Vivus has posted financials for the fourth quarter which show that its much-touted diet pill Qsymia had sales of just $2 million.
In September, the company launched Qsymia (phentermine/topiramate) the first new medication approved in the USA in 13 years for the treatment of obesity. However, its uptake has been severely hindered because of problems getting coverage for the drug and the fact that it has only been sold through home delivery pharmacies as part of the risk evaluation and mitigation strategy linked to its approval by the US Food and Drug Administration.
On the positive side, Vivus signed an agreement in December with Express Scripts, the USA's largest pharmacy benefits manager, to cover Qsymia. A similar pact has been inked with health insurer Aetna.
Chief executive Leland Wilson said that since approval, "we have dedicated resources and been actively engaged in the process of educating physicians and creating awareness for Qsymia". He added that in order to expand access to the drug, Vivus submitted to the FDA in October a modification of the REMS that, pending approval, "would allow patients to access Qsymia through select certified retail pharmacies".
Mr Wilson said "we continue to make substantial progress in obtaining reimbursement coverage". He noted that "there is an addressable patient population in the USA of approximately 100 million people, and less than 2% are currently being treated with pharmacotherapy for obesity. We believe that Qsymia can change this dynamic".
Another goal for 2013, Mr Wilson added, is to secure partnerships for Stendra (avanafil), Vivus' erectile dysfunction drug which was approved by the FDA back in April last year.
Net loss for the quarter came in at $56.7 million, up from $11.5 million, due to higher selling, general and administrative expenses related to Qsymia and the firm ended the quarter with cash and equivalents of $58.6 million. Last week, European regulators rejected the drug last week for the second time (see link).
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