No but thanks much for finding the royalty link. I will bookmark it this time. Are you limited to one sticky at a time?

That's why I asked you. Thought moderator had privileges.

Hey Fritz, can you put the royalty link back in the sticky please?
Sure made it easier to keep up with royalty growth.

Thanks,

Rod

Fritz, still waiting for the answer to your quiz.

Early Happy New Year from India!!!

PAG Phase III update today.

59 US centers recruiting.

145 exUS centers recruiting.

7 centers active not recruiting.

Primary completion October 2018.

"A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma



This study is currently recruiting participants.
See Contacts and Locations

Verified November 2017 by Janssen Research & Development, LLC

Sponsor:

Janssen Research & Development, LLC


ClinicalTrials.gov Identifier:

NCT03301220

First Posted: October 4, 2017

Last Update Posted: November 16, 2017"


Second Phase III Dara sc now recruiting.

Giovanni Caforio - Bristol-Myers Squibb Co.

Gregg, let me just add on that, because I think it's really important as part of our strategy as a company, given the number of assets we have in development, the potential for combinations, to continue to lead in terms of innovating delivery models. Murdo's comments are really important in the U.S. A significant part of our business is outside of the U.S., where the constraints with resources at hospital level and the number of distribution on oncology sites is, in some cases, a limiting factor.

The other thing I would say is that one of our key priorities across multiple tumor types has really been, from the beginning, to accelerate immuno-oncology into the adjuvant setting. And clearly, when you look at patients that are healthy and (58:09) in the adjuvant setting, clearly, thinking about different delivery models is going to be very important for us as well.

Two post from BMY Q3 transcript
https://seekingalpha.com/article/4117040-bristol-myers-squibb-bmy-q3-2017-results-earnings-call-transcript

Murdo Gordon - Bristol-Myers Squibb Co.

Yeah. Thanks, Gregg. On Halozyme, we're really excited about this opportunity to partner with them on their technology. And yes, you highlight, there's definitely a large patient convenience and infusion chair time benefit to having an injectable version, versus an infusion version of our products.

But we also have to think beyond this, in terms of where site of care may take place in the future. It is possible that site of care may move from academic hospitals, academic cancer centers, to more office-based treatment, particularly if patients are on these treatments beyond a one-year timeframe and they have large travel distances. So that's one area.

The other thing to think about is, at least in the U.S., an injectable product will be reimbursed through a different payment channel, so that's something to think about as a potential advantage in the future. And last but not least, we have over 11 different assets in this agreement that we could use potentially in combination with one another in different ways, that this technology might allow us to improve again how patients receive their administrations.

Now, this is also something that is related to new payment models going forward in terms of outcomes for patients. And I think patient reported outcomes and how they experience treatment could be important. So there's a number of different strategic advantages to that agreement.

Shire Q3 webcast worth the look/listen for Halo investors.

Two milestones, Phase II and Phase III at same time.

"Jeffrey Holford, Jefferies LLC, Research Division - Equity Analyst [21]

--------------------------------------------------------------------------------

Just wondering if you can just give us a little bit more color on DARZALEX. I guess, I'm actually talking about in the U.S., whether you'll have better information hopefully. Just your market share in the lines of therapy that you're in and what kind of duration of therapy you think you're going to get to in those lines?

--------------------------------------------------------------------------------

Joaquin Duato, Johnson & Johnson - Executive VP & Worldwide Chairman of Pharmaceuticals [22]

--------------------------------------------------------------------------------

Thank you. So as far as DARZALEX, as I commented, our market share in third line class is north of 40% in the U.S. already, and in second line, depending on the shortage, generally north of 20%, and it continues to grow. Our -- the trends that we are seeing in the market are very positive, particularly, after the approval in one prior line and the data we presented in one prior line, and also, as I commented earlier, we already finished the study in first line in combination with BMP, and we are planning to file before the end of the year. So all is positive on that side.

Importantly, we are also working, as you guys know, in developing a subcu formulation, and we are going to start our Phase III study with a subcu formulation this year. So increasingly, we see daratumumab, DARZALEX becoming a backbone therapy in the treatment of multiple myeloma, and that's the feedback that we are getting from customers."

J&J confirmed Phase III Dara sc starting this year. In Q3 transcript Q&A.

You covered everything I heard in the call. Have not read the transcript but will by the weekend. Thanks for sharing. Seems all the updates were in the Q&A. The presentation with appendix was devoid of Halo specific detail. Talk about a long read without nuggets.

Roche reports on the 19th so guidance on all those items could be forthcoming.

Two Phase III Dara sc trials scheduled to start November and a big combination 2-3 milestone payment coming. Should put Halo well over $400 million cash year end.

From the presentations, I would not be surprised if another deal was announced before year end.

Starting January 2018, Halo will have to report royalties when earned and not delayed a quarter. If not known, they must be estimated and adjusted later if needed.

PEG now has 204 centers actively recruiting with primary completion October 2018. The recruitment goal is 420 with an interim read at 320 events.

So many events and potential lined up for Enhanze and PEG for years to come.

The BMY/Roche deals blew me away.

"A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma



This study is not yet open for participant recruitment.
See Contacts and Locations

Verified September 2017 by Janssen Research & Development, LLC

Sponsor:

Janssen Research & Development, LLC


ClinicalTrials.gov Identifier:

NCT03301220

First Posted: October 4, 2017

Last Update Posted: October 4, 2017"

Another Phase III trial starting.

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma


This study is not yet open for participant recruitment.
See Contacts and Locations

Verified September 2017 by Janssen Research & Development, LLC

Sponsor:

Janssen Research & Development, LLC

Information provided by (Responsible Party):

Janssen Research & Development, LLC


ClinicalTrials.gov Identifier:

NCT03277105

First received: September 7, 2017

Last updated: NA

Last verified: September 2017

History: No changes posted

Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record



Purpose

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).




Condition

Intervention

Phase


Multiple Myeloma

Drug: Dara SC

Drug: Dara IV

Phase 3







Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma


This study is currently recruiting participants.
See Contacts and Locations

Verified August 2017 by Janssen Pharmaceutical K.K.

Sponsor:

Janssen Pharmaceutical K.K.

Information provided by (Responsible Party):

Janssen Pharmaceutical K.K.


ClinicalTrials.gov Identifier:

NCT03242889

First received: August 4, 2017

Last updated: August 23, 2017

Last verified: August 2017

History of Changes

Lilly Phase 1 trial with HALO

A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants


This study is currently recruiting participants.
See Contacts and Locations

Verified July 2017 by Eli Lilly and Company

Sponsor:

Eli Lilly and Company

Collaborator:

Halozyme Therapeutics

Information provided by (Responsible Party):

Eli Lilly and Company


ClinicalTrials.gov Identifier:

NCT03220126

First received: July 14, 2017

Last updated: July 21, 2017

Last verified: July 2017

History of Changes

That would be almost $3.5 billion market cap. Don't see that happening. Think we could see $20 if all the Enhanze pieces start falling into place.

Adoption in US should be much faster. Launching in one country verses 30 plus countries with a lower patient total should show huge improvement. that is why all companies prefer a US launch plus higher price approval although I look for that to change and get more inline with EU over time.

Herceptin/perjeta combo eliminates Herceptin biosimilal competition. MabThera is gonna be awesome. Who wants pin cushion veins.

Did you see the first Genentech pegph20 trial started recruiting ahead of schedule?

launch within 1-2 weeks speaks volumes. revenue starting early Q3.

Starting January 1, royalties must be estimated and no longer deferred. revenues will be current on q reports. sure makes keeping up a whole lot easier.

may be wishful thinking nut looking for Herceptin filing Q 2 or 3 on a slide hidden away in a roche Q presentation

anyone that prefers IV over SC has a mental problem

what would you and everyone you know cheese? collapsed veins, stints installed, risk of IV infection or a 5-7 minute stick in the ass, abdomen or thigh with ability to alternate.

Yes, all comers. eom

yes eom

FDA Panel Supports Subcutaneous Rituximab for Blood Cancers Jason M. Broderick @jasoncology Published Online: Wednesday, Mar 29, 2017 - See more at: http://www.onclive.com/web-exclusives/fda-panel-supports-subcutaneous-rituximab-for-blood-cancers#sthash.I4XB72Zb.dpuf

"Subcutaneous rituximab has been available in the European Union under the trade name MabThera since 2014, and is also approved in nearly 50 other countries." - See more at: http://www.onclive.com/web-exclusives/fda-panel-supports-subcutaneous-rituximab-for-blood-cancers#sthash.I4XB72Zb.dpuf

That is new and a recent significant increase in countries launched.

Good find, good read. Thanks for sharing.

Investor Update

Basel, 24 March 2017

FDA grants breakthrough therapy designation for MabThera/Rituxan (rituximab) in pemphigus vulgaris
?Pemphigus vulgaris (PV) is a life-threatening, autoimmune condition with limited treatment options1
?Roche is currently enrolling a Phase III clinical trial in patients with moderate to severe PV
?The FDA previously granted orphan drug designation to MabThera/Rituxan for PV
?Fifteenth breakthrough therapy designation granted to Roche medicines since 2013


Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to MabThera/Rituxan® (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes.2 FDA breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. Roche is currently enrolling a Phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options.1

“People with pemphigus vulgaris need more options and we look forward to working with the FDA to make MabThera/Rituxan available to patients with this potentially deadly disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to developing therapies that target B cells in areas of unmet need across a range of immune and malignant diseases, including new antibody constructs that enhance efficacy, safety or both.”

This is the fifteenth breakthrough therapy designation granted to Roche medicines since 2013.

Breakthrough therapy designation was granted based on data from a Roche-supported randomised trial conducted in France which evaluated MabThera/Rituxan plus oral corticosteroid (CS) treatment compared to CS as a first-line treatment in patients with moderate to severe pemphigus.3 Results of the study, published in The Lancet, show that MabThera/Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.3

In 2015, the FDA granted orphan drug designation to MabThera/Rituxan for the treatment of pemphigus vulgaris.

I don't know but I do think a filing is coming this year. Thanks for sharing.

It's in the 10K but nothing to get excited about. Found it interesting after all the other ties popping up over the past two years.

The 10K does contain a few interesting tidbits like the large increase of API sales to Baxalta although some claim stagnation of HyQvia sales. Increased API inventory. New API manufacturing eoy which just happens to fall in line with US approval/launch. Well worth the read with a lot of data you wont get elsewhere.

"During the fourth quarter of 2016, we established a new Swiss subsidiary, Halozyme
Switzerland GmbH (Halozyme Switzerland)."

"Investor Update

Basel, 02 March 2017

Phase III APHINITY study shows Roche’s Perjeta® regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin® and chemotherapy
?Perjeta plus Herceptin and chemotherapy showed a statistically significant improvement in invasive disease-free survival (iDFS) for people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone
?Data will be discussed with health authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)

Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) today announced positive results from the phase III APHINITY study. The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone. The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies1, and no new safety signals were identified. Full results from the APHINITY trial will be presented at an upcoming medical meeting in 2017.

“These results from the positive APHINITY study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “We look forward to discussing these adjuvant results with global regulatory authorities.”

Gunter von Minckwitz, MD, study coordinator from the Breast International Group and academic study partners, added, “APHINITY provides yet another example of the importance of industry-academic collaborations and their value in advancing cancer care for people affected by this challenging disease.”

HER2-positive breast cancer is an aggressive form of the disease, which affects approximately one in five people with breast cancer2 and is associated with a poor prognosis if left untreated.3 Despite advancements in the treatment of HER2-positive eBC, up to one in three people treated with Herceptin and chemotherapy may eventually see their cancer return.4,5 Treatment options are needed to improve the outcomes of people with this aggressive disease. Treating breast cancer early, before it has spread, may improve the chance of preventing the disease from returning and potentially reaching an incurable stage.6 Adjuvant therapy is given after surgery and is aimed at killing any remaining cancer cells to reduce the risk of the cancer returning.6

The combination of Perjeta, Herceptin and chemotherapy is licenced as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in more than 75 countries worldwide following approvals by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).1,7 In the US, the regimen is currently available under the FDA accelerated approval programme. The APHINITY trial reflects the commitment to evaluate the Perjeta-based regimen as part of a complete treatment approach for eBC. These data will be discussed with health authorities across the world, including the US FDA with the hope to convert the current US accelerated approval to a full approval.

About APHINITY8

APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as an adjuvant therapy in 4,805 people with operable HER2-positive eBC.

People enrolled in the study underwent surgery and were randomised to one of two arms (1:1) to receive either:
?Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with Perjeta and Herceptin, followed by Perjeta and Herceptin every three weeks for a total of one year (52 weeks) of treatment.
?Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with placebo and Herceptin, followed by placebo and Herceptin every three weeks for a total of one year (52 weeks) of treatment.

Radiotherapy and/or endocrine therapy could be initiated at the end of adjuvant chemotherapy. The APHINITY study allowed for a range of standard chemotherapy regimens to be used and both lymph node-positive and lymph node-negative participants were eligible for enrolment. The primary efficacy endpoint of the APHINITY study is iDFS, which is the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life."

Perjeta sc Phase I trial. The first and only trial I am aware of.

One cohort out of eight excludes rhuph20 as the excipient.

https://clinicaltrials.gov/ct2/show/NCT02738970?term=rhuph20&rank=59

Experimental: Cohort 8: SC Perjeta 1200 mg (Without rHuPH20) + SC Herceptin
Cohort 8 will include healthy male volunteers from Part 1. A single, mixed SC injection containing 1200 mg Perjeta (formulated without recombinant human hyaluronidase [rHuPH20] as an excipient) and 600 mg Herceptin will be administered.

Even the formulation for this cohort is mixed with Herceptin sc as a single injection.

This trial completes Sept. 2017

No but I assume since it took years to get reimbursement, Roche will complete the IV plan then start sc conversion. Why throw a wrinkle into something that was difficult, before what is approved is complete.

Your estimates are reasonable imo.

Any thoughts on China reimbursement approval for Herceptin and MabThera with 20% growth as they continue to move into provinces?

I know Roche started work on this years ago for Herceptin but this is first I heard about MabThera and now both with reimbursement and strong growth is new to me.

Roche is now very stingy with detail about sc, it went from qtr. to half year and now a mention. Remember limited discussion on this board last year about Herceptin sc in Hong Kong and how mainland crossed border for drugs? It may take awhile but I must believe with reimbursement and expansion, sc will be next step in China.

The Perjeta/Herceptin read out this Q will be important for Halo also, with projected 5 year Perjeta sales over $5 billion and in early sc trial. The direction of Perjeta sc should be known by eoy.
The success of a Perjeta sc, Herceptin sc combo therapy will be huge for both companies.

"Does anyone know what the insty % was before the Jan. 2016 dump?"

Around 70%

Updated 2016 guidance from Q3 remains the same. New guidance for 2017 given.

Expense remains in line with 2016. Lower 2017 revenue does not include milestones or new Enhanze deals nor does 2017 eoy cash.

In multiple talks with potential new Enhanze partners. DARA going to Phase III will be a big milestone payment. If either or both of these events happen, the cash position will grow accordingly.

Based on Q3, the annual run rate for royalties, bulk, and Hylenex is $108 million. The 2017 guidance is $115-130 million. Adds and potential adds to the $108 million annual run rate based on Q3, 2016, increases in bulk sales and royalties from existing markets, increase in bulk sales for Rituxan sc launch, DARA milestone, new Enhanze partner or partners, and existing partners going into clinical. While we can't count our chickens, the probability of increased royalty/bulk sales, Rituxan sc approval, and DARA Phase III are high. These three events will raise revenue and cash position. Add one Enhanze deal and we have enough cash for 2018.

Phase III, 170 centers recruiting. PEGPEM, dose expansion started. Two scientific presentations in first half 2017. Perjeta sc highlighted.

No I don't.

"Estimated Enrollment: 420
Study Start Date: February 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Dr. Torley continues to say 200 sites while clinicaltrials.gov list 225 sites. 301 website list 45 sites recruiting while clinicaltrials.gov list 38 US sites recruiting. Dr. Torley stated 160 sites recruiting while ct.gov list 135.

One of the 2016 goals was to have 90% of 200 sites by eoy and they got 80%. Close enough and hopeful that stage II results will prompt more centers to open and more patient interest.

The Phase II is over, it was successful in confirming Phase III design that was based on stage I. While I expect more detail at upcoming scientific presentations, the next real event is the Phase III interim for PAG.

After a 50 minute presentation on Phase II, I hope very little of the upcoming 25 minute presentation is on Phase II and what is presented is only that which is relevant to the Phase III target population. I want more information on the rest of the business.

Would like to see goals for 2017. Some of the 2016 goals were not met.

So far, three of our Enhanze partners are duds but I still appreciate their money.