SAN DIEGO, Dec. 1 /PRNewswire/ — Prometheus Laboratories Inc., a specialty pharmaceutical company, announced today that it has entered into an agreement with AstraZeneca LP for the exclusive marketing, sales and distribution of Entocort(R) EC (budesonide) Capsules in the United States beginning January 1, 2005. Entocort EC is the only FDA approved drug indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. It is anticipated that net sales for Entocort EC will approximate $30 million for AstraZeneca in 2004.
“Consistent with our strategy to gain access to and build our pharmaceutical business with proprietary products, we are excited to have entered into this agreement with AstraZeneca. Entocort EC is extremely well-suited to our existing business and we believe that it offers tremendous benefits to patients,” said Joseph M. Limber, President and Chief Executive Officer of Prometheus. “We anticipate that Entocort EC will provide a significant commercial opportunity for Prometheus and will be the first of a number of proprietary products which we believe will be integral to the growth of our company.”
“AstraZeneca is pleased to have entered into this agreement with Prometheus,” said Jim Helm, Vice President, AstraZeneca, AZENITY Business unit. “As a company that focuses on the diagnosis and treatment of gastrointestinal diseases, Prometheus is well positioned to continue the work that AstraZeneca has started of educating patients and physicians on the benefits and appropriate use of Entocort EC. This partnership will help ensure that patients and physicians are aware of Entocort EC as an important therapeutic option.”
Entocort EC is a first-line therapy and the only pharmacological product indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. Entocort EC is a non-systemic glucocorticosteriod, which means that it works locally or in one area of the body. AstraZeneca launched Entocort EC Capsules in November 2001. The most common side effects of Entocort EC observed in clinical trials were headache, respiratory infection, nausea and symptoms of hypercorticism.
The five-year agreement includes an upfront payment with potential milestones and royalties based on sales. AstraZeneca will continue to manufacture the product and is responsible for all clinical and regulatory processes relating to the product. Specific terms of the agreement are not being disclosed.
Crohn’s disease is a chronic inflammatory bowel disease of unknown origin. An estimated 500,000 Americans have the disorder. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhea, abdominal pain, fever and sometimes rectal bleeding. The condition can be difficult to manage clinically and consumes a substantial amount of healthcare resources in terms of physician time, procedures and medications.
