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
Commercial Product Highlights
Development Product Highlights
About ProleukinProleukin (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 InformationTherapy 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-2Interleukin-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 ECEntocort® 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 InformationSince 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 PrometheusPrometheus 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.Proleukin is a registered trademark of Novartis.ENTOCORT is a registered trademark of the AstraZeneca group of companies. CIMZIA is a registered trademark of the UCB group of companies.HUMIRA is a registered trademark of Abbott Laboratories.REMICADE is a registered trademark of Centocor Ortho Biotech Inc.(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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