Navigation Links
Ocera Therapeutics Receives Orphan Drug Status for AST-120 for Pouchitis
Date:1/7/2008

Company to Present at 26th Annual JP Morgan Healthcare Conference

SAN DIEGO, Jan. 7 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AST-120 for the treatment of Pouchitis.

Ocera will provide an overview of the Company and an update on AST-120 at the 26th Annual JP Morgan Healthcare conference being held today, at 2:30 pm (PT) at the Westin St. Francis Hotel in San Francisco in the Elizabethan Room.

"We are pleased by the FDA's decision to grant orphan drug status for AST-120 in Pouchitis," stated Dr. Laurent Fischer, president and CEO of Ocera Therapeutics. "This designation, along with the recent positive results from the exploratory Phase 2 trial for AST-120, allows us to expand the development of AST-120 for the treatment of Pouchitis, a frequent and severe complication in patients with a J-Pouch for which there are currently no drugs approved."

Patients who suffer from ulcerative colitis often require a resection of the colon and creation of a J-Pouch to reduce the risk of cancer. A J-Pouch collects stool, but the pouch can become inflamed, resulting in a condition known as Pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. AST-120, an oral agent known to adsorb bile acids and bacterial toxins, as well as to mediate inflammation in the gastrointestinal tract, is currently being evaluated in a Phase 2 trial in patients with active Pouchitis.

Less than 100,000 patients in the United States suffer from Pouchitis which qualifies AST-120 for Orphan Drug status in this condition. Orphan Drug status was created by the FDA to encourage companies to develop medicines for the treatment of rare diseases by providing the developer with market exclusivity of the product for seven years, in addition to other incentives.

AST-120 was in-licensed from Kureha Corporation, Japan in 2005 and is currently being studied in a Phase 3 trial in Fistulizing Crohn's disease.

About Ocera Therapeutics, Inc.

Ocera Therapeutics, Inc. is a privately held biopharmaceutical company focused on the licensing, development and commercialization of proprietary compounds to treat a broad range of gastrointestinal and liver diseases. Ocera is based in San Diego and is pursuing the development of AST-120 in Crohn's disease, Pouchitis and conducting proof of concept trials in other gastrointestinal and liver diseases including, Hepatic Encephalopathy, Irritable Bowel Syndrome and Proton Pump Inhibitor-resistant Gastroesophageal Reflux Disease. Ocera Therapeutics has raised $26.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at http://www.oceratherapeutics.com.

For more information on Pouchitis, visit the Crohn's and Colitis Foundation of America website at http://www.ccfa.org.

Media Contact: Company Contact:

Melissa Hill Laurent Fischer

Porter Novelli Life Sciences Ocera Therapeutics, Inc.

619-849-6004 858-436-3901

mhill@pnlifesciences.com lfischer@ocerainc.com


'/>"/>
SOURCE Ocera Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. National Patient Safety Foundation Partners with Vocera Communications
2. Prime Therapeutics Receives TIPPS Certification
3. Adams Respiratory Therapeutics to Celebrate 10th Anniversary of its Incorporation on September 12
4. Transition Therapeutics Announces Fiscal 2007 Year End Financial Results
5. Lorus Therapeutics announces election of three new Directors and appoints a new Chairman
6. Deane F. Johnson Center for Neurotherapeutics to Launch First Mobile Medical Unit on October 4th
7. Russell Investment Group Advises Protalix Biotherapeutics of Index Adjustment
8. Adams Respiratory Therapeutics Announces FDA Approval of Grape-Flavored Delsym(R)
9. Prime Therapeutics Announces URAC Accreditation
10. Cell Therapeutics, Inc. (CTI) to Present at BIO Investor Forum
11. Horizon Therapeutics, Inc. Scheduled to Present at Upcoming BioPartnering Europe Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Story Highlights: ... the health care industry is causing providers to review ... Deloitte offers a suite of solutions for health care ... cost optimization: labor resource analysis, revenue cycle optimization and ... outcomes and better economics ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
Breaking Medicine Technology: