Prometheus Laboratories Inc., a specialty pharmaceutical company today announced that it has entered into an exclusive license agreement to develop and commercialize COLAL-PRED® 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® 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.
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.
Contact: Prometheus Laboratories Inc. Beth Kriegel, Senior Director, Finance and Investor Relations 858/410-2516
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.