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Amgen's bone drug beats Lilly's Forteo in a Phase III osteoporosis trial
September 2, 2015 | By Damian Garde
Amgen's ($AMGN) investigational bone-growing drug met its main goal in a late-stage trial, clearing its first Phase III hurdle by besting an Eli Lilly ($LLY) blockbuster for osteoporosis.
The antibody, romosozumab, hit its primary endpoint of significantly beating Lilly's bone-building Forteo over 12 months, Amgen said. In a study on 436 postmenopausal women with osteoporosis, patients getting a monthly injection of romosozumab experienced a higher average change in hip bone mineral density than those getting a daily subcutaneous dose of Lilly's drug, according to the company.
HALO is famous for short lead times on Earning Report Announcements- Why 4 weeks now? Possibly to maximize Analyst coverage- Companion Dxtic IDE is due and P3 is about to begin. Also Kadcyla Safety and dosing info may be announced. Good time to add. LLY Upfront payment came in Q4 and is counted without a 1 Q lag.
Roche is showing ABBV and JNJ how to introduce Enhanze into the market and save Brand revenue. Remicade is getting killed and S Korean Biosimilar up for FDA approval- Woody sees what he has to do.
Both around $8B WW Revenues- Remicade due to lose 40% to Biosimilars in next 2 yrs- JNJ will pull trigger soon- spurred by ABBV Humira decision- "this ain't rocket science"
A HR of 1.0 means both arms as likely as each other to yield a result. Clearly HALO CEO is setting up accelerated approval by means of meeting PFS Endpoint w supporting OS- rather than wait for OS results- Both FDA and EMA granted this rare surrogate as primary endpoint in metastatic disease to HALO at last years end of P2 meetings.
Sorry you were premature but forgive me for being happy about "Growing pretty substantially in 2016"! Nice Find- I think end of 202 enrollment to be announced as well- fingures crossed on Cdx
At least 1 HALO catalyst @ JPM. Companion Dxtic may be 2nd.
especially when the payback moment comes after the seminal moment (with open data)
Shows CEO's respect for HALO Shareholders- There were over 10 secondary offerings this week in Biotech- accelerated by newly increasing interest rates. By the time HALO has to pay back the loan -which raises Cash on hand to $270M- P3 well underway with results of P2 in the books.
So Short reads SHIRE and Thinks Baxter- when it's Baxalta that is being taken out by SHIRE. That's why the guy is short a stock with 3 big Q1 catalysts.
"SHIRE has lowest debt-to-EBITA ratio-0.33x- among its peers- can finance several buying opportunities besides Baxalta." BIDNESSetc
Hylenex is the #1 Drug for spreading eye anesthesia- only $16M annual sales with skeleton HALO sales force- Helen Torley certainly will sell any non cancer properties.
So the point of this post is that in spite of a slow start- both BAXALTA- in every Quarterly Mtg -and SHIRE- by virtue of their bid for HyQvia and the other BXLT Products- feel HyQvia is a valuable asset worth owning.
People complained that BXLT CEO spent too much time on HyQvia during initial press conference- Guess Not- Payors pay less (labor) BXLT Makes MORE!!!
New Data Shows Halaven® (eribulin) Mode of Action and Potential Combinations at San Antonio Breast Cancer Symposium 2015 (SABCS)
HATFIELD, England, December 11, 2015 /PRNewswire/ --
PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS
New data supports the previously shown ability of Halaven® (eribulin) to reverse epithelial-to-mesenchymal transition, the process by which cancerous cells are made more aggressive and harder to treat at the San Antonio Breast Cancer Symposium 2015. The study suggests that eribulin keeps E-cadherin, a transmembrane protein, within the cancerous cell, thereby restricting further metastasis. This data is consistent with the mode of action of eribulin.
The study, "Eribulin affects E-cadherin localization consistent with a reversal of the epithelial-to-mesenchymal transition" was presented as a poster (P5-03-09) at SABCS on Friday 11 December.
"The results of this study allow us to further understand how eribulin works at a cellular level. The fact that eribulin is able to reverse the epithelial-to-mesenchymal transition is important because this leaves the cancer cells weaker and less aggressive than they would have otherwise been. This then means that subsequent chemotherapies later in the treatment cycle might prove more effective because eribulin has weakened the cancer,"
Accumulation of Extracellular Hyaluronan by Hyaluronan Synthase 3 Promotes Tumor Growth and Modulates
the Pancreatic Cancer Microenvironment BioMed Research International
Volume 2014 (2014), Article ID 817613- Accumulation of hyaluronan was associated with loss of plasma membrane E-cadherin and accumulation of cytoplasmic β-catenin, suggesting disruption of adherens junctions. PEGPH20 decreased the amount of nuclear hypoxia-related proteins and induced translocation of E-cadherin and β-catenin to the plasma membrane.
It was anticipate from the start that Remicade would have patent extension with a HALO partnership- which is why Both rhipH20 AND Halozyme Therapeutics are named and claimed in the Remicade composition of matter patent- From Remicade Patent: "Term herein includes rHuPH20 commercially available from Halozyme Therapeutics"
Then this happened- Johnson & Johnson Announces Further Patent and Trademark Office Action Related to REMICADE
New Brunswick, NJ (April 29, 2015) – Johnson & Johnson (NYSE: JNJ) today announced receipt of a further action from the United States Patent and Trademark Office (PTO) regarding the reexamination of U.S. Patent No. 6,284,471 (‘471) relating to REMICADE® (infliximab) in which the PTO maintained its rejection of the patent. Based on the receipt of today’s action, the company’s subsidiary, Janssen Biotech, Inc., will have until June 12 to file a notice of appeal to the PTO’s Patent Trial and Appeal Board and plans to do so.
Currently the ‘471 patent expires in September 2018. Patent ‘471 remains a valid and enforceable patent as it undergoes reexamination at the PTO. Janssen Biotech will continue to defend its intellectual property rights, and if necessary, will pursue all available appeals.
And Losing 7% Revenue Q2 15 compared to Q2 14.
All signs point to JNJ- already parthered w HALO naming Remicade as an Enhanze partner. This will also bring HALO closer to Merck- makers of Keytruda- who markets Remicade in Europe, Russia and Turkey.
"Robust Immunology Pipeline
Abbvie's Immunology Pipeline is designed to bring Best-in-Class therapies to market acros disease categories,
restating markets and driving continued leadership.
Developing proprietary delivery technology (Halozyme) that may allow reduced number of injections at higher
doses, as well as other performance benefits."
Halozyme presented at a 2007 national Meeting it's performance benefit for Humira- by combining
Enhanze with Humira- Increased Bioavailability by 59%. Remicade revenues down 8% Q2 14 to Q2 15- w
Biosimilars emerging in EU- ABBV won't let that happen. JNJ to come around to HALO soon on Remicade.
Yes this is the 1st time an IL-10 inhibitor which removes the direct action HMW HA has on T cells besides is circulating with a PD-1 inhibitor in a human- stay tuned.