jueves, 20 de septiembre de 2012

VIVUS: Al fin QSYMIA en el mercado...(USA)

MOUNTAIN VIEW, Calif., Sept. 18, 2012 /PRNewswire/ -- VIVUS, Inc. today announced the U.S. market availability of Qsymia™ (pronounced Kyoo sim ee' uh). Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). It is the first FDA-approved once daily combination therapy — and the first new medication available in 13 years — for the treatment of obesity.


"VIVUS is proud to be leading the way in the treatment of obesity, a disease with very serious health consequences," said Peter Tam, President of VIVUS. "Qsymia is the first ever combination treatment made available, and today's introduction marks a new beginning for many patients who struggle with obesity. We are excited about making this new treatment option available to patients because Qsymia is the first FDA-approved oral medication that has been shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification program


Vivus previously announced pricing for Qsymia -- ranging from $4-6 per day depending on the dosage strength -- that was in line with investor expectations.

Qsymia combines two drugs, phentermine and topiramate, that are available as generics for a combined price of around $1-3 per day. Will doctors choose to prescribe Qsymia to their obese patients or recommend the individual, generic components? Investors have been debating the question leading up to the drug's launch.

"Feedback from doctors indicates that generic substitution is unlikely to be widespread given the associated liability of either prescribing or dispensing the generic components separately so long as the product [Qsymia] is not made too cost prohibitive," said J.P. Morgan biotech analyst Cory Kasimov in a recent research report.

But in August, Jefferies analyst Thomas Wei downgraded Vivus, citing concerns that doctors will choose to prescribe the generic components of Qsymia instead of the branded (and higher priced) product.



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