They said they had offers, however I could understand why they would not just take a bad offer. Silver lining is they are still thinking they can crawl out of it on their own without giving it away for nothing. I would like to know the plan.
HSA’s earlier advisory on the use of allopurinol
In 2001, the Pharmacovigilance Branch conducted a safety assessment of all local spontaneous ADRs associated with the use of allopurinol and found that 50% of the ADRs reported with allopurinol were serious skin reactions such as SJS, TEN and AHS. In addition, two local studies3,4 revealed 18 cases of serious local reports of ADRs to allopurinol which comprised mainly of AHS. In view that these adverse reactions are associated with significant morbidity and mortality, a Dear Healthcare Professional Letter5 was issued to advise doctors on the appropriate use of this drug.
In the advisory, doctors were advised to prescribe allopurinol with care for the treatment of:
Recurrent episodes of acute gout unresponsive to prophylactic colchicines and when uricosuric agents cannot be used due to intolerance, lack of efficacy, renal insufficiency or poor patient compliance
Chronic tophaceous gout
Recurrent uric acid calculi
Recurrent calcium oxalate renal calculi when associated with hyperuricosuria
Prevention of acute urate nephropathy in patients receiving cytotoxic therapy for malignancies
In particular, doctors were also advised that the dose of allopurinol should be reduced in patients with impaired renal function.
If in fact Krystexxa improves renal function......................one can dream
Q4 conference call Q&A:
Steve Byrne - Bank of America
Hi. Ken, in the dialysis study, did you see any improvement in kidney function in these patients?
Kenneth Bahrt - Chief Medical Officer
That’s something that we did look at; however, we don’t have the data just yet. So that’s something that we’ll be anticipating within the next few weeks to month.
Steve Byrne - Bank of America
And based on your understanding of the biology, do you think that that’s a reasonable outcome?
Kenneth Bahrt - Chief Medical Officer
That is a possibility based upon the biology; but as you know, sometimes the results are different than what the biology would predict. So we’re going to wait until we see what the data is.
And now couple a paragraphs from a recent scientific paper:
Furthermore, lowering uric acid in patients with established renal disease has been reported to
stabilize renal function independent of other confounders, suggesting a causative role of elevated uric acid in
progression of CKD, rather than as an incidental finding related to CKD severity
While these studies suggest a potential benefit of lowering
uric acid in subjects with CKD, it is important to
realize these are small clinical studies and that major
clinical trials need to be performed prior to routinely
lowering uric acid in subjects with CKD. This is particularly
true since allopurinol can induce a hypersensitivity
syndrome that can be fatal.
Who is running this company?
OK, its not half, its more of 32 paid for every 20 unpaid.
KPP was good in the beginning to get a foot in the door. Now, according to 10 Q they have visited most RU offices and majority of patients are treated in the hospital. Will you be enticed to seat in chair for two hours and risk a side effect because its free? No, you will do it no matter what if you really need it, like being in the hospital in pain due to your toes being larger then your head, because those are the only patients using Krystexxa.
Savient has co-pay assistance in place as well as free drug for people that cant afford it.
I truly believe, that Europe was scraped because they are about to kick in a major price increase and it is virtually impossible to conduct pricing negotiations on country by country basis based on "old" price and then have the public and elected officials screaming about a huge price discrepancy between US and EU.
Let me clarify, I said 5 free vials per responding patient.
42% respond to therapy
So, for example, out of ten patients only 4 respond to therapy and continue taking Krystexxa. All Ten patients received 20 combined free doses, or 5 doses per a responder.
Each person that responds receives on average about 10 doses.
My fuzzy math is that half the product is free.
Bottom line is KPP needs to go because the sickest of the sick, that are already in the hospital due to gout complications will try it anyway.
In reality, Savient is shipping over 3000 vials every Quarter.
If priced properly we could be profitable 6 months from now.
A business update prior to AGM is forthcoming. IMO
It's not over yet.
I was surprised to see that they are still doing KPP, giving away first 2 vials. Every responding patient equals 5 free vials if you take into account 42% response rate. Given, that an average responding patient stays on the drug less than 6 months, the math says they are giving away as much product as they sell.
In 10Q they stated, that most of their patients are most severe and treated in the hospital. It makes no sense to give away product in that setting. KPP was good in the beginning to get a foot in the door.
as QCOR prior to price increase.
Most Krystexxa patients are treated in the hospital.
Acthar vial is over 30K now so as Provenge so as few others.
The price is justified and nobody can say there is something better and cheaper. Moreover, Krystexxa is not a generic that became a brand and compounding pharmacy does not make an equivalent.
Savient has over 500 million in accumulated deficit.
Its directors fiduciary duty to enhance shareholder value.
Well, it seems like they only realized few months ago that they actually have a problem, just about when Meeker came on board.
Today's 10Q is their first real cry for help and maybe a precursor for a price hike. Shareholder meeting should be fun, I don't think they will wait till then.
BTW, I think Ferarri should pack his bags, just for his Sandy excuse.
Jacking a price high and fast brings bad publicity, no company wants to go there until its a last straw. QCOR had 14 million left when they did it. Time is now, but who knows what they are thinking....
Sell the company for 1.5-3.00 per share if someone as willing to pay that much.
Do a QCOR type price increase and see what happens.
Do nothing, collect your salary and fold.
Which one will they choose?
"We believe the majority of our potential patients are presently treated by the Rheumatologist in the hospital setting"
Hospital setting means worst of the worst. How much does a hospital stay cost?
Major price increase is justified and in fact a last straw.
QCOR revenues 4.1 million prior to price increase, 14 and 27 immediately after.
2000 vials sold in Q4 and 1637 sold in Q1. Q1 is soft due to reimbursement, so going rate is about 2000 vials. They need to raise the prise to 15K per vial to stay viable and they need to do it now.