Prometheus Highlights Record Performance in 2010

SAN DIEGO, March 1, 2011 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today highlighted its financial results and product development progress for the year ended December 31, 2010.

"Prometheus had another record year in 2010, our 14th consecutive year of sales growth," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "In addition, we made significant progress advancing a number of internal development programs, including our proprietary CEER™ oncology platform and we continue to pursue additional opportunities through product licensing or with acquisitions of products."

2010 Financial Highlights

• Prometheus reported a 26% increase in net sales to $519.0 million for 2010, compared to $341.5 million in 2009. For the five-year period 2005 through 2010, the Company's net sales have grown by a compounded annual growth rate (CAGR) of 30%.
• The Company reported 2010 earnings before interest, taxes, depreciation and amortization (EBITDA) of $138.9 million and net income of $48.2 million.
• As of December 31, 2010, the Company had cash and cash equivalents of $87.8 million.

Commercial Product Highlights

• In February, Prometheus began selling Proleukin® (aldesleukin) in the United States under an exclusive distribution, promotion and selling agreement with Novartis signed in December 2009. Proleukin is a recombinant human interleukin-2 for treatment in adults with metastatic melanoma and metastatic kidney cancer. Net sales for Proleukin were approximately $64 million in the U.S. for the eleven month period that it was distributed by Prometheus in 2010.
• In July, Prometheus announced its commercial launch of its proprietary PROMETHEUS® Crohn's Prognostic test representing a significant advance in the Prometheus Inflammatory Bowel Disease (IBD) franchise of diagnostic and prognostic tests, and complements the market-leading PROMETHEUS® IBD Serology 7. The Crohn's Prognostic test combines six serologic markers and three genetic mutation markers to provide physicians with a personalized serogenetic profile for their patients.  This test helps enable physicians to quantify these patients' risk of developing disease complications and is designed to provide information to assist physicians in determining optimal treatment strategies for their Crohn's patients.
• In December, Prometheus extended its distribution agreement with AstraZeneca LP for the exclusive marketing, sales and distribution of ENTOCORT® EC (budesonide) Capsules in the United States the earlier of December 31, 2011 or 30 days after the sale of a generic equivalent in the United States.  Entocort EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn's disease involving the ileum and/or the ascending colon.  Entocort EC is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon (up to 8 weeks with repeated 8-week courses as necessary for recurring episodes of active disease), and the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.  Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of greater than or equal to 150.

Development Product Highlights

• In March, Prometheus executed a research collaboration and license agreement with Bayer Schering Pharma AG, Germany, a worldwide leading pharmaceutical company. The collaboration partners Prometheus' proprietary oncology diagnostic CEER™ platform with certain compounds in Bayer's broad oncology pipeline in an effort to stratify patients to appropriate drug candidates and potentially accelerate the development of novel oncology therapeutic products. Prometheus received an upfront payment, research and development support and testing fees, and potentially will receive additional payments upon the achievement of certain development milestones. Upfront, research and development and milestone payments could reach up to $160 million if all drug candidates are successfully developed and obtain regulatory approval.
• In May, Prometheus announced a new method for detecting antibody levels in individual patients treated with infliximab, a biologic therapy that has been used to treat more than a million patients across a number of autoimmune diseases, including rheumatoid arthritis, Crohn's disease and ulcerative colitis. Human anti-chimeric antibody (HACA) levels have been associated with decreased duration of response and increased side effects in infliximab-treated patients(1). To overcome current testing limitations, Prometheus has developed a proprietary highly sensitive method to measure HACA and infliximab levels in patient serum in real time. Prometheus believes this method can also be applied to detect other biologic drugs and their antibodies.
• In September, Prometheus and Tarrot Laboratories, a business unit of Cedars-Sinai Medical Center, entered into an exclusive research collaboration and license agreement.  The collaboration is focusing on identifying genetic or serologic markers associated with clinical responses to anti-TNF therapies such as Cimzia®, Humira® and Remicade® utilized in the treatment of Crohn's Disease, and the subsequent development of diagnostic tests.
• In December, Prometheus entered into an oncology-focused mutation analysis services agreement with Bayer Schering Pharma AG, Germany. The addition of this mutation analysis services agreement broadens Bayer's oncology-focused molecular and pathway activation profiling collaboration with Prometheus to include comprehensive mutation analyses.  The expanded information derived from this agreement has the potential to improve patient stratification in clinical studies and accelerate the development of novel oncology diagnostic and therapeutic products.
• In December, Prometheus and The Regents of the University of California, Los Angeles campus, entered into an exclusive research agreement that will focus on the identification of biological markers of mucosal healing in patients with Inflammatory Bowel Disease (IBD). The research is being led by Dr. Jonathan Braun, Chair of the Department of Pathology and Laboratory Medicine and a professor of molecular and medical pharmacology, David Geffen School of Medicine at UCLA.

About Proleukin

Proleukin (aldesleukin) for injection is a recombinant human interleukin-2 for treatment in adults with metastatic melanoma and metastatic kidney cancer. Proleukin therapy is a form of immunotherapy that enhances the body's natural immune system to help fight these types of cancer. Proleukin has been used for over 10 years in the treatment of metastatic melanoma and over 15 years in the treatment of metastatic kidney cancer (renal cell carcinoma).

Important Safety Information

Therapy with Proleukin (aldesleukin) should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

About Interleukin-2

Interleukin-2 (IL-2) is a protein that occurs naturally in the body and plays an important role in activating the immune system. The immune system protects the body from foreign substances, cells, and tissues by responding to and resisting diseases. Proleukin therapy is a genetically engineered or recombinant version of IL-2. Proleukin therapy possesses the same properties as naturally occurring IL-2 and helps activate the immune system to recognize and eliminate certain kinds of cancer cells.

Please see full Prescribing Information for Proleukin.

About Entocort EC

Entocort® EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn's disease involving the ileum and/or the ascending colon.  Entocort EC consists of an encapsulated formulation of budesonide granules, a glucocorticosteriod.  The granules are coated to protect dissolution in gastric juice, but dissolve at pH >5.5, normally when the granules reach the duodenum.  Thereafter, a matrix controls the release of the drug into the intestinal lumen in a time-dependent manner.  Eighty to ninety percent of Entocort EC does not enter the systemic circulation.  Entocort EC may reduce the incidence of some corticosteroid-associated side effects such as acne and moon face compared to prednisolone(2).

Important Safety Information

Since Entocort® EC (budesonide) Capsules is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitaryadrenal axis to stress. Supplementation with a systemic GCS is recommended before surgery or other stress situations.

Adrenocortical function monitoring may be required in patients being transferred to Entocort EC from a systemic GCS, and the dose of the systemic GCS should be reduced cautiously.

Patients on drugs that suppress the immune system are more susceptible to infections, which may be more severe, and should avoid exposure to infections such as chicken pox or measles.

Caution should be taken in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where GCSs may have unwanted effects.

Reduced liver function affects the elimination of GCSs, and increased systemic availability of oral budesonide has been observed in patients with liver cirrhosis. Patients with moderate to severe liver disease and patients who are concomitantly taking ketoconazole or any other CYP3A4 inhibitor should be closely monitored for increased signs and/or symptoms of hypercorticism. Reduction in the dose of Entocort EC should be considered in these patients. Patients should be advised to avoid consuming grapefruits and grapefruit juice while being treated with Entocort EC.

Safety and effectiveness in pediatric, geriatric, and pregnant patients have not been established. Entocort EC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.

Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Entocort EC, taking into account the clinical importance of Entocort EC to the mother and the potential for serious adverse reactions in the nursing infant.

The adverse event profile of Entocort EC in 6 mg once daily clinical trial treatment (52-week) was similar to that of 9 mg daily clinical trial treatment (8-week).  The most frequently reported adverse events in clinical trials with Entocort EC were headache, respiratory infection, nausea, and symptoms of hypercorticism.

Please see full Prescribing Information for Entocort EC.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus' corporate offices are located in San Diego, California.

(1) Afif W et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9.

(2) ENTOCORT EC (budesonide) Capsules Prescribing Information

SOURCE Prometheus Laboratories Inc.

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