KING OF PRUSSIA, Pa., March 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK ), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today opened its expanded office in King of Prussia, Pennsylvania. Located on First Avenue, the new space is designed to accommodate the Company’s growing development, manufacturing, and commercial organizations.
“It’s an incredibly exciting time at Paratek as we get closer to potentially bringing our lead product candidate, omadacycline, to market,” said Evan Loh, M.D., President, Chief Operating Officer, Chief Medical Officer and Director at Paratek. “Our expanded home in King of Prussia provides our growing team with the physical space and resources to fuel our continued commitment to bringing the very best in innovative antibiotic treatment options to patients to improve and potentially save lives.”
On hand for the office’s ribbon cutting ceremony were state and local officials, as well as local organizations and community partners.
“Paratek’s expanded presence in King of Prussia is a testament to the vibrant life sciences industry in this region,” said State Representative Tim Briggs, D-Montgomery. “The world-class talent available here and breadth of like-minded companies focused on scientific discovery and development make King of Prussia a natural fit for Paratek to help fuel the Company’s commitment to biotech innovation.”
“Paratek's work to address the significant unmet need for new antibiotics to treat common, serious infections is hugely important for the health of our communities,” said Christopher P. Molineaux, President and Chief Executive Officer, Life Sciences Pennsylvania. “We are proud that this promising effort is happening here in Pennsylvania.”
The renovated office space will initially house approximately 30 full-time employees, the majority of whom are focused on development and registration activities to support the potential New Drug Application to the U.S. Food and Drug Administration (FDA). At the appropriate time, Paratek plans to expand to bring in talented resources to provide for a successful launch of omadacycline, a novel broad spectrum once-daily oral and intravenous antibiotic being developed to treat serious community-acquired infections such as acute skin and skin structure infections and community-acquired bacterial pneumonia. Paratek anticipates adding as many as 65 employees in King of Prussia over the next 24 months as registration and pre-commercial activities ramp up prior to launch and has built the new office space to accommodate this projected rapid expansion.
The ability to continue to build a thriving organization in King of Prussia is an important part of Paratek’s growth strategy. Paratek opened its first office in the area in 2015 to complement the Company’s corporate headquarters in Boston, Massachusetts and attract highly skilled talent from the area’s biopharmaceutical industry. In the past two years, the Company has nearly tripled in size and evolved to being an active member of Life Sciences PA, the state’s industry association, thereby drawing leadership lessons coupled with business and scientific comradery from other biopharmaceutical companies in the area.
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 acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared to linezolid. A Phase 3 registration study for community-acquired bacterial pneumonia (CABP) comparing IV-to-once-daily oral omadacycline to IV-to-oral moxifloxacin was initiated in November 2015 and completed enrollment in January 2017. Paratek will report top-line data from this study early in the second 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 from this study 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 and positive top-line PK proof-of-principle data were reported in November 2016. The company plans to begin enrolling patients in a proof-of-concept Phase 2 study in complicated UTI as early as the fourth quarter of 2017. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for several indications.
In October 2016, Paratek announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm dosing regimens and assess efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax).
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 Phase 3 data are expected in the first half of 2017.
For more information, visit www.paratekpharma.com .
Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our having the resources to execute on our clinical studies. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
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