Prometheus Licenses COLAL-PRED(R) From Alizyme

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

Under the terms of the agreement, Prometheus made an up-front paymentwhich may be followed by additional payments on the successful achievement offuture development milestones, including U.S. Food and Drug Administration

(FDA) approval of the product. Prometheus will also sponsor substantially allof the clinical development costs for COLAL-PRED in North America and payroyalty rates which increase with higher annual net sales levels ofCOLAL-PRED. Subject to the successful completion of clinical trials,Prometheus anticipates that it will file a new drug application (NDA) with theFDA in 2011.

"We are delighted to partner with Prometheus in North America for thedevelopment and commercialization of COLAL-PRED," said Tim McCarthy, Alizyme'sChief Executive Officer. "As a leader in the provision of therapeutics andcomplementary diagnostics to gastrointestinal specialists throughout theUnited States, we believe Prometheus is uniquely positioned to maximize thecommercial potential of COLAL-PRED. This partnership with Prometheus marks animportant step in the commercialization of COLAL-PRED in North America inparallel with our own development and commercialization plans in Europe andthe rest of the world."

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

Ulcerative colitis is an inflammatory bowel disease (IBD), the generalname for disease that causes inflammation in the small intestine and colon.Ulcerative colitis can be difficult to diagnose because its symptoms aresimilar to other intestinal disorders and to another type of IBD calledCrohn's disease. Ulcerative colitis is marked by inflammation and ulcerationof the innermost lining of the colon. Crohn's disease differs because itcauses inflammation deeper within the intestinal wall and can occur in otherparts of the digestive system including the small intestine, mouth, esophagus,and stomach. Currently, it is estimated around 700,000 Americans suffer fromulcerative colitis.

About Prometheus

Prometheus is a specialty pharmaceutical company committed to developingnew ways to help physicians individualize patient care. Prometheus focuses onthe treatment, diagnosis and detection of gastrointestinal, autoimmune andinflammatory diseases and disorders. Prometheus' strategy includes themarketing and delivery of pharmaceutical products complemented by itsproprietary, high-value diagnostic testing services. By integratingtherapeutics and diagnostic services, Prometheus addresses the continuum ofpatient care, thereby providing physicians with a comprehensive solution totreat chronic diseases. Prometheus' corporate offices are located in SanDiego, California. Additional information about Prometheus can be found athttp://www.prometheuslabs.com.

About Alizyme plc

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

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

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

This press release contains certain "forward-looking statements" withinthe meaning of the Private Securities Litigation Reform Act of 1995. Suchforward-looking statements are subject to various risks, and Prometheuscautions that any forward-looking information is not a guarantee of futureperformance. Actual results may differ materially from those set forth inthis release due to the risks and uncertainties inherent in Prometheus'business, including risks related to COLAL-PRED and the license agreement withAlizyme (including, without limitation, Prometheus' ability to develop thelicensed 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 anyresulting product liability claims, the potential market for the drug deliverytechnology, and the potential for termination of the license agreement).There can be no assurance that Prometheus can successfully commercialize orpenetrate the market for the licensed products.SOURCE Prometheus Laboratories Inc.Beth Kriegel, Senior Director, Finance and Investor Relations of PrometheusLaboratories Inc., +1-858-410-2516