Olympics should be good for SHPG and HALO- Very Bad for those gambling Against.
Yes they treated the controls- this study in 2 parts- dose escalation data in NSCLC may be out before year end.
yes I'm saying UNinterrupted Rx works better than INTERRUPTED- out on a limb? not- AGAIN PFS is KING
Dumb Short- HALO Presented compelling Data for Pancreatic and Ovarian Keytruda And Or Ppdivo Trials as well-
You've seen Stage 1 interrupted data with cross over- have an adult you trust explain to you what we're awaiting that you simply have not seen- over & out low brow.
1.195 Countries in the world - not , as you represented, 20.
2. 53K cases this year in US.
3. OH YOU KNOW OS IN STAGE 2 (Post Halt UNinterrupted) 202 ?!?! PLEASE Share this Blinded Insider Information with the world Before You Are Taken away for SEC Violations or (more likely) Insanity.
4. PFS is Primary Endpoint of 202 NOT OS - Low Brow....
Low Brow- US is 20th out of 195 Countries in the World- the point of the list is to demonstrate a correlation between Fat-Pancreatic Cancer- We KNOW the US will have- per SEER- over 53K new cases of Pancreatic Cancer this yr- We also know that PDA is proof of concept for HALO. Many more targets to come.
This isn't hard to associate - #2 Slovakia #3 Armenia #4 Hungary #5 Slovenia - not a lot of Arugula salads there... So HALO will Rx POPULATIONS with High Fat Diets for #1 Cancer Killer- hmm might be a market.
PFE looking for a dosing advantage via Halozyme - over Regeneron and Amgen- will trumpet positive signs
It means we will find HALO's new rhupH20 international drug name on Roche products and we shouldn't get confused- same as "rhupH20" - wholly HALO owned and royalty generating.
INN for PegpH20=pegvorhyaluronidase alpha for rhupH20-vorhyaluronidase alpha @Roche using w MabThera/Herceptin SC inserts
International Nonproprietary Names (INN) facilitate the ID of pharmaceuticals=unique name that is globally recognized and is public property- WHO
Roche’s subcutaneous formulation of MabThera receives approval in Europe for people with chronic lymphocytic leukaemia
• Subcutaneous (SC) formulation of MabThera saves time and eases treatment burden compared with intravenous form
• The phase Ib SAWYER study demonstrated comparable safety and efficacy between MabThera SC and intravenous MabThera in combination with chemotherapy
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved the subcutaneous (SC) formulation of MabThera® (rituximab) for people with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). The approved dose for CLL is 1600mg. Following the approval of MabThera SC (1400 mg) for common forms of non-Hodgkin lymphoma in March 2014, this is the second European approval for the formulation.
“MabThera SC provides patients with significantly faster treatment administration and the opportunity to enjoy more time outside the clinical setting compared to intravenous delivery of the medicine,” said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “Today’s approval in CLL means the benefit of MabThera SC can be offered to even more patients.”
The European approval was based primarily on data from the phase Ib SAWYER study, in which previously untreated CLL patients received either MabThera SC (1600 mg) or intravenous MabThera (500mg/m2) in combination with chemotherapy (fludarabine and cyclophosphamide), a current standard of care. SAWYER demonstrated treatment with MabThera SC resulted in comparable levels of the medicine in the blood (serum concentrations), as well as efficacy and safety, to intravenous MabThera, and results were recently published in The Lancet Haematology(1)
SAWYER Study- "Subcutaneous MabThera : applies Enhanze technology, partnered with Halozyme"
Nice pick up- She holds 358,000 shares of HALO_ so perhaps she left for personal reasons- Bloomberg says "She served as a Director of Halozyme Therapeutics, Inc. since May 2007 until May 24, 2016." She made a big Big Medivation Buy last year- Shares Price/Share Value
02/27/2015 Kathryn E. Falberg Director 25,000 $117.67 $2,941,684.00 (Split 2:1 in July 15) and they are the subject of M&A right now. Many moving pieces- not the least of which is Connie Matsui's tie to Genentech though her work with them on Rituxin/Mabthera while at Biogen Idec.
Recall 2 recent Genetech hires and the actual Genentech name on HALO ASCO Study 202 abstract.
Herceptin SC contains rhupH20 by definition-the formula sold all over Europe and South America:
"Herceptin SC is a new more convenient formulation of Herceptin that uses Enhanze™ Technology, developed by Halozyme Therapeutics, Inc. which contains the novel excipient (carrier for active ingredients of a medication), rHuPH20. rHuPH20 (recombinant human hyaluronidase) reversibly breaks down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin. This facilitates the distribution of injected volumes over a greater area and enables painless subcutaneous administration of the large volume of Herceptin SC (a fixed dose of 600 mg (5ml))."
HALO Just Received $8M for the THIRD LLY target- does anyone know any of the 3? Pfizer just chose another unnamed target ($1/2M) Progess is being made- we are just currently in the dark.
Once again you demonstrate an incomplete and in some way faulty understanding of the facts. Here is the description of the part of the dose finding P1 Roche study- NCT02738970- to which I referred- "Primary Outcome Measures:
SC Perjeta Loading Dosage (in Milligrams) that Results in Comparable Exposure to IV Perjeta (When SC Perjeta is Mixed with Herceptin SC and Given as a Single Injection) "
SO when Perjeta is mixed with Herceptin SC, it's being mixed with HALO rhupH20.
(as far a titers- You should read more - The FDA allows HyQvia to be used and is being studied in Pregnant women and the EU Just approved it in children- guess you're the last one concerned.)
I tweeted this Friday (May 20) Dimitrios Chandros is the reason for the Genentech credit- He's still working there while serving as Halozyme's VP for Clinical Development. In fact when HALO announced that they were expanding to a S SanFrancisco office on Gateway Blvd, they were announcing that their new hire(took over for Sam Dychter) was staying at his desk at Genentech. I confirmed this in December a month after the announcement- a Genentech operator picked up Chandros's phone. So I believe he is serving the same role Torley played for Amgen before they bid for Onyx. Like Torley, he is blinded to Stage 2 202 data but has a good sense of how good it is. As an employee of Genentech, he's free to share what he knows. I expect a run up and a bid in Q4.