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
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:
APD 334 Phase 1B data in healthy volunteers). No clinically significant heart rate events were noted for APD334
Heart rate data from Arenas Etrasimod phase 1b trial. It got dropped somehow when I cut and pasted it. Here it is.
APD 334 Phase 1B data in healthy volunteers). No clinically significant heart rate events were noted for APD334
"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."
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.
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]
To evaluate the effects of lorcaserin in patients with pre-existing Food and Drug Administration (FDA)-defined valvulopathy.
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.
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.
These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy.
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.
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
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.
Lorcaserin halts weight regain after bariatric surgery - published abstract
Surgery for Obesity and Related Diseases (SOARD), The Official Journal of the American Society for Metabolic and Bariatric Surgery (ASMBS)
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.
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
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.
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
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.
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.
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
[DISCLAIMER FOR WEB POSTING: SEE BELVIQ.COM FOR FULL SAFETY AND PRESCRIBING INFORMATION]
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?