Navigation Links
Prometheus Licenses COLAL-PRED(R) From Alizyme
Date:11/29/2007

SAN DIEGO, Nov. 29 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical company today announced that it has entered into an exclusive license agreement to develop and commercialize COLAL-PRED(R) for gastrointestinal diseases or other applications in North America from Alizyme Therapeutics Limited, a wholly owned subsidiary of Alizyme plc. COLAL-PRED has a unique competitive profile based on Alizyme's proprietary COLAL(R) drug delivery technology which is designed to release a drug, in this case an anti- inflammatory steroid, in the colon to provide efficacy but without the undesirable side effects usually associated with the use of systemic steroids.

Under the terms of the agreement, Prometheus made an up-front payment which may be followed by additional payments on the successful achievement of future development milestones, including U.S. Food and Drug Administration (FDA) approval of the product. Prometheus will also sponsor substantially all of the clinical development costs for COLAL-PRED in North America and pay royalty rates which increase with higher annual net sales levels of COLAL-PRED. Subject to the successful completion of clinical trials, Prometheus anticipates that it will file a new drug application (NDA) with the FDA in 2011.

"We are delighted to partner with Prometheus in North America for the development and commercialization of COLAL-PRED," said Tim McCarthy, Alizyme's Chief Executive Officer. "As a leader in the provision of therapeutics and complementary diagnostics to gastrointestinal specialists throughout the United States, we believe Prometheus is uniquely positioned to maximize the commercial potential of COLAL-PRED. This partnership with Prometheus marks an important step in the commercialization of COLAL-PRED in North America in parallel with our own development and commercialization plans in Europe and the rest of the world."

"We are excited to have entered into this partnership with Alizyme," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "COLAL-PRED adds a therapeutically and commercially attractive development stage product to our portfolio of proprietary, marketed pharmaceutical products, thus strengthening our gastrointestinal franchise for the future. COLAL-PRED can provide a complementary therapeutic to our IBD Serology 7 diagnostic test, which helps physicians diagnose ulcerative colitis and Crohn's disease."

Ulcerative colitis is an inflammatory bowel disease (IBD), the general name for disease that causes inflammation in the small intestine and colon. Ulcerative colitis can be difficult to diagnose because its symptoms are similar to other intestinal disorders and to another type of IBD called Crohn's disease. Ulcerative colitis is marked by inflammation and ulceration of the innermost lining of the colon. Crohn's disease differs because it causes inflammation deeper within the intestinal wall and can occur in other parts of the digestive system including the small intestine, mouth, esophagus, and stomach. Currently, it is estimated around 700,000 Americans suffer from ulcerative colitis.

About Prometheus

Prometheus is a specialty pharmaceutical company committed to developing new ways to help physicians individualize patient care. Prometheus focuses on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Prometheus' strategy includes the marketing and delivery of pharmaceutical products complemented by its proprietary, high-value diagnostic testing services. By integrating therapeutics and diagnostic services, Prometheus addresses the continuum of patient care, thereby providing physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California. Additional information about Prometheus can be found at http://www.prometheuslabs.com.

About Alizyme plc

Alizyme is a specialty biopharmaceutical development company, focused on the therapeutic areas of metabolic disorders, gastrointestinal disorders and cancer supportive care. In addition to COLAL-PRED, it is developing cetilistat for the treatment and management of obesity and related diseases, such as Type II diabetes, renzapride for the treatment of irritable bowel syndrome ("IBS"), and ATL-104 for mucositis, a side effect of cancer therapy.

COLAL-PRED is the combination of Alizyme's proprietary colonic drug delivery system, COLAL, and prednisolone metasulfobenzoate sodium ("PMSBS"), an approved steroid in Europe. COLAL-PRED has a starch coating that is only broken down in the gut by bacteria occurring in the colon. This leads to topical delivery of PMSBS to the colon rather than systemic delivery with the objective of providing efficacy, but without the side effects of steroids; however, the efficacy and safety of COLAL-PRED must be shown in well-controlled, prospective clinical trials and approved by the FDA.

COLAL is a drug delivery technology which enables drugs to be taken orally, but then be specifically released in the colon. Achieving colonic release with conventional oral dosage forms has proven difficult because of the variation between individuals in transit times and conditions within the gastrointestinal tract. COLAL overcomes this difficulty by covering small pellets containing the drug with a coating of ethylcellulose and a specific form of amylose (derived from starch). This coating prevents drug release in the stomach and small intestine. When the pellets reach the colon, the amylose in the coating is broken down by bacterial enzymes and the drug is released.

This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to various risks, and Prometheus cautions that any forward-looking information is not a guarantee of future performance. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Prometheus' business, including risks related to COLAL-PRED and the license agreement with Alizyme (including, without limitation, Prometheus' ability to develop the licensed products, or complete any required clinical trials, Prometheus' ability to obtain required regulatory approvals of the licensed products, adverse side effects or inadequate therapeutic efficacy of COLAL-PRED and any resulting product liability claims, the potential market for the drug delivery technology, and the potential for termination of the license agreement). There can be no assurance that Prometheus can successfully commercialize or penetrate the market for the licensed products.


'/>"/>
SOURCE Prometheus Laboratories Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. BioMarin Licenses Technology From Leading Cystic Fibrosis Research Laboratory at the University of California, San Francisco
2. MedImmune Licenses Reverse Genetics Technology to Novartis for Use in Influenza Vaccine Development and Production
3. Medinet Licenses MaxCyte Cell Loading Technology for Cancer Immunotherapy in Japan
4. Codexis Licenses New Drug Metabolite Profiling and Lead Diversification Technology From the California Institute of Technology
5. Southern Research Institute Licenses Anti-Cancer Drug Compound to Virium Pharmaceuticals
6. Protherics Licenses its CoVaccine HT Adjuvant to Nobilon for Influenza Vaccine Indications
7. HUYA Bioscience International Licenses Clinical Stage Anti-Arrhythmic Compound from the Shanghai Institute of Materia Medica
8. Syngenta Licenses Chromatin Gene Stacking Technology
9. Utrecht University Licenses MetaDrug From GeneGo for Drug Innovation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ("Biorem" or "the Company") ... shareholders, Clean Technology Fund I, LP and Clean Technology ... based venture capital funds which together hold approximately 59% ... diluted, as converted basis), that they have entered into ... holdings in Biorem to TUS Holdings Co. Ltd. ("TUS") ...
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created ... services and solutions to the healthcare market. The company's primary focus is on ... sales and marketing strategies that are necessary to help companies efficiently bring their ...
(Date:6/24/2016)... 2016  Regular discussions on a range of subjects including ... two entities said Poloz. Speaking at a lecture ... , he pointed to the country,s inflation target, which is ... "In certain areas there ... common economic goals, why not sit down and address strategy ...
(Date:6/23/2016)... ... June 23, 2016 , ... Mosio, a leader in ... Trials Patient Recruitment and Retention Tips.” Partnering with experienced clinical research professionals, Mosio ... practical tips, tools, and strategies for clinical researchers. , “The landscape of how ...
Breaking Biology Technology:
(Date:4/13/2016)... physicians supporting Medicaid patients in Central Florida ... telehealth thanks to a new partnership with higi.   ... can routinely track key health measurements, such as blood ... they opt in, share them with IMPOWER clinicians through ... location at no cost. By leveraging this data, IMPOWER ...
(Date:3/29/2016)... March 29, 2016 LegacyXChange, Inc. ... "LEGX" and SelectaDNA/CSI Protect are pleased to announce our ... in a variety of writing instruments, ensuring athletes signatures ... created collectibles from athletes on LegacyXChange will be assured ... the DNA. Bill Bollander , CEO ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... (NSO), which operates the highest sample volume laboratory in ... Tute Genomics and UNIConnect, leaders in clinical sequencing informatics ... the launch of a project to establish the informatics ... NSO has been contracted by the ...
Breaking Biology News(10 mins):