Thursday, April 27, 2017 11:48:46 PM
"On Slide 32, on March 29, we had an FDA ODAC committee on the subcutaneous. It was 11-0 vote in favor of the benefit-risk of rituximab subcutaneous for all proposed blood cancer indications. If you remember, initially, our subcutaneous for MabThera was originally focused on an ex U.S. development. But we had since filed, now the PDUFA date is set for June 26. Just to remind you, I mean, the original decision not to launch the subcutaneous in the U.S. is based predominantly upon previews regulatory and market considerations and both of those have changed now. And in particular, on the market considerations side, there is a difference in administration fees for subcu versus IV, with IV being more generous in terms of the administration fees.
However, no differences of decreased, and importantly, the capacity constraints that many practices have increased. So there are market research shows the practices realize the benefit of the subcu if they're capacity constrained and the benefit comes in terms of significant time savings. You can see it here, from 2.5 hours down to around 15 minutes or so. It's a significant dynamic change. So this is with some of this just in the market practice, this is why we're now pursuing subcutaneous program in the United States and hope to be launching that very shortly."
"On the adjuvant setting, oh, yes, specifically related to the subcutaneous coformulation Herceptin and Perjeta, so yes, this is really interesting. We initially thought that this is going to be more challenging from a technical development standpoint. We're certainly not out of the woods yet. But we've got a Phase I trial going on, we are looking at the dosing of this.
Bottom line is that we think this could potentially, potentially be a convenience for patients that would be significant. So but I wouldn't I would say that it would be -- it would be applicable across the different regimen."
https://seekingalpha.com/article/4066526-roche-holdings-rhhby-ceo-dr-severin-schwan-q1-2017-results-earnings-call-transcript?auth_param=75ovl:1cg5cms:d5a6e7d664d084d0d7dda9e961548018&uprof=45
Recent HALO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/18/2024 10:49:57 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/18/2024 08:01:16 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/17/2024 08:03:48 PM
- Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis • PR Newswire (US) • 09/13/2024 05:30:00 PM
- Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer • PR Newswire (US) • 09/13/2024 12:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/12/2024 09:56:59 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/12/2024 08:12:07 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/11/2024 08:05:49 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/10/2024 08:16:18 PM
- Halozyme to Present at Upcoming Investor Conferences • PR Newswire (US) • 08/28/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/27/2024 11:49:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/21/2024 10:03:29 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/21/2024 08:11:18 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/20/2024 08:16:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/15/2024 08:59:35 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/15/2024 08:31:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 08:57:27 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/14/2024 08:08:38 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/13/2024 08:19:53 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 08:07:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 08:03:09 PM
- HALOZYME REPORTS SECOND QUARTER 2024 FINANCIAL AND OPERATING RESULTS • PR Newswire (US) • 08/06/2024 08:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 09:48:14 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/24/2024 08:05:48 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM