Let the battle of the obesity drugs begin
Vivus becomes the second pharma this year approved to sell a weight-loss treatment.
Vivus will compete with Arena Pharmaceuticals (ARNA), which is preparing its own launch of a diet drug.
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The announcement came after USA Today inadvertently put out a story online Tuesday that reported the drug was already approved -- before it actually had been. The story was pulled and USA Today made a statement about the goof. In that article, Vivus President Peter Tam was quoted as saying he didn't believe insurance companies would initially cover the cost of the drug. Without revealing a price, he told the paper it won't be "outrageous." The FDA did approve the drug later in the day.
Shares of Vivus bounced around all day Tuesday. They closed down 8% to $26.46 but were back up over 11% Wednesday in early afternoon trading.
The competition will certainly depend heavily on the marketing message for the drugs' safety and effectiveness. Vivus may claim it has a more effective drug but its product also carries safety risks. The approval comes with an agreement that Vivus conduct a so-called risk evaluation and mitigation strategy to inform women of potential birth defects caused by taking the drug.
One of the ingredients in Qsymia (formerly known as Qnexa) is topiramate, which poses the risk of cleft lips in newborns of women taking the drug, according to the FDA and Vivus' own studies. Topiramate already is on the market to treat epileptic seizures and migraine headaches.
Vivus also must perform post-approval safety studies, including research to assess cardiovascular risk of taking the diet drug.
Last month, the FDA approved Arena's diet pill Belviq for sale in the U.S., making it the first new weight-loss drug approved in this country in more than a decade.
Both Vivus and Arena won backing of expert advisers to the FDA earlier this year. The companies and rival Orexigen Therapeutics (OREX) argue that obesity has become an epidemic in this country, contributing to a number of health issues such as diabetes and heart disease.
Vivus is the only company among the three diet pill makers who doesn't have a development partner, a fact that has led to speculation that it may be acquired. Arena is partnered with Japanese drug maker Eisai, while Orexigen is linked up with another company from Japan, Takeda Pharmaceutical (TKPYY). Orexigen is more than two years away from even being considered again for approval but the company believes it can compete.
It hasn't been an easy road for the diet drug companies. The FDA rejected Vivus and Arena's new drug applications in 2010 and Orexigen's in early 2011 because of fear of side effects. Abbott Laboratories (ABT) pulled its diet pill Meridia from the market in 2010 due to concerns about heart attack and stroke risk. The diet pill combination known as fen phen was taken off the U.S. market in 1997 because of risk of heart valve damage.
Vivus, Arena, and Orexigen drugs all carry safety risks. When the FDA approved Belviq, it said obesity is a "major public health concern," and that the benefits outweighed the risks of the drugs. Last night, the agency made similar remarks.
Shares of Arena fell more than 7% Wednesday to $10.23, while Orexigen was up 1.7% in afternoon trading $7.26.
More from Minyanville
In December, the FDA unexpectedly announced that weight loss products containing HCG were illegal. As one of those who had used this hormone based weight loss supplement with tremendous results (and fully intended to use the product in te future), I was curious to discover the reasoning behind the announcement, particularly given that it occured in December, i.e. just before the annual January weight losss frenzy. The articles I read from the FDA were "thin", if not anorexic. For the most part, they decried the 500 calorie per day recommended diet plan. (A plan I never strictly followed - more like 1000 calories a day for me - but still ejoyed the 1 pound per day promised result.) Almost EVERYONE I know who used the supplement had no side effects, increased energy and weight loss averaging a pound a day. So why would the FDA ban this supplement by calling it "illegal"?
Th answer came in the past few weeks. Two new weight loss drugs, both developed by publicly traded companies, were approved by the FDA. These new diet pills were in the final stages of approval in December 2011 and would be direct competitors of the HCG supplement. They announcement that HCG is "illegal",paved the way for these new market entrants without having to explain to the consumer why their results would never approach the results of HCG. In a nut shell, removal of HCG from the market increased the liklihood of profits - and better stock performance - of the drug companies.
You gotta love the FDA.
Obesity is not a disease, it is a choice. Same goes for smoking and alcohol addition. No one is born with an addiction (except crack babies). Smoking, alcoholism and obesity are all self imposed conditions.
I don't want to hear anything about thyroid issues or McDonalds food being addictive.
I invented a new obesity pill, waiting for fda approval...
I call it Qlampjaw , my propietary formula that, chewed
upon awakening , glues your piehole shut for 16 hours.
side effects include excess mumbling and impaired
ability to french kiss.....
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