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Management has not given us many reasons to cheer, so I doubt it.
The ViiV HIV indication only satisfies deal #1 if one accepts the new world of Helen overpromise and underdeliver, since this indication is not at all new in any sense other than the apparent addition of an auto-injector.
Given the lies and misinformation employed daily by RVNC's competition, it is baffling that RVNC does not feature this differentiating info in their marketing materials.
The thrombocytopenia trial was also ph3. FWIW, that's what happened to HALO's pegph20 cancer trial as well.
So efgartigimod sc has failed in pemphigus and thrombocytopenia. HALO needs to scratch both off of their claimed partner pipeline in the halozyme.com website. ARGX had five indications listed there and they are now down to 3.
Helen promised three deals this year, and her failure to deliver is a huge negative, no matter how one chooses to spin it.
That is also very plausible.
Another theory is that tomorrow is options expiry day and it looks like maybe someone wants to keep this under $40. Just a thought...
Feels like there is some nasty bit of news that we wee folk are not yet privy to. I hope I'm wrong...
Yes, young Sir, that is in fact the origin story behind the phrase "drink the cool aid".
Word might be getting out but it's still a rumor and my point was that Merck is not being upfront about it. This is in stark contrast to HALO partnerships where the source of the enzyme is usually included in the PR. I wonder at the reason for this. Might it be concerns that there are patent issues?
Great detective work. Thanks. Why is Merck being so cagey about the composition of this do you think?
And back to my original query, since Alteogen is not mentioned in the article's discussion of MK-5180, so I'm not at all sure that his is the source of the hyaluronidase. It is a possibility but not confirmed anywhere AFAIK. I can be a little dyslexic too so I may have missed something.
I think you may have transposed the numbers from 5180 to 5108.
It would seem to be the case, but only HALO's legal staff can give a definitive answer. Are American patents enforceable if the offending product is not marketed in the US?
I hadn't thought of the exclusivity agreement in this context, but it is certainly a strong possibility.
Do we know that MK-5180 is not an Alteogen enzyme?
Thanks for the Alteogen info. Here's some more from them:
Merck should just buy Halozyme and save themselves a lot of trouble.
One positive note from that article was that the Comera exec admitted that the barriers to entry are high.
I could be wrong, but I think the author is off base regarding the comparison of enhanze and caffeine.
As I understand it, Enhanze is not used to "stabilize" the formulation but to dissolve the hyaluronan structures of the subcu region thereby making room for the injected material which then has access to the blood stream. This is always how it's been presented by HALO to the investing public, unless I've been missing something.
Thanks for the link. As I understand it, the primary source of medical hyaluronidase prior to rHUph20 was porcine. There are also ovine based products. I don't know about their tendency to invoke immunogenicity, but one could assume that they are both problematic and inferior to rHUph20.
Interestingly IMGN was trading at this price 23 years ago.
If anyone could just use plain old hyaluronidase in reformulating a drug to a subcu version, HALO wouldn't exist as a company. This leaves me wondering what exactly Merck has in their enzyme....
Thanks for sharing your thoughts about Musk; now I can put all of your opinions in a better context.
Thanks for the heads up. What were your key takeaways?
rare failure for ARGX sc efgartigimod
argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia
-????????????Study did not meet primary or secondary endpoints
-????????????Favorable safety and tolerability profile consistent with previous clinical trials
-????????????Conference call scheduled for today, November 28, 2023 at 8:30am ET (2:30pm CET)
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Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced topline results from the ADVANCE-SC study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia (ITP). The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.
Additional analyses of the dataset are ongoing and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication.
Mizuho cuts RVNC PT from $35 to $16.
ARGX Announces European Commission Approval of Subcu VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis
Amsterdam, The Netherlands— November 16, 2023 —argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved SC injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The EC previously approved VYVGART IV in August 2022. Following this decision, VYVGART is now approved in Europe for both IV and self-administered SC use. The approval is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein. argenx will work with local health authorities to secure patient access for VYVGART SC in the region.
“Today’s approval reflects our commitment to providing a choice of effective, innovative therapies to people with autoimmune disease. We are proud to deliver this second formulation to the European gMG community, just 15 months after the initial approval of VYVGART IV,” said Anant Murthy, General Manager of argenx EMEA. “The availability of two formulations, including the possibility for patients to self-administer at home, allows people living with gMG to choose the treatment that best works for their lifestyle, further reinforcing the individualized treatment approach offered by VYVGART.”
The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART IV in Europe in August 2022.
About Phase 3 ADAPT-SC Trial
The Phase 3 ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of VYVGART SC compared with VYVGART IV in adult patients with gMG. The pharmacodynamic effect was measured by percent change from baseline for both total IgG and AChR autoantibody levels at day 29. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed. A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial. Patients were randomized in a 1:1 ratio to receive VYVGART IV or SC for one treatment cycle consisting of four doses at once-weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle. At the completion of ADAPT-SC, patients had the opportunity to roll-over to ADAPT-SC+, an open-label extension study.
About VYVGART® SC
VYVGART SC is a SC injectable formulation of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART. It is formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology, to facilitate SC injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART results in the reduction of circulating IgG autoantibodies. VYVGART SC was approved in the United States in June 2023 and is marketed as VYVGART® Hytrulo.
About Generalized Myasthenia Gravis
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises.
For further information, please contact:
Media:
Ben Petok
Bpetok@argenx.com
re Diagnostics: That's enlightening and surprising given the heft of the corporate lobby. One would think that this is an easily addressable issue.
Dew, wondering why is diagnostics such a tough space in which to make money?
Thanks,
-Fritz
Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1
The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2
A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1
Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers.1 The CHMP recommended Tecentriq SC for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder and breast cancer.2 A final decision on its approval is expected from the European Commission in the near future.
“Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Subcutaneous administration offers a faster and more convenient alternative to IV infusion. The CHMP’s recommendation brings us a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.”
The CHMP’s positive opinion is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.3 Roche recently presented mature overall survival (OS) data with a median follow-up of 9.5 months at the European Society for Medical Oncology (ESMO) Congress 2023. The updated analysis confirmed the earlier results and showed that OS and other efficacy endpoints were consistent between the SC and IV treatment arms.1 A majority of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer (90%) and that it could save time for healthcare teams compared with the IV formulation (75%).1
Tecentriq SC, which recently received its first marketing authorisation in Great Britain, was developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside of the hospital setting. It is Roche’s fourth subcutaneous cancer therapy.4-6 Multiple oncology studies suggest that the majority of cancer patients generally prefer SC over IV administration due to reduced discomfort, ease of administration and shorter duration of treatment.7-11
About the IMscin001 study
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq SC, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients.
Part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Efficacy, as measured by progression-free survival (PFS), objective response rates (ORR) and OS, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq SC was also consistent with that of Tecentriq IV.
About Tecentriq SC (subcutaneous)
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).
About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Burotto M, Zvirbule Z, Alvarez R, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity, healthcare provider perspectives and patient-reported outcomes from the randomised Phase III study of atezolizumab subcutaneous vs intravenous in patients with locally advanced or metastatic non-small cell lung cancer. Presented at ESMO; 23 October 2023. Poster #1447P.
[2] European Medicines Agency. Tecentriq, INN-atezolizumab. SmPC. [Internet; last updated 25 July 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf.
[3] Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693-702.
[4] Phesgo, INN-pertuzumab/trastuzumab. SmPC. [Internet; last updated 02 March 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf.
[5] European Medicines Agency. Herceptin, INN-trastuzumab. SmPC. [Internet; last updated 17 March 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf.
[6] European Medicines Agency. MabThera, INN-rituximab. SmPC. [Internet; last updated 22 March 2023; cited October 2023] Available from:
https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf.
[7] Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
[8] De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.
[9] O’Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.
[10] Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.
[11] Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
Thanks for your input. Feel free to chime in any time. It's good to have differing opinions contending so that we all can be as clear as possible in making our decisions.
Good luck
-Fritz
Piper Sandler lowers PT from $44-$42, maintains OVERWEIGHT rating.
Needham adjusts PT from $35-$25, maintains BUY rating.
Herocar, What are your thoughts on all of the various schools of thought on the current situation?
Hero, no disrespect meant to be sent your way. My scorn is 100% directed at the HALO management who has frittered away about a billion dollars in cash buying back shares with no plan for the future, limping along in the status quo.
Buying shares and then selling them again to a financier at what will surely be a dilutive and more expensive proposition is what I fear will happen if Helen gets the buying itch again. Spinning wheels is not returning value to shareholders, IMHO.
Best wishes,
-Fritz
What, and unwind all of that enormous "value returned to shareholders"? LOL!