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 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
Airtel and Cisco Team to Improve Mobile User Experience25.2.2018 12:00 | Pressemelding
Utilizing Cisco's Self-Optimizing Network solutions to manage and support the massive growth in data and voice traffic BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - With mobile data consumption surpassing usage of the U.S. and China in 20171, mobile service providers in India are working to enhance their network infrastructure to manage and support the growth surge and ensure quality of customer experience. Bharti Airtel (Airtel), India's largest telecommunications services provider, and Cisco have joined forces to improve customer experience by taking their SON collaboration to next level. SON is now carrying out optimization based on customer experience and predictive analytics apart from the traditional approach of responding to network degradations. SON self-healing applications have been enriched for taking proactive actions in near real time, using predictive machine learning and interworking of SON with NOC tools, PM analytics & customer experience
Cisco Spearheads Multi-Vendor Open vRAN Ecosystem Initiative For Mobile Networks25.2.2018 12:00 | Pressemelding
First ecosystem of its kind brings together innovators including Reliance Jio, Altiostar, Aricent, Intel, Mavenir, Phazr, Red Hat, and Tech Mahindra BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Mobile network operators are facing strong pressures to evolve their businesses and operations for profitable growth and differentiation. Explosive demand for bandwidth persists, while ARPU pressures mount due to competition and limited service innovation. Addressing these challenges requires industry innovation focused on delivering new revenue-generating services based on a more flexible and agile service delivery environment, while reducing Capex and Opex. Innovations such as network function virtualization have laid the groundwork for a new fundamental architecture to emerge. While many functions of a mobile network are being virtualized, including the Evolved Packet Core (EPC), IP Multimedia Subsystems (IMS), the Gateway Internet LAN (Gi-LAN) and data transpor
TIM and Cisco Join Forces To Increase The IT Security Of Italian Companies25.2.2018 12:00 | Pressemelding
TIM Safe Web, the new security service developed in collaboration with Cisco and integrated into the TIM network, going live in March BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Starting from March, TIM, the leading provider of mobile and fixed telecommunication services in Italy, in partnership with Cisco will offer "TIM Safe WEB", a highly secure platform service, integrated in the TIM network, able to safeguard small business users from malware, such as ramsomware, phishing, and other malicious cybersecurity activities. TIM Safe Web combines TIM's unique technologies and information with the capabilities of the Cisco Umbrella cloud-based security platform, which leverages a constantly updated global database of threat intelligence. This "over-the-network" service enhancement will be provided to about 600.000 TIM Business customers in order to improve both security and quality of service starting from small business market that is very exposed to cyber
Cisco Launches New '5G Now' Portfolio for Service Providers Taking Action Today25.2.2018 12:00 | Pressemelding
More than 20 global service provider and mobile operator customers worldwide are advancing their 5G action plans with Cisco BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Continuing on its path to disrupt the industry by redefining the network, Cisco announced today its '5G Now' portfolio for service providers ready to go full throttle on their 5G roadmap. 5G services promise to offer emerging new services at significantly faster speeds, expanded capacity and stronger coverage to accommodate the more than 27 billion connected devices1 expected on service provider networks by 2021. Beginning 2020, 5G connections will grow more than a thousand percent from 2.3 million in 2020 to over 25 million in 20212. At Mobile World Congress this week, many technology vendors are focused on the spectrum advantages, radio equipment and architecture to support 5G services. Cisco is committed to showing service providers and mobile operators why 5G is important to plan for,
Cisco and TIM: Together to Accelerate Italy's Digitization25.2.2018 12:00 | Pressemelding
BARCELONA, Spain, Feb. 25, 2018 (GLOBE NEWSWIRE) -- Mobile World Congress - Cisco and TIM, the leading service provider in Italy, announced a major agreement aimed at accelerating Italy's digitization today at Mobile World Congress. The two companies are engaged in developing a joint business and innovation program. They will leverage their unique competences and technologies, to create next generation solutions and services focused in particular on Cybersecurity, Internet of Things, Industry 4.0, Smart Cities and 5G. This Memorandum of Understanding (MOU) has been signed in the framework of Digitaliani, the three-year investment plan launched by Cisco in January 2016, whose objectives are well aligned with TIM own digitization program. The partnership is based on three pillars. Sharing competences and solutions for the digital transformation of companies, public sector and services targeted to citizens A common effort to develop a partner ecosystem able to leverage the new opportuniti
Valero to Purchase SemLogistics Milford Haven Fuel Storage Facility23.2.2018 22:15 | Pressemelding
LONDON, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Valero Logistics UK Ltd, a subsidiary of Valero Energy Corporation (NYSE:VLO), and SemGroup Europe Holding L.L.C., a SemGroup Corporation company, have today signed an agreement for the purchase of SemLogistics Milford Haven fuel storage facility on the west coast of Wales. Situated across the Haven from Valero's refinery at Pembroke, the facility is one of the largest petroleum products storage facility in the United Kingdom (UK) with 8.5 million barrels of capacity for storing gasoline, gasoline blendstocks, naphtha, jet fuel, gas oil, diesel, and crude oil. Over 67 percent of the storage capacity is multiproduct or dual purpose, giving Valero the flexibility to meet customers' demands in the UK and throughout Northwest Europe. Additionally, Milford Haven will continue to operate as a third-party storage facility, offering storage options for third party customers across the European petroleum markets. "This facility complements our Pembroke
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom