I was admittedly never very good when it came to limbo because I'm not very flexible and I'm all legs. Sanofi (SNY 0.68%) and Isis Pharmaceuticals (IONS -1.52%), 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 (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's (NASDAQ: DNDN) 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 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' (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' Belviq that sales of Qsymia began to ramp up.
If anything, these two points demonstrate that physicians do care about price and that patients ultimately care about their out-of-pocket costs.
So, what does this mean for Sanofi/Isis and Aegerion? I think it means convenience and safety with respect to Juxtapid are really going to need to be demonstrated in a side-by-side with Kynamro, otherwise I see no reason why Kynamro won't receive a majority of physicians' prescriptions. Aegerion could ultimately bring its price down on Juxtapid into a more comparable range with Kynamro, but it would almost certainly threaten the company's chance at profitability then. I know it's early and anything could happen, but I'm crowning Sanofi & Isis the HoFH limbo champs for right now and betting that Kynamro's sales will trump Juxtapid's in a matter of a few quarters.
