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:2/12/2016)... Boca Raton, FL (PRWEB) , ... February 12, ... ... nation’s largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving ... patient services – hosted over 250 members of South Florida’s philanthropic community at ...
(Date:2/12/2016)... ... 12, 2016 , ... Each year, the American Physical Therapy Association (APTA) offers ... the Anaheim Convention Center. Almost 10,000 physical therapists across the country are expected to ... more about their chosen field and network with their colleagues. As in years ...
(Date:2/12/2016)... ... February 12, 2016 , ... T.E.N., ... have closed for the ISE Southeast Awards 2016. Finalists and winners of the ... ISE® Southeast Executive Forum and Awards Gala on March 15, 2016 at the ...
(Date:2/12/2016)... ... 2016 , ... Every winter, someone is killed, injured or loses a home ... Center, part of the Allegheny Health Network, has partnered with Etna Volunteer Fire ... Need Space” campaign. , “Space Heaters Need Space” aims to bring awareness ...
(Date:2/12/2016)... Arlington, TX (PRWEB) , ... February 12, 2016 , ... ... Worth, and other communities across eastern Texas, is launching a cooperative charity drive with ... and families. , Serving more than 50,000 individuals and families in need, the Tarrant ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... 2016 On Thursday, Feb. 11, 2016, surgeons ... David,s North Austin Medical Center successfully completed the first ... ® Surgical System with Trumpf Medical,s advanced operating ... Lakshman , M.D., colorectal surgeon at the Texas Institute ... Table Motion technology, which seamlessly combines the da Vinci ...
(Date:2/12/2016)... and Company (NYSE: LLY ) today announced that the ... patent would not presently be infringed by Actavis marketing pemetrexed ... Italy and Spain ... --> --> In ... Lilly,s patent would be indirectly infringed by Actavis marketing certain ...
(Date:2/12/2016)... -- OMS Supply, a large provider of oral surgery supplies ... recent launching of their new company website. The OMS ... enhance the user experience and enable practitioners to browse ... --> --> Despite the fact that ... in early 2016, they have already made an unprecedented ...
Breaking Medicine Technology: