The biggest winner is "The Biggest Loser" in a compelling weight-loss reality drama in which two celebrity fitness trainers join with top health experts to help overweight contestants transform their bodies, health and ultimately, their lives. With over 11 million viewers each week, the show is easily NBC’s most popular. So, that is twenty-two contestants working their asses off at some ranch in Simi Valley, California while 10,999,978 of us sit at home wishing there was just some “magic pill” to help us lose weight.
Lorcaserin (APD-356) is a serotonergic weight-loss drug that just might make that wish come true. On or around March 30th, 2009 there'll be an announcement of FDA results for Lorcaserin that could create a very high return on investment for those who dare to play in the risky field of biotech.
According to published statements, Lorcaserin is a selective 5-HT2C receptor agonist, and in vitro testing of the drug showed reasonable selectivity for 5-HT2C over other related targets.5-HT2C receptors are located almost exclusively in the brain, and can be found in the choroid plexus, cortex, hippocampus, cerebellum, amygdala, thalamus, and hypothalamus. The belief is that the activation of 5-HT2C receptors in the hypothalamus promotes weight loss through appetite suppression, and this is supported by animal studies, but it is unclear whether the dose range used in human trials will be sufficient to demonstrate the same level of weight loss. While it is generally thought that 5-HT2C receptors help to regulate appetite as well as mood, motor behavior, and endocrine secretion, the exact mechanism of appetite regulation is not yet known.
The drug has successfully cleared both Phase 1 and 2 FDA clinical trials:
The company states that "data from Phase 2 clinical trials of Lorcaserin demonstrated that patients who received the drug experienced significantly greater weight loss than patients who received placebo." At the end of 12 weeks, the groups which were administered Lorcaserin lost an average of 4.0 pounds (10 mg/day), 5.7 pounds (15 mg/day), and 7.9 pounds (20 mg/day). The placebo group lost an average of 0.7 pounds, despite the fact that all groups received no diet or exercise instruction.
Upon discontinuation of Lorcaserin treatment, lost weight is regained. In Phase 2 clinical trials, patients were tracked for 2 weeks post trial completion, and all groups regained weight more rapidly than they had lost. In pre-clinical trial studies, lab rat weights returned to control levels.
The company is taking care to demonstrate that Lorcaserin does not cause heart valve damage in the same way as previously withdrawn serotonergic weight loss drugs such as fenfluramine and chlorphentermine. They stated that the Phase 2 clinical trials, the participants of which had been pre-screened to exclude valvulopathy, show that Lorcaserin "has no effect on heart valve regurgitation at 12 weeks."
We are just weeks away from the announcement of Phase 3 results, the last trial before it could become “a billion-dollar drug”, according to Forbes Magazine. Plugging those kinds of sales figures into the company that owns this drug could make the $5.98 share price rise by almost 1,000% after March 30th, 2009. The projected release date for Lorcaserin is 2010.
Arena Pharmaceuticals, Inc. (Ticker Symbol: ARNA) is a clinical-stage biopharmaceutical company committed to discovering and developing innovative therapies offering significant medical advances and new options for patients. They are focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Their lead drug candidate, Lorcaserin hydrochloride, is intended for the treatment of obesity and is being evaluated in a Phase 3 clinical trial program.
Arena has developed a marketing plan to target the massive base of overweight and obese consumers, including pre-launch marketing and brand positioning that commenced in 2007, packaging, support, and internet development that started in 2008, and a "Speaker's Program" beginning in 2009 during their New Drug Application process with the FDA. This plan predicts an initial number of prescriptions of 10 million for revenue potential of $1 billion.
Latest News
SAN DIEGO, Feb 04, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the company is scheduled to present at the BIO CEO & Investor Conference on February 10, 2009 at 1:45 p.m. Eastern Time (10:45 a.m. Pacific Time) at the Waldorf=Astoria Hotel in New York City. Jack Lief, Arena's President and Chief Executive Officer, is scheduled to provide an overview of the company, including its clinical development and discovery programs.
SAN DIEGO, Jan 08, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the company is scheduled to present at the 27th Annual J.P. Morgan Healthcare Conference on January 14, 2009 at 3:00 p.m. Pacific Time (6:00 p.m. Eastern Time) at the Westin St. Francis Hotel in San Francisco. Jack Lief, Arena's President and Chief Executive Officer, is scheduled to provide an overview of the company, including its clinical development and discovery programs.
At the end of March, FDA results will be announced, but early results from the Phase 3 trial, show that Lorcaserin beats the placebo (no drug) by 500%, and has successfully treated almost every single one of those on drug among the 3,000 patients currently enrolled in the clinical trials.
Remember that Lorcaserin has already cleared the Phase 1 and the Phase 2 trials. In other words: all that's left is the red tape of filing it with the FDA. That's why most new drugs usually see their biggest returns long before the FDA gives official approval.
As I was writing this article, CNBC released this report with Jack Lief, Arena Pharmaceuticals chairman/CEO and CNBC's Mike Huckman:
Targeting Obesity
“A major focus in the biotech industry is the worldwide epidemic of obesity and drugs being developed to address it”
http://www.cnbc.com/id/15840232?video=1027447539
Not a day goes by in this country when there isn't some new study or news report detailing the negative effects of obesity. The bottom-line is: The number of overweight people in America is attracting the notice of medical professionals everywhere, and even 11 million weekly viewers of NBC’s “The Biggest Loser”.
Arena Pharmaceuticals, Inc. (Ticker Symbol: ARNA) has developed a drug it thinks will transform America’s bodies, health and ultimately, their lives. Lorcaserin could transform their wallets and create “The Biggest Winning Investors”. But, be careful. Biotech is a very risky play, and it has been known to bite. There is also potential to shed dollars and the wrong kind of pounds.
Author Resource:-
Mark Ripple is a veteran stockbroker and horseplayer who wrote the book “Handicapping the Wall Street Way.” The book shows how securities investment theories can be incorporated into horse wagering and is an excellent work for novice to intermediate horseplayers. To purchase a copy of the book, visit http://www.UberHorse.com. To view FREE horseracing handicapping tips visit http://www.UberLock.com.
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