Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Sanofi SA (SNY) & ISIS Pharmaceuticals, Inc. (ISIS) Out-Limbo Aegerion Pharmaceuticals, Inc. (AEGR) in HoFH

Page 1 of 2

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.

Sanofi SA (ADR) (NYSE:SNY)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.

Page 1 of 2

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!