IV Immunoglobulin is GENERIC- The Invention that was Developed is rhupH20- by Greg Frost- coFounder of Halozyme- He's combined it with Roche products and now Baxter- this is not mere supplying, this is creating- the competition can only deiver small quantities of Ig so a patient gets stuck 25 times a month with the competition, instead of ONE stick a month w HyQ- That's the advantage HALO developed. Baxter is marketing it.
$900M US $300M EU per Barclay's Analyst Huang- Pretty Big= $1.2B Actually
HyQvia - Actually 2 Yrs Not 18 mos as I Previously wrote- Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
So You don't think the National Strategic Stockpile has Generators and Refrigerators for Blood Products? You think they'd want to store 2-4x as much product requiring that much more labor to distribute and supervise administration in order to avoid refrigeration? I don't. In emergencies, Less Work for More Effect is Key.
Eye on FDA - Rx for Pharma Industry Communications and Planning
From - When Does FDA Extend a PDUFA Date?
August 30, 2010
18 month shelf life is more than sufficient specifically because HyQ can be given once a month vs Multiple times a month- such as with other SC Ig Products- so less stock is required per population and less ancillary healthcare is required at a time when that staff will be otherwise occupied.
IVIG is already stockpiled- so what formulations and why?- the addition of rhupH20 to Ig does nothing to reduce it's duration of activity. Explain your theory.
Well HyQvia will be as well- as a subcutaneous Rx it is more Mobile and faster to administer for same level of protection. It will be packaged like the Imitrex shots Migraine pts give themselves now (sort of Spockian).
I agree with most, but clearly the estimation of the new leadership's innovation should have been held until the partnering therapy for PegpH20 in the new NSC Lung Ca indication is revealed- Abraxane? Avastin? Xalkori? They all signal very different and promising directions.
Cervical cancer is not listed as high in hyaluronan in Therapeutic Targeting of Hyaluronan in Stromal Tumors- So I'm more interested in Avastin for NSC Lung CA- Avastin fails in Squamous cell lung ca and in all NSC Lung CA in those over 65 yo- perhaps Peg will change that.
The market acts as if Abraxane is generic and HALO is studying it- when in fact it's an important part of Celgene's portfolio and is in need of help tio keep Dr Leonatrd Saltz and those oncologists who think like him from taking it off formulary at their hospitals ( his is Sloan Kettering).
So, Celgene is potentially involved in 2 sites with Peg------- As Don Corleone Said to Michael- Whoever comes to you with the deal is gonna take you out (GSK, LLY, Roche, PFE, and Celgene all have horses in the NSCLC race).
J Histochemistry and Cytochemistry
June 2, 2014
Characterization of a Novel Recombinant Hyaluronan Binding Protein for Tissue Hyaluronan Detection
Arnold B. Gelb
Gregory I. Frost
H. Michael Shepard
Department of Research and Development, Halozyme Therapeutics, Inc., San Diego, California (LJ, LH, GW, QZ, ABG, GIF, PJ, HMS)
Laurence Jadin, PhD, Halozyme Therapeutics, Inc, 11388 Sorrento Valley Road, San Diego, CA 92121, USA. ↵1 These authors contributed equally to this work.
Tumor necrosis factor-Stimulated Gene 6 protein (TSG-6) is a hyaluronan (HA)-binding glycoprotein containing an HA-binding Link module. Because of its well-defined structure, HA binding properties and small size, TSG-6 is an excellent candidate as an alternative to animal-derived HA-binding protein (HABP) for the detection of HA. The present work describes the generation and characterization of a novel recombinant HA-binding probe obtained by fusion of a modified TSG-6 Link module with mutationally inactivated heparin-binding sequence and the Fc portion of human IgG1 (TSG-6-ΔHep-Fc) for tissue HA detection in histological samples. Direct binding assays indicated strong binding of TSG-6-ΔHep-Fc to HA, with little residual binding to heparin. Histolocalization of HA in formalin-fixed, paraffin-embedded tissue sections using biotin-TSG-6-ΔHep-Fc resulted in hyaluronidase-sensitive staining patterns similar to those obtained with biotin-HABP, but with improved sensitivity. HA was detected in many human tissues, and was most abundant in soft connective tissues such as the skin dermis and the stroma of various glands. Digital image analysis revealed a linear correlation between biotin-HABP and biotin-TSG-6-ΔHep-Fc staining intensity in a subset of normal and malignant human tissues. These results demonstrate that TSG-6-ΔHep-Fc is a sensitive and specific probe for the detection of HA by histological methods.
Ahead of Breast and Colon- Cancer Research 5/19/14 - Projected Cancer Incidence and Deaths - Rahib, L , Smith B, et al.
GlaxoSmithKline failed in Ph3 trial with its MAGE-A3 Immunotherapeutic agent and Lilly failed in Liver trials with Cryamza and is now trying it on NSCLC. the high Hyaluronan target makes pegpH20 a likely catalyst.
HALO stated that they took into account commercial potential- perhaps with a new partner in need. Pfizer also has a drug for NSCLC but it's oral- Xalkori (crizotinib).
Exactly- 110 Americans die of Pancreatic CA a day- in the months that Ebola has been spreading, 932 have died- 30% of patients with the current strain of Ebola survive with no treatment- Pancreatic CA is more common and more deadly.
07 AUGUST 2014
Long-term survival among patients with pancreatic cancer has hardly improved in four decades, a charity has warned.
Just 3% of patients with the disease live for at least five years after diagnosis, Cancer Research UK said.
This is only a slight improvement from the 1970s when only 2% of patients survived for five years.
The majority of patients die within a year of diagnosis, the charity said.
Most cases of pancreatic cancer are not detected until it is too late and a lack of effective tests and treatments for the disease contributes to the poor survival rates.
It is the 10th most common cancer in the UK - every year around 8,800 people are diagnosed with the disease and around 8,300 die from it.
Over the next five years Cancer Research UK is planning to more than double the £6 million it spends on research into the disease each year, a spokesman said.
Charity chief executive Harpal Kumar said: "It's shocking that so many patients are still losing their lives to pancreatic cancer, which is why we've made it a priority to ignite a new wave of research that will see the disease detected earlier and much-needed treatments getting to patients sooner.
"Overall, more than half of all cancer patients now survive at least a decade, which is testament to the power of research to transform people's lives. But disappointingly, we are nowhere near that level with pancreas cancer, and we won't stop until we can bring those kinds of results to all patients, regardless of their cancer type."
He called HALO "FDA Roulette" - Let's see- Peg Hold Released by FDA- check. HyQvia Risk/Benefit voted positive by 15:1 in FDA ADCOM- check- this will lead to new label for Hylenex by end of year as long term use of rhupH20 will be cleared in HyQvia approval and Hylenex had much lower hypoglycemia numbers than Afrezza- already approved- imagine 3 turns at the "roulette wheel" coming up positive while you let it ride- yes time to cover.
So sorry- I'm writing for those with a remedial understanding of Halozyme Therapeutics- The PegpH20 Ph 1b data is now mature- that makes one of you.
The Hylenex label for long term use of RhupH20 will be made possible by the Hylenex approval for long term use of RhupH20. Mature Data for PegpH20 has never been published or presented- the Sept 13 2013 529 day Median Overall Survival result in the High Hyaluronan group was immature (more than 1/2 of patients still alive at the time) as of the Nov 5 2013 Greg Frost @ Q3 2013 Earnings call.