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It seems Fool readers were a little more optimistic about the timing of Arena Pharmaceuticals' (Nasdaq: ARNA  ) resubmission of its obesity drug to the Food and Drug Administration than the company is.

A little more than half of the readers figured the company could get the drug approved within a year when I polled them in October. Today, the company said it's shooting to resubmit the lorcaserin new-drug application by the end of 2011, which would put a potential approval in the middle of 2012, assuming a six-month review.

That could put Arena behind Orexigen's (Nasdaq: OREX  ) obesity drug Contrave, which scored a surprise FDA panel recommendation earlier this month and will get a final word from the FDA at the end of next month. Vivus (Nasdaq: VVUS  ) is also waiting to resubmit its obesity drug Qnexa, but it'll likely get the packet in before Arena.

No matter. An approval is most important; whether it's first or third doesn't matter all that much. But first, Arena has to address three nonclinical issues.

The first has to do with the diagnosis of rats with mammary tumors in its animal studies. Some of the readings -- benign versus malignant -- were changed from the initial to the final report. The FDA wants to know which one is the correct call, so a panel of five animal pathologists will reread the results. Unless you think Arena was trying to mislead the FDA with its original final report -- I don't -- this one should be the least worrisome for investors.

Of greater concern is how the rats got the tumors in the first place and whether that's relevant to humans. Arena thinks it has an easy answer: Lorcaserin increases prolactin levels in rats, which is known to cause mammary tumors. Proving that could be a little harder. First, it has to control for variable levels of prolactin, and then it'll have to show a persistent increase in prolactin level in rats taking lorcaserin.

Third, there's the issue of brain tumors in male rats. Since Arena doesn't have a mechanism of action for this one, Arena plans to compare the levels of lorcaserin in rats relative to humans. Figuring out the level of lorcaserin in rats' brains isn't that hard; just chop their heads off. Finding humans willing to undergo the corresponding experiment would be a little tougher. Instead, Arena is going to measure the drug level in spinal fluid. Whether it can show the level of drug is lower in humans than it is in rats that got brain tumors and whether the spinal fluid data will be good enough for the FDA, remains to be seen.

Keep in mind that lorcaserin doesn't really have stellar efficacy data. It helps patients lose more weight than placebo, but just barely. Because the drug doesn't treat a life-threatening disease, the FDA will require a stellar safety profile. The agency clearly doesn't want to see a repeat of Wyeth's fen-phen, Abbott Labs' (NYSE: ABT  ) Meridia, and sanofi-aventis' (NYSE: SNY  ) Acomplia, where regulators approved the drugs only to later have to pull them from the market.

What say you now, Fools? Take the poll and tell us when, if ever, lorcaserin will be approved.

Motley Fool Rule Breakers is always on the hunt for hot drug stocks and other cutting-edge picks. Click here to see all of our latest discoveries with a free 30-day trial subscription.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Motley Fool Alpha owns shares of Abbott Labs. The Fool has a disclosure policy.

Read/Post Comments (5) | Recommend This Article (5)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On December 23, 2010, at 12:03 AM, PhillyDan wrote:

    Not to be a nit picker. But efficacy is not an issue. Na Na!

    Two: You omitted the human study with 10 volunteers for a week with elevated doses of Lorcaserin to determine the amount of lorc in the CSF. Once they have the volunteers, this will be completed quickly.

    Bloom-DM data has been submitted to the FDA but FDA won't do the formal review until the resubmission.

    Arena management seemed very confident of being able to make their case on the prolactin increase causing the tumors at high dosage levels by the way. Yes, they are waiting for some clarification from the FDA based on their meeting, but once they have this, it should take them 3-4 months to cement their evidence.

    The reclassification and report by the five independent pathologists should be completed in fairly quick order.

    The reduction in HbAIC levels will be a critical component of why Arena will receive approval.

    In addition, remove the rat tumor issue and Arena has the best adverse event profile and tolerability of the three.

    The Arena Management was under promising and will over deliver in my opinion. Remember the CC was being listened to by several lawyers working for the class action law firms. Why provide them with ammunition that can be used against Arena.

    I would predict that the resubmission will be in May/June and approval in Nov/Dec of 2011.

  • Report this Comment On December 23, 2010, at 3:54 AM, Blindnomore wrote:

    Somethings that should be remembered about Lorc. It is a safe drug and the tumor and cancer scare tactics are just that, propaganda tactics. How I see this whole scam being committed by those hedge funds and MM's and firms who were and are shorting ARNA is that the stories the shorts are throwing around are baseless and biased. How many women do you know who use birth control medication? Do those pills come with warnings about cancer developing with their use and even more so if they smoke? Is avoiding pregnancy a life threatening disease? How about anyone who takes Ambien or Lunesta for sleep aid? Do those drugs not have side effects of which death is one? Do they also have the potential for addiction and abuse? How about Xanax? This is an extremely heavily prescribed and abused drug for anxiety that causes addiction and has some scary side effects when abused or taken as directed. Is anxiety or insomnia life threatening. None of these are and all are heavily used every day and the FDA has no concern about them. Why not is the question you should ask yourself and maybe then you'll start to understand the complete and total corruption rampant in the FDA and DEA and maybe then you might start to look at the rest of gov't and how it too is corrupt to the core. From top to bottom at every level and every agency it is disgusting and they just do not care about anything except how to keep the money coming in to pay for their scams perpetrated against those in this country who work in the private sector and produce actual worth with our labor without stealing just as much to sustain our jobs. Wake up people. Bot programs trade with the blessing of the SEC when we all know those programs keep prices of their targeted stocks low or high until they get in or out of a position or continue to rape and pilage a position like they are with ARNA. A tiny biotech does not trade 32M shares a day with a float of only 110M shares. It can't happen without the aid of bots scalping and front running the market all day. When I ask you, when will the people of this nation stand up and put a stop to this lawlessness? This corruption of our entire government which will eventually bring about this country's demise if not curtailed? With the recent election we made our voices known without a doubt. But did it have any effect upon how they continue to do business as usual? Not a bit. They do not care what we say or what we are angry about or anything at all that concerns us, the people who make up this country. They do care a great deal about their own selves and their own welfare. As is evident when they force their unfair ways upon us and exclude themselves from those same laws. Wake up people. Please wake up and take a stand like our fore fathers did in order to bestow upon us liberty and freedom of our choice and will. We have become so regulated by the gov't we now have limited choices between the desires they offer to us, not a choice of free will. Wake up America before it is too late. Wake up. Don't stop fighting what was begun with the movement to ursurp the lame duck Congress still forcing bad laws onto the country that they themselves will not be a part of.

  • Report this Comment On December 23, 2010, at 8:06 AM, vigsteven wrote:

    My Notes on the Arena conference call 12 22 2010

    Item one: FDA agreed to Arena’s choice of 5 pathologists to review rat cancer slides. The pathologists will especially look at fibroadenomas (benign) versus adenocarcinomas (malignant). Increased rates of breast cancer in female rats were seen at 82 times the human dose of lorcaserin.

    Item two: FDA wants Arena to demonstrate that persistently elevated prolactin levels do in fact exist in rats at doses of lorcaserin high enough to induce rat breast tumors. Demonstration of elevated prolactin levels would be good for Arena, since elevated levels of prolactin in rats could explain increased incidence of breast tumors in rats. Drugs in humans that elevate prolactin levels (eg. risperdal) do not per se cause increased rates of breast cancer in humans. This rat study would be a new study, and Arena is talking with clinical research organizations to plan the study. Note that some drugs, like bromocryptine, are known to decrease prolactin levels.

    Item three: 10 human study patients will have spinal taps to get lorcaserin levels on the cerebral spinal fluid compared with lorcaserin levels in the blood. (Note that lorcaserin levels in homogenized brains of rats or monkeys determined by equilibrium dialysis would be a better way to estimate brain levels of lorcaserin). The FDA is interested in levels of lorcaserin in the brain because of higher rate of brain cancer in rats at 55 times the human dose of lorcaserin.

    Item four: This involves discussion about whether lorcaserin should be considered a schedule IV controlled substance. This is not really a big deal for physicians. We currently prescribe many schedule IV controlled substances.

    Item five: This involves looking at the results from the Bloom diabetes mellitus study, including a look at echocardiogram results pooled with the Bloom and Blossom studies. Recall that there was a 0.9% drop in the hemoglobin aic level (compared to 0.4% drop in placebo). Weight decreased in diabetics and fasting glucose levels improved.

    Overall timeline for resubmission roughly was for the end of 2011, although Jack Lief said that there may be ways to “accelerate the timeline”. Cost of the studies would be “a few million dollars” with assistance from partner Eisai. Arena Pharmaceuticals will have 150 million dollars left at the end of 2010.

    Steven Vig md internal medicine Tucson, Arizona 12 22 2010

  • Report this Comment On December 23, 2010, at 9:33 AM, uropa1 wrote:

    Pts will have a lot of weight loss after they have these tumors and the drugs efficacy will substantially increase.

  • Report this Comment On December 23, 2010, at 2:14 PM, BioBat wrote:

    Jack Lief might fool people into thinking he can accelerate things but you can't accelerate animal studies. They're going to take time and they have to be well designed because the prolactin hypothesis as it stands is pretty damn weak.

    Approval won't come until the end of 2011 at the earliest. More likely ARNAs looking at 2012.

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