MY IMPRESSION AS A WEIGHT LOSS DOCTOR...
Let me first introduce myself, my name is Erik and I am an emergency medicine doctor. As of several years ago I decided to go into bariatrics (weightloss), and went through the american society of bariatric physicians to get my board certification. I have had my own practice open now for approximately 1 year, and partnered with another physician that has been doing this for 7 years. I want to help investors understand some of the studies that have been done, as well as convey my experiences as a specialist in an office based weightloss practice.
I first learned about Lorqess several years ago and have been following it since. As a physician I have spent countless hours researching this stock. In fact I have probably driven my wife mad doing my due diligence, pulling up articles, researching statistics, and so on. When I have a question I have access to several brilliant specialists (many of them are close friends) , which gives me an advantage over many investors.
This is my take on past and current events:
1. The echo studies done may show a small statistical increase in the chance of developing a valvulopathy, therefore post-approval echo studies will probably be required. This takes time depending on how they arrange it.....but I would assume they would be done at 3,6,9, and 12 months......so you are looking at at least 15 months out from approval before the results are submitted back to the FDA post-approval.....
2. Developing cancer from this drug is not a side effect until you go 80x the normal dose!!! however there is a small chance of developing a fibroadenoma, which is a begin breast tumor.
3. I think the potential to have the DEA schedule the drug is there. If it happens most likely it will be a schedule IV, which means an abuse potential is there. However, the studies that Arena did with 40-60mg did not indicate that....but what happens when you go past dose. Lorqess is dosed 10mg twice a day. At this dose there may be some mild cognitive problems, or psychological changes (which can occur in almost all drugs on the market that affect the brain,ie antidepressants...etc) in a small % or patients. At higher doses, there maybe abuse potential....however, I know a number of abused drugs that are not scheduled with the DEA.Remember Arena developed the drug to have specificity to the 5HT2-C receptor (the appetite control center in the hypothalamus), and not the 5HT2-A (this functions in he other parts of the brain and may cause the psychological side effects. If it does become a scheduled drug, it may decrease Arena's overall profit, but I speculate by only a small amount because the vast majority of physicians have a DEA license and will be able to prescribe this.I believe the abuse potential is theoretical, but will not stop approval. I also believe there is a small chance it will be a scheduled drug because of the theoritical abuse, but the studies at double prescribed dose did not show abuse potential.
4. Lorqess will be the only long term drug to treat obesity out the other than Xenical. Xenical is a fat blocker that stops the absorption of 1/3 of fat ingested. Alot of my patients will not take this because it causes stetorrhea (fatty stools), thus diarrhea and sometimes anal leakage. Qnexa, a drug looking for approval in July, is a combo topamax and phentermine. We use this in the clinic already as a generic. It is a good drug, and we get good results from it, but we hesitate to use it because the topamax causes 'brain fog/cognatative problems/short term memory problems in 20-30% of our patients. We also have to be careful with prescribing to women of child bearing age because of fetal deformities. Also, to be realistic, we get just as good results with weightloss just giving our patients phentermine alone. I don't know if Qnexa has gone for FDA approval for long term use (maybe someone can answer this question for me), but I know the FDA has only approved phentermine for use up to 3 months. This approval was in 1957, and to be honest with you I think it is antiquated medicine to think the necessary behavioral changes can be aquired in 3 months to sustain your weightloss......but this is another discussion. If the FDA does not change its decision and wants to keep the 3 month time limit on phentermine, Qnexa will only be approved for short term use. Once again allowing for Lorqess to be the only long term viable drug option available (unless you dn't mind alot of diarrhea). Of course, as physicians we are allowed to use meds off label, ie phentermine for more than 3 months, but the DEA frowns on this, and I have heard of physicians being reprimanded for this.
5. Lorqess needs to meet one of the two endpoints for weightloss approval, and it does so. It would have been nice to meet 2/2.....but it still passes. This is not an opinion, it is a fact, and for those who think otherwise, I would be happy to have a scholarly conversation with you.
6. I won't get into the financial prospectives of this drug, but alot of the calculations are based on capturing 1-5% of the obese population. We treat far more overweight people in our clinic (Body mass index from 25-29.9), than obese people ( BMI >30). The current guidelines are to use the drug on people who have a BMI of >27 with one co-morbid disease (ie... hypertension), or if the BMI>30. This increases the population that can use this substantially! Not to mention, once again, as physicians we are allowed to use drugs off label.....get the picture. The current guidelines set up by the ASBP (American Society of Bariatric Physicians) are to use weightloss drugs with these guidelines as well a few others:
-your job is dependent on your weight....ie dancers, medics that fly in helicopters, etc
- you had recent weight gain....ie post pregnancy weight gain that has been hard to come
off, rebound from a recent weightloss program....
- a high body fat percentage (for men>25%, women >30%), even with a normal BMI
A good stastic to know is that 33% of the US population is overweight, and 33% is obese. So,
+/- 66% of the population are candidates for this drug! Show me any other drug that has this potential demographic! Not to mention, almost a monopoly as a drug for long term use!!!
5. I am waiting for it to be combined with phentermine. Arena has the right to it until 2023 or something around there......look at the stats for fen-phen, +/- 25 million Rx in the US alone!!! Blockbuster! This is when investors want to be in!
6. Because obesity is now the number one killer in America (it just surpassed smoking), the benefits of approving this drug outweight the risks. I am long on this stock, and I know sound science will prevail....good luck, and don't let the MM, Hedge Funds, and not medical speculators push you out of this company! Do your DD and you will be rewarded!