Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate
Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately 15 months after Takeda received a contract to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).1
The randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the investigational vaccine candidate in 240 male and female subjects between the ages of 18 and 49. The Phase 1 trial also will assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.2 The trial will take place in the continental U.S. and U.S. territories and is being conducted under a U.S. Investigational New Drug (IND) application.
“We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda. “This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”
Takeda was selected by BARDA in September 2016 to develop a vaccine to support the Zika response effort in the U.S. and affected regions around the world.
In recent years, the Zika virus has had a devastating impact, spreading across more than 84 countries, territories or subnational areas, including the U.S.3 In February 2016, the World Health Organization (WHO) declared the Zika outbreak to be a Public Health Emergency of International Concern (PHEIC)4 and the Centers for Disease Control and Prevention (CDC) elevated its response efforts to its highest level (Level 1).5 Although WHO has since declared an end to the PHEIC,6 Zika continues to pose a significant threat to public health, especially for pregnant women, and a vaccine is still needed.
Given the public health threat posed by Zika, Takeda mobilized a multifunctional team immediately following signature of the contract with BARDA and has prioritized all aspects of the development program, enabling the Phase 1 trial to start within 15 months of funding.1 Initial data from ZIK-101 are expected in 2018, and, if available Phase 1 data support it, Takeda will work toward initiating Phase 2 studies as soon as possible.2
“BARDA remains committed to making available safe and effective Zika vaccines,” said Rick Bright, Ph.D., BARDA Director. “Takeda’s Phase 1 clinical study is an important step toward this goal.”
Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.
Acknowledgment of Federal Funding
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.
About Takeda’s Zika Virus Vaccine Candidate (TAK-426)
Takeda’s Zika virus vaccine candidate (TAK-426) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine. The candidate is being developed as part of a broader effort to prevent the spread of the Zika virus in susceptible populations around the world.
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health.7 For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; the transaction may not be consummated; the anticipated benefits of the transaction may not be realized; the transaction could disrupt relationships with employees, licensees, customers and other business partners or governmental entities; future sales could be adversely affected by competition or other factors; and integration costs may exceed current expectations. In addition, the combined business could be adversely affected by industry, economic or political conditions outside of BARDA or Takeda’s control, including general economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of the date of this press release, and neither BARDA nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.
1 Takeda Newsroom: Takeda to develop Zika Vaccine with up to
$312 million in funding from US Government. Accessed November 2017 from https://www.takeda.com/newsroom/newsreleases/2016/Takeda-to-develop-Zika-Vaccine-with-up-to-$312-million/
2 ClinicalTrials.gov. Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants. 2017. Accessed November 2017 from https://www.clinicaltrials.gov/ct2/show/NCT03343626?term=ZIK-101&recrs=ab&rank=1
3 WHO Zika virus and complications: 2016 Public Health Emergency of International Concern. Accessed November 2017 from http://www.who.int/emergencies/zika-virus/en/
4 WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations. Accessed November 2017 from http://www.who.int/mediacentre/news/statements/2016/1st-emergency-committee-zika/en
5 CDC Emergency Operations Center moves to highest level of activation for Zika response. Accessed November 2017 from https://www.cdc.gov/media/releases/2016/s0208-zika-eoca-activation.html
6 Fifth meeting of the Emergency Committee under the International Health Regulations (2005) regarding microcephaly, other neurological disorders and Zika virus. Accessed November 2017 from http://www.who.int/mediacentre/news/statements/2016/zika-fifth-ec/en
7 UNICEF Immunization Facts and Figures April 2013. Accessed November 2017 from https://www.unicef.org/immunization/files/UNICEF_Key_facts_and_figures_on_Immunization_April_2013(1).pdf
Takeda Pharmaceutical Company Limited
For media outside of Japan:
For Japanese media:
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Customers of Palau Telecoms to Enjoy ‘Always On’ Connectivity with SES Networks19.2.2018 10:50 | Tiedote
Customers of Palau’s local internet services provider Palau Telecoms will continue to enjoy enhanced and reliable fibre-like connectivity delivered by SES Networks. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180218005047/en/ Customers of Palau Telecoms to Enjoy ‘Always On’ Connectivity with SES Networks (Photo: Business Wire) SES announced today that in the latest contract signed, Palau Telecoms, which has been enjoying SES’s Networks exceptional networks performance since 2014, will be extending its contract until 2020, and increasing the amount of medium earth orbit (MEO) connectivity by 150%. A long-term customer of SES Networks, Palau Telecoms is utilising their existing MEO service to augment fibre capacity, providing an ‘always on’ service to its customers. This enhanced, robust infrastructure provides a solid foundation for their 4G implementation plans, giving their end users the quality experience they demand reg
New data presented at the American Academy of Dermatology show LEO Pharma’s Kyntheum® (brodalumab) improves psoriasis on the nail19.2.2018 09:00 | Tiedote
NOT FOR DISTRIBUTION IN THE UNITED STATES OR UNITED KINGDOM: LEO Pharma today announced new data demonstrating long-term improvements in psoriasis on the nail with Kyntheum® (brodalumab) when compared to placebo or ustekinumab.1 Psoriasis on the nail, which is challenging to treat,2 affects approximately half of the estimated 125 million people living with psoriasis worldwide.2,3 The data were presented at the 76th annual American Academy of Dermatology (AAD) meeting in San Diego, California, US. Psoriasis is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin, but also impacts emotional, psychological and physical health.4 The heavy and far-reaching burden of the disease can be disabling and stigmatising with a substantial negative impact on those affected and their families.4 Due to the visible nature of the condition, psoriasis on the nail can be particularly upsetting for patients.4 In moderate to severe cases, psoriasis on the nail can be pain
OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers18.2.2018 00:00 | Tiedote
Celgene Corporation (NASDAQ:CELG) today announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. “Reducing oral ulcers, which are painful and can negatively im
CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study17.2.2018 11:00 | Tiedote
Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO). The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1 The UK-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients. The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR and ADR rates. In addition, at week 54, the remission rate was 39.7%, 39.0% and 32.7% for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1 The PANTS study investigates
Avanti Communications HYLAS 4 Satellite Arrives in French Guiana16.2.2018 21:26 | Tiedote
Avanti Communications Group plc (“Avanti”), a leading provider of satellite data communications services in Europe, the Middle East and Africa (“EMEA”), announces its HYLAS 4 satellite has arrived safely in French Guiana ahead of its March 2018 launch. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005586/en/ Avanti Communications HYLAS 4 Satellite Arrives in French Guiana (Photo: Business Wire) The spacecraft, built by Orbital ATK was packed and shipped at their Satellite Manufacturing Facility in Dulles, Virginia, United States and flown to French Guiana, where it was unloaded and will be taken to the Arianespace launch facilities in Kourou. HYLAS 4 uses the latest High Throughput Satellite technology, doubling Avanti's Ka-band capacity across EMEA. The latest addition to Avanti's HYLAS fleet will provide: Backhaul services for mobile network operators Wholesale broadband for ISPs Connectivity for governments (civil a
General Cable Corporation Stockholders Approve Acquisition By Prysmian Group16.2.2018 20:05 | Tiedote
General Cable Corporation (NYSE: BGC) today announced the voting results from the Company’s special meeting of stockholders held this morning. Stockholders of General Cable approved the Company’s previously announced acquisition by Prysmian Group (BIT: PRY) for $30.00 per share in cash. A total of 38,140,754 shares, representing approximately 75.34% of the total number of shares of common stock outstanding and approximately 99% of the total votes cast, were voted in favor of the merger. Subject to regulatory approvals and other customary closing conditions, the transaction is expected to close by the third quarter of 2018. About General Cable General Cable (NYSE:BGC), with headquarters in Highland Heights, Kentucky, is a global leader in the development, design, manufacture, marketing and distribution of aluminum, copper and fiber optic wire and cable products for the energy, communications, automotive, industrial, construction and specialty segments. General Cable is one of the larges
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme