CAMBRIDGE, Mass. and FUCHU-SHI, Tokyo, May 12, 2021 (GLOBE NEWSWIRE) -- Biogen Inc (Nasdaq: BIIB) and TMS Co., Ltd. announced today that Biogen exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, from TMS. Biogens decision to acquire TMS-007 was based on positive data from a Phase 2a study. The study met its primary safety objective with no incidence of symptomatic intracranial hemorrhage (sICH) and demonstrated positive impacts on both blood vessel reopening in the brain as well as patient functional recovery. Patients were dosed up to 12 hours after the onset of stroke symptoms; average time to treatment was 9.5 hours for patients who received TMS-007 and 9.3 hours for those who received placebo. All patients who received TMS-007 were dosed beyond the time window of approved thrombolytic agents.
We are encouraged by these results and made the decision to acquire TMS-007 based on the totality of the safety, imaging and clinical outcome data from the Phase 2a study, said Alfred Sandrock, Jr., M.D., Ph.D., head of research and development at Biogen. It has been almost 25 years since the last thrombolytic agent was approved for acute ischemic stroke and we believe this novel investigational drug may expand the number of eligible patients who could potentially receive thrombolytic therapy and thus have a higher chance of functional independence after stroke.
Approved thrombolytic agents are limited in their use due to their benefit-risk profile in later time windows. According to the American Heart Association1, sICH is the most feared complication of the current thrombolytic therapy, tissue Plasminogen Activator (tPA), which works by dissolving blood clots that block blood flow to the brain. In time windows up to 9 hours after stroke onset, sICH has occurred in patients receiving tPA at rates as high as six percent in controlled studies.
The randomized, placebo-controlled, ascending dose Phase 2a study included 90 participants in Japan (n=52 TMS-007, n=38 placebo). The primary endpoint of the study evaluated safety as assessed by the incidence of sICH with worsening of National Institute of Health Stroke Scale of four points or more. There were no events reported in the patients who received TMS-007 compared to an incidence of three percent in the patients who received placebo.
In addition, TMS-007 demonstrated a significant improvement on the secondary endpoint of functional independence at 90 days, with 40 percent of patients who received TMS-007 achieving scores of 0 or 1 on the modified Rankin Scale, a measure of independence in daily living, indicating either no residual symptoms or no significant disability, compared to 18 percent of patients who received placebo (P=< 0.05). This was supported by objective angiographic evidence of recanalization in the subset of patients with a visible occlusion receiving TMS-007. The recanalization rate, as measured by magnetic resonance angiography, was 58.3 percent (14 out of 24) for patients who received TMS-007 compared to 26.7 percent (4 out of 15) for patients who received placebo (odds-ratio 4.23; 95 percent confidence interval (0.99, 18.07)).
Biogen will make a one-time $18 million payment as part of the acquisition of TMS-007. TMS is eligible to receive up to an additional $335 million in potential post-acquisition development and commercial payments should TMS-007 achieve certain developmental milestones and sales thresholds. TMS is also eligible to receive tiered royalties in the high single digits to sub-teen percentages on annual worldwide net sales. Biogen will be solely responsible for the costs and expenses related to the development, manufacturing and commercialization of TMS-007 following the acquisition.
Biogen is currently evaluating the next steps for the clinical development of TMS-007, including plans for global studies. Final data results from the Phase 2a study are expected to be communicated at a future scientific forum.
About Acute Ischemic StrokeStroke is a potentially debilitating or even deadly cerebrovascular event. It is the second leading cause of death worldwide, with about 13 million cases and 5.5 million deaths each year, and with lasting functional deficits in stroke survivors caused by irreversible damage to the brain. Caused by blockages of blood supply to the brain, acute ischemic stroke accounts for about 85 percent of all strokes, with no approved medical therapies for treatment beyond the 3 to 4.5-hour time window. There is a substantial unmet medical need for new therapies that can both improve clinical outcomes with improved efficacy and safety as well as extend the time after stroke onset that a patient can receive a thrombolytic treatment.
About TMS-007TMS-007 is a small molecule plasminogen activator with a proposed novel mechanism of action associated with breaking down blood clots and potentially inhibiting local inflammation at the site of thrombosis. This unique combination could position TMS-007 as a potential next generation thrombolytic for individuals with acute ischemic stroke with the aim to provide an extended treatment window as compared to currently approved thrombolytic agents.
About the Phase 2a StudyTMS-007 was evaluated in a multi-center, single-administration, double-blinded, randomized, placebo-controlled, ascending dose trial with three TMS-007 groups (1, 3 and 6 mg/kg) and a placebo group (52 patients who received TMS-007 and 38 patients who received placebo). The study run by TMS Co, Ltd., which took place in Japan, included patients with acute ischemic stroke within 12 hours after onset and ineligible for tissue Plasminogen Activator (tPA) or thrombectomy. The primary endpoint was evaluation of safety with secondary endpoints evaluating vessel recanalization as well as clinical outcomes at 90 days after stroke onset.
About BiogenAt Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the worlds first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimers disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors on our website atwww.biogen.com. To learn more, please visitwww.biogen.comand follow us on social media Twitter, LinkedIn, Facebook, YouTube.
About TMS Co., Ltd.TMSCo., Ltd. is aprivatelyheld, clinical stage biotechnology company based in Fuchu-shi, Tokyo. The company was founded in 2005 to develop therapeutics based on novel discoveries to modulate the fibrinolytic system, identified by a team of scientists at TokyoUniversityof Agriculture and Technology (TUAT), led by Dr.KeijiHasumi, Professor of theUniversityand Chief Scientist of TMS.
Biogen Safe Harbor StatementThis news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements about results from the Phase 2a study of TMS-007; the potential clinical effects of TMS-007; the potential benefits, safety and efficacy of TMS-007; clinical development programs, clinical trials, data readouts and presentations related to TMS-007; the potential of Biogens commercial business and pipeline programs, including TMS-007; Biogens strategy and plans; the identification and treatment of acute ischemic stroke; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as aim, anticipate, believe, could, estimate, expect, forecast, intend, may, plan, potential, possible, will, would and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, uncertainty of success in the development and potential commercialization of TMS-007; unexpected concerns may arise from additional data, analysis or results obtained during clinical studies; actual timing and enrollment of future studies of TMS-007; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogens drug candidates, including TMS-007; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce Biogens data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogens business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogens expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogens most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogens current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Reference:
Read more:
- Despite currently being unprofitable, EDAP TMS (NASDAQ:EDAP) has delivered a 52% return to shareholders over 5 years - Simply Wall St - April 18th, 2024 [April 18th, 2024]
- BrainsWay Expands Deep TMS Access in Israel Following Significant Increase in Reimbursement Rates - GlobeNewswire - April 18th, 2024 [April 18th, 2024]
- Mastery Logistics Systems partners with Transflo to integrate Workflow AI with MasterMind TMS to deliver a ... - Business Wire - April 18th, 2024 [April 18th, 2024]
- New form of magnetic brain stimulation spells hope for patients with treatment-resistant depression - The Straits Times - April 18th, 2024 [April 18th, 2024]
- Port of Oakland's new TMS provides real-time insights for truckers - CCJ - February 5th, 2024 [February 5th, 2024]
- TMS Taps Michelson To Oversee Global Talent Development 01/02/2024 - MediaPost Communications - February 5th, 2024 [February 5th, 2024]
- 11.24% CAGR Growth in Transportation Management Systems (TMS) Market by Solution (on-premise and cloud-based ... - PR Newswire - February 5th, 2024 [February 5th, 2024]
- MileMaker announces partnership with Turvo to bring advanced TMS - TheTrucker.com - The Trucker - February 5th, 2024 [February 5th, 2024]
- Transportation Management Software & Solutions - Who are the Major Players in the Indian Market? - India Shipping News - February 5th, 2024 [February 5th, 2024]
- Neural effects of TMS trains on the human prefrontal cortex | Scientific Reports - Nature.com - December 25th, 2023 [December 25th, 2023]
- What to know about TMS and how it can treat mental health issues - News3LV - December 25th, 2023 [December 25th, 2023]
- Neuronetics lands FDA clearance for TMS therapy accessory - Medical Device Network - December 25th, 2023 [December 25th, 2023]
- Neurobiological mechanisms of ECT and TMS treatment in ... - BMC Psychiatry - October 31st, 2023 [October 31st, 2023]
- Mishimoto Partners with Redwood Logistics for Seamless TMS ... - Supply Chain Dive - October 31st, 2023 [October 31st, 2023]
- 3 benefits of integrating WMS and TMS software - TechTarget - October 31st, 2023 [October 31st, 2023]
- Trinium and BlueCargo join forces to increase resiliency and agility ... - American Journal of Transportation - October 31st, 2023 [October 31st, 2023]
- Psychiatrist Convicted of Billing Medicare and Private Insurance ... - Department of Justice - October 31st, 2023 [October 31st, 2023]
- FreightPOP TMS Application Earns Acumatica Certification - PR Web - October 31st, 2023 [October 31st, 2023]
- AML RightSource Offers Support for Transaction Monitoring System Selection and Integration - Global Banking And Finance Review - October 31st, 2023 [October 31st, 2023]
- TMS therapy: The cloud hanging over me was gone - WellSpan Health - May 18th, 2023 [May 18th, 2023]
- Depression Relief: Brain Signal Reversal by Magnetic Pulses - Neuroscience News - May 18th, 2023 [May 18th, 2023]
- HWS CENTER LAUNCHES TMS THERAPY, BRINGING CUTTING-EDGE MENTAL HEALTH TREATMENT TO NEW JERSEY - EIN News - May 18th, 2023 [May 18th, 2023]
- Incoming TMS students take tours of site - Yahoo News - May 18th, 2023 [May 18th, 2023]
- Passion Drives TMS Titanium's Todd Harrison - Drag Illustrated - May 18th, 2023 [May 18th, 2023]
- EDAP TMS S A : Positive results from two studies reconfirm safety ... - Marketscreener.com - May 18th, 2023 [May 18th, 2023]
- Shiba Inu (SHIB) Whale Purchasing Into The TMS Network (TMSN ... - Analytics Insight - May 18th, 2023 [May 18th, 2023]
- TMS Coils Market 2023 Business Growth and Opportunities with Top ... - Cottonwood Holladay Journal - May 18th, 2023 [May 18th, 2023]
- The Top Cryptos To Buy In 2023 - Arbitrum, Polygon and TMS Network - Analytics Insight - May 18th, 2023 [May 18th, 2023]
- Accelerated delivery of transcranial magnetic stimulation is safe and effective - Newswise - May 18th, 2023 [May 18th, 2023]
- Polygon (MATIC) and Solana (SOL) Drop by 10%, While TMS ... - Crypto Reporter - May 18th, 2023 [May 18th, 2023]
- VeChain (VET) & Curve DAO Token (CRV) Investors Diversify Their ... - Analytics Insight - May 18th, 2023 [May 18th, 2023]
- As Cardano (ADA) Stumbles And Dogecoin (DOGE) Falters, TMS ... - UseTheBitcoin - May 18th, 2023 [May 18th, 2023]
- Nexstim's Quality System and NBS 6 Receive MDR - GlobeNewswire - May 18th, 2023 [May 18th, 2023]
- Uniswap (UNI) and Shiba Inu (SHIB) Underwater as Crypto Looks ... - The Merkle Hash - May 18th, 2023 [May 18th, 2023]
- NeuroStim TMS Celebrates Landmark Achievement, Delivering Over 100,000 TMS Treatments Upon Reaching Five Year Anniversary - Yahoo Finance - May 6th, 2023 [May 6th, 2023]
- Modeling the antidepressant treatment response to transcranial ... - Nature.com - May 6th, 2023 [May 6th, 2023]
- USD Coin (USDC) & Optimism (OP)'s Investors Are Aping Into TMS ... - Analytics Insight - May 6th, 2023 [May 6th, 2023]
- TMS Network (TMSN) Presale Gains 2400%: Optimism (OP) and ... - Analytics Insight - May 6th, 2023 [May 6th, 2023]
- The Best Anime By TMS Entertainment - GameRant - May 6th, 2023 [May 6th, 2023]
- TMS Network (TMSN) Predicted To Pass Shiba Inu (SHIB) And Stacks (STX) In Popularity Within A Year | - Bitcoinist - May 6th, 2023 [May 6th, 2023]
- Towering Over Solana (SOL) and Dogecoin (DOGE), TMS Network (TMSN) Takes the Crown | Bitcoinist.com - Bitcoinist - May 6th, 2023 [May 6th, 2023]
- Market Corrections Push Cardano (ADA) and Polygon (MATIC ... - Analytics Insight - May 6th, 2023 [May 6th, 2023]
- Chainlink vs TMS Network vs TRON : One of them With Deliver ... - The Coin Republic - May 6th, 2023 [May 6th, 2023]
- PCS Software Named a Preferred Partner as Kuebix TMS Sunsets - Benzinga - May 6th, 2023 [May 6th, 2023]
- Could Musk Suit Have Negative Impact on Dogecoin (DOGE) and ... - Crypto Reporter - May 6th, 2023 [May 6th, 2023]
- The Future of Logistics: How Technology is Revolutionizing the ... - Robotics and Automation News - May 6th, 2023 [May 6th, 2023]
- Baru Gold Designated "National Vital Object" and Updates ... - Junior Mining Network - May 6th, 2023 [May 6th, 2023]
- Early Bird offer for TMS Awards - The Maritime Standard - May 6th, 2023 [May 6th, 2023]
- St Helen's Hospital patient says many are 'devastated' by its imminent closure - ABC News - May 6th, 2023 [May 6th, 2023]
- Transcranial Magnetic Stimulation (TMS) | Sibley Memorial Hospital in ... - March 31st, 2023 [March 31st, 2023]
- Psychiatry | Sibley Memorial Hospital in Washington, D.C. - March 31st, 2023 [March 31st, 2023]
- Want To Win Big? Experts Suggest To Choose TMS Network (TMSN) Over Arbitrum (ARB) And Polygon (MATIC) | - Bitcoinist - March 31st, 2023 [March 31st, 2023]
- TMS Network (TMSN) AI Infrastructure Will Give You 100x Returns, Way Better Than SingularityNET (AGIX) And - Bitcoinist - March 31st, 2023 [March 31st, 2023]
- TMS: What It Felt Like for Me I Psych Central - February 20th, 2023 [February 20th, 2023]
- Are we in a recession? Crypto giant Bitcoin and Ethereum stall out while TMS Network makes its mark - FXStreet - February 20th, 2023 [February 20th, 2023]
- Are GameFi coins like SHIB and Decentraland (MANA) as good of a long term investment as TMS Network? - FXStreet - February 20th, 2023 [February 20th, 2023]
- Launch of New Tron (TRX)-powered AI on the Way, Doritos Launches Project on Polygon (MATIC) While TMS Network (TMSN) Brings New Hopes for Brighter... - February 20th, 2023 [February 20th, 2023]
- What is a Transportation Management System? | Oracle - January 31st, 2023 [January 31st, 2023]
- TMS (Transcranial Magnetic Stimulation): What It Is - January 19th, 2023 [January 19th, 2023]
- HC Wainwright Adjusts Price Target on EDAP TMS S.A to $12 From $11, Maintains Buy Rating - Marketscreener.com - November 21st, 2022 [November 21st, 2022]
- Breakthrough in brain stimulation offers cautious hope for depression - Harvard Health - October 21st, 2022 [October 21st, 2022]
- Life-changing treatment program in Ohio expanding for veterans and first responders - WTRF - October 19th, 2022 [October 19th, 2022]
- Over 60% Of Pokemon Fans Are Most Excited For This Feature In Scarlet & Violet - SVG - October 19th, 2022 [October 19th, 2022]
- Radaro and NorthStar Digital Solutions partner to solve industry-wide process gaps in LTL & TL transportation - PR Newswire - October 19th, 2022 [October 19th, 2022]
- Avalanche Technology and TMS-Elektronik Announce Representation Agreement for the Republic of Turkey - PR Web - October 17th, 2022 [October 17th, 2022]
- Global Talent Management Software (TMS) Market Report 2022: A $25+ Billion Market by 2027 - Industry Trends, Share, Size, Growth, Opportunities and... - October 17th, 2022 [October 17th, 2022]
- A Foreword to Adam Smith's The Theory of Moral Sentiments - Independent Institute - October 17th, 2022 [October 17th, 2022]
- Deutsche Telekom to buy 100% electric company cars from 2023 - www.electrive.com - October 17th, 2022 [October 17th, 2022]
- What Happens in the Brain During Transcranial Magnetic Stimulation? - Technology Networks - October 13th, 2022 [October 13th, 2022]
- TMS and SIS to vie for soccer championship - Saipan Tribune - October 13th, 2022 [October 13th, 2022]
- Soterix Medical Announces award of Fast Track NIH grant to develop a Parcel-Guided software to improve efficacy of rTMS treatment for Depression - PR... - October 13th, 2022 [October 13th, 2022]
- Interview: Kindra Neely Talks Healing Through Art and Personal Hope in 'Numb to This' - The Mary Sue - October 13th, 2022 [October 13th, 2022]
- Local veteran finds success with TMS therapy | Local News | thenewsenterprise.com - Elizabethtown News Enterprise - September 29th, 2022 [September 29th, 2022]
- Racin' Today Everything's Big In Texas Including Criticism Of TMS - RacinToday.com - September 29th, 2022 [September 29th, 2022]
- Start over from scratch: Race weekend at TMS stirs up track reconfiguration rumors - The Dallas Morning News - September 29th, 2022 [September 29th, 2022]
- $28 Billion Transportation Management System Markets - Global Forecast to 2027: Increasing Demand for TMS to Tackle High Demand from e-Commerce -... - September 29th, 2022 [September 29th, 2022]
- EDAP TMS Hosting Urology Expert Panel and Live Focal One Technology Demonstration - GlobeNewswire - September 29th, 2022 [September 29th, 2022]
- Reddick prevails in wild race that sees record number of yellow flags at TMS - Denton Record Chronicle - September 29th, 2022 [September 29th, 2022]
- e2log and Wipro Discuss How Technology Accelerates Logistics Engines That Drive Global Supply Chains at Gartner Supply Chain Symposium/Xpo 2022 EMEA -... - September 29th, 2022 [September 29th, 2022]
- Transcranial Magnetic Stimulators Market Size And Forecast To 2022 |eNeura BrainsWay Ltd., MagVenture, Nexstim Plc, TMS Neuro Solutions, Magstim The... - September 29th, 2022 [September 29th, 2022]