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:6/23/2017)... ... June 23, 2017 , ... ... Conference from Sept. 18 to 20. , The two-day conference is focused on ... the goal of improving patients’ lives and eliminating racial breast cancer-related disparities. The ...
(Date:6/23/2017)... ... , ... Ross Insurance Agency ( http://www.rossinsuranceagency.com ) saves clients ... (FEMA) recent update of flood zones, more people than ever are in flood ... to reflect the actual risk in flood zone areas during a time when ...
(Date:6/23/2017)... ... June 23, 2017 , ... Jusino Insurance Services, ... communities in the greater Chicago metropolitan area, is embarking on a charity drive ... in Chicago. , Founded in 1897, Hephzibah Children’s Association is one of the ...
(Date:6/22/2017)... FL (PRWEB) , ... June 22, 2017 , ... Branches, ... received more than $245,000 in grant funding to support its programs focused on providing ... Branches, Inc. was awarded a grant by the Foundation of $15,000 to support its ...
(Date:6/22/2017)... ... June 22, 2017 , ... Children’s National Health System ... (AHA) to launch a Rheumatic Heart Disease Center, with the goal of developing ... heart disease (RHD) in high-risk, financially disadvantaged countries and low-income communities across the ...
Breaking Medicine News(10 mins):
(Date:6/16/2017)... Datascope Corp. is voluntarily performing a worldwide field correction of ... test failure code.     ... PART NUMBER ... 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX ... This field correction also applies to ...
(Date:6/13/2017)... June 13, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... announced that the U.S. Food and Drug Administration (FDA) has ... 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning Letter related ... facility is a measure of the progress we have made ...
(Date:6/9/2017)... INDIANAPOLIS , June 9, 2017 More ... a further effort to help spread lessons learned from ... the International Diabetes Federation (IDF) and Eli Lilly and ... for the second phase of the Bringing Research in ... reaffirming their commitment to helping people with diabetes effectively ...
Breaking Medicine Technology: