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Arena Pharmaceutical's New Management Is Attracting New Interest From Wall Street

FBR & CO initiated coverage of Arena Pharmaceuticals on 15 September with an "outperform" rating and a $6.00 price target. I attribute this squarely to the new management.

FBR noted:

We are initiating coverage of Arena Pharmaceuticals, Inc. with an Outperform rating and a 12-month price target of $6 per share. Historically, ARNA focused on obesity with its one approved drug, Belviq (lorcaserin). However, given the company's expertise in discovery and drug development targeting G protein- coupled receptors (GPCRs), it is now primarily focused on advancing the pipeline with (1) etrasimod (APD334), a S1P receptor modulator for the potential treatment of ulcerative colitis (UC); (2) ralinepag, a prostacyclin receptor (PGI2) agonist for the potential treatment of pulmonary arterial hypertension (PAH); and (3) APD371, a cannabinoid receptor 2 (CB2) agonist in development for GI pain associated with Crohn's disease.

Arena is a perfect Business School case study on:

  • How weak management can hurt a company that has great products.
  • How good management can turn around a company that was failing due to bad management.

Arena had a classic case of Founder's Syndrome where the challenge gets too big for a founder. A lot of people helped it get FDA approval on its very important drug, Belviq despite attempts by some short sellers to dissuade FDA against its approval despite the very clean safety and good efficacy of Belviq, the obesity pandemic, and proof that diet and exercise alone don't work in most cases because of the changes in the brain and metabolism of obese people - and it can lead to some 50 diseases (as per Dr. Aronne, a top specialist).

Belviq's excellent safety and efficacy can be summarized as follows (with full details on belviq.com).

· In clinical trials, patients on Belviq had a 10.6 to 1 odds of losing weight versus quitting due to adverse side effects. (1 out of 10.6 patients quit), while Contrave had a 2 to 1 ratio of success to side effects related discontinuation (1 out of 2 patients quit). So Belviq is far more tolerable and has milder side effects. Its most common side effects are a mild transient headache and dry mouth. Some people have reported being able to sleep deeper, quit smoking, and enjoy other positive health benefits as well. Some have reported lots of weight-loss without any side effects whatsoever.

· Clinical trials showed that Belviq is very effective for responders: those who lost 5% or more in 3 months went on to lose around 12% in a year. Real world numbers have proven even more impressive with many responders losing large number of pounds with very little or no side effects. I personally have two friends who lost over a 100 pounds without any side effects. The patient and doctor testimonials are very long and impressive.

Arena spent 10 years and $1 Billion developing a medicine which many doctors, including Dr. Steven Vig in Arizona who's prescribed it to hundreds of patients. He calls it "a very safe and effective drug".

Certatin aspects of Arena's management was a dream come true for the short-sellers, because not only did Arena make a number of poor management mistakes, it did not appear to have the courage to fight back against the systematic, professional disparagement which followed, to dissuade patients and doctors against Belviq (this arguably hurt the entire obesity space). Belviq was portrayed as the exact opposite of what it is, using bogus logic and irrelevant data like placebo-adjusted efficacy that even FDA's own experts have said don't apply in real world (See Jim Cramer’s video in which he touts lying and deceiving “when in hedge-fund mode” as a way of doing business – what a scum!).

Powerful entities on Wall Street (hedge funds short-sellers) with analysts and journalists and even some doctors in their pockets, set out to hurt Belviq by spreading FUD (Fear Anxiety Doubt) because success of Belviq would have meant 10's of millions in losses for them.

At the same time some of the same people were promoting Contrave which is a weight-loss drug with an inferior safety profile (e.g suicidal thoughts) made by Orexigen whose stock is doing very poorly at a pre-reverse-split value of 34 cents. But Arena's stock price was also walked down, in part because of some management issues that were noted by various authors previously.

Keep in mind, the target market for Belviq is huge, and neither Eisai nor Arena had it wrong in foreseeing the success. What they did wrong was on Arena's side, a totally useless approach towards disparagement to the point that some skeptics even questioned the sincerity of the CEO and the team he assembled (e.g. putting rookies in key executive roles -- VP of Global Alliance Management and also the VP in charge of IR had no experience in those fields respectively, prior to joining Arena. What in the world Jack Lief was thinking is inconceivable for me. And the fact that his Board supported that. How did investors feel when they saw these kinds of things? Or on the legal side, Arena did not fight back against Chinese infringement of their solid composition of matter patent there which according to a top Chinese IP lawyer they could have. They were warned of the IP violation well before Eisai takes China. And we saw the consequence of not fighting back, including FDA warnings of illegal products that contain lorc, without authorization. Such examples of management screwups are many. So many that some skeptics wondered... since even intentionally it is hard to screw up as such

Thank God that chapter was over with the ousting of the CEO, after the stock lost over 80% of its value since after approval of Belviq, a superior first in class product in a very ripe, huge market. Some tend to blame the doctors or patients or insurance companies but a deep root cause analysis gives me the opinion that it was to a great extent due to mismanagement of certain key aspects of the business and not just external factors.

Jack Lief was forced out by the Board, and Amit Munshi was appointed the new CEO. The company did a major restructuring, which I believe was very prudent. It's now going forward lean and mean. A new hotshot CFO, Kevin Lind has also been hired, along with a number of other executives. Craig Audet and Steven Spector, the last of the Jack Lief dynasty are still there, and there's speculation on whether they will remain on board or not. I personally like to see them resign given what happened to shareholder value on their watch, so that the management team is comprised of more new blood with a fresh outlook and attitude than the one that did not work before.

The tide is turning. After tripling of short interest after approval to 66m, it has recently dropped to 12 million - and with increase in analyst coverage, that artificial supply turning into real demand can be very helpful for the stock. We have also recently seen a number of hedge funds such as such as LPL Financial, KCG Holdings, Nationwide Fund Advisors, Advisor Group start to take position.

I anticipate this momentum will continue because the company has a strong cash position, in set to collect more royalty payments as more countries are approve Belviq (Mexico recently approved it), and I expect more partnership deals to come for the rest of the pipeline.

Based on the coverage Arena received after the last set of data on etrasimod (APD334), Arena is worth $29 per share by Receptos' (RCPT) standards, or around $7 billion in valuation. So the entire company seems significantly undervalued at $400m.

Phase 3 data showed the rate of FDA defined valvulopathy was similar with Belviq and placebo. Due to highly selective nature of Belviq's effect on GPCRs, many experts believe that Belviq is not expected to cause heart valve problems like fenfluramine. Dr. Aronne states:

The most careful part of the study was looking at heart valves and the answer is, there is no evidence, there is no difference between a placebo and this medication in looking at heart valves.

Nevertheless, the FDA mandated Phase 4 CVOT trial (Camellia-TIMI-61) is ongoing and its results will likely make Belviq the widely preferred obesity, pre-diabetes, and T2DM treatments with off-label use for addictions like smoking (both anecdotal reports, and Phase 2 trial conducted by Eisai, showed:

The primary endpoint was achieved by 5.6%, 8.7%, and 15.3% of patients in the placebo, lorcaserin 10 mg once daily and twice daily groups, respectively, with the lorcaserin twice daily group demonstrating a statistically significantly higher continuous quit rate than placebo (p-value 0.003 and odds ratio of 3.02). In addition to smoking cessation efficacy, a reduction in bodyweight was also observed.

Lorcaserin (Belviq) has also been studied for cocaine addiction in human trials, with positive results. Pre-clinical studies show it could be used for a variety of addictions.

Arena's deep pipeline has other potential stars. APD371 could address the huge opiate addiction epidemic. It's a pain medication designed to be a highly selective, peripherally restricted, full agonist to provide pain relief without psychotropic effects, loss of efficacy over time, or the dependence, abuse potential or adverse event profile associated with other pain treatments.

Ralinepag (APD811), a best in class drug for Pulmonary Arterial Hypertension (PAH) will have Phase 2 data released in not too distance of future, and could serve as a good catalyst for the stock.

Axovant has licensed Nelotanserin (5HT2A Inverse Agonist), and is in the process of conducting multiple Phase 2 tests with data on one of them due out in the next few months.

Each of these and more gems in their pipeline add to the base model of $7b valuation for etrasimod. So my target price projection here is not that aggressive. Anticipation for next set of data could drive the price nicely into double digits.

Arena's fair value, right now, in my opinion is $3b which translates to around $12 a share. The stock is selling for $1.7 because of that disconnect mentioned above, but the fiction-makers are almost out of the woods with a nice profit, and Arena's new management is set on getting the company fair valuation.

The strength of the technology is the core subject here. Put good technology in good management's hands and see what happens. I believe that transition has just started to start to show effect, and given the coil is so tightly wound by years of manipulation and misrepresentation, going back to fair value could be pretty swift.

Tobira’s shares went from $4.75 to $39 overnight. This is the beauty of biotech and confirm my belief that current valuations are meaningless (funny that the acquisition of Tobira was for NASH drugs; Belviq has shown to help with NASH due to weight loss). I believe Arena (ARNA) is deeply undervalued and a shock skyrocketing of the stock is in the cards.

Always do your own research. The above is not an investment advice. I own shares of Arena (Nasdaq: ARNA).

Other recent coverage:

  • Jefferies Group reiterated a "buy" on August 10th.
  • Needham & Company reiterated a "hold" on August 13th.
  • JPMorgan Chase reiterated a "hold" on August 8th.



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Folks, I found the following which someone posted to be interesting. Of course it's just a projection into future, so should be definitely considered speculation and nothing more. But I like the basic idea and share the kind of sentiment that ARNA is incredibly undervalued, and to put my money on that opinion, I've been buying.

Revised valuation model given P2 results (added Belviq). $34 to $57 / share

Nuplazid is the only drug in the pipeline of ACAD and ACAD's valuation is almost 5 billion. Bring it down to Arena's royalty level and downgrade it to Phase 2, given the latest results were excellent (p < 0.05 achieved for primary endpoint despite very small sample size) I anticipate the full results will even be better, Arena's valuation on just Nelotanserin should be around 750M dollars (currently being zero). So those phase 2 results later this year should add around $3 a share. So with no other results, that should put the share price at $4.50.
Let's add some valuations based on other upcoming 2017 P2 results. Positive P2 APD371 should be worth at very least 1 billion, but potentially 3 or more billions depending on the quality of the data. Etrasimod, at the very least 3 billion, potentially 5 billion. Let's give Ralinepag a mere 1 billion (likely 2-3 billion if additional benefits observed).
Nelotanserin +: .75B = +3
Ralinepag +: 1-3B = +4 to +12
APD371 + : 1-3B = +4 to +12
Etrasimod + :3-5B = +12 to +20 
ARNA 2017 Target Share Price: $24.5 to $48.5 (1.5+3+4+4+12) to (1.5+3+12+12+20) 
You can do the math on the combination of possibilities. I personally think all the above trials will yield positive results. $25 to $48 per share in December 2017 is not out of the question. Let's go super conservative and half that. $12.5 to 24 December 2017 will do me good. I just bought some shares at 1.48
Bottom line is 1.49 is an incredible bargain, according to the above model.
 
Belviq CVOT positive results means a mega market opening. Royalty adjusted my guess would be at least $2B in valuation for Arena = $9/share 
 
So if the trial results are good and CVOT kicks in positive results in early 2018, Q2-Q3 2018 we're looking at a potentially $34 to $57 a share. 
 
Do your own research.
 

~~~~
DISCLAIMER / REMOVAL INSTRUCTIONS
I can't guarantee the accuracy of the above points. Do your own research. This email is not an investment advice and is not a medical advice.
See www.belsuccess.com for Belviq reviews and www.belviq.com for Belviq prescribing and safety information. I am not affiliated with Arena or Eisai in any way, except being a shareholder of Arena (NASDAQ: ARNA).



Etrasimod by Arena Pharma (NASDAQ: ARNA)

An investor wrote his opinion NOT AN INVESTMENT ADVICE in December 2016:   "Etrasimod Phase 2 data will make ARNA worth at least $5 billion ($20/share). The company knows that, so there will be no dilution. Sorry shorts. 4 other readouts before then will position the stock to easily reach 20 or 25. Depends on the trial outcomes no doubt, but a safe bet, imho."


Etrasimod/APD334 vs. Ozanimod/RCP1063 -- An opinion piece by a medical doctor, with permission:

"Etrasimod/APD334  appears superior to Ozanimod/RCP1063 because of cardiac safety and elevations in liver function tests (signs of liver damage). This is supported by direct comparisons from published data on the phase 1 studies in healthy volunteers.
 
Ozanimod did demonstrate serious heart rate issues including heart block and pauses in the heart rate (although at higher doses than eventually tested in phase 2/3) and this caused them to design all of their studies with a titration phase where they have to gradually increase the dose over the first week of dosing.  This seems to mitigate the heart rate problems.  Arena, however, did not see any  serious heart rate problems in their phase 1B study and does not use a dose titration in their phase 2 study for ulcerative colitis.  Just as Receptos RCP1063 appears to be safer than Gilenya, I believe Arena's APD334 will trump both drugs and eventually become the "gold standard" for this class of drugs for multiple autoimmune conditions.
  
Below are the heart rate data from the phase 1 trials for both RCP1063 and APD334. If anything, APD334 (2 patients/5%) appears to have fewer patients with a heart rate below 50 (bradycardia) than RCP1063 ( 8 patients /13.3%). for the doses tested. The RCP1063 group also had 3 potentially dangerous heart rhythm events in the 1.5-3 mg dose groups.  This caused them to design their phase 2 trials with a dose titration regimen over 1 week which has been shown to reduce the bradycardia. 
 
In contrast, Etrasimod demonstrated reduced bradycardia (slowing of the heart rate) and no serious heart problems (heart block) even at the highest doses tested.  this should be a distinct competitive advantage, and allowed our phase 2 trial to be designed without a titration (gradual increase of dose over the first week).  
 
 
 
 
RCP1063 Phase 1 Heart Rate Data in healthy volunteers 
 
 
 
 

APD 334 Phase 1B data in healthy volunteers). No clinically significant heart rate events were noted for APD334

The other area where Etrasimod appears to be superior to Ozanimod is in the elevation of liver function tests (>3 times).  The above chart below is from the 2015 Investor Day Presentation linked above the message board. The green boxes show the positive features of each drug.  There has been even less data published about MT-1303 so we can not be certain of how it compares to Etrasimod for liver function tests."
 



Heart rate data from Arenas Etrasimod phase 1b trial.  It got dropped somehow when I cut and pasted it. Here it is.

 
 
RCP1063 Phase 1 Heart Rate Data in healthy volunteers 
 
 
 
 

APD 334 Phase 1B data in healthy volunteers). No clinically significant heart rate events were noted for APD334
 





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"Ozanimod looks to have "musculoskeletal" chest pain and orthostatic hypotension (lowering of blood pressure on standing) in up to 8% of patients.  Ozanimod also has transient (but worrisome) primary and secondary AV blocks (heart electrical impulse issues) in about 2% of patients.  Up to 5% of ozanimod patients also had "short runs" of tachycardia (rapid heart beat) which is probably one of the scariest cardiac issues anyone can have.  Not sure if these cardiovascular issues showed up in the same ozanimod patients or different ones (if different then the cardiovascular issues with ozanimod could approach 15% (8 + 2 + 5).  I do believe as well that tachycardia places emergency room visitors on the top of the triage list for attention.  The use of the term "short runs" of tachycardia instead of "transient" is possibly significant here because "short runs" may be something that do not disappear with regular dosing.  One "short run" a day for ever? Etrasimod looks to be the safer of the two, especially since dosing with it doesn't appear to have any of these cardiovascular issues.    For one, I think that I would feel uncomfortable with chest pain of any kind as my mind would automatically think "heart problem" instead of rib cage pain.   Etrasimod certainly seems to have a bright future if phase 2 results look good."


Etrasimod Posters...

_______________________________________________________

Celgene paid $7.2 Billion for Receptos to obtain Ozanimod (RPC1063). Arena's Etrasimod (APD334) is potentially better and safer than Ozanimod based on the data we've seen so far (Arena doubled in price on that data, but got walked down again, due to a number of internal and external factors, none that had to do with the science (which I generally summarize as lousy past management).

Nomura Securities thought Celgene got a good deal and RPC1063 is worth more than 7 Billion since it's well below the 3-4x peak sales multiple. At the bottom section of this page is a doctor's discussion about the comparison.
http://belsuccess.yolasite.com/Articles.php

In ARNA terms 7 Billion translates to around $30 / share. Currently ARNA is trading at $1.40. Data phase 2 data is due out in the coming year. Separately, a number of other data readings on other pipeline components are due also in the coming year. It should be a good year for Arena assuming the data will be good, which I am assuming based on the data we already have, and Arena's technology platform which allows for very safe (clean side effect profile) drugs.

My guess is just on 334 positive data and no other news, the company will be worth at least 3 Billion ($12.50 per share which is a 9 times multiple from here. And then there are at least 3 other exciting compounds with data coming up.

Belviq itself, the company's approved obesity & T2DM product will have a major boost with the CVOT (phase 4) results.
I believe it's a very good bargain anywhere under $3 but you do your own research...

I repeat: THIS IS NOT AN INVESTMENT ADVICE... just sharing my research...




Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced the formation of Beacon Discovery Inc. ("Beacon"), an independent, privately-held drug discovery incubator.  

How does it help Arena?

"1.  They no longer have to pay to do research, Beacon will have to raise their own money to move forward.  Cutting research expenses for new research.
 
2.  Arena owns the patents on the GPCR technology so any drugs discovered using this technology even if partnered away, Arena will get a royalties from it.
 
3.  Beacon will continue as a paid third party research company to advance our collaborations and our pipeline for us which we will receive all of the benefits from to partner or sell off.
 
4.  How does this help current shareholders, it reduces our costs to do on going research and focuses the company on the drugs we have in the pipeline.  Is it smart, is it the right decision, some say yes some say no.  They believe that the drugs in the pipeline will add the most value to the shareholders in the short run.  We need to monetize the discoveries we have and the drugs we have in front of us, not spend 10's of millions on discovering more compounds and more potential drugs.  We don't have the capital to get those through the next 7 years.  If and when the drugs in the pipeline are successful we can start up our own research and development again if needed. However, if all three of these actually perform as current and past management expect, I highly doubt Arena will look anything like it does today.  Sold off in pieces, as a whole, who knows. "

NOVEMBER 2016 GOODIES

Publication: Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials

Obesity journal   2016 Nov 26. doi: 10.1002/oby.21695. [Epub ahead of print]

OBJECTIVE:

 

To evaluate the effects of lorcaserin in patients with pre-existing Food and Drug Administration (FDA)-defined valvulopathy.

METHODS:

This is a pooled, post hoc analysis of three Phase 3 studies. BLOOM and BLOSSOM patients were 18 to 65 years of age without diabetes and with a body mass index (BMI) of 27 to 29.9 kg/m2 and ≥1 weight-related comorbidity or a BMI of 30 to 45 kg/m2 . BLOOM-DM patients had a BMI of 27 to 45 kg/m2 and type 2 diabetes. Patients were treated with placebo, lorcaserin 10 mg once daily, or lorcaserin 10 mg twice daily. Serial echocardiographs were obtained at baseline and every 6 months.

RESULTS:

Included patients (N = 169) had FDA-defined valvulopathy at baseline and a week 52 echocardiogram. At week 52, 35.5% and 52.7% of patients experienced changes from baseline in aortic and mitral regurgitation, respectively. Numerically greater proportions of patients taking lorcaserin versus placebo had decreases in aortic (33.0% vs. 28.3%) or mitral (41.3% vs. 36.7%) regurgitation. Fewer patients taking lorcaserin versus placebo had increases in aortic (2.8% vs. 6.7%) or mitral (8.3% vs. 21.7%) regurgitation. No adverse event-related discontinuation was due to a valve problem.

CONCLUSIONS:

These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy.

 

https://www.ncbi.nlm.nih.gov/pubmed/27888609 

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Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study

This is Mayo pilot study that they are now following up on.

 Introduction: Post-cessation weight gain (PCWG) is a major barrier to maintaining abstinence, especially in weight-concerned smokers. Varenicline is the most effective medication for smoking cessation but has minimal impact on PCWG. Lorcaserin is an FDA-approved medication for weight management in overweight or obese patients which also provides a noticeable benefit in treating drug dependence. We hypothesized that combining varenicline with lorcaserin may help prevent post-cessation weight gain. We conducted an open-label, single arm, Phase II clinical pilot study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing PCWG in overweight and obese smokers.                     

Methods: Twenty overweight or obese (body mass index 27-40 kg/m2) cigarette smokers were enrolled. The primary outcomes were weight and waist circumference (WC) changes at 12 and 26 weeks in smokers meeting criteria for prolonged smoking abstinence. All participants received open-label varenicline (1 mg twice a day) and lorcaserin (10 mg twice a day) for 12 weeks with follow up at 26 weeks.

Results: Ten subjects met criteria for prolonged smoking abstinence at 12 weeks (50%) and 6 at 26 weeks (30%). Among those achieving prolonged smoking abstinence at 12 weeks, WC was +0.2±6.0 cm (90% CI; -2.9,+3.4) and weight gain was +1.1±3.9 kg (90% CI; -0.9,+3.1).

Conclusions: Weight gain and WC increases following prolonged smoking abstinence may be reduced among overweight and obese smokers using combination varenicline and lorcaserin. This combinatory treatment warrants further research in the obese and weight-concerned smoking population.

Implications. This is the first published prospective pilot study to evaluate lorcaserin for use in reducing post cessation weight gain (PCWG) in overweight and obese smokers. When combined with varenicline, lorcaserin minimized PCWG and increases in waist circumference. In addition to the benefit on PCWG reduction, lorcaserin may be a potential new pharmacological treatment for smoking cessation and warrants further larger studies.  

http://ntr.oxfordjournals.org/content/early/2016/11/16/ntr.ntw304 

_____________________________________________________________________________________ 

 The next study already ongoing, is going to be where it gets really interesting.   Lorcaserin is continued for longer, to 24 weeks and not all patients will receive lorcaserin with Varenicline so there will be a true comparison.   

Some individuals smoke with the perception that smoking helps control body weight. Smokers gain an average of as much as 10 pounds in the months following smokingabstinence, with heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research Program will randomize 100 nondiabetic, overweight or obese adult smokers to active lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of lorcaserin for decreasing weight gain after stopping smoking.

_____________________________________________________________________________________ 

Post hoc analysis- Lorcaserin treatment and impact on glycemic parameters

http://www.tandfonline.com/doi/full/10.1080/00325481.2016.1240591

Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with ≥5% weight loss

Yehuda Handelsma, Randi Fain, Zhixiao Wang, Xuan Li, Ken Fujioka & William Shanahan

Methods: This is a post hoc analysis of three Phase 3 studies in adults with and without type 2 diabetes mellitus (T2DM) treated with lorcaserin 10 mg BID or placebo. NNT is reported for patients achieving ≥5% or ≥10% weight loss, achievement of either HbA1c <5.7% or FPG <100 mg/dL in patients with prediabetes, and reduction of HbA1c to <7% in patients with T2DM at Week 52.
Results: In the modified intention-to-treat (MITT) population, NNTs for ≥5% and ≥10% weight loss were 3.6 and 6.2 (without T2DM) and 4.3 and 7.5 (with T2DM); in Week 12 responders (≥5% weight loss at Week 12), NNTs were 1.7 and 2.6 (without T2DM) and 1.9 and 3.2 (with T2DM). In patients with prediabetes, NNTs to achieve HbA1c <5.7% were 9.9 (MITT) and 5.2 (Week 12 responders). In patients with T2DM, NNTs to achieve HbA1c <7% were 4.2 (MITT) and 2.3 (Week 12 responders).
Conclusion: In addition to weight management, lorcaserin improved glycemic control in patients with prediabetes and facilitated targeted HbA1c reduction in patients with T2DM, especially for those who achieved ≥5% weight loss by Week 12. Assessment of treatment response at Week 12 is a valuable tool to achieve efficient use of healthcare resources.

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Lorcaserin halts weight regain after bariatric surgery - published abstract

 http://www.soard.org/article/S1550-7289(16)30519-6/abstract

Surgery for Obesity and Related Diseases (SOARD), The Official Journal of the American Society for Metabolic and Bariatric Surgery (ASMBS) 

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Publication: Lorcaserin for Smoking Cessation and Associated Weight Gain (11/4/16)

Nicotine and Tobacco Research  

Methods: This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. 603 adult smokers with a Body Mass Index (BMI) of 18.5–35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg QD, 10 mg BID or placebo; all received standardized smoking cessation counseling weekly. The target quit date was Day 15.                     

The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for Weeks 9-12 (Month 3).

Results: Continuous Abstinence Rates for Month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p=0.0027. Change in weight at Week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p=0.0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving Month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue.

Conclusions: Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted.

http://ntr.oxfordjournals.org/content/early/2016/11/04/ntr.ntw301.abstract 

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presentation. VASCULAR DISEASE SESSION TITLE: NOVEL MECHANISMS OF PULMONARY VASCULAR DISEASE Abstract 16601: APD811, a Novel and Highly Selective Non-prostanoid IP Receptor Agonist in Smooth Muscle Cells From Patients With Pulmonary Hypertension

Abstracts and presentations are embargoed for release at date and time of presentation or time of AHA/ASA news event. Failure to honor embargo policies (http://newsroom.heart.org/newsmedia/embargo-policy) will result in the abstract being withdrawn and barred from presentation.
VASCULAR DISEASE
SESSION TITLE: NOVEL MECHANISMS OF PULMONARY VASCULAR DISEASE
Abstract 16601: APD811, a Novel and Highly Selective Non-prostanoid IP Receptor Agonist in Smooth Muscle Cells From Patients With Pulmonary Hypertension
Lei Shen, Jigisha Patel, Dominic Behan, John Adams and Lucie Clapp
Circulation. 2016;134:A16601

Introduction: APD811 is an oral, non-prostanoid IP receptor agonist with a long plasma half-life (~ 24 hr) in development by Arena Pharmaceuticals Inc for pulmonary arterial hypertension (PAH). Little is known about the pulmonary pharmacology of this agent. We assessed the ability of APD811 to generate cyclic AMP (cAMP) and inhibit cell proliferation in pulmonary artery smooth muscle cells (PASMCs) isolated from PAH patients. The role of the IP receptor was investigated alongside prostacyclin mimetics already licensed for PAH.

Methods: Distal PASMCs were stimulated with 9% serum and treated with agonists ± RO-118452 (IP receptor antagonist; IPRA) for 1 hr or 4 days to measure cAMP (ELISA) and cell proliferation (MTS), respectively. The concentration (EC50) producing the half maximal (EMax) response was determined.

Results and conclusions: Iloprost APD811, MRE 269 (selexipeg metabolite) and treprostinil increased cAMP (EC50 17, 252, 340, 550 nM, respectively). EMax was lower (P<0.001; n=5) for all three agents (64, 45, 25%, respectively) compared with treprostinil. In cell proliferation assays, APD811 was 10 fold more potent (14 nM) than MRE-269 (145 nM); both produced a lower EMax compared to treprostinil (57% versus 89%). RO-118452 (1 μM) essentially abolished agonist-induced cAMP generation and the effects of APD811 and MRE-269 in cell proliferation assays. In contrast, the antiproliferative effects of treprostinil and iloprost were weakly inhibited by RO-118452. In combination with other PAH therapies, APD811 produced a greater (range 0.1-10,000 nM) antiproliferative response in the presence of riociguat (100nM) and to a lesser extent with 100nM treprostinil or the phosphodiesterase inhibitor, sildenafil but not when combined with 100nM endothelin receptor antagonists (bosentan and macitentan).

Summary: In human PASMCs, APD811 and MRE-269 both behave as selective, but partial IP receptor agonists in cAMP and cell proliferation assays, with APD811 a more effective agonist than MRE-269. Iloprost and treprostinil inhibit proliferation through IP-receptor independent pathways. Agents stimulating cyclic GMP could work better at inhibiting cell proliferation in combination with APD-811 than endothelin receptor antagonists.

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So compared to placebo Lorcaserin has a consistently higher quite rate than Chantix. So far two trials demonstrate its superiority to Chantix. It is funny that Eisai sees no value in that. It would be simple enough to do a head to head comparison. Perhaps it needs to be done because the Chantix data reported a completely unrealistic placebo quite rate. However, trial data only valid when compared to Placebo in that trial. Based on two trials, Lorcaserin is a superior drug with no weight gain.

3 December 2016

To: Esteemed Advisory Committee Members of the NY Medicaid Evidence Based Benefit Review Board 

I encourage you to approve Belviq for Medicaid coverage in New York State for two simple reasons: 

1)     Belviq works.

2)     Belviq is safe.

Several trials on thousands of patients, and subsequent “real world” accounts of success stories (please see www.belsuccess.com a non-profit site I operate), clearly indicate that if a patient is a responder, Belviq can work wonders for them. I have two friends who have lost over 100 pounds on Belviq without any side effects, and I know of many more who have lost in excess of 50 pounds with nothing more than mild, transient headache and/or dry mouth (known side effects). I also know many Belviq patients who have reported other positive effects such as glycemic benefits, deeper sleep, smoking cessation, reduction or elimination of anti-depressant use, etc. 

A responder is one who loses 5% weight or more within 3 months. Responders will go on to lose around 12% in a year. Obesity experts know that even a 5% reduction has significant health benefits.

Belviq is also a T2DM medicine. Obesity and T2DM cost the healthcare system in the USA one billion dollars a day. 

I felt obliged to write to you because, unfortunately, Belviq was a victim of severe misinformation by certain financial entities who bet against its approval because they could not understand that placebo-adjusted efficacy does not apply in the real world (this statement is confirmed by FDAs own experts). And, Arena’s management did not fight the organized misinformation campaign which the SEC calls “short and distort”. Because you may be faced with that false info, I felt obliged to include the above website where the “real world’s” patients express their feelings about Belviq.  On that site there is also a tab for doctor comments.

For example, Dr. Steven Vig of Tuscan, AZ, swears by Belviq. He has written a thousand prescriptions for   patients and calls Belviq “a very safe and effective drug”. 

Belviq’s safety is rooted in its highly selective nature in targeting 5HT2c GPCR. It is not a stimulant, and doesn’t carry the “dirty” side effects of drugs like Contrave, which can cause suicidal thoughts, or Qsymia, which can cause birth defects (the FDA has a REMS program on it). 

Patients on Belviq showed the best tolerance level of the other obesity drugs because of its excellent and “clean” safety profile. 

Given that Obesity is an epidemic in the US and a pandemic in the world, proven to lead so some fifty other diseases, it is clear that Belviq is the best and safest drug to address this problem. 

New York State Medicaid will benefit financially by approving Belviq by virtue of its recipients losing weight and becoming healthier, more productive individuals. I   encourage you to please approve it. 

Of further interest, a change of management has taken place within Arena Pharmaceuticals, the San Diego, CA based maker of Belviq. The company is developing additional compounds that, like Belviq, will target urgent medical needs. In the meantime, many studies ongoing by other parties address the positives associated with  Belviq. Just in November 2016, we saw the following.

·      These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy. https://www.ncbi.nlm.nih.gov/pubmed/27888609 

·      Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. http://ntr.oxfordjournals.org/content/early/2016/11/04/ntr.ntw301.abstract

·      Weight gain and WC increases following prolonged smoking abstinence may be reduced among overweight and obese smokers using combination varenicline and lorcaserin. http://ntr.oxfordjournals.org/content/early/2016/11/16/ntr.ntw304 

·      Lorcaserin halts weight regain after bariatric surgery - published abstract – The Official Journal of the American Society for Metabolic and Bariatric Surgery (ASMBS)

·      In addition to weight management, lorcaserin improved glycemic control in patients with prediabetes and facilitated targeted HbA1c reduction in patients with T2DM, especially for those who achieved ≥5% weight loss by Week 12. Assessment of treatment response at Week 12 is a valuable tool to achieve efficient use of healthcare resources. http://www.tandfonline.com/doi/full/10.1080/00325481.2016.1240591 

Best Regards

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March 20, 2017

From an investor:

"Actelion is getting bought for $28B based on Selexipag success.  Amit stated on the last conference call very clearly that they believe Ralinepag is clearly superior and will be best in class.  If the data mid-year shows this, Arena should be worth $10+ or at least $2.5B IMO.  Will it run to these results, will the market even care, who knows?  
 
ARNA has been disconnected for some time.  Short interest at all time lows and the trading continues to see manipulation.  I'm just holding and hanging out to see how 2017 progresses.  Too much good data coming this year to not be excited about the future, especially after the last few years.  I've bought a bit more in the $1.40's and $1.50's as ARNA at these prices is a never expiring options with multiple shots on goal.  No reason ARNA won't be sold for 10-20X these prices in the next 12-18mo if we get strong data.  We also have CAMELLIA data shortly thereafter.  
 
2017 & 2018 maybe the pay off for the last several years of pain and dead money.  GLTA!  "

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