NASDAQ OMX

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency

Del

WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit.

"The MAA filing represents a significant milestone for Tetraphase as it is our first regulatory application for marketing authorization and a major step toward making eravacycline available as a new antibiotic treatment option for patients with serious hospital infections," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "I am proud of the dedicated team at Tetraphase who made this  happen and who support our commitment to develop novel antibiotics to treat drug-resistant infections. We look forward to working with the EMA during their review of this application and to focusing on the submission of the New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2018."

About Eravacycline

Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens that have been highlighted as urgent public health threats by both the World Health Organization and the U.S. Centers for Disease Control (CDC). Eravacycline has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.  Eravacycline is in phase 3 clinical development for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Eravacycline is currently being investigated in the Company's phase 3 IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) program. To date, eravacycline has been administered to over 1,500 patients and in two completed phase 3 trials in cIAI. In IGNITE1, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the MAA for IV eravacycline for the treatment of patients with cIAI now under review by the EMA. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company plans to use the results from IGNITE1 and IGNITE4 to support an NDA submission for IV eravacycline in cIAI. Tetraphase is also currently conducting IGNITE3, an additional phase 3 trial evaluating once-daily IV eravacycline in patients with cUTI and, assuming a positive outcome, the Company plans to use the results from IGNITE3 to support a supplemental NDA submission for eravacycline in cUTI. In parallel, Tetraphase is continuing its efforts to develop an oral dose formulation of eravacycline. A phase 1 clinical program is ongoing which is designed to evaluate and optimize the oral dosing regimen for eravacycline.

About Complicated Intra-abdominal Infections (cIAI)
Intra-abdominal infection (IAI) is a common problem in clinical practice and comprises a wide variety of disease processes. IAI is classified as uncomplicated or complicated based on the extent of the infection. Complicated intra-abdominal infection extends beyond the source organ into the peritoneal space (the space between the two membranes that separate the organs in the abdominal cavity from the abdominal wall) as a result of perforation or other damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. IAI is an important cause of morbidity and mortality and is the second most common cause of infectious mortality in the intensive care unit. Early detection, containment and appropriate antimicrobial treatment are essential to the successful treatment of IAI. This is even more critical with increasing rates of infections caused by drug-resistant bacteria, which limit the effectiveness of currently available antibiotics.

About Tetraphase Pharmaceuticals, Inc.

Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the multidrug-resistant (MDR) bacteria highlighted as urgent public health threats by the CDC. Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase's pipeline includes three antibiotic clinical candidates: eravacycline, which is in phase 3 clinical trials, and TP-271 and TP-6076, which are in phase 1 clinical trials. Please visit www.tphase.com for more company information.

Forward-Looking Statements

Any  statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "anticipates," "believes," "expects," "plans," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward- looking statements as a result of various important factors, including: whether results obtained in  previous clinical  trials will be indicative of results obtained in future clinical trials; whether eravacycline  or any other clinical candidate will advance through the clinical trial process on a timely basis or at all; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if any clinical candidate obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on August 2, 2017. In addition, the forward-looking statements included in this press release represent our views as of August 17, 2017. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some  point in the future, we specifically disclaim any obligation to do so.

Investor Contacts: 
Tetraphase Pharmaceuticals 
Teri Dahlman
617-600-7040
tdahlman@tphase.com

Argot Partners 
Maeve Conneighton 
206.899.4940
maeve@argotpartners.com

Media Contact: 
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.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: Tetraphase Pharmaceuticals via Globenewswire

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

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

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

Nasdaq Welcomes Secoo Holding Limited (Nasdaq: SECO) to The Nasdaq Global Market22.9.2017 21:11Pressemelding

NEW YORK, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Secoo Holding Limited (Nasdaq:SECO), Asia's largest online integrated upscale products and services platform, rang the opening bell at the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Global Market. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/45f7dc57-524d-4463-a839-d201c341a0f1 http://www.globenewswire.com/NewsRoom/AttachmentNg/149603ca-4949-4531-bf94-aeb6ded2e6df http://www.globenewswire.com/NewsRoom/AttachmentNg/e80a55e0-3858-41cb-80d3-9c9296d6143a Secoo is a consumer-focused online retail platform that offers offline experience centers to provide customer support and membership services. Secoo has built a trusted and comprehensive global supply chain for upscale produ

Alipay teams up with Nordic partners to bring "smart tourism" to Chinese visitors22.9.2017 11:42Pressemelding

HANGZHOU, China, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Alipay, the world's largest online and mobile payment platform, operated by Ant Financial Services Group ("Ant Financial", "Ant"), today announced that it has signed separate MoUs with Finpro (Finland), Svensk Handel (Sweden) and the Scandinavian Tourist Board, which will enable merchants across Nordic region to accept payment via Alipay and reach Chinese customers before, during and after their visit via Alipay's in-app marketing platform. This will bring Chinese tourists the same convenient payment and travel experience that they enjoy in China. Douglas Feagin, President of International Business, Ant Financial Services Group, said, "Alipay has been leading the trend of smart living in China. People not only use Alipay for payment, but also for settlement of all types of needs in their daily life. As part of our globalization strategy, we are focused on working with local partners to bring this

OpenAire brings in the sun with retractable structures across Europe22.9.2017 08:00Pressemelding

OAKVILLE, Ontario, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Venues around the world have been thrilled by OpenAire's retractable roof and enclosure designs since 1989. In 28 years, OpenAire's team of experts has completed nearly 1,000 unique retractable roof enclosures and operable skylights for venues of every size and kind internationally, including many groundbreaking designs across Europe. From Russia to warm and sunny Gibraltar, OpenAire has provided many commercial enterprises, resorts and even some private residences with beautiful retractable enclosures that suit their location and climate perfectly. OpenAire works closely with every client from the start, providing them with the flexibility to make their visions a reality. Many clients across Europe have seen increased business and excellent reviews after building an OpenAire solution. Some notable OpenAire designs include: Aqua Sferra's record-breaking 5,667 m2 (60,999 sq. ft.) free-standing aluminum dome housing its indoor

XBiotech to Present at Cantor Fitzgerald's Global Healthcare Conference21.9.2017 14:00Pressemelding

AUSTIN, Texas, Sept.  21, 2017  (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that management will be presenting at Cantor Fitzgerald's Global Healthcare Conference taking place September 25-27 at the InterContinental New York Barclay Hotel in New York City. Mr. Benjamin Guzman, the Company's Senior Vice President of Corporate Strategy & Finance, will provide a corporate overview on Wednesday, September 27th at 2:50pm Eastern Time. About True Human(TM) Therapeutic Antibodies Unlike previous generations of antibody therapies, XBiotech's True Human(TM) antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability. About XBiotech

At the 10th anniversary of the iPhone, Chairman of Pilatus Bank draws a stark comparison of the role technology has played in banking vs telecommunication21.9.2017 08:58Pressemelding

LONDON, Sept. 21, 2017 (GLOBE NEWSWIRE) -- Ali Sadr, Chairman of Pilatus Bank, believes that banks have failed to capture the true essence of technology for improving quality of service, as well as lacking the vision necessary to capture customers' imaginations. Meanwhile, other industries have been revolutionized and continue to thrive by the same technology. America has in the last 10 years been forced to close 10,000 branches. Since 2008, Europe has lost close to 48,000 branches, which is more than 20% of its branch network. There is little doubt that branch banking is on the decline, and online banking is failing to provide a quality service.  As we mark the 10th anniversary of the iPhone, Ali Sadr, Chairman of Pilatus Bank, gives a sobering count of the current state of affairs in the use of technology among well established banks, and elaborates on a vision that has the potential to become the largest revolution the banking industry is yet to experience. Chairman Al

Asure Software to Attend at Quora Consulting's Smartworking Summit21.9.2017 07:00Pressemelding

Asure Join's Industry Leaders to Discuss "Understanding the Productivity Enigma" AUSTIN, Texas, Sept. 21, 2017 (GLOBE NEWSWIRE) -- Asure Software, (NASDAQ:ASUR), a leading provider in human capital management and workspace management software, will be sponsoring Quora Consulting's Smartworking Summit in central London, September 28th 2017. These summits have continued to lead in addressing work space issues, such as occupancy, utilization, and productivity in the workforce. Dominic Jackson, Asure Sales Director of EMEA commented, "It is workplace issues like productivity that have driven thought leadership here at Asure." He continued "Utilization of workspace solutions help you recruit and retain the best talent, improve employee productivity, streamline operations, and realize a significant ROI on your most valuable assets - people, space and technology. We are thrilled to be not only part of the discussion, but part of the solu

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

Besøk vårt presserom