Investor's focus, on Questcor's (QCOR) drug Acthar, has been changing over the last few weeks. While Aetna's (AET) policy bulletin update was expected to be released the weekend of October 13th, it doesn't seem as important as it was back when the stock first reacted to the Jefferies Group (JEF) downgrade. You are probably reading this article after the weekend, and my guess is there was no update. Aetna is probably still looking at the situation, and the expected date is not a mandatory date.
In the meantime, multiple analyst firms have made changes to their ratings, and after the United Health Care (UNH) Oxford bulletin, they have released new ratings. Generally speaking, they have remained the same, with a few upgrades. Price targets, of all but one, appear to be $28 and ranging back up above $50. You may have already read my article on Oxford's bulletin (Questcor And UNH's Oxford Policy Bulletin Update: Good For Longs).
The American Society of Nephrology is hosting Kidney Week, in San Diego, the week of October 30th, and a lot of attention has been focused on the abstracts from studies that will be presented. There are 7 studies involving Adrenocorticotropic hormone (ACTH), and more specifically, Questcor's highly purified natural Acthar Gel (39 Amino Acids) .
The list of abstracts consists of:
- A Pilot Study to Determine Dose, Effectiveness and Depletion of Anti- PLA2R Antibodies of Adrenocorticotrophic Hormone (ACTH Acthar® Gel) in Subjects with Nephrotic Syndrome and Idiopathic Membranous Nephropathy (IMN)
- Use of ACTH Gel in a Patient with Progressive Nephrotic Syndrome Secondary to Transplant Glomerulopathy (TG)
- Effects of H.P. Acthar Gel® in the NZB/W Mouse Model of Spontaneous Lupus Nephritis
- Treatment of Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) with Adrenocorticotropic Hormone (ACTH) Gel
- Reemergence of Adrenocorticotropin Hormone as Novel Therapy for Focal Segmental Glomerulosclerosis
- Effects of HP Acthar Gel® in the STZ Rat Model of Diabetic Nephropathy
- Adrenocorticotropic Hormone Therapy for Idiopathic Glomerulonephritis: 6-Week Interim Data from an Ongoing, 6-Month Trial
In all, there were a combined 34 patients (and some mice) who received Acthar for kidney disease related protienuria symptoms, and the results for treating Protienuria were high. One study had an outlier, which received only 40IU (half the dose an MS patient normally receives), and they did not show much improvement. Questcor's prescribing information indicates that dosage needs to be individualized for other than IS and MS. This study may serve as a baseline guide for future studies and Nephrologists treating patients.
Also of note is a study that hasn't received much press that I could locate. It was first presented in spring of 2012, during the National Kidney Foundation's Clinical Meetings and utilized Acthar Gel.
- Adrenocorticotropin Hormone (ACTH) for the Treatment of Primary Focal Glomerulosclerosis (FSGS)
This study was started in 2009, at Stanford University, and consisted of 11 patients with varying degrees of Glomuler Fibrosis. Six of ten patients had a reduction in proteinuria, two were in partial remission, and one was in complete remission. Dr. Lafayette suggests additional studies to identify patients that would benefit, and assess long term responses.
All of these studies are important, as the lend supporting evidence to Questcor's NS related sales ramp up. Their last Form 8k filing indicated the following per day prescription rates; July 5.1, Aug 5.2, Sept 5.5, as I discussed in my article Questcor's 8-K Filing: Digging In The Details.
There are also new studies in the works. According to the government's Clinical Trial website, the following studies are in various stages. Note, the previously mentioned studies also appear on the website and additional publication information may be found under those completed studies.
- Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients
- Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients
- Clinical 15 Months Study Comparing Monthly Pulse ACTH (Acthar Gel) Therapy With Monthly Methylprednisolone (MP, Solumedrol) for Multiple Sclerosis (MS) Patients Who Are on Regular Beta-interferons (Avonex, Betaseron or Rebif)
- Dermatomyositis and Polymyositis Registry
- Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy
One of the determining factors that Aetna stated, was a lack of supporting evidence. It is now apparent that researchers are actively filling that gap, and arriving at positive results for some of Acthar's many indications.
As I also mentioned in my previous article, other insurance companies are taking a neutral stance right now, and not jumping on the bandwagon to modify their policy coverage.
I am maintaining my BUY recommendation on QCOR, and reiterating my near term conservative price targets of $28 to $34, based on the last year's price support levels.