Prove number 3. You said $180 million in existing revenues. Not a run rate. How do you know what is the revenue for Q3 2014, by the way? Market opportunity for SPI-2012 could be any number you want to believe.
Numbers 2 and 7 could be true or false. Give us a prove. After paying $25M to TOPO, cash should be less then $100M. Market opportunities for SPI-2012 is questionable. Number 3 is false. Revenue for last four Qs is $157.2 M.
AMGN 416 could compete with Sensipar (Cinacalcet) in future. They will have results from head-to-head study next year.
Amgen Announces Positive Phase 3 Results for AMG 416 for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease Receiving Hemodialysis
"Secondary hyperparathyroidism can be a challenging disease to manage and control. There is an
important role for an effective calcimimetic that can be administered intravenously with hemodialysis to
help treat this disease," said Sean E. Harper, M.D., executive vice president of Research and
Development at Amgen. "We are encouraged by the results of this study and look forward to sharing
results from a second placebo-controlled study later this year, and a head-to-head study evaluating AMG
416 compared to cinacalcet next year."
My point is that I could not see a logic in your original post. The drugs that you mentioned are all in ultra-orphan space.Therefore, prices are sky-high. Then you stated that bladder cancer is sixth largest cancer. Therefore, apaziquone cannot be an orphan drug. By definition, to be orphan, the disease should affect less than 200 000 patients in US. Bladder cancer affects more than 500 000 patients in US. I would follow your logic if your compared apaziquone to some type 2 diabetes drugs, or oncology drugs for prevalent types of cancer.
BTW here is analysis of apaziquone potential from thepharmaletterDOTcom
The bladder cancer therapeutics market in the six major countries is forecast to climb from $239.3 million in 2012 to $297.5 million by 2017, at a compound annual growth rate (CAGR) of 4.5%, says a new report from research and consulting firm GlobalData.
GlobalData expects the worldwide sales of US pharma company Spectrum Pharmaceuticals’ EOquin (apaziquone for intravesical instillation) to reach $13.2 million in 2016, before almost doubling to $26.1 million by 2017, accounting for 8.8% of sales in that year. Early last year, Spectrum reacquired all rights to the drug from partner Allergan and at the time was in discussion with the US Food and Drug Administration on a regulatory filing
Do not want to argue but PCYC's drug Imbruvica and QCOR's Achtar are both orphan drugs. Provenge is a different story. It is personalized medicine, you cannot produce it without patient's blood.
Too optimistic. You mentioned drugs in ultra-orphan category, therefore prices are high. Then you said that bladder cancer is sixth largest type of cancer, therefore no way apaziquone belongs to ultra orphan category. Price should be much lower than for the drugs that you mentioned. Not sure whether apaziquone even has an orphan status.
OS for Acute Lymphoblastic Leukemia patients of 60 years old and older is 5-7 months (US study). OS for DLBCL patients of same age is longer than 10 years (German study).
"We expect the final data supporting the use of new formulation as a high-dose conditioning agent for patients with multiple myeloma undergoing autologous stem cell transplantation to be available to us by the end of the second quarter."
News could be released any day now.
Same is true for Folotyn and Istodax. 26% response rate in relapsed or refractory population is a good result and it has nothing to do with today's SP. It was known long time ago. Did you just realized it? After spending that much time on this message board?
Around $10/share if overall market conditions are OK and no unexpected negative news from Spectrum. But it is not my prediction. It is my wishful thinking.
Since FDA killed PDUFA-related rally in SP by earlier positive decision, you should not expect sell-on-approval type of reaction.
In post marketing requirements, Spectrum needs to run a phase 3 study of Folotyn+CHOP against Beleodaq+CHOP against CHOP alone. Somehow, one of their drugs against another one. Weird stuff. How many Phase 3 studies Spectrum needs to run to satisfy FDA to sell their drugs?
It is a big deal. Most anti-diabetic drugs, including insulin, work to reduce hyperglycemia. Not sure about XMetA but XMetS looks very promising for Type 2 diabetes.
For hypoglycemia caused by chronic excess of insulin in the body like insulinoma or hyperinsulinism, development of XMetD is a good idea. Orphan drugs are real money makers.
Hypoglycemia is treated by ingestion of carbohydrates. It can be taken as food or drink. For example, orange juice. Did you mean hyperglycemia?
He was involved in 3 trials with XOMA 052 (Gevokizumab). They all are completed now. The last one, in Type 1 diabetes, was completed in September 2013. Most likely, the results are not very impressive.
We did not observe XMetA-mediated hypoglycemia (less than 40 mg/dL) or symptomatic hypoglycemia in any of the diabetic animals up to a dose of 30 mg/kg, indicating a wide therapeutic index for XMetA. Serum levels of XMetA followed dose proportionality with half-lives supporting a weekly dosing interval of XMetA. Based on the above information, we are now investigating the efficacy and the durability of XMetA in a weekly repeat-dose, long-termstudy in these diabetic monkeys. Together with our previous results in rodent models of diabetes, our current findings demonstrate that XMetA reduces blood glucose levels without the risk of hypoglycemia in spontaneously diabetic monkeys and therefore could potentially provide a novel and improved alternative for diabetic patients depending on a daily insulin regimen.
Spontaneous type 2 diabetes develops naturally in nonhuman primates, and shares extraordinary similarities to humans, thus representing the clinically most relevant animal model of diabetes. XMetA is a fully human IgG2 allosteric monoclonal antibody that binds and activates the insulin receptor (INSR). As a novel INSR partial agonist, we tested the ability of XMetA to treat diabetes in rhesus monkeys. Six diabetic rhesus monkeys (Macaca mulatta) were selected based on insulinopenia and hyperglycemia, and were aged 16-24 years with 7-29 kg in weights. XMetA was administered subcutaneously in single escalating doses of 0, 1, 3, 10, and 30 mg/kg. XMetA reduced fasting blood glucose levels in diabetic monkeys both dose and time-dependently up to 10 mg/kg. At 10 mg/kg, XMetA substantially and signifi cantly reduced 18-hr fasting blood glucose values by an average of 30.7% in diabetic monkeys on the day following XMetA administration, and the glucose lowering effect of XMetA lasted for 15 days before complete subsidence. In addition, there was a trend toward the reduction of fed blood glucose levels with XMetA treatment. We did not observe XMetA-mediated hypoglycemia (