e-Commerce company RooLife Group Ltd (ASX:RLG) (“RLG” or “Company”) is delighted to announce that it has been appointed by The Hydration Pharmaceuticals Company Limited (ASX:HPC) (“HPC”) to exclusively market, sell and distribute its Hydralyte range of electrolyte-rich tablets, liquids and powders in China.
RLG is contracted to provide digital marketing, social media operations and e-commerce store operations with exclusive distribution rights for all online and physical store sales, including cross border e-commerce and general trade in China.
Under the terms of the agreement, RLG will generate fees for the provision of digital marketing, social media and e-commerce store operation and receive a margin on all products it sells.
The initial term of the agreement is 2 years 5 months with periodic marketing investment reviews at which marketing spend, which is funded by HPC, may be increased or the parties may elect to cease activities.
The addition of the Hydralyte range further expands RLG’s offering in the lucrative online sports nutrition channel in China, where more than 80% of sales take place via eCommerce1, with the size of the global health and wellness market being over USD$5.2 trillion in 2022 and projected to reach USD$8.9 trillion by 20322.
RooLife Group CEO, Bryan Carr said: “We are excited to add such a high-profile and proven brand as Hydralyte to our healthy, functional food and beverage portfolio in China where we continue to grow out our online and physical store channels, servicing the high consumer demand for quality international products with China’s large, emerging middle class. We look forward to working with Hydralyte’s very dynamic team, extending their global sales footprint considerably by leveraging the growing awareness of health and wellness generally in China and the established trust and awareness for Australian wellness brands, making Hydralyte a great match for RLG and our capabilities in China.
Along with expanding our product offering, we are continuing to build out more channels to market, having added distribution through ALDI, Ole and Alibaba’s HEMA supermarkets in addition to our new partnership with AULife for RLG Marketplace in China. We look forward to providing further updates as we open additional sales channels for our health and wellbeing product range.”
The Hydration Pharmaceuticals Company CEO, Oliver Baker added: “RLG’s well-established online sales channels and access to growing physical store network is the perfect platform to expand our presence in the China market. Their highly capable sales & marketing offering and understanding of how to sell and promote a product to Chinese consumers presents us with a very unique opportunity to establish the Hydralyte brand here.”
The initial contracted service fees are not yet material in the context of RLG’s annual total revenue and RLG is not yet able to accurately forecast the quantum of expected Hydralyte products sales, however the high profile and brand awareness of the Hydralyte range in Australia, U.S.A. and Canada is expected to drive awareness and sales in China and progressively contribute towards RLG’s annual revenue.
About The Hydration Pharmaceuticals Company Limited
The Hydration Pharmaceuticals Company Limited (HPC) is a well-known brand developed in Australia in 2001 to produce a range of electrolyte-rich tablets, liquids and powders and aims to grow its footprint in new international markets, led by an experienced management team and high skilled Board of Directors. HPC has exclusive rights to the Hydralyte brand in North and South America, Europe (excluding Turkey), China (excluding Taiwan) and Hong Kong.
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This article includes content from The Hydration Pharmaceuticals Company Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the acceptance of an abstract for an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting taking place May 13-17, 2025, in New Orleans, LA.
Details of the oral presentation are as follows:
Title : ADI-270, an Armored Allogeneic Anti-CD70 CAR γδ T Cell Therapy, Demonstrates Robust CAR-Directed and -Independent Anti-Tumor Activity Against Hematologic and Solid Tumor Models Compared to Conventional CAR αβ T Cells Session Name : Engineered Immune Effector Cells for Solid Tumors Presenting Author: Melinda Au Date and Time : May 17, 2025; 11:45 a.m. 12:00 p.m. CT
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20250428536799/en/
Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Precision AQ
212-362-1200
janhavi.mohite@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
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HIGHLIGHTS
The offer of the Placement CNs was made to sophisticated and professional investors in Australia and successfully closed, achieving binding commitments of A$1.0 million.
Stephen Turner, NGS CEO and Managing Director, commented on the CN Placement:
“We are very pleased with the strong support shown by investors in this placement, which provides important growth capital to support our retail expansion into leading U.S. retailers, including CVS and Wakefern. We would like to thank our shareholders for their ongoing support as we execute our growth strategy and build on the momentum from our recent distribution achievements.”
The conversion of the convertible notes into fully paid ordinary shares in NGS will take place at a price of between A$0.03 and A$0.025 per ordinary share within 10 business days of NGS shareholders approving their conversion including for the purposes of ASX Listing Rule 7.1. NGS expects to convene a general meeting of its shareholders to consider whether to approve the conversion of the convertible notes into fully paid ordinary shares in NGS and whether to approve the issuance of options within the next few weeks.
Until the convertible notes are converted into ordinary shares or redeemed, they bear interest which is payable quarterly in arrear at either 10% per annum (if the holder of the convertible notes elects not to receive ordinary shares in NGS in lieu of cash interest), or 15% per annum (if the holder of the convertible notes elects to receive ordinary shares in NGS in lieu of cash interest). Issuance of ordinary shares in NGS in lieu of cash interest is subject to NGS being in compliance with the ASX Listing Rules. If the convertible notes have not been converted by the date that is 2 years after their issue date, they will be redeemed by NGS at their issue price.
Each investor who is issued with ordinary shares on conversion of the convertible notes will be issued with one option for each fully paid ordinary share that is issued on conversion of the convertible notes, with that issuance of options to take place on the same date as the ordinary share issuance date. This is expected to be within 10 business days of NGS shareholders approving that issuance of options including for the purposes of ASX Listing Rule 7.1. These options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per option, and will expire 3 years following their issue date if they have not been exercised during that 3 year period (the CN Holder Options). Quotation of the CN Holder Options on the ASX will be sought.
USE OF PROCEEDS
The net proceeds from the issue of the convertible notes are planned to be used in the following areas:
LEAD MANAGER OPTIONS
The Company engaged GBA Capital Pty Ltd (AFSL 544680) to act as lead manager for the CN Placement (Lead Manager).
Under the terms of the mandate with the Lead Manager, the Lead Manager will be issued with 30% of the number of CN Holder Options (the Lead Manager Options). The Lead Manager Options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per Lead Manager Option. The Lead Manager Options will expire 3 years following their issue date if they have not been exercised during that 3 year period.
The Lead Manager Options will be issued within 10 business days of NGS shareholders approving that issuance including for the purposes of ASX Listing Rule 7.1. NGS expects the Lead Manager Options to be issued at the same time as the issuance of the CN Holder Options. Quotation of the Lead Manager Options on the ASX will be sought.
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This article includes content from Nutritional Growth Solutions Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025 .
"AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael , chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term."
First -Quarter Results
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
Recent Events
Full-Year 2025 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 - $12.19 to $12.09 - $12.29 , which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra's licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie's business.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X (formerly Twitter), Facebook , Instagram , YouTube or LinkedIn .
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central Time .
Non-GAAP Financial Results
Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Media: | Investors: |
Gabby Tarbert | Liz Shea |
(224) 244-0111 | (847) 935-2211 |
Todd Bosse | |
(847) 936-1182 | |
Jeffrey Byrne | |
(847) 938-2923 |
Key Product Revenues Quarter Ended March 31, 2025 (Unaudited) | |||||||||||||||
% Change vs. 1Q24 | |||||||||||||||
Net Revenues (in millions) | Reported | Operational a | |||||||||||||
U.S. | Int'l. | Total | U.S. | Int'l. | Total | Int'l. | Total | ||||||||
NET REVENUES | $9,979 | $3,364 | $13,343 | 10.4 % | 2.9 % | 8.4 % | 8.3 % | 9.8 % | |||||||
Immunology | 4,883 | 1,381 | 6,264 | 17.6 | 13.4 | 16.6 | 20.1 | 18.1 | |||||||
Skyrizi | 2,919 | 506 | 3,425 | 76.2 | 43.9 | 70.5 | 52.3 | 72.0 | |||||||
Rinvoq | 1,220 | 498 | 1,718 | 68.3 | 35.3 | 57.2 | 42.8 | 59.7 | |||||||
Humira | 744 | 377 | 1,121 | (58.0) | (24.4) | (50.6) | (19.5) | (49.5) | |||||||
Neuroscience | 1,972 | 310 | 2,282 | 15.0 | 24.0 | 16.1 | 31.0 | 17.0 | |||||||
Vraylar | 763 | 2 | 765 | 10.3 | 13.1 | 10.3 | 20.2 | 10.3 | |||||||
Botox Therapeutic | 723 | 143 | 866 | 18.2 | 4.8 | 15.8 | 11.4 | 17.0 | |||||||
Ubrelvy | 233 | 7 | 240 | 17.6 | 23.3 | 17.8 | 29.3 | 18.0 | |||||||
Qulipta | 172 | 21 | 193 | 34.2 | >100.0 | 47.6 | >100.0 | 48.3 | |||||||
Vyalev | 6 | 57 | 63 | n/m | >100.0 | >100.0 | >100.0 | >100.0 | |||||||
Duodopa | 20 | 76 | 96 | (19.4) | (16.0) | (16.7) | (11.7) | (13.3) | |||||||
Other Neuroscience | 55 | 4 | 59 | (9.5) | (1.0) | (8.9) | 6.5 | (8.4) | |||||||
Oncology | 1,027 | 606 | 1,633 | 6.0 | 5.4 | 5.8 | 10.0 | 7.5 | |||||||
Imbruvica b | 529 | 209 | 738 | (13.3) | (8.2) | (11.9) | (8.2) | (11.9) | |||||||
Venclexta | 312 | 353 | 665 | 11.0 | 6.0 | 8.3 | 13.4 | 12.3 | |||||||
Elahere | 165 | 14 | 179 | >100.0 | n/m | >100.0 | n/m | >100.0 | |||||||
Epkinly c | 21 | 30 | 51 | 66.7 | >100.0 | 89.8 | >100.0 | 94.8 | |||||||
Aesthetics | 640 | 462 | 1,102 | (17.4) | (2.4) | (11.7) | 1.6 | (10.2) | |||||||
Botox Cosmetic | 295 | 261 | 556 | (24.3) | 6.9 | (12.3) | 11.1 | (10.7) | |||||||
Juvederm Collection | 75 | 156 | 231 | (29.0) | (18.5) | (22.2) | (15.0) | (20.0) | |||||||
Other Aesthetics | 270 | 45 | 315 | (3.5) | 18.1 | (0.9) | 23.2 | (0.3) | |||||||
Eye Care | 221 | 285 | 506 | (2.6) | (8.0) | (5.7) | (2.0) | (2.2) | |||||||
Ozurdex | 30 | 93 | 123 | (12.1) | (3.8) | (6.0) | 1.1 | (2.4) | |||||||
Lumigan/Ganfort | 48 | 58 | 106 | 69.2 | (6.8) | 17.0 | (0.5) | 21.4 | |||||||
Alphagan/Combigan | 26 | 34 | 60 | 68.5 | (21.4) | 1.9 | (15.4) | 6.3 | |||||||
Other Eye Care | 117 | 100 | 217 | (21.4) | (7.1) | (15.4) | (0.2) | (12.5) | |||||||
Other Key Products | 636 | 173 | 809 | (7.2) | (19.4) | (10.1) | (14.8) | (9.0) | |||||||
Mavyret | 142 | 164 | 306 | (0.7) | (20.4) | (12.3) | (15.8) | (9.6) | |||||||
Creon | 355 | — | 355 | 24.6 | n/m | 24.6 | n/m | 24.6 | |||||||
Linzess/Constella | 139 | 9 | 148 | (46.1) | 3.1 | (44.4) | 9.3 | (44.2) | |||||||
a | "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
b | Reflects profit sharing for Imbruvica international revenues. |
c | Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. |
n/m = not meaningful | |
Consolidated Statements of Earnings (Unaudited) | ||||
(in millions, except per share data) | First Quarter Ended March 31 | |||
2025 | 2024 | |||
Net revenues | $ 13,343 | $ 12,310 | ||
Cost of products sold | 4,002 | 4,094 | ||
Selling, general and administrative | 3,293 | 3,315 | ||
Research and development | 2,067 | 1,939 | ||
Acquired IPR&D and milestones | 248 | 164 | ||
Total operating costs and expenses | 9,610 | 9,512 | ||
Operating earnings | 3,733 | 2,798 | ||
Interest expense, net | 627 | 453 | ||
Net foreign exchange loss | 4 | 4 | ||
Other expense, net | 1,441 | 586 | ||
Earnings before income tax expense | 1,661 | 1,755 | ||
Income tax expense | 372 | 383 | ||
Net earnings | 1,289 | 1,372 | ||
Net earnings attributable to noncontrolling interest | 3 | 3 | ||
Net earnings attributable to AbbVie Inc. | $ 1,286 | $ 1,369 | ||
Diluted earnings per share attributable to AbbVie Inc. | $ 0.72 | $ 0.77 | ||
Adjusted diluted earnings per share a | $ 2.46 | $ 2.31 | ||
Weighted-average diluted shares outstanding | 1,772 | 1,773 | ||
a | Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) | |||||
1. Specified items impacted results as follows: | |||||
Quarter Ended March 31, 2025 | |||||
(in millions, except per share data) | Earnings | Diluted | |||
Pre-tax | After-tax a | EPS | |||
As reported (GAAP) | $ 1,661 | $ 1,286 | $ 0.72 | ||
Adjusted for specified items: | |||||
Intangible asset amortization | 1,858 | 1,574 | 0.89 | ||
Change in fair value of contingent consideration | 1,518 | 1,477 | 0.83 | ||
Other | 62 | 33 | 0.02 | ||
As adjusted (non-GAAP) | $ 5,099 | $ 4,370 | $ 2.46 | ||
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. |
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2025 included acquired |
2. The impact of the specified items by line item was as follows: | |||||||
Quarter Ended March 31, 2025 | |||||||
(in millions) | Cost of | SG&A | R&D | Other | |||
As reported (GAAP) | $ 4,002 | $ 3,293 | $ 2,067 | $ 1,441 | |||
Adjusted for specified items: | |||||||
Intangible asset amortization | (1,858) | — | — | — | |||
Change in fair value of contingent consideration | — | — | — | (1,518) | |||
Other | (28) | (13) | (16) | (5) | |||
As adjusted (non-GAAP) | $ 2,116 | $ 3,280 | $ 2,051 | $ (82) | |||
3. The adjusted tax rate for the first quarter of 2025 was 14.2 percent, as detailed below: | |||||
Quarter Ended March 31, 2025 | |||||
(dollars in millions) | Pre-tax | Income taxes | Tax rate | ||
As reported (GAAP) | $ 1,661 | $ 372 | 22.4 % | ||
Specified items | 3,438 | 354 | 10.3 % | ||
As adjusted (non-GAAP) | $ 5,099 | $ 726 | 14.2 % | ||
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) | |||||
1. Specified items impacted results as follows: | |||||
Quarter Ended March 31, 2024 | |||||
(in millions, except per share data) | Earnings | Diluted | |||
Pre-tax | After-tax a | EPS | |||
As reported (GAAP) | $ 1,755 | $ 1,369 | $ 0.77 | ||
Adjusted for specified items: | |||||
Intangible asset amortization | 1,891 | 1,603 | 0.90 | ||
Acquisition and integration costs | 511 | 486 | 0.27 | ||
Change in fair value of contingent consideration | 660 | 643 | 0.36 | ||
Other | 21 | 19 | 0.01 | ||
As adjusted (non-GAAP) | $ 4,838 | $ 4,120 | $ 2.31 | ||
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. |
Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. |
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2024 included acquired |
2. The impact of the specified items by line item was as follows: | |||||||||
Quarter Ended March 31, 2024 | |||||||||
(in millions) | Cost of | SG&A | R&D | Interest | Other | ||||
As reported (GAAP) | $ 4,094 | $ 3,315 | $ 1,939 | $ 453 | $ 586 | ||||
Adjusted for specified items: | |||||||||
Intangible asset amortization | (1,891) | — | — | — | — | ||||
Acquisition and integration costs | (79) | (280) | (128) | (24) | — | ||||
Change in fair value of contingent consideration | — | — | — | — | (660) | ||||
Other | (16) | (3) | — | — | (2) | ||||
As adjusted (non-GAAP) | $ 2,108 | $ 3,032 | $ 1,811 | $ 429 | $ (76) | ||||
3. The adjusted tax rate for the first quarter of 2024 was 14.8 percent, as detailed below: | |||||
Quarter Ended March 31, 2024 | |||||
(dollars in millions) | Pre-tax | Income taxes | Tax rate | ||
As reported (GAAP) | $ 1,755 | $ 383 | 21.8 % | ||
Specified items | 3,083 | 332 | 10.8 % | ||
As adjusted (non-GAAP) | $ 4,838 | $ 715 | 14.8 % | ||
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SOURCE AbbVie
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TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks. If approved, TrenibotE will be the first neurotoxin of its kind available to patients. –Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program.
NORTH CHICAGO, Ill. , April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.
"The submission provides evidence of TrenibotE's differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin," said Darin Messina , Ph.D., senior vice president, aesthetics R&D, AbbVie. "TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category."
New patients wanting to experience the aesthetic benefits of a neurotoxin cite "fear of looking unnatural" as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic.
The BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the Phase 3 pivotal studies were previously shared .
"Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment," said Cheryl Burgess , MD, FAAD, lead clinical investigator for one of the Phase 3 studies. "Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX® Cosmetic."
BOTOX ® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX ® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
- Moderate to severe platysma bands associated with platysma muscle activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT |
CONTRAINDICATIONS
BOTOX ® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX ® Cosmetic are specific to the preparation and assay method utilized. BOTOX ® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX ® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX ® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX ® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX ® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX ® . The safety and effectiveness of BOTOX ® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX ® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.
Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions ). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.
Dysphagia and Breathing Difficulties
Treatment with BOTOX ® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning ).
Preexisting Conditions at the Injection Site
Use caution when BOTOX ® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX ® Cosmetic
There have been reports of dry eye associated with BOTOX ® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX ® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX ® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX ® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
The safety profile of BOTOX ® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX ® Cosmetic for other indications.
DRUG INTERACTIONS
Coadministration of BOTOX ® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX ® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX ® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX ® Cosmetic in pregnant women. There are no data on the presence of BOTOX ® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
For more information on BOTOX ® Cosmetic, please see accompanying full Prescribing Information, including Boxed Warning and Medication Guide.
US-FA-01754 10/24
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube .
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Media: Adelle Infante | Investors: Liz Shea |
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--Mr. Grissinger brings more than four decades of leadership experience in pharmaceutical business development and strategic transactions--
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the appointment of Michael Grissinger to its Board of Directors. Mr. Grissinger brings more than four decades of experience in business development, strategy, and M&A leadership roles at global pharmaceutical companies.
"We are honored to welcome Michael to our Board of Directors," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "His extensive operational and business development experience across the global pharmaceutical industry, especially his deep expertise in immunology, brings a wealth of knowledge and invaluable strategic insight to Adicet. Michael's notable accomplishments in driving business and commercial success will be instrumental in shaping the next stage of our growth as we continue to advance our gamma delta T cell platform for the treatment of autoimmune and solid tumor indications."
Mr. Grissinger spent more than two decades at Johnson & Johnson. During his Johnson & Johnson tenure, Mr. Grissinger served in a variety of senior level management roles including Vice President and Head of Worldwide Pharmaceutical Licensing and Vice President and Head of Worldwide Pharmaceutical Corporate Development and M&A. At Johnson & Johnson, Mr. Grissinger led the Immunology Therapeutic Area Business Development and Licensing Group and was also a member of the Immunology R&D/ Commercial leadership team for Johnson & Johnson's Worldwide Immunology Franchise. Prior to Johnson & Johnson, Mr. Grissinger spent 12 years at Ciba-Geigy in finance, marketing and business development roles. Mr. Grissinger also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc. Mr. Grissinger holds a B.S. in Chemistry from Juniata College and an M.B.A. from Temple University-Fox School of Business.
"I am pleased to join the Board of Adicet, a company rooted in harnessing the power of the immune system by developing off-the-shelf gamma delta CAR T cell therapies to make a meaningful difference in patients' lives," said Mr. Grissinger. "I look forward to working alongside the Board and management team and contributing to the advancement of current pipeline programs focused on autoimmune and oncology indications."
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: expectations related to Adicet's business development, strategic opportunities and growth; Adicet's plans and expectations for advancing its autoimmune programs across multiple autoimmune and solid tumor indications; and the anticipated contribution of the members of Adicet's Board of Directors to the Company's business.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet's business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Adicet's most recent quarterly report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
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Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Precision AQ
212-362-1200
janhavi.mohite@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
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