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They may not have earnings yet, but they will be providing their future earnings projections.
7/18 release from Michael Murphy. Forgive me if this is a repeat, but reading this confirmed my decision to go long ARNA.
Dear New World Investor:
Vivus (VVUS) received approval last night for Qsymia, formerly Qnexa, as I expected, and held their conference call this morning. I first thought the new name was pronounced (kiss' my a...), but the company says it is (kyoo sim ee' uh). I thought the FDA might not approve the top dose for safety reasons, but they did.
The drug is administered for two weeks at the low dose, then 12 weeks at the mid-dose. If the patient doesn't achieve 3% weight loss at 14 weeks, they can be moved to the highest dose for another 12 weeks. If they don't get to a 5% loss at the end of 26 weeks, patients are supposed to stop the drug.
The trials were not titrated the same way, but about 80% of patients on the mid-dose of the drug lost 3% of their weight by week 12, and 80% of the top-dose patients lost 5% of their weight by week 28.
In contrast, Arena Pharmaceuticals' (ARNA) Belviq is measured for a 5% weight loss at the 13 -week point. So the FDA has set a tougher standard for Belviq, although doctors are not required to stop administering Belviq if a patient is losing some weight. In the real world, I expect obesity doctors to add phentermine to Belviq and give that combination a try before they give up on Belviq.
The Risk Evaluation and Mitigation Strategy (REMS) for Qsymia is quite weak. It requires only a medication guide for patients and a healthcare guide for doctors focused on preventng and testing for pregnancy, and mail-order pharmacy distribution at first. Vivus can apply later to modify the REMS to get rid of mail-order distribution.
Vivus will be required to do 10 postmarketing studies. Like Arena, they have a few to extend the use of Qsymia for pediatric and adolescent use, and a cardiovascular outcomes trial (CVOT) for at-risk patients. In addition, Vivus has to do a study to assess renal function.
Vivus has hired district managers, but it did not sound like they have many sales people yet. On August 7 the company will hold another conference call to discuss the launch plan. They plan to launch in the fourth quarter.
Although the tougher weight loss standard for Belviq, 5% weight loss at 12 weeks versus 3% at 14 weeks, is inexplicable, I doubt it will have any real market impact. I have always expected doctors to start with Belviq, because 80% of the obesity patients are women of child-bearing age. (Not 80% of the obese, but 80% of those who seek help.) It will be safer to start with Belviq, and in the trials 42% of those on the drug achieved 5% weight loss after 12 weeks. My spreadsheet assumed that only 35% in the real world will achieve that level of weight loss, and the rest will move on to Qsymia or, if it is approved, Contrave. Given those assumptions, Arena can achieve my target prices and be a huge success.
Also, there is a lot of FUD about who will be in the market first. Eisai does not have to wait for DEA approval to start calling on obesity clinics and doctors, and getting them ready for the Belviq launch. I expect them to train during the summer and begin the sales campaign after Labor Day, September 3. Vivus won't even have their whole sales force hired by then. So whether Belviq clears the DEA process in September or January will make little difference in the long run.
We should get the European Medicines Agency 120-day questions for Arena tomorrow, and I am hoping for a conference call within a week - it is not required, of course. All in all, I see the Qsymia approval as about what I expected, and therefore there is no change to my outlook for the launch or first few years of sales. ARNA remains a Core Holding and a Trading Buy under $10 for the European/ROW partnership announcement and Belviq rollout, with a $22+ target in 2012.
Thank you very much. This information is quite helpful.
Thanks!
Also, wasn't the EMA scheduled to give ARNA a response to their submission (not approval, but response ) sometime this month?
Has Michael Murphy issued any updates or predictions lately? I haven't seen anything from him since right before the
FDA approval. TIA
Btw - I understand that Vivus still owes the FDA some info to complete their CRL requirements. That should make Tuesday a bit more interesting.
There is no way Qnexa will be approved without restrictions. too dangerous. Comprendez?
Will someone please post the number of outstanding shorted shares that must be covered by tomorrow as of the end of today when that information becomes available? Thanks!
I agree with Detonate...sts66, although he is a very knowledgable moderator, is always very caustic with his/her replies. You can't take it personally and they are not always right (just like the rest of us). Thanks for caring enough to share!
Like I said, call it what you want. Time will tell. You guys must be pretty nervous to be coming out of the woodwork the way you are!
Great article, if you own VVUS and forgot the fact that ARNA's drug hasn't been enhanced with a metabolic booster yet because it had to be approved on its own merits.
By the way, why are you showing up on this board at this VERY late stage in the game? Who is paying you to write this malarkey?
Call it hype or whatever you'd like, it's nice to see that a company can produce a novel and safe obesity drug vs. asking the FDA to approve dangerous combinations of drugs that are already on the market and tired.
Interesting viewpoint, Shane. Why would a big pharmaceutical company buy out VVUS, a company offering a combo of two drugs that have been on the market forever, can already be prescribed and are dangerous? Not to mention, VVUS doesn't even have a marketing partner (who would want to partner with a company that only offers a combo of generic drugs?). Have a nice life...
I find it interesting that Adam Fueurenstein waited until today to report that the AdComm minutes were less than fully supportive of Lorcaserin getting approved. As I recall, Adam live blogged while he watched the entire AdComm meeting firsthand and reported at that time that he was impressed with ARNA's response to the FDA and said he felt Lorcaserin would be approved. If he heard the whole presentation firsthand and felt Lorcaserin would be approved, why would he change his mind based on the minutes? He's a real piece of work.
Pun intend or not, I concur...thanks so much for all of your help with the research, UMIAK, you are very benevolent.
Actually, UMIAK has helped us all MANY times over and I very much appreciated her posting of the "Halftime Report". THANK YOU, UMIAK!!!! Her forwarded video clips and postings regarding ADCOMM are much more relevant to this message board than this posting of yours.
Many thanks to UMIAK,lovethatgreen, alexander 77, clawmann, GIXXER and the rest who have made this such an unbelievable ride...GLTYA!!!! Looking forward to celebrating with you on the 28th!
Found this on the FDA website - if you ask me, Lorcaserin is a candidate for accelerated approval -
Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit. For example, a surrogate endpoint could be the lowering of HIV blood levels for short periods of time with anti-retroviral drugs.
Gleevec (imatinib mesylate), an oral treatment for patients with a life-threatening form of cancer called chronic myeloid leukemia (CML), received accelerated approval. The drug was also approved under the FDA's orphan drug program, which gives financial incentives to sponsors for manufacturing drugs that treat rare diseases. Gleevec blocks enzymes that play a role in cancer growth. The approval was based on results of three large Phase 2 studies, which showed the drug could substantially reduce the level of cancerous cells in the bone marrow and blood.
Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval.
Because premarket review can't catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.
I have a couple of questions that I'd appreciate your help with:
1) How would an early approval announcement be handled? Does the stock stop trading prior to the announcement, is the stock allowed to trade during the announcement or is this type of announcement made after hours?
2) Is there an age restriction with regard to Lorcaserin prescriptions? In other words, will obese children be able to benefit from this drug or will they have to wait? I agree with UMIAK's data/observations, that's a HUGE market (no pun intended).
Ty and glta
I read on the Yahoo board that Qnexa was rejected for review by the EMA after it got the nod from the FDA's Advisory Committee but the EMA agreed to review Lorcaserin shortly thereafter. Is this true? Sorry if this information was in an earlier board message and I missed it...
Another thought is also that a delay is not a denial...unless the FDA summarily rejects Lorcaserin (which they definitely could not do without MAJOR backlash), they would delay it and the stock price would drop but probably not dramatically (judging by the effect that had on VVUS's pps). My sense is that the upside is really huge here, but the downside is very limited and we will receive several clues that the stock price will tank dramatically before it actually does. Does my theory hold water?
If the FDA does not announce a delay for Lorcaserin's approval date in the next few days, wouldn't it be fairly safe to assume that the drug will be approved on the 27th? To me no delay indicates that the FDA has no more concerns they require that ARNA address and Colman seemed to be pleased with the drug's efficacy so no worries there. I know that the FDA is totally unpredictable, but with so much focus on fighting obesity (with Dr. Margaret Hamburg - commissioner of FDA and First Lady Michelle both viewing it as a high priority) it seems it would be impossible for the FDA to reject Lorcaserin. If they did they would get MAJOR backlash from the masses unless they have any serious concerns about the drug (which I assume would result in a delay and which I also assume would have been brought up at the ADCOMM review). My roundabout question here is don't you think it would be safe to assume that if we can make it to the 26th with no delay we all ought to feel confident in holding onto our shares and sleeping well through the night of the 26th?
Thanks for the update re: Kaul, sts...that is excellent news!
I agree. I have been following this stock very closely since 2009 and have made enough money to retire comfortably by actively trading it during that period of time. I thank the moderators on this site because I appreciate all of the data and market information they share so freely - you have helped me gain insight and boosted my confidence with regard to decisions I've made along the way. Thank you!
I sense that there are many individual traders buying now because they see the potential for this drug/company/stock. All bets are off when it comes to this one. There is enough media attention focused on this stock to keep the price up. I can't imagine a successful bear raid at this point.
I agree. I have been following this stock very closely since 2009 and have made enough money to retire comfortably by actively trading it during that period of time. I thank the moderators on this site because I appreciate all of the data and market information they share so freely - you have helped me gain insight and boosted my confidence with regard to decisions I've made along the way. Thank you!
I sense that there are many individual traders buying now because they see the potential for this drug/company/stock. All bets are off when it comes to this one. There is enough media attention focused on this stock to keep the price up. I can't imagine a successful bear raid at this point.
Fair enough. Meant to say "if" your risk tolerance is very low. Also, I sincerely doubt that the IHub board greatly influences the stock price, although I sincerely wish it did. GLTYA, I'm all in for the long haul, btw...
Personally, as crazy as this may sound, I don't think that moving averages/analytics, etc. will help you out here as the FDA, historically, is very unpredictable. The best thing for you to do would be to conduct the appropriate due diligence, think for yourself and accept the outcome of your decision. I am not being condescending. Trust me, I've consulted with I-Hub and researched on my own and the sentiment you get here is consistent with what you find elsewhere. ARNA has a great pharmaceutical offering but there are no guarantees that it will be approved by the FDA. Also, you want to make sure you feel confident YOU feel you are making the best choice. With a little research you should be able to bolster your confidence...if that doesn't work for you, it's probably best that you sit on the sidelines as your risk tolerance is very low. This seems like a sure bet, but there are absolutely NO guarantees in life.
Don't know if Lorc-phen will require detox but the stress of the next 30 trading days may make it advisable for ARNA investors...
Thanks so much! I just looked at FDA website and it said the ADCOMM meeting notes would be posted online. I'll read them when they come out so I don't have to keep asking you all for more information. Thanks for listening in and giving us updates.
I read earlier from those who listened to ADCOMM that the FDA representatives at the meeting spoke up in defense of ARNA repeatedly. Will you please elaborate?
Also, I don't really understand the approval process and am curious re: how many of the deciding FDA members are present at the ADCOMM of a drug.
It is also my understanding that the FDA can approve or reject ARNA before 6/27, that 6/27 is merely a deadline...not a guaranteed date of response. Is that correct?
Again, thanks to all of you who have been doing so much due diligence and who have been so generous in sharing their knowledge. I believe strongly that "what comes around go around" and you all deserve abundant blessings for your many kindnesses.
Public thanks and apology to GIXXER...he just sent me a very kind and classy private reply.
Thought you were working? BTW, although you thought I was a shorter, I actually have a long position...and am very happy about that. Now go back to work.
Thanks to an amazing group of moderators. You all did a fantastic job of sharing your wealth of knowledge re: ARNA and the findings of your DD. I am very grateful and wish you the best.
Thanks to UMIAK and lovethatgreen for your helpful and constructive responses. Much appreciated.
Please see below:
UPDATE 3-US FDA staff focus on safety of Arena obesity pill
11:44 am ET 05/08/2012 - Reuters
* Obesity pill one of three vying for U.S. approval
* Shares up 14 pct after FDA staff minimize cancer issues
* FDA staff focus on heart safety
* FDA expert panel to review drug on Thursday (Adds FDA comment, more details from FDA review, updates shares)
By Anna Yukhananov
WASHINGTON, May 8 (Reuters) - U.S. drug reviewers on Tuesday said Arena Pharmaceuticals Inc's obesity pill appeared to help people lose weight and was unlikely to cause tumors in humans, but questioned if the company had provided enough data to rule out heart problems.
Lorcaserin is one of three new potential obesity treatments vying to gain U.S. approval and be the first new weight-loss treatment on the market in over a decade, after initial rejections over safety issues.
Shares of Arena were up 14 percent to $3.10 in late-morning trading on Nasdaq after the FDA posted its review online.
The Food and Drug Administration first rejected lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, in October 2010, citing potential cancer risks.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States with nearly a third of the population falling into the category.
The pricetag of obesity has also soared, with the condition contributing an additional $190 billion a year in healthcare costs, or one-fifth of all healthcare spending.
But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.
Arena resubmitted its application with more data to show that the previous findings of tumors in rats did not apply to people, which seemed to assuage some of the FDA's concerns.
The FDA documents come ahead of an advisory panel of outside experts, which will review the pill on Thursday. The FDA will make its final decision by June 27, taking into account the panel's recommendations.
LESS TUMOR, MORE HEART RISKS
The FDA staff said Arena submitted more data that showed malignant tumors in rats increased only at very high doses of lorcaserin, with rats getting at least 24 times more of the drug than the recommended dose for people.
The FDA staff said the safety margin for malignant tumors was "reassuring," but pointed out that lower doses of the drug were still linked to benign tumors in rats.
Arena has argued the findings of rat tumors did not apply to people because they resulted from high doses or biological mechanisms specific only to rodents. No increase in cancer cases was seen in people.
The FDA reviewers' main concerns seemed to be risks to heart valves seen with lorcaserin, which could be a sign of broader heart damage. Heart problems have dogged the obesity field for decades, making the FDA especially cautious about any potential problems.
Arena's lorcaserin was designed to block appetite signals in the brain in a similar way to "fen-phen," an infamous diet pill that was pulled from the market in 1997 after reports of sometimes fatal heart-valve problems.
Another diet pill, Meridia, was withdrawn in 2010 after also being linked to heart problems.
The same FDA advisory panel that is due to review lorcaserin recommended in March that all new obesity drugs need heart safety studies, even if clinical trials do not initially show evidence of increased heart risk.
Some analysts have said Arena's pill may have the lowest chance of approval, with a smaller weight loss compared to drugs from Vivus Inc and Orexigen Therapeutics Inc, meaning the FDA may be willing to accept fewer risks.
Lorcaserin helped people lose at least 5 percent of their weight compared to placebo, meeting the FDA's threshold, according to a combined analysis of three clinical trials for the drug. But if any of the trials were analyzed alone, the drug did not meet the bar, the FDA staff said. (Reporting by Anna Yukhananov; Editing by John Wallace, Maureen Bavdek and Tim Dobbyn)
Sounds as if today's reviewers are hung up on heart valve concerns and the lower efficacy of Lorcaserin, but no one here seems to think the drug won't get approved. Am I missing something? I'm long on ARNA, but beginning to get a bit concerned.
Heard a few weeks back that ACLS is an acquisition target for a large semi-conductor company, but their stock price has only tanked since I heard that rumor. Has anyone else heard that and/or can anyone explain the continued drop in their stock price (beyond last week's disappointing earnings report). Thanks!
Thanks to all of the moderators...I've been following this stock for quite some time and you all have been very helpful.
I know oil prices are down now, but what has happened to HK?!?!? Can any of you explain why it's tanking?
I am long on HK and a true believer in Floyd Wilson, but the past few weeks have made me question whether or not I should rebalance my portfolio.
Thanks to all of the moderators...you are a tremendous help to newbie investors like me. I am long on ARNA, but have a couple of questions:
1) Why is the insider trading a negative number (albeit a small number, but a negative number just the same)
2) I liked Brumley's article, but is he legit? I caught two major spelling mistakes in his piece and I'm no English language expert
3) What do the rest of you think the odds of ARNA getting the nod on Thursday are? I say 80% yes, but am curious to hear what the rest of the group says.
Again, thanks to you all - GLTY