Nasdaq GlobeNewswire

Biogen Enters Exclusive Option Agreement to Acquire TMS' Phase 2 Asset for Acute Stroke

Del
  • 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.

About Biogen 
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 - TwitterLinkedInFacebookYouTube.

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.

MEDIA CONTACT:

Biogen 
David Caouette
Ph: +1 617-679-4945
public.affairs@biogen.com
INVESTOR CONTACT:

Biogen
Matt Calistri
Ph: +1 781-464-2442
IR@biogen.com 



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Vicor Introduces 10kW Power Tablet™ AC-DC Converter16.10.2018 03:00Pressemelding

Power Tablet RFM Enables High-Density Server Racks BEIJING, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Vicor Corporation (NASDAQ: VICR) has announced a 3-phase, AC-DC converter module (“RFM”), capable of delivering 10kW of regulated 48VDC in a power tablet configuration measuring 9.4 x 5.9 x 0.6in (24 x 15 x 1.5cm). The RFM™ provides a power-factor-corrected, regulated, and isolated DC output with integrated filtering and built-in fault protection for redundant operation. The RFM can be configured to accept worldwide 3-phase AC mains from 200 to 480VAC. The low-profile power tablet design of the RFM enables unprecedented power density and thermal management flexibility. For example, four RFMs in parallel, including input-disconnect circuitry, rectification and hold-up energy storage at 48V, can supply 40kW of power within 1U of rack space. The RFM power tablet package provides adept thermal management for advanced cooling, including liquid cooling, of high-power server racks for demanding HPC a

Elite Petro & Gas, a new brand by Elite Capital & Co. Limited15.10.2018 16:15Pressemelding

LONDON, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Today at Elite Petro & Gas headquarters in the City of London, Dr. Faisal Khazaal (Chairman) and Mr. George Matharu (President) announced the official launch of this new Division within Elite Capital & Co. Limited, which was setup to provide Finance, Trading and Advisory services in the global Oil and Gas markets. “Elite Petro & Gas is a Finance, Trading and Advisory firm with a focus on downstream activities in the global Oil and Gas markets. We are a results-driven business, working closely with our clients to deliver tangible solutions and outcomes.” Mr. George Matharu, President of Elite Petro & Gas, said. The oil and gas industry is facing challenging times, particularly from changes in the political landscape and increased price volatility. Understanding the nuances of working internationally, often in emerging economies and less stable regimes, is key to ensuring that business risks are appropriately managed. The Elite Petro & Gas (“EPG”

Prof. Dr. C. Oliver Kappe is awarded the 2018 IUPAC-ThalesNano Prize for Flow Chemistry15.10.2018 16:08Pressemelding

KARLSRUHE, Germany and BUDAPEST, Hungary and GRAZ, Austria, Oct. 15, 2018 (GLOBE NEWSWIRE) -- The 2018 IUPAC-ThalesNano prize has been awarded to Professor C. Oliver Kappe. The prize will be presented at the 15th International Conference on Microreaction Technology (IMRET15) in Karlsruhe on October 21, 2018. The award address will be delivered at the Flow Chemistry Europe Conference in Cambridge, UK on February 26th, 2019. The prize consists of an award of $10,000 US Dollars. Professor Kappe is Professor of Chemistry at the University of Graz (Austria) and Scientific Director for Continuous Flow Synthesis and Processing (CC Flow) at the Research Center Pharmaceutical Engineering GmbH (RCPE). Professor Kappe has over 400 publications in the areas of continuous flow chemistry, application of microreactors, process intensification, and microwave-assisted reactions. He and his team have published syntheses with challenging systems and chemistry. He has served as an Ambassador for Flow Chem

Gunvor Closes Innovative US $745 Million Facility Linked to Sustainability Targets15.10.2018 12:00Pressemelding

Related savings will go to support new Gunvor Foundation GENEVA, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Gunvor Group (“Gunvor”) has closed an innovative US $745 million secured borrowing base facility (“Facility”) that includes performance commitments related to Gunvor’s sustainability targets. Gunvor is the first energy commodities trading company to close a financing in which the interest rate will be dependent on the company’s year-on-year improvements in areas such as transparency, governance and the environment. The Facility, originally launched at US $625 million in 2012, was a renewal to provide for the working capital requirements of the company’s Antwerp and Rotterdam refineries. It was significantly oversubscribed to US $745 million through the addition of new lenders. The Facility was arranged by ING Bank, who acted as sole Coordinator and Active Bookrunner while maintaining its roles as Security Agent, Facility Agent and Fronting Bank. The structure for the sustainability target

Nasdaq Launches ESG futures in the Nordics15.10.2018 10:00Pressemelding

STOCKHOLM, Sweden, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq: NDAQ) today announced the launch of futures based on the recently launched OMXS30 ESG Responsible index (OMXS30ESG). The product is the first exchange listed and ESG compliant index future in the world. “In recent years we have seen institutions increase efforts to integrate sustainability into their investment strategies, with the Nordic region being in the forefront of this trend,” says Alessandro Romani, Head of European Equity Derivatives at Nasdaq. “Those looking to invest in a more sustainable way need more investment products based on established and liquid indexes. Our existing OMXS30 index future contract is among the most traded in Europe and we expect to see the same interest for the ESG version.” The OMXS30ESG Index was developed in cooperation with a number of leading Nordic asset managers, including Swedbank Robur. “At Swedbank, innovation and constant development are an important part of the business, a

Telix and ANMI Expand PSMA Imaging Partnership15.10.2018 00:00Pressemelding

MELBOURNE, Australia and LIÈGE, Belgium, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) (“Telix”, the “Company”), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR), today announced that it has expanded its partnership with Advanced Nuclear Medicine Ingredients SA (“ANMI”) for the 68Ga-HBED-CC-PSMA-11 (68Ga-PSMA) cold kit. The 68Ga-PSMA kit is developed by ANMI and commercialized by Telix for the US market where it is marketed as illumetTM . In response to considerable clinical interest in the illumetTM product, Telix has commenced scale-up manufacturing in the United States, following the recent filing of a drug master file (DMF) and the launch of several major clinical trials using the product, including the 750 patient VISION phase III trial (Endocyte, Inc.) and a 500-patient phase II study at Memorial Sloan Kettering C

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom