BOSTON, Oct. 04, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK ) will today ring the closing bell at Nasdaq to mark the company’s 20 th anniversary of working to develop new antibiotics. Paratek Chairman and Chief Executive Officer Michael Bigham will be joined by his colleagues for the Closing Bell ceremony at 3:45 pm ET.
“We are honored to have been invited to participate in the Nasdaq Closing Bell ceremony and to celebrate Paratek’s 20 th anniversary,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “Through the steadfast devotion and hard work of our team our lead drug candidate omadacycline is in late phase 3 development, with one successful phase 3 study announced in June of this year, and with two additional phase 3 studies actively enrolling. Omadacycline is a broad spectrum, well-tolerated, once-daily oral and intravenous antibiotic being developed for the treatment of serious community-acquired bacterial infections, particularly where resistance is of concern.”
A live stream of the Nasdaq Closing Bell ceremony will be available at https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos of the ceremony will be available at http://business.nasdaq.com/discover/market-bell-ceremonies
About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. In June 2016 Paratek announced positive efficacy data in a Phase 3 registration study in ABSSSI demonstrating the efficacy and safety of omadacycline compared to linezolid. A Phase 3 registration study for community acquired bacterial pneumonia (CABP) comparing IV-to-oral omadacycline to IV-to-oral moxifloxacin was initiated in November 2015. Enrollment continues on track to report top line data as early as the third quarter of 2017. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top line data are expected as early as the second quarter of 2017. A phase 1b study in uncomplicated urinary tract infections (UTI) was initiated in May 2016. Enrollment is nearly complete with top line data expected as early as the fourth quarter of 2016. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line data are expected in the first half of 2017.
For more information, visit www.paratekpharma.com .
Forward Looking Statement Certain statements in this press release are forward-looking statements. These forward-looking statements are based upon Paratek's current expectations and involve substantial risks and uncertainties. These risks and uncertainties include, but are not limited to: (i) unexpected results may cause the designs of the clinical trials to change, or the projected timelines of the trials to be extended, (ii) unexpected decline in the rates of patient enrollment in the clinical trials, (iii) unforeseen adverse effects experienced by patients resulting in a clinical hold, (iv) failure of patients to complete clinical trials, (v) risks related to regulatory oversight of the trials, (vi) the need for substantial additional funding to complete the development and commercialization of product candidates and (vii) risks that data to date and trends may not be predictive of future results. These and other risk factors are discussed under "Risk Factors" and elsewhere in Paratek's Annual Report on Form 10-K for the year ended December 31, 2015 and Paratek's other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.
CONTACTS: Media Relations: Michael Lampe (484) 575-5040 michael@scientpr.com Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568
