Navigation Links
Paratek Pharmaceuticals Announces Expanded FDA Grant of Qualified Infectious Disease Product (QIDP) Designation for Its Lead Product Candidate, Omadacycline
Date:5/1/2013

BOSTON, May 1, 2013 /PRNewswire-iReach/ -- Paratek Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibiotic candidate, omadacycline, as a Qualified Infectious Disease Product (QIDP) for the treatment of complicated Urinary Tract Infections (cUTI).  This QIDP designation is applicable for both intravenous (IV) and oral formulations of omadacycline.

The QIDP designation provides Paratek access to certain incentives, including priority review associated with a New Drug Application (NDA) submission, eligibility for fast-track status for smaller population studies targeting certain resistant organisms, and a five-year extension of exclusivity under the Hatch-Waxman Act upon FDA approval of omadacycline. This designation is in addition to that announced by Paratek on January 3, 2013 granting QIDP status for IV and oral formulations of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

The QIDP designation, which the Company believes is a first for an orally available antibiotic for the treatment of cUTI, is provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted in July 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), formerly known as Prescription Drug User Fee Act V (PDUFA V).  Experts have noted that there is a serious unmet need for new oral antibiotics to treat multi-drug resistant (MDR) bacteria such as E. coli that occur in cUTI and other infections.  In studies conducted to date, omadacycline achieves high concentrations in the urinary tract following oral dosing and retains activity against MDR E. coli and other bacteria common to community-acquired cUTI.  Paratek plans to conduct a cUTI Phase 2 clinical study with omadacycline. 

Paratek has completed clinical studies necessary to advance its commercial-ready oral and IV formulations of omadacycline into Phase 3 development. Paratek has obtained two Special Protocol Assessment, or SPA, agreements, one in ABSSSI and one in CABP for omadacycline.

About Paratek Pharmaceuticals

Paratek is a pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. The Company's lead product candidate, omadacycline, is a new tetracycline-derived, broad-spectrum antibiotic being developed for use as a first-line monotherapy for acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), urinary tract infections (UTI) and other serious community-acquired bacterial infections.

Media Contact: Kathryn Boxmeyer Paratek Pharmaceuticals, Inc., 617-275-0040, kboxmeyer@paratekpharm.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Paratek Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. GW Pharmaceuticals Announces Pricing of Initial Public Offering on the NASDAQ Global Market
2. Tolero Pharmaceuticals announces Worldwide Agreement with Sanofi for the In-license of Alvocidib (Flavopiridol)
3. Avanir Pharmaceuticals Announces Date of Fiscal 2013 Second Quarter Financial Results and Conference Call
4. Catabasis Pharmaceuticals Announces Issuance of Patents for CAT-1000 and CAT-2000 Series
5. Selexis SA Sells Rights to Royalty Payments for More Than 15 Biologic Development Programs to Ligand Pharmaceuticals
6. Oramed Pharmaceuticals to Present Results of its Key Clinical Studies of Oral Insulin in Type 1 Diabetes Patients at the GTC Diabetes Summit, Boston, MA; April 29-30, 2013
7. Auxilium Pharmaceuticals Completes Acquisition Of Actient Holdings LLC To Create A Leading Urology Franchise With A Diversified Product Portfolio And Strong Growth Profile
8. Absorption Pharmaceuticals to Receive Patent for Premature Ejaculation Topical Medication
9. Novartis Pharmaceuticals Corporation disputes allegations in two US Government lawsuits and looks forward to a fair discussion of the facts
10. Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Thursday, May 2
11. Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)...   Lexicon Pharmaceuticals, Inc. (Nasdaq: ... 2 clinical study of sotagliflozin, a dual SGLT1 and ... the leading global organization funding type 1 diabetes research. ... trial, which randomized a total of 87 patients, was ... dose of sotagliflozin compared to a placebo control in ...
(Date:12/5/2016)... Mich. , Dec. 5, 2016  Sharn Anesthesia ... preferred anesthesia sales and distribution partner for Salter Labs.  ... of the Year in recognition of outstanding sales performance. ... devices for respiratory and anesthesia care, including the market ... is also the master distributor of the Parker Flex-Tip® ...
(Date:12/5/2016)... TrainerMD , the first HIPAA compliant software collaboration platform for patients, ... . Styku, a California -based software ... world-class, real-time 3D body scanning and analysis. Together with its other ... and feel their health like never before. ... , , ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... December 06, 2016 , ... Gateway Analytical, one of ... particle counting and sizing services for USP 788 and 789 particulate standards compliance. ... as a response to the needs of pharmaceutical and medical device manufacturers, who ...
(Date:12/6/2016)... (PRWEB) , ... December 06, 2016 , ... 'Tis the ... disrupt daily routines. That means it's also the season when eating healthy, staying active, ... with diabetes) on schedule is harder to do. , "Shopping trips, parties and ...
(Date:12/6/2016)... Dublin, CA (PRWEB) , ... December 06, 2016 ... ... Community College District , the only authorized OSHA Training Institute Education Center headquartered ... Health Fundamentals certificate program focused on providing occupational safety and health training to ...
(Date:12/5/2016)... ... December 05, 2016 , ... Edward Buckingham ... announce the arrival of the newest Sciton laser in January 2017. The Halo ... tunable non-ablative and ablative wavelengths for exceptional results. Outperforming more traditional lasers, the ...
(Date:12/5/2016)... ... December 05, 2016 , ... Researchers at Johns Hopkins All Children’s ... of young athletes. Over the course of three years, researchers will study concussions and ... The mouth guards, equipped with special sensors, will track the location and force of ...
Breaking Medicine News(10 mins):