Fred Kadiddlehopper
20 hours ago
Roche’s OCREVUS subcutaneous injection receives EU CHMP positive opinion for relapsing and primary progressive multiple sclerosis
If approved, OCREVUS subcutaneous (SC) would be the first and only twice-a-year, 10-minute injection for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in the EU
OCREVUS SC will be a new, faster way of administering OCREVUS with a comparable efficacy and safety profile to the well-established intravenous (IV) infusion
OCREVUS SC has the potential to expand treatment options to centres without IV infrastructure or with IV constraints
Basel, 29 April 2024 - 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 OCREVUS® (ocrelizumab) subcutaneous (SC) for its multiple sclerosis (MS) indications. OCREVUS SC maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, with a 10-minute injection. A final decision on its approval from the European Commission is expected mid-2024.
“More than 300,000 people with MS have been treated globally with twice-a-year OCREVUS IV infusions to date. However, access to IV facilities may be challenging for some patients, and, conversely, some MS centres have limited IV capacity,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation brings us a step closer to offering the 10-minute OCREVUS SC injection in the EU, expanding access to even more people with MS who could benefit from this treatment.”
The CHMP’s positive opinion is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation in patients with relapsing MS (RMS) and primary progressive MS (PPMS). Suppression of relapses and MRI disease activity in patients treated with OCREVUS SC 920 mg up to 48 weeks were comparable to those described with OCREVUS IV 600 mg. The safety profile of OCREVUS SC was well tolerated and no new safety concerns were identified. In the trial, more than 92% of patients reported being satisfied or very satisfied with the SC administration of OCREVUS.
OCREVUS SC was developed to provide an alternative twice-a-year treatment option, in addition to IV, so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals (HCPs). The SC injection was designed to be HCP administered, with the flexibility to administer either in the clinic or in settings outside the clinic. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of MS, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with MS.
About OCREVUS SC
OCREVUS SC combines OCREVUS with Halozyme Therapeutics’ Enhanze® drug delivery technology.
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.
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 OCREVUS to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream.
OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting MS [RRMS] and active, or relapsing secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS.
About the OCARINA II study
OCARINA II (NCT05232825) was a Phase III, global, multicentre, randomised study that evaluated the pharmacokinetics, safety and clinical and radiological efficacy of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion in 236 patients with relapsing MS (RMS) or primary progressive MS (PPMS).
The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, as well as comparable efficacy on reduction of relapses and brain lesions. The safety profile of OCREVUS SC was also consistent with the well-established safety profile of OCREVUS IV.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.
People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their clinical symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression as early as possible.
Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.
About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.
Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer’s disease, Huntington’s disease and Parkinson’s disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.
About Roche
Founded in1896 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 fifteenth 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.
Roche Investor Relations
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Fred Kadiddlehopper
4 days ago
Mahesh Krishnan Elected to Halozyme's Board of Directors
April 25 2024 - 4:45PM
PR Newswire (US)
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SAN DIEGO, April 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the election of Mahesh Krishnan, M.D. to its Board of Directors. Dr. Krishnan has more than 20 years of experience in healthcare, biotechnology and health services.
"Mahesh is a dynamic and highly accomplished healthcare executive, and we are pleased to welcome him to the Halozyme board," said Dr. Helen Torley, president and chief executive officer. "His experience with building and growing business opportunities in addition to his medical expertise, will provide valuable perspective as we expand our leadership as the premier provider of innovative drug delivery technologies."
Dr. Krishnan currently serves as Group Vice President of Growth at DaVita, Inc., one of the largest providers of kidney care services in the U.S. He was co-lead of the DaVita Venture Group, where he oversaw strategic partnerships in technology and research and development within the organization. In his current role, he also oversees aspects of medical policy in Washington, D.C. Dr. Krishnan previously served as DaVita's Group Vice President of Research and Development and was the company's first international Chief Medical Officer. Prior to DaVita, he served in various roles at Amgen Inc., including as the Global Development Leader for Epogen® and Executive Director, Medical Policy for all of Amgen's domestic products. Prior to his time at Amgen, Dr. Krishnan was a practicing nephrologist at Virginia Nephrology Group.
"I am honored to join Halozyme as a board member at such an exciting time for their business," said Dr. Krishnan. "As they continue to innovate with their disruptive drug delivery technologies and execute their patient centric vision, I look forward to leveraging my background and sharing my expertise to support their growth."
Dr. Krishnan earned his B.S. in pre-medicine from The Pennsylvania State University and M.D. from Jefferson Medical College at Thomas Jefferson University. He also holds an M.P.H. from Johns Hopkins University and an M.B.A. in healthcare management from the Johns Hopkins Carey School of Business.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
easycomeandgo
5 days ago
Look, the market is weak, no matter how much encouraging word is put out about the economy. Inflation is persistent, which is hardly surprising in view of crazy spending in order to buy the election. The no new taxes for under $400 thousand earners is likewise rubbish, as inflation is a hidden tax impacting all, low earners especially. Bidenamics is not a good thing. I am not saying that Trump is a good thing in other ways. Having said all that, what one shareholder thinks Halozyme stock “should” do is immaterial. The stock does what it does regardless of the “should”s. Institutions holding most of the stock are not idiots, if it were so cheap and should go up, they would buy and it would go up. There is more to this story, way more, that this message board doesn’t know or doesn’t say. Management more than likely knows the rest of the story, but doesn’t say. It doesn’t serve them to say. This stock is out in the wilderness, only a fool buys it blindly. Not enough fools, surprisingly, at least not Halozyme wanting fools.
stockrafter
1 week ago
Mr Kadidlehopper........
"Do you think it possible that Halozyme is simply selling the rhuph20 as a commodity without a partnership deal"
Not an expert on the matter, but see no reason why they couldn't for preliminary studies, heck give it to them for preliminary work, but would suspect a deal would need to be made before any clinical trial, for legal reasons.
At this point, really tired of this company. Thought ATRS was bad at PR, but this is crazy. So much going on yet so little information from the company.
Still waiting for the New Fancy 10 ml injector patent filing to be posted. Helen mentioned it more than a year ago, and a filing needs to get posted before any public trial can be conducted.
Still waiting for additional use of any of the injectors. Both ATRS and HALO mention products that could be developed like Xyosted, but nothing. Internal products are something HALO controls and could discuss the progress. Several patent filings show several potential products.
Still waiting for new Enhanze deals, as many others have mentioned....
Still waiting for info on the two products I posted on with hard facts......
Still waiting, and waiting, for the SP to go above and stay above average buy price....but there it goes down again at this time......
easycomeandgo
3 weeks ago
Hmmmm… Come on “doom and gloom” brothers, a little more vigorous efforts, if you please. More gloom, Scotty, this thing needs help to achieve warp gains. We have pumpers on the starboard bow, life, yes…, but not as we know it, jinxing the good ship Halozyme. Oh, I almost forgot about the market tanking. Does THAT make any difference? Why? Are we in unfriendly territory, neutralizing the salutary doom and gloom efforts?
maumar
3 weeks ago
Halozyme Therapeutics Inc forms bullish "Double Moving Average Crossover" chart pattern
Apr 08, 2024
Trading Central has detected a "Double Moving Average Crossover" chart pattern formed on Halozyme Therapeutics Inc (HALO:NASDAQ). This bullish signal indicates that the stock price may rise from the close of $39.91.
Tells Me: The price is generally in an established trend (bullish or bearish) for the time horizon represented by the moving average periods.
Moving averages (MA) are used to smooth out the volatility or "noise" in the price series, to make it easier to discover the underlying trend. By plotting the average price over the last several bars, the line is less "jerky" than plotting the actual prices. In the double crossover method, a bullish event is generated when a faster moving average crosses above a slower moving average (21-bar MA crosses 50-bar, or 50-bar MA crosses 200-bar). In this state, the price is likely in an established uptrend. The opposite is true when the faster slips below the slower moving average, triggering a bearish event.
This bullish pattern can be seen on the following chart and was detected by Trading Central proprietary pattern recognition technology.
I actually think the crossover happened today but the article is from yesterday. According to yahoo finance, the 50 is at $38.74 and the 200 at $38.66. Hopefully, some good news is around the corner.
https://finance.yahoo.com/quote/HALO/chart?nn=1#eyJsYXlvdXQiOnsiaW50ZXJ2YWwiOiJkYXkiLCJwZXJpb2RpY2l0eSI6MSwidGltZVVuaXQiOm51bGwsImNhbmRsZVdpZHRoIjo4Ljc5MzY1MDc5MzY1MDc5NCwiZmxpcHBlZCI6ZmFsc2UsInZvbHVtZVVuZGVybGF5IjpmYWxzZSwiYWRqIjp0cnVlLCJjcm9zc2hhaXIiOnRydWUsImNoYXJ0VHlwZSI6ImxpbmUiLCJleHRlbmRlZCI6ZmFsc2UsIm1hcmtldFNlc3Npb25zIjp7fSwiYWdncmVnYXRpb25UeXBlIjoib2hsYyIsImNoYXJ0U2NhbGUiOiJsaW5lYXIiLCJwYW5lbHMiOnsiY2hhcnQiOnsicGVyY2VudCI6MSwiZGlzcGxheSI6IkhBTE8iLCJjaGFydE5hbWUiOiJjaGFydCIsImluZGV4IjowLCJ5QXhpcyI6eyJuYW1lIjoiY2hhcnQiLCJwb3NpdGlvbiI6bnVsbH0sInlheGlzTEhTIjpbXSwieWF4aXNSSFMiOlsiY2hhcnQiXX19LCJzZXRTcGFuIjp7Im11bHRpcGxpZXIiOjYsImJhc2UiOiJtb250aCIsInBlcmlvZGljaXR5Ijp7InBlcmlvZCI6MSwidGltZVVuaXQiOiJkYXkifSwic2hvd0V2ZW50c1F1b3RlIjp0cnVlLCJmb3JjZUxvYWQiOmZhbHNlLCJ1c2VFeGlzdGluZ0RhdGEiOnRydWV9LCJvdXRsaWVycyI6ZmFsc2UsImFuaW1hdGlvbiI6dHJ1ZSwiaGVhZHNVcCI6eyJzdGF0aWMiOnRydWUsImR5bmFtaWMiOmZhbHNlLCJmbG9hdGluZyI6ZmFsc2V9LCJsaW5lV2lkdGgiOjIsImZ1bGxTY3JlZW4iOnRydWUsInN0cmlwZWRCYWNrZ3JvdW5kIjp0cnVlLCJjb2xvciI6IiMwMDgxZjIiLCJldmVudHMiOnRydWUsInN0cmlwZWRCYWNrZ3JvdWQiOnRydWUsImV2ZW50TWFwIjp7ImNvcnBvcmF0ZSI6eyJkaXZzIjp0cnVlLCJzcGxpdHMiOnRydWV9LCJzaWdEZXYiOnt9fSwiY3VzdG9tUmFuZ2UiOm51bGwsInN5bWJvbHMiOlt7InN5bWJvbCI6IkhBTE8iLCJzeW1ib2xPYmplY3QiOnsic3ltYm9sIjoiSEFMTyIsIm1hcmtldCI6InVzX21hcmtldCIsInF1b3RlVHlwZSI6IkVRVUlUWSIsImV4Y2hhbmdlVGltZVpvbmUiOiJBbWVyaWNhL05ld19Zb3JrIiwicGVyaW9kMSI6MTY2NTM4NTIwMCwicGVyaW9kMiI6MTcxMjcwMDAwMH0sInBlcmlvZGljaXR5IjoxLCJpbnRlcnZhbCI6ImRheSIsInRpbWVVbml0IjpudWxsLCJzZXRTcGFuIjp7Im11bHRpcGxpZXIiOjYsImJhc2UiOiJtb250aCIsInBlcmlvZGljaXR5Ijp7InBlcmlvZCI6MSwidGltZVVuaXQiOiJkYXkifSwic2hvd0V2ZW50c1F1b3RlIjp0cnVlLCJmb3JjZUxvYWQiOmZhbHNlLCJ1c2VFeGlzdGluZ0RhdGEiOnRydWV9fV0sIndpZHRoIjoyLCJzdHVkaWVzIjp7IuKAjG1h4oCMICg1MCxtYSwwKSI6eyJ0eXBlIjoibWEiLCJpbnB1dHMiOnsiUGVyaW9kIjo1MCwiRmllbGQiOiJmaWVsZCIsIlR5cGUiOiJtYSIsIk9mZnNldCI6MCwiaWQiOiLigIxtYeKAjCAoNTAsbWEsMCkiLCJkaXNwbGF5Ijoi4oCMbWHigIwgKDUwLG1hLDApIn0sIm91dHB1dHMiOnsiTUEiOiIjRkYwMDAwIn0sInBhbmVsIjoiY2hhcnQiLCJwYXJhbWV0ZXJzIjp7ImNoYXJ0TmFtZSI6ImNoYXJ0IiwiZWRpdE1vZGUiOnRydWV9LCJkaXNhYmxlZCI6ZmFsc2V9LCLigIxtYeKAjCAoMjAwLG1hLDApIjp7InR5cGUiOiJtYSIsImlucHV0cyI6eyJQZXJpb2QiOiIyMDAiLCJGaWVsZCI6ImZpZWxkIiwiVHlwZSI6Im1hIiwiT2Zmc2V0IjowLCJpZCI6IuKAjG1h4oCMICgyMDAsbWEsMCkiLCJkaXNwbGF5Ijoi4oCMbWHigIwgKDIwMCxtYSwwKSJ9LCJvdXRwdXRzIjp7Ik1BIjoiI0ZGMDAwMCJ9LCJwYW5lbCI6ImNoYXJ0IiwicGFyYW1ldGVycyI6eyJjaGFydE5hbWUiOiJjaGFydCIsImVkaXRNb2RlIjp0cnVlfSwiZGlzYWJsZWQiOmZhbHNlfX19LCJldmVudHMiOnsiZGl2cyI6dHJ1ZSwic3BsaXRzIjp0cnVlLCJ0cmFkaW5nSG9yaXpvbiI6Im5vbmUiLCJzaWdEZXZFdmVudHMiOltdfSwicHJlZmVyZW5jZXMiOnsiY3VycmVudFByaWNlTGluZSI6dHJ1ZSwiZGlzcGxheUNyb3NzaGFpcnNXaXRoRHJhd2luZ1Rvb2wiOmZhbHNlLCJkcmF3aW5ncyI6bnVsbCwiaGlnaGxpZ2h0c1JhZGl1cyI6MTAsImhpZ2hsaWdodHNUYXBSYWRpdXMiOjMwLCJtYWduZXQiOmZhbHNlLCJob3Jpem9udGFsQ3Jvc3NoYWlyRmllbGQiOm51bGwsImxhYmVscyI6dHJ1ZSwibGFuZ3VhZ2UiOm51bGwsInRpbWVab25lIjoiQW1lcmljYS9OZXdfWW9yayIsIndoaXRlc3BhY2UiOjUwLCJ6b29tSW5TcGVlZCI6bnVsbCwiem9vbU91dFNwZWVkIjpudWxsLCJ6b29tQXRDdXJyZW50TW91c2VQb3NpdGlvbiI6ZmFsc2V9fQ--
easycomeandgo
4 weeks ago
Oh, go take a hike! Do you really believe I am going to scour the board for my old posts just to obey your frivolous quibbles? Do you realize how goofy you sound?I tell you this much, since I looked, the shares I bought below 34 I bought on 06/06/23. The ones I sold just below 40 I bought earlier, around the same price or less. Don’t worry, I have already settled with the IRS. If that isn’t enough for you, too bad.
OK, I looked. On 06/07/23 I posted:
“After posting my reservations about this company, many of which remain, I think it is only proper to note that yesterday I picked up some shares. I didn’t bet the farm, I don‘t do that any more on any stock, but did pick up a few thousand shares. I hope that the downside is limited, but I don’t know what my upside hopes are as the company has been utterly mute. Definitely not “to the Moon, Alice”. I expect to take half off the table in the mid 40’s, as things now appear.”
Now, take a hike!
easycomeandgo
4 weeks ago
I see that even the thought of my having bought Halo in the low 30’s upsets you. Tell you what: don’t worry about it, not good for your health. Be happy instead about what you call my “doom and gloom”, which in your mind will be of great benefit to you. Thank me. You used to thank those who were not sufficiently gung-ho, and informed them that you are going to use your inexhaustible funds to buy the shares they would sell. Notice also I am not quoting you, don’t go postal about words I use without attributing them to you. Bad for your health, like I said. It is my impression that when others express doubts, they are “doom and gloom” people. When you indict management it is completely warranted, constructive and an inducement for management to do better. Halozyme’s price is not where I thought it would be by now. My hopes for the stock have changed. Call that whatever you want, it changes nothing. Where I buy and sell the few share that I do, does not make you better or worse off. If you think I am lying, gloat with a contented grin and maintain a superior silence. Like I said, Happy Easter.
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OncoJock
14 hours ago
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