XERAVATM (eravacycline) Now Available to Hospitals in
Conference Call Today at
“During the third quarter of 2018, we reached our most significant milestones as a company to date – the regulatory approvals of XERAVA for the treatment of complicated intra-abdominal infections (cIAI) in both the U.S. and
Mr. Macdonald added, “We are also pleased to have entered into a loan agreement for up to
Key Upcoming Milestones
- Commence Phase 1 bronchopulmonary disposition study for TP-6076 – 1Q 2019
- Complete Phase 1 multiple ascending-dose study for oral TP-271 – 2Q 2019
- Begin phased launch of XERAVA in
Europe– 1H 2019
Third Quarter and Recent Highlights
- AnnouncedCommercial Launch of XERAVA for cIAI Following the
U.S. Food and Drug Administration( FDA) Approval in August
The Company commercially launched XERAVA in the U.S. in
October 2018. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI infections. The salesforce will be focusing on institutions responsible for treating patients in 90% of the Gram-negative marketplace.
XERAVA’s launch followed
FDAapproval of XERAVA in August for the treatment of cIAI in patients 18 years of age and older. Supporting XERAVA’s approval were results from two Phase 3 clinical studies that showed the therapy was well-tolerated and achieved high clinical cure rates in patients with cIAI, thus demonstrating statistical non-inferiority to two widely used carbapenems – ertapenem and meropenem.
- Received Marketing Authorization from the
European Commission(EC) for XERAVA in the European Union(EU)
In September, the EC adopted the
July 2018positive opinion issued by the Committee for Medicinal Products for Human Useof the European Medicines Agency(EMA) to grant marketing authorization for XERAVA for the treatment of cIAI in adults in all EU member states as well as Iceland, Liechtensteinand Norway. Following this approval, the Company is on track for a phased European launch of XERAVA, beginning with Germanyand the UKin the first half of 2019.
- Presented XERAVA and TP-6076 Data at the
Infectious Disease Societyof America’s (IDSA) 2018 IDWeek
In October, the Company presented data related to XERAVA and TP-6076 at IDSA’s IDWeek. Among the data presented were results from a post-hoc analysis of XERAVA Phase 3 data, which showed high clinical cure rates and microbiological eradication with XERAVA among patients with cIAI and concurrent bacteremia. Data from a Phase 1 randomized, placebo-controlled, double-blind, multiple-ascending-dose study demonstrating positive safety, tolerability and pharmacokinetic results for the Company’s novel, fully synthetic tetracycline, TP-6076 were also presented.
- Presented XERAVA Data at the
American College of Clinical Pharmacy(ACCP) 2018 Global Conference
In October, the Company announced positive data from a post-hoc analysis of two Phase 3 trials of XERAVA in higher risk populations – obese patients and those with altered renal function. Similar clinical cure rates were observed for XERAVA across all classifications of renal function, further supporting that the drug is an effective empiric treatment for cIAI comparable to carbapenems which may provide an alternative to antibiotics that require dosing modification in patients with altered renal function. XERAVA was also effective in treating patients with cIAI regardless of body mass index when dosed 1mg/kg IV every 12 hours, based on total body weight when compared to carbapenems.
- Entered into Loan and Security Agreement with
Solar Capital Limited
November 2018, the Company entered into a loan agreement with Solar Capital Limitedproviding us up to $75 millionwith $30 millionfunded at closing, to be used to support the commercial launch of XERAVA and general corporate purposes. Armentum Partnersacted as advisor to the Company on the transaction.
Third Quarter 2018 Financial Results
Revenues during the third quarter of 2018 were
Research and development (R&D) expenses for the third quarter of 2018 were
Sales, general and administrative expenses for the third quarter of 2018 were
For the third quarter of 2018, Tetraphase reported a net loss of
Conference Call and Webcast Information
Tetraphase will host a conference call today at
A replay of the conference call will be available from
XERAVA (eravacycline) for injection is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. It is approved for use in the U.S. and
XERAVATM Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.
XERAVA is not indicated for the treatment of complicated urinary tract infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.
XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.
To report SUSPECTED ADVERSE REACTIONS, contact
Please see full prescribing information for XERAVA.
Tetraphase is a 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 bacteria highlighted as urgent public health threats by the
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 eravacycline will be successfully distributed and marketed and other regulatory and commercial risk factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the period ended
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|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||11,665||28,777||44,162||83,237|
|Selling, general and administrative||9,481||5,600||22,350||15,797|
|Total operating expenses||21,146||34,377||66,512||99,034|
|Loss from operations||(19,995||)||(30,310||)||(51,892||)||(91,896||)|
|Other income (expense)|
|Other income (expense), net||437||302||1,215||620|
|Net loss per share-basic and diluted||$||(0.37||)||$||(0.63||)||$||(0.97||)||$||(2.23||)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders-basic and diluted||52,937||47,347||52,131||40,942|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (unaudited)|
|September 30,||December 31,|
|Cash and cash equivalents||$||96,959||$||136,411|
|Prepaid expenses and other current assets||5,302||6,382|
|Property and equipment, net||1,142||1,395|
|Liabilities and Stockholders' equity|
|Accounts payable and accrued expenses||$||14,391||$||17,865|
|Total deferred revenue||9||660|
|Other liabilities, noncurrent||79||105|
|Total stockholders' equity||96,970||130,410|
|Total liabilities and stockholders' equity||$||111,449||$||149,040|
Source: Tetraphase Pharmaceuticals, Inc.