Minerva Announces Amended Agreement for MIN-202 in Insomnia
Minerva to gain global strategic control over development of MIN-202 for insomnia
Janssen cash payments to Minerva of up to $70 million, including $30 million upfront
All shares in Minerva held by an affiliate of Janssen (approximately 3.9 million shares representing approximately 10% of outstanding shares) to be repurchased at par value
Minerva Phase 2 development payments totaling $13 million to be waived
WALTHAM, Mass., May 31, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it has entered into a binding term sheet to amend its co-development and license agreement with Janssen Pharmaceutica NV (Janssen) related to MIN-202 (JNJ 42827922), a selective orexin-2 receptor antagonist, and to repurchase all Minerva shares owned by Johnson & Johnson Innovation - JJDC, Inc. (an affiliate of Janssen). This amendment and the stock repurchase are conditional upon the closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen and approval by the European Commission.
Under the amended agreement, Minerva will gain global strategic control of the development of MIN-202 to treat insomnia, and Janssen will forego its right to royalties on MIN-202 insomnia sales in Minerva territories. Minerva will retain its current rights to MIN-202 as adjunctive therapy for major depressive disorder (MDD), which include an exclusive license in the European Union, Switzerland, Liechtenstein, Iceland and Norway, with royalties payable by Minerva to Janssen, and royalties on sales payable by Janssen to Minerva elsewhere worldwide.
Payments to Minerva by Janssen under this new agreement include an upfront payment of $30 million, $20 million at the start of a Phase 3 insomnia trial for MIN-202 and $20 million when 50% of the patients are enrolled in this trial. Janssen will waive the remaining payments due from Minerva for Phase 2 development of MIN-202, which total approximately $13 million. Minerva will assume all financial responsibility for Phase 3 development costs for MIN-202 in insomnia. All Minerva stock currently owned by Johnson & Johnson Innovation - JJDC, Inc. totaling approximately 3.9 million shares and representing approximately 10% of total Minerva shares outstanding will be repurchased by Minerva at par value of $.0001 per share or approximately $389 in total.
"We view the new agreement with Janssen as a structure that will ensure a more focused and efficient clinical development of MIN-202 in insomnia by Minerva," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "We look forward to continuing our collaboration with Janssen while accelerating the clinical advancement of our portfolio. In addition, the infusion of financial resources under this agreement significantly extends Minerva's financial runway."
Minerva expects that these combined financial resources will support the development of MIN-101, its lead product candidate to treat negative symptoms in schizophrenia, and the development of MIN-202 in insomnia and MDD to the end of 2019. Within that time frame, Minerva expects to generate data readouts from its planned Phase 3 trial with MIN-101 and three Phase 2b trials with MIN-202 in both indications. Additional clinical activities planned during that period include a Phase 2 trial with MIN-117 and a Phase 1 trial with MIN-301.
About MIN-202 (JNJ 42827922)
MIN-202 is a selective orexin 2 receptor antagonist under development for the treatment of insomnia and as adjunctive therapy for MDD. In the brain, the orexin system is involved in the control of several key functions, including metabolism and wakefulness. MIN-202 seeks to inhibit the activity of the neurons that promote wakefulness by selectively blocking the orexin 2 receptor. Rather than making an individual sleepier, blocking the orexin 2 receptor reduces the level of the neurotransmitters that signal the brain to maintain vigilance and wakefulness.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases. Minerva's proprietary compounds include: MIN-101, in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); MIN-202 (JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson's disease. Minerva's common stock is listed on the NASDAQ Global Market under the symbol "NERV." For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the approval by the European Commission and subsequent closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen; our ability to negotiate and execute the definitive agreements described above; the timing and results of future clinical milestones with MIN-202 in insomnia and major depressive disorder, including the timing and scope of future clinical trials and results of clinical trials with this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our agreements with Janssen related to MIN-202; our ability to successfully develop and commercialize MIN-101, MIN-202, MIN-117 and MIN-301; the sufficiency of our current cash position to fund our operations; and management's ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, the inherent uncertainty in approval by the European Commission and subsequent closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen; whether MIN-101, MIN-202, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-101, MIN-202, MIN-117 and MIN-301, if any, will be consistent with the results of past clinical trials; whether MIN-101, MIN-202, MIN-117 and MIN-301 will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management's ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption "Risk Factors" in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 4, 2017. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
Concurrent Achieves Sales Milestone for Zephyr Transcode19.10.2017 15:35 | Pressemelding
Concurrent Customers Now Transcoding on Three Continents ATLANTA, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Concurrent (NASDAQ:CCUR), a global leader in storage, protection, transformation, and delivery of visual media assets, announced today that Zephyr Transcode, which Concurrent launched last year as an integral part of its content delivery network (CDN) solutions, is now deployed with customers in Asia, Europe and North America. The deployments already support thousands of on-demand assets being transcoded to multiple formats and bit-rates to support any place, any device content availability. Zephyr Transcode supports multiple formats and quality levels including H.264 (MPEG-4) and H.265 (HEVC), strengthening Concurrent customers' capability to provide high-quality standards-based streams to any device their end-users desire. Zephyr Transcode is software-based and capable of running in traditional Central Processing Units (CPU) as well as Gra
German Armed Forces Renews Contract for Hexagon Geospatial Products19.10.2017 15:11 | Pressemelding
Defense agency will work closely with Hexagon Geospatial Premium Partner for next two years NORCROSS, Ga., Oct. 19, 2017 (GLOBE NEWSWIRE) -- At the HxGN LOCAL Defense Summit, a conference dedicated to defense and security in Western Europe, Hexagon Geospatial announced that the Bundeswehr Geoinformation Centre (BGIC) recently renewed a large software maintenance contract for Hexagon Geospatial products. The two-year renewal is for more than 100 licenses, mainly within the GeoMedia and ImageStation product families. The contract also includes consulting for workflow optimization. The contract was issued to Geosystems, a Hexagon Geospatial Premium Partner, which will work closely with the local subsidiary of Hexagon Safety & Infrastructure in Bonn and Munich to support BGIC. "The strong Hexagon Geospatial partner network allows our defense customers to benefit from a unique pool of expertise and tradecraft in the areas of remote sensing, GIS, and photog
Novel Preclinical Research Tools Provide Humanized Immune Response to Advance Immunotherapeutic Development, Live Webinar Hosted by Crown Bioscience19.10.2017 14:00 | Pressemelding
SANTA CLARA, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces a live webinar to be presented by Dr. Michelle Mack, Director of Global Scientific Engagement, entitled "Beyond Syngeneics - Novel Tools for Addressing Human Specificity in Immuno-Oncology." Checkpoint inhibitors like anti-PD-1, anti-PD-L1, and anti-CTLA-4 have revolutionized cancer treatment and have recently gained approval in several cancer types. Despite their potential, immunotherapies face significant development challenges due to the specificity and complexity of the human immune system upon which they act. Crown Bioscience has generated innovative research models to address these obstacles early during preclinical drug development.
Perfectus Aluminum Inc. Responds to Trade Group19.10.2017 13:00 | Pressemelding
ONTARIO, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Perfectus Aluminum Inc. has issued the following: On October 12, 2017 the Aluminum Extruders Council (AEC), an industry group representing largely American aluminum extruders, posted to its blog a false narrative regarding a suit to which Perfectus Aluminum Inc. is a related party. The government is not "seeking unpaid duties from Perfectus for goods brought into the country." Rather, the government is attempting to use a 2017 Department of Commerce determination to assess retroactive antidumping duties on goods imported as early as 2011. It is discouraging that AEC would tout such an obviously egregious government overstep as a "victory" to their members and the industry: were it one of AEC's own members facing such an obvious violation of fair play and due process, it would rightfully argue that government overreach is a threat to manufacturers everywhere. In addition to the hypocrisy of the AEC's promotion of this case, its s
Payvision's annual report reveals cross-border ecommerce trends in 201719.10.2017 09:00 | Pressemelding
With online marketplaces and consumer technology leading the way for growth AMSTERDAM, The Netherlands, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Payvision, global acquirer and data-driven omnichannel solutions provider, has published the findings of its fifth annual cross-border ecommerce research report, in collaboration with Juniper Research. The paper includes the results of a global survey of various industry players regarding the game-changers, the biggest challenges, the best practices for going cross-border, and much more. When compared to last year's findings, the report reveals a new and exciting context for global cross-border trade. The compound annual growth rate predicted for the next three years for cross-border ecommerce is now 17%, whereas it stands at just 12% for ecommerce overall. Also, over the past 12 months, merchants' attitudes towards cross-border ecommerce have become more positive, with 50% of respondents agreeing and 31% strongly
High Seizure Frequency in Children with Dravet Syndrome Negatively Impacts Quality of Life, New International Caregiver Survey Finds19.10.2017 08:00 | Pressemelding
Global survey of 584 caregivers of children, young adults and adults with Dravet illustrates the detrimental effect of debilitating, frequent seizures on quality of life and co-morbidities Results suggest a need for more effective antiepileptic treatments EMERYVILLE, Calif. and BREST, France, Oct. 19, 2017 (GLOBE NEWSWIRE) -- The Dravet Syndrome European Federation and Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, announced today the publication of the initial results from a landmark survey into the clinical, social and economic consequences of Dravet syndrome on children, young adults and their families in Developmental Medicine & Child Neurology [doi:10.1111/dmcn.13591]. This study was led by Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium, Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom