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Halozyme Announces Global Collaboration and License Agreement with Takeda to Develop and Commercialize Vedolizumab with ENHANZE®
Prnewswire· 2026-01-08 13:00
®Agreement provides Takeda with exclusive access to ENHANZE drug delivery technology for vedolizumab ® SAN DIEGO, Jan. 8, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the Company entered into a global collaboration and exclusive license agreement with Takeda in December 2025. The agreement provides Takeda with access to Halozyme's ENHANZE drug delivery technology, the leading proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20), for use with vedolizumab. Vedol ...
Halozyme and Skye Bioscience Announce Global Collaboration and License Agreement to Evaluate Nimacimab Co-Formulated with ENHANZE® for Obesity
Globenewswire· 2026-01-05 12:00
Agreement supports development and commercialization of higher-dose, subcutaneous administration strategies for nimacimabSAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Skye Bioscience, Inc. (Nasdaq: SKYE) today announced the companies entered into a non-exclusive global collaboration and license agreement in December 2025. Under the collaboration, Skye has licensed Halozyme's ENHANZE® drug delivery technology for the development and potential commercialization of ...
Lexaria Releases Additional Results from its Successful Phase 1b Study GLP-1-H24-4
Thenewswire· 2025-12-30 14:20
Core Insights - Lexaria Bioscience Corp. has released additional data from its Phase 1b clinical study GLP-1-H24-4, which focuses on the efficacy of its DehydraTECH™ technology compared to Rybelsus® [1][2] Secondary Efficacy Parameters - At week 16, the DHT arms showed no statistically significant differences compared to the Rybelsus® control in mean fasting glucose, cholesterol, and LDL cholesterol [3] Body Composition - The DHT-semaglutide arm showed a modest reduction in fat mass of -1.08 kg and total mass of -1.40 kg, while the Rybelsus® control arm achieved greater reductions of -3.55 kg in fat mass and -5.36 kg in total mass, with a higher reduction in lean mass of -1.72 kg [4] Blood Pressure Analyses - The DHT-CBD arm achieved significant reductions in blood pressure, with a mean change of -4.6 mmHg in systolic and -4.0 mmHg in diastolic blood pressure at week 4 [5][6] Pharmacokinetic Exploratory Analyses - Plasma CBD concentrations were quantifiable through week 16 in the DHT-CBD arms, while semaglutide concentrations were not quantifiable due to assay issues, although preliminary tests indicated measurable levels [8] Health Survey Results - Participants in the DHT-semaglutide arm reported mean improvements of over 5 points in physical components and over 3 points in mental components of the SF-36 health survey, compared to modest improvements in the Rybelsus® control arm [9][10] Overall Conclusions and Next Steps - The study met its primary endpoint, demonstrating good safety and tolerability of all DHT test articles, with positive findings across various parameters compared to Rybelsus® [11] Future Plans - Lexaria plans to pursue further clinical testing with a DHT + SNAC + semaglutide composition and is in discussions with a pharmaceutical company regarding the dataset from the study [15][17][18]
U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer
Prnewswire· 2025-12-18 12:00
Compared to intravenous (IV) delivery, RYBREVANT FASPROâ"¢ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm). "Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPROâ"¢ has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration, ...
Gelteq Furthers Asia Presence Through Partnership with Hong Kong Flag Football Program
Globenewswire· 2025-12-16 14:05
Core Insights - Gelteq Limited has announced a partnership with the Hong Kong Flag Football Program to integrate its hydration and sports performance formulations into training and competition for national teams [1][2] - The collaboration highlights the growing interest in high-performance sports programs in the region, supported by a recent sales agreement with Shenzhen Mana Health Management Co. Ltd. worth at least USD $1.3 million [2] - Gelteq's proprietary delivery technology is increasingly being adopted in both sports and wellness applications, driven by demand for research-based products that enhance athlete performance [3] Company Developments - Gelteq's gel-based formulations are designed to aid athletes in managing hydration, energy regulation, and recovery, and are already utilized by elite programs in Australia and Asia [6] - The partnership with Hong Kong's national teams marks a significant step in the development of American football in the region, as all three teams recently achieved their first official international victories [4] - The CEO of Gelteq emphasized the versatility of their gel-based platform and the company's commitment to supporting athlete performance through science-driven innovation [5] Industry Trends - Flag football is recognized as one of the fastest-growing team sports globally, with increasing participation among youth and adults due to its accessibility and low-contact nature [5] - The growth of flag football in the region is bolstered by rising investments in sports science and high-performance training [5] - Gelteq is actively exploring additional opportunities in the region to expand its sports product portfolio and advance commercial discussions regarding its gel-based platform [7]
NEXGEL Announces Spin-Off of Drug Delivery Program into NexGelRx
Globenewswire· 2025-12-11 13:00
Core Viewpoint - NEXGEL is spinning off select drug delivery application assets into a new entity, NexGelRx, which will focus on developing prescription drug delivery solutions using NEXGEL's proprietary hydrogel technology [1][3] Group 1: Spin-off Details - NEXGEL shareholders will receive a non-dilutive 19.99% equity interest in NexGelRx, along with up to $8 million of capital investment [1][2] - NEXGEL will also receive a 5% global royalty in perpetuity on products sold using its drug delivery technology [1][2] Group 2: Management and Strategic Focus - Adam Levy, CEO of NEXGEL, emphasized that the spin-off allows the company to pursue high-value prescription opportunities while maintaining focus on contract manufacturing and consumer products [3] - Dr. Jerome Zeldis, a director of both NEXGEL and NexGelRx, highlighted the potential of the hydrogel technology to create new therapies and enhance existing treatments [3] Group 3: Company Background - NEXGEL is a provider of healthcare, beauty, and OTC products, specializing in high-water-content hydrogel products for various applications [4] - The company has over two decades of experience in developing and manufacturing electron-beam, cross-linked hydrogels [4]
Gelteq Preclinical Study Demonstrates Enhanced Oral Delivery of Oil-Soluble and Poorly Soluble Drugs Using Its Gel-Based Platform
Globenewswire· 2025-12-05 15:30
Core Insights - Gelteq Limited has announced preclinical findings that demonstrate the effectiveness, flexibility, and safety of its proprietary gel-based oral delivery systems, addressing significant challenges in pharmaceutical development [1][6]. Preclinical Study Results - Two preclinical studies showed a 300% increase in bioavailability of an oil-soluble compound in Gelteq's gel base compared to an existing FDA-approved reference product within the first hour, which is critical for rapid onset of action [2]. - Overall absorption of the oil-soluble compound improved by more than 20% over 24 hours when using Gelteq's gel base compared to the reference product [3]. - The gel platform enables controlled movement through the digestive system, targeted release, and effective absorption while ensuring full clearance of both the active pharmaceutical ingredients and the gel material [4]. Mechanism of Action - The gel disperses the active ingredient uniformly along the small intestine, enhancing absorption through mucoadhesive interactions and presenting the drug across a larger intestinal surface area [5]. - The gel's structural matrix allows for efficient transit and rapid early absorption of the active pharmaceutical ingredient, reinforcing its safety and compatibility with oral administration [6]. Industry Context - Over 40% of approved drugs and up to 90% of developmental candidates face issues with poor solubility and bioavailability, leading to significant annual investments in new technologies to address these challenges [7]. - Gelteq's platform offers a streamlined solution that may reduce developmental burdens, enhance bioavailability, and potentially revive previously shelved or challenging molecules [7]. Therapeutic Applications - Therapeutic areas likely to benefit from Gelteq's gel-based delivery system include neurology, inflammation and pain management, hormonal therapies, cardiovascular medicine, nutraceuticals, weight management, oncology, and veterinary health, where lipid-based or poorly soluble APIs are common [8]. Strategic Positioning - By enabling consistent absorption, targeted delivery, reduced reliance on excipients, and strong safety characteristics, Gelteq positions itself as a valuable development partner for pharmaceutical and nutraceutical companies looking to reformulate existing assets or tackle complex formulation challenges [9].
Halozyme Wins Preliminary Injunction Against Merck's Keytruda SC in Germany
Prnewswire· 2025-12-04 18:26
Core Viewpoint - Halozyme Therapeutics has secured a preliminary injunction from a German court against Merck, preventing the distribution of Keytruda SC in Germany due to patent infringement concerns related to Halozyme's MDASE™ technology [1][2]. Legal Developments - The Munich Regional Court identified imminent infringement of Halozyme's European Patent No. 2 797 622 (EP 622) by Merck's Keytruda SC, leading to the injunction [2]. - Merck has initiated separate nullity proceedings against the patent in August 2025, which are currently pending [2]. - Halozyme is confident that the injunction will withstand any potential appeal by Merck [2]. Patient Access - Patients will still have access to the intravenous (IV) version of Keytruda, which is not affected by the injunction or Halozyme's patent [3]. Company Statements - Halozyme expressed satisfaction with the court's decision, emphasizing the validity of its MDASE patents and its commitment to defending them [4]. - The company is also pursuing patent infringement claims against Merck in the U.S. federal district court, alleging that the subcutaneous formulation of Keytruda marketed as QLEX infringes 15 of Halozyme's patents [4]. Patent and Technology Overview - The MDASE™ patents are distinct from Halozyme's ENHANZE licensing program, meaning the outcome of the lawsuit will not affect ENHANZE or its associated revenues [5]. - Halozyme's MDASE technology is based on extensive research into human hyaluronidases, which facilitate rapid subcutaneous drug delivery [4]. Company Profile - Halozyme is a biopharmaceutical company focused on innovative drug delivery solutions, with its ENHANZE technology having impacted over one million patients globally [6][7]. - The company is also developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and delivery methods [8].
Halozyme to Participate in the 8th Annual Evercore Healthcare Conference
Prnewswire· 2025-11-25 13:30
Core Insights - Halozyme Therapeutics, Inc. will present at the 8th Annual Evercore Healthcare Conference on December 2, 2025, at 10:20 am PT / 1:20 pm ET, hosted by Dr. Helen Torley, the president and CEO [1] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes for both emerging and established therapies [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of injected drugs, improving convenience and reducing treatment burden [4] - ENHANZE® has impacted over one million patients through ten commercialized products across more than 100 global markets, with partnerships involving major pharmaceutical companies such as Roche, Takeda, and Pfizer [4] Technology Development - Halozyme is developing Hypercon™, a microparticle technology aimed at hyper-concentration of drugs and biologics, which is expected to reduce injection volume while expanding at-home and healthcare provider administration opportunities [5] - The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson and Eli Lilly, enhancing the company's drug delivery capabilities [5] Product Portfolio - The company also develops drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence, with proprietary products like Hylenex® and XYOSTED® [6] - Halozyme has ongoing development programs in collaboration with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. [6] Corporate Information - Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey; Minnetonka, Minnesota; and Boston, Massachusetts [7]
AptarGroup, Inc. (ATR) Presents at Jefferies London Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-11-19 13:53
Core Insights - Aptar Group has been in operation for approximately 80 years and has been publicly traded for 35 years, with the pharmaceutical segment contributing nearly 70% of EBITDA [2]. Company Overview - The company focuses on proprietary drug delivery devices, primarily for nasal and inhalation applications, as well as ophthalmic and dermal delivery systems [2]. - The beauty and closure segments also contribute to the company's portfolio, targeting demographics such as the aging population and health-conscious consumers [3]. Market Focus - Aptar Group's pharmaceutical applications are mainly aimed at chronic disease treatments, including asthma, COPD, and allergic rhinitis, which require daily medication [3]. - The company organizes its operations into three reporting segments but manages its business primarily through technology platforms [3].