I was admittedly never very good when it came to limbo because I'm not very flexible and I'm all legs. Sanofi SA (ADR) (NYSE:SNY) and ISIS Pharmaceuticals, Inc. (NASDAQ:ISIS) , however, rocked the limbo bar like a champ last week following the approval of homozygous familiar hypercholesterolemia, or HoFH, drug, Kynamro.
It was somewhat of a toss-up whether Kynamro would get the nod of approval from the Food and Drug Administration because -- in addition to the same liver toxicities noted in competing drug Juxtapid, made by Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) and approved in December -- Kynamro's trials also included abnormal growths known as neoplasms in 3.1% of all patients tested. Ultimately, with few options for suffers of the high-cholesterol disease, the benefits were seen to outweigh the risks, and Kynamro was approved.
What's really worth noting is Sanofi's pricing of the drug. As cited by the Wall Street Journal, Aegerion's CEO, Mark Beer, went on the record noting that a full-year's treatment of the pill will run $235,000 to $295,000 depending on the stage of the disease. But as I mentioned earlier, Sanofi and Isis broke out the limbo bar and one-upped, or should I say, one-downed, Aegerion by pricing their injectable HoFH treatment at a cost of $176,000 per year.
Understandably, there are some marked differences between the two drugs. Juxtapid is a pill that received far less scrutiny by the FDA panel as was evidenced by the vote of 13-2 to recommend approval. Kynamro must be injected, and those aforementioned neoplasms resulted in a not-so-convincing FDA panel vote for recommendation of just 9-6. But is this a $59,000-$119,000 difference? I'm not so sure!
We've seen a major backlash from physicians and patients in recent years if insurability or reimbursement is an issue. It's one of the primary reasons Dendreon Corporation (NASDAQ:DNDN)'s advanced-stage prostate cancer treatment Provenge failed to take off. At $93,000 for a full course of treatments, few insurers stepped up to the plate. Only recently has Aetna Inc. (NYSE:AET) lightened its stance on who's covered to take Provenge, yet the qualifying factors list is still pretty extensive.
Pricing has even affected relatively low-cost drugs like VIVUS, Inc. (NASDAQ:VVUS)' newly approved chronic weight management drug, Qsymia. VIVUS' chief commercial officer, Mike Miller, had noted previously that up to 30% of all early Qsymia prescriptions were being left at the pharmacy because the cost of the medication was coming directly out of patients' pockets. It wasn't until November when Aetna announced coverage of Qsymia and Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)' Belviq that sales of Qsymia began to ramp up.