Biogen Enters Exclusive Option Agreement to Acquire TMS' Phase 2 Asset for Acute Stroke
- TMS-007 is designed to restore blood flow following acute stroke, with an extended treatment window versus current standard of care
- Biogen to pay $4 million upfront and $18 million upon exercise of the option, plus potential milestones of up to $335 million and royalties
- Agreement reinforces Biogen's commitment to stroke within its acute neurology portfolio, a strategic emerging growth area
CAMBRIDGE, Mass., June 07, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq:BIIB) announced today it has entered into an exclusive option agreement with TMS Co., Ltd. to acquire TMS-007 and backup compounds. The agreement includes an upfront payment of $4 million and an additional $18 million payment if Biogen exercises its option, with up to $335 million in potential development and commercialization milestones as well as tiered royalties.
TMS-007 is a plasminogen activator with a novel mechanism of action associated with breaking down blood clots, and is believed to inhibit local inflammation at the site of thrombosis. This unique combination could position TMS-007 as a best in class thrombolytic for individuals with acute ischemic stroke (AIS) with potential for an extended treatment window as compared to current thrombolytic agents.
"Stroke represents a compelling opportunity that takes advantage of our deep expertise and capabilities in neuroscience as we seek to make a meaningful difference in patients' lives. Stroke impacts millions of people every year, and is a leading cause of death and long-term disability worldwide," said Michael Ehlers, M.D., Ph.D., executive vice president, Research and Development at Biogen. "TMS-007 complements our broader efforts in stroke, including our Phase 3 ready asset BIIB093 (intravenous glibenclamide), which targets prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke. By growing our acute neurology portfolio, we aim to make new advances in a disease that in the past decades has seen limited therapeutic innovation."
Stroke is the fifth leading cause of death in the U.S. with AIS accounting for approximately 85% of cases and large hemispheric infarction accounting for approximately 15% of AIS cases.
TMS-007 is a small molecule which has previously demonstrated an acceptable safety profile in a Phase 1 study and has also reduced infarct volume (area of dead tissue resulting from failure of blood supply) in experimental rodent and primate embolic and thrombotic stroke models.
TMS-007 is currently being evaluated in a double-blind, placebo-controlled Phase 2 study in Japan, designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 60-90 patients with AIS up to 12 hours after stroke onset. The Phase 2 study initiated with the first patient dosed in February 2018.
At 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. One of the world's 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, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer's disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media - Twitter, LinkedIn, Facebook, YouTube.
About TMS Co., Ltd.
TMS Co.,Ltd. is a privately-held, 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 Tokyo Univesity of Agriculture and Technology (TUAT), led by Dr. Keiji Hasumi, Professor of the university and CEO of TMS.
Biogen Safe Harbor
This press release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits and results that may be achieved through the option agreement with TMS Co., Ltd., Biogen's objectives and intentions regarding the option agreement, when, and whether, Biogen expects to exercise its option on TMS-007 and backup compounds, risks and uncertainties associated with drug development and commercialization, the potential benefits, safety and efficacy of investigational drugs including TMS-007 and BIIB093, the timing and status of current and future regulatory filings, the anticipated completion and timing of the transaction, and the potential of Biogen's commercial business and pipeline programs, including BIIB093. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will," 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: risks that the transaction will be completed in a timely manner or at all; uncertainty as to whether the anticipated benefits of the transaction can be achieved; risks of unexpected costs or delays; uncertainty of success in the development and potential commercialization of TMS-007, the backup compounds and/or BIIB093, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen's 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 our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Ph: +1 617-679-4945
Ph: +1 781-464-2442
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biogen Inc. via Globenewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
INVNT No Longer Involved, As Bethel Woods Music and Culture Festival Changes Direction and Becomes Three Separate Events18.2.2019 23:37:00 | Pressemelding
NEW YORK, NY, Feb. 18, 2019 (GLOBE NEWSWIRE) -- INVNT, the global live brand storytelling agency™ today announces that it will not be producing Bethel Woods Music and Culture Festival: Celebrating the golden anniversary at the historic site of the 1969 Woodstock festival. The festival, which was planned for August 16-18, 2019 at Bethel Woods Center for the Arts, will now comprise three separate events over three days, and forms part of the venue’s Season of Song & Celebration commemorations, a year-long schedule of exhibits, programs and events. Scott Cullather, CEO, INVNT explained that the agency is proud of its support and contributions to the celebration plans and the global awareness that its efforts brought to Bethel Woods Center for the Arts, as a result. "INVNT will not be involved in the new format and we wish Bethel Woods and Live Nation, as well as the organizers of the other 50th anniversary celebrations taking place around the world, the very best," he said. "Bethel Woods
Align Technology Launches New iTero Element 5D Imaging System for Comprehensive Preventative and Restorative Oral Care at IDS18.2.2019 12:00:00 | Pressemelding
SAN JOSE, Calif., Feb. 18, 2019 (GLOBE NEWSWIRE) -- First intraoral scanner with near-infrared imaging (NIRI) technology that scans the internal structure of a tooth (enamel & dentin) in real time1. First integrated dental imaging system that simultaneously records 3D, intra-oral color and NIRI, and enables comparison over time using iTero® TimeLapse1. NIRI technology of the iTero Element® 5D system aids in detection and monitoring of interproximal caries lesions above the gingiva without using harmful radiation1. New web-based interface MyiTero.com complements visualization of the iTero Element 5D system. Limited-release direct doctor-lab workflow automatically sends scan to lab of choice. Align Technology, Inc. (NASDAQ: ALGN) today announced that it is launching the iTero Element 5D Imaging System, which provides a new comprehensive approach to clinical applications, workflows and user experience that expands the suite of existing high-precision, full-color imaging and fast scan time
General Electric Company: Dividend Declaration18.2.2019 08:00:00 | Pressemelding
FAIRFIELD, Conn., Feb. 18, 2019 (GLOBE NEWSWIRE) -- GE Board of Directors Authorizes Regular Quarterly Dividend The Board of Directors of GE (NYSE: GE) today declared a $0.01 per share dividend on the outstanding common stock of the Company. The dividend is payable April 25, 2019 to shareowners of record at the close of business on March 11, 2019. The ex-dividend date is March 8, 2019. About GE GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. For more than 125 years, GE has invented the future of industry, and today it leads new paradigms in additive manufacturing, materials science, and data analytics. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com GE's Investor Relations website at www.ge.com/investor and our corporate b
CTG Promotes Three Long-time Business Leaders in Europe15.2.2019 15:00:00 | Pressemelding
Bob Daelman, Guido Helsloot and Rénald Wauthier named Vice Presidents BUFFALO, N.Y., Feb. 15, 2019 (GLOBE NEWSWIRE) -- CTG (NASDAQ: CTG), a leading provider of information technology (IT) solutions and services in North America and Western Europe, announced today that three of the Company’s high-performing managers in its European business, Bob Daelman, Guido Helsloot and Rénald Wauthier, have each been named vice president. “Bob Daelman and Rénald Wauthier have proven track records of significantly expanding their respective businesses in Europe. Guido Helsloot has been key enabler in effecting two acquisitions in the past six years that expanded our operations and was again instrumental in driving our recent Tech-IT acquisition that will give CTG broader end-to-end capabilities to better-serve our clients. Together, this team has greatly contributed to our success in Europe, where CTG has recorded eight consecutive years of revenue growth,” commented Filip Gydé, current Executive Vic
Jazwares Announces Partnership with Kellytoy for Russ Berrie™ Worldwide15.2.2019 01:00:00 | Pressemelding
Sunrise, FL, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Jazwares LLC, a global leader in toys and licensing, announced today that its affiliate Zag Toys, LLC (“Zag Toys”) formed a strategic partnership for their wholly owned brand Russ Berrie™, with Kellytoy, an influential manufacturer and distributor of plush toys and pet products. This relationship will carry on the 50+ year legacy of the Russ Berrie™ brand, positioning it globally as the premier plush brand on retail shelves in Fall 2019. Kellytoy will market the Russ Berrie™ brand through its global distribution channels, which include almost every market segment. “Working together with Kellytoy will maximize the Russ Berrie™ legacy,” says Judd Zebersky, Jazwares CEO and President. “By leveraging Russ Berrie™ and its reputation for quality and commitment to “Make Someone Happy™” with Kellytoy’s global footprint we’ll secure placement in retailers all around the world, putting Russ Berrie™ at the forefront of today’s plush presence at retai
PROFEPA report confirms no contamination of soil from overflow of contingency pond at the San Jose Mine, Mexico in October 201814.2.2019 19:46:00 | Pressemelding
VANCOUVER, British Columbia, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to report that the Federal Attorney's Office for Environmental Protection (PROFEPA) has completed its investigation into the overflow of the contingency pond at the dry stack tailings facility at the San Jose Mine on October 8, 2018, which was caused by heavy seasonal rains (refer to Fortuna news release dated October 11, 2018). PROFEPA’s final report confirms that the overflow did not contaminate soil, and therefore no remediation is required. The Company awaits a final report from the Mexican National Water Commission (CONAGUA). The Company reiterates its commitment to safeguarding the wellbeing of the environment, local communities and our work force. About Fortuna Silver Mines Inc. Fortuna is a growth oriented, precious metals producer focused on mining opportunities in Latin America. Our primary assets are the Caylloma silver Mine in southern Peru, the San Jos