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:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/2/2017)... 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... and Consulting, LLC , and named its founder as ... in Tennessee , will operate under ... EnvoyHealth,s service offerings for health care partners to include ... "In an interoperable world, technology delivers ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... Rockville, Maryland (PRWEB) , ... October 12, 2017 ... ... a magnetic drug delivery system that we intend to develop to enable prevention ... regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the ... – Miles by Moonlight to raise money for the American Heart Association Heart Walk. ... , Teams will work together to keep their treadmills moving for 5 hours. Treadmills ...
Breaking Medicine News(10 mins):