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isis pharmaceuticals inc (ISI) Details

Isis Pharmaceuticals, Inc. is engaged in the discovery and development of antisense drugs using novel drug discovery platform. The company’s flagship product includes the KYNAMRO injection, which is an apo-B synthesis inhibitor for patients with homozygous familial hypercholesterolemia; and for the reduction of low-density lipoprotein cholesterol. It also has a pipeline of 31 drugs in development for the treatment of various diseases, including cardiovascular and metabolic diseases; severe and rare diseases, including neurological disorders; and cancer. The company has strategic alliances and collaboration agreements primarily with AstraZeneca AB, Biogen Idec MA Inc., Bristol-Myers Squibb, Eli Lilly and Company, Genzyme Corporation, GlaxoSmithKline, Hoffman-La Roche Inc., F. Hoffmann-La Roche Ltd., Alnylam Pharmaceuticals, Inc., Antisense Therapeutics Limited, Excaliard Pharmaceuticals, Inc., iCo Therapeutics Inc., OncoGenex Technologies Inc., and Xenon Pharmaceuticals Inc. Isis Pharmaceuticals, Inc. was founded in 1989 and is headquartered in Carlsbad, California.

365 Employees
Last Reported Date: 03/3/14
Founded in 1989

isis pharmaceuticals inc (ISI) Top Compensated Officers

Founder, Executive Chairman, Chief Executive ...
Total Annual Compensation: $1.1M
Chief Operating Officer, Corporate Secretary ...
Total Annual Compensation: $898.2K
Senior Vice President of Antisense Research
Total Annual Compensation: $546.0K
Senior Vice President of Development
Total Annual Compensation: $541.9K
Senior Vice President of Drug Discovery & Cor...
Total Annual Compensation: $524.3K
Compensation as of Fiscal Year 2012.

isis pharmaceuticals inc (ISI) Key Developments

Isis Pharmaceuticals, Inc. Reports Final Phase 2 Data on ISIS-APOCIII Rx in Patients with High Triglycerides Taking Fibrates

Isis Pharmaceuticals, Inc. announced the final results from its Phase 2 study of ISIS-APOCIII(Rx) in patients with high to severely high triglycerides on stable doses of fibrates. In this study, patients treated with ISIS-APOCIII(Rx) achieved average reductions of up to 71% in apolipoprotein C-III (apoC-III) and up to 64% in triglycerides, and average increases of up to 52% in high-density lipoprotein cholesterol (HDL-C), the 'good' cholesterol. While the starting average triglyceride level in the 300 mg group was 384 mg/dL, 70% of these patients reduced their triglyceride level to below the normal level of 150 mg/dL. In addition, lipoprotein particle analysis showed significant dose-dependent reductions in the number of very low-density lipoprotein (VLDL) particles and significant increases in the number of HDL particles. These new data for ISIS-APOCIII(Rx) were presented by Dr. Vickie Alexander at the American College of Cardiology meeting in Washington DC. The Phase 2 study of ISIS-APOCIII(Rx) was a double-blind, randomized, placebo-controlled 13 week study designed to assess the safety and activity of 200 mg and 300 mg doses of ISIS-APOCIII(Rx). The data reported are the final data analysis (including treatment and follow up period through day 176) in patients with high to severely high triglyceride levels on stable doses of fibrates. Isis reported an interim analysis of these data in July 2013. Consistent with the interim analysis, ISIS-APOCIII(Rx) produced statistically significant mean percent reductions from baseline in triglycerides and apoC-III and apoC-III-associated VLDL in both dose cohorts. Furthermore, patients treated with ISIS-APOCIII(Rx) demonstrated a rapid, prolonged and statistically significant mean percent increase from baseline in HDL-cholesterol in both dose cohorts. The effects of ISIS-APOCIII(Rx) observed on these lipid parameters were sustained for at least six weeks after the last dose and in addition to those achieved with each patient's existing therapeutic regimen of fibrates. In addition to measuring changes in lipoprotein cholesterol levels in the blood, changes in lipoprotein particle numbers were evaluated in these patients. In this study, patients treated with ISIS-APOCIII(Rx) demonstrated dose-dependent reductions in atherogenic particle numbers and increases in HDL-C particle numbers compared to placebo. These results are consistent with the observed changes in lipoprotein cholesterol levels in the blood and provide further evidence of enhanced clearance of triglycerides associated with reduction of apoC-III. In this study 28 patients received either 200 mg or 300 mg dose of ISIS-APOCIII(Rx) or placebo via weekly subcutaneous injections. All patients were on stable doses of fibrates with average baseline levels of fasting triglycerides between 282 and 457 mg/dL. The three groups of patients were reasonably well balanced in baseline characteristics. In this study, ISIS-APOCIII(Rx) was found to be generally safe and well tolerated. The most common adverse event was injection site reactions, which were infrequent and consisted of mild erythema that typically resolved within one to two days. In this study, there were no flu-like symptoms, no elevations of liver enzymes greater than three times upper limit of normal, no abnormalities in renal function and no clinically meaningful changes in other laboratory values. As previously reported in July, there was one treatment-related serious adverse event reported, which resolved completely. ISIS-APOCIII(Rx) is an antisense drug intended to treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents. ISIS-APOCIII(Rx) targets apoC-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides. Humans who do not produce apoC-III have lower levels of triglycerides and lower instances of cardiovascular disease. Humans with elevated levels of apoC-III have high triglycerides associated with multiple metabolic abnormalities, such as insulin resistance and/or metabolic syndrome. In addition, the prevalence of type 2 diabetes is increased in patients with elevated triglycerides. Humans with severely elevated levels of triglycerides are at risk of many serious health conditions, including pancreatitis, which can be life-threatening and require hospitalization.

Isis Pharmaceuticals, Inc. Announces Preclinical Data from Hepatitis B Virus, Infection Study with ISIS-HBVRx in Animal Models

Isis Pharmaceuticals, Inc. has announced preclinical data from hepatitis B virus, or HBV, infection study with ISIS-HBVRx in animal models. The company has announced that treatment with an antisense compound targeting hepatitis B virus (HBV) produced dose-dependent reductions in all measured liver and serum viral markers of HBV infection in animal models of HBV infection. Isis is currently evaluating antisense targeting of HBV with ISIS-HBVRx in a Phase I study in healthy volunteers. These preclinical data, which will be presented by Dr. Gaetan Billioud from The Scripps Research Institute during a presentation on April 12 at EASL, demonstrate that antisense targeting of HBV RNA could be an effective approach to treating patients with chronic HBV infection. In this study, an antisense compound targeting HBV produced dose-dependent reductions of HBV-associated antigens, including HBsAg hepatitis B surface antigen), which is present in both acute and chronic infections and is associated with a poor prognosis in patients with chronic HBV infection. In addition, other measures of viral infection were reduced in both the liver and serum in this mouse model of disease. The Phase I study of ISIS-HBVRx is a randomized, placebo-controlled, dose-escalation study in approximately 30 healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of ISIS-HBVRx. ISIS-HBVRx, formerly referred to as ISIS-GSK3Rx, is an investigational drug that is designed to target viral mRNA and reduce the production of viral proteins associated with HBV infection and replication. ISIS-HBVRx is part of Isis' alliance with GSK. Isis will develop ISIS-HBVRx to completion of Phase II proof-of-concept, after which GSK has an exclusive option to in-license and further develop and commercialize ISIS-HBVRx. Isis has already earned $10 million in milestone payments from GSK for ISIS-HBVRx and is eligible to earn additional pre-licensing milestone payments from GSK as ISIS-HBVRx advances in development. Isis is also eligible to receive double-digit royalties on sales of ISIS-HBVRx.

Isis Pharmaceuticals Initiates Phase 1 Study of ISIS-ANGPTL3 Rx to Treat Hyperlipidemia

Isis Pharmaceuticals, Inc. announced that it has initiated a phase 1 clinical study for ISIS-ANGPTL3(Rx), an antisense drug targeting angiopoietin-like 3 protein (ANGPTL3), an independent risk factor for cardiovascular disease. ISIS-ANGPTL3(Rx) is designed to act as a broad dyslipidemia agent. By reducing ANGPTL3, ISIS-ANGPTL3(Rx) has the potential to reduce LDL-cholesterol and triglycerides, and to increase insulin sensitivity. Isis plans to evaluate ISIS-ANGPTL3(Rx) in patients who have severe metabolic or cardiovascular disease and who would benefit from a drug that simultaneously addresses a variety of adverse lipid and metabolic parameters contributing to their disease. The phase 1 study of ISIS-ANGPTL3(Rx) is a blinded, placebo-controlled, dose-escalation study in approximately 48 healthy volunteers. The study is designed to assess the safety, tolerability and pharmacokinetics of both single and multiple doses of ISIS-ANGTPL3(Rx).


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