will be a big boon for the battle against obesity.
Almost one third of the U.S. population is facing obesity. The drugs introduced in the market earlier to fend off obesity had to be pulled out because of their association with heart problems. Fen-phen, an anti-obesity medicine was banned in 1997 because of fatal heart valve problems. Another similar medicine Meridia was pulled off last year because of its links with heart problems.
Apart from lorcaserin, the FDA rejected two more drugs on health concerns. One is Contrave, a combination of antidepressant bupropion and naltrexone, a drug used against addiction. The other is Qnexa, which combines the appetite suppressant phentermine and the anti-seizure drug topiramate. These two have also been rejected on the basis of potential heart risk. Lorcaserin is an anti-obesity drug which is not associated with heart problems. It works by targeting brain receptors for serotonin, a chemical associated with hunger. If its association with cancer risk is found to be untrue, millions of patients who cannot shed their weight just on diet and exercise alone, will get a new option for losing weight.
Report this Comment On September 17, 2011, at 8:31 PM, hatch23 wrote:
And another ARNA article:
Lorcaserin, a 5-HT2C Agonist, Decreases Nicotine Self-Administration in Female Rats.
Levin ED, Johnson JE, Slade S, Wells C, Cauley M, Petro A, Rose JE.
SourceDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 104790, Durham, NC 27710. edlevin@duke.edu.
Abstract
Lorcaserin, a selective 5-hydroxytryptamine(2C) (5-HT(2C)) agonist, has been shown to facilitate weight loss in obese populations. It was assessed for its efficacy in reducing nicotine self-administration in young adult female Sprague-Dawley rats. The effect of short-term doses (subcutaneous) on nicotine self-administration (0.03 mg/kg per infusion) with a fixed ratio 1 schedule was assessed in 3-h sessions. Short-term lorcaserin doses (0.3125-20 mg/kg) were administered in a counterbalanced order.
Significant reduction of nicotine self-administration was achieved with all of the short-term doses in this range. Tests of lorcaserin on locomotor activity detected prominent sedative effects at doses greater than 1.25 mg/kg with more modest transient effects seen at 0.625 to 1.25 mg/kg.
Long-term effects of lorcaserin on locomotor activity were tested with repeated injections with 0.625 mg/kg lorcaserin 10 times over 2 weeks. This low lorcaserin dose did not cause an overall change in locomotor activity relative to that of saline-injected controls.
Long-term lorcaserin (0.625 mg/kg) significantly reduced nicotine self-administration over a 2-week period of repeated injections. Long-term lorcaserin at this same dose had no significant effects on food self-administration over the same 2-week period of repeated injections.
These studies support development of the 5-HT(2C) agonist lorcaserin to aid tobacco smoking cessation.
PMID: 21636655 [PubMed - in process] PMCID: PMC3164341[Available on 2012/9/1]
http://www.ncbi.nlm.nih.gov/pubmed/21636...
Report this Comment On September 17, 2011, at 8:32 PM, hatch23 wrote:
And another Great article on ARNA:
http://seekingalpha.com/article/292994-is-arena-s-lorcaserin...
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