The Burrill Report


Omeros said that it’s experimental therapy OMS103HP to cut pain and swelling in patients undergoing arthroscopic knee surgery failed in a late-stage trial. The news sent Omeros shares tumbling to less than $5 from $8. OMS103HP is a proprietary combination of the drugs ketoprofen, amytriptyline, and oxymetazoline that is injected into standard arthroscopic irrigation solutions and perfused through the joint in low concentrations during surgery. The company said no conclusions could be made regarding drug effect due to confounding factors in the studies. “Given the strength of the data from previous clinical studies of OMS103HP, we are obviously disappointed and surprised by the outcome,” says Omeros CEO Gregory Demopulos. “Our analysis of the data does not demonstrate a lack of drug effect nor does it appear to undermine the viability of our Phase 3-ready OMS103HP program for meniscectomy surgery.”

Amgen and Takeda said motesanib, their experimental treatment for non-squamous non-small cell lung cancer, failed to extend life in a late-stage clinical trial, Bloomberg reported. Motesanib works by choking off the blood supply to tumors. It’s part of a class of drugs known as VEGF inhibitors. Results from the study will be presented at a future medical meeting. The two companies have not yet decided whether to continue development of the drug. The trial also showed that motesanib carried more serious adverse events among patients treated with motesanib and chemotherapy compared with patients who received placebos and chemotherapy. This included high blood pressure, gallbladder complications, abdominal pain, diarrhea, nausea, vomiting, and fatigue.

People using a high-dose of the cholesterol drug Lipitor may have an increased risk for developing type 2 diabetes, particularly if they have several risk factors for the disease, according to a new study, Reuters reported. A number of studies have linked Lipitor and other cholesterol-lowering statin drugs to a small increase in users' risk of diabetes. The new study, published in the Journal of the American College of Cardiology, is based on a three large clinical trials that compared people taking high-dose Lipitor with either a lower dose statin or placebo. But the study also suggests that the risk may largely exist among people who also have the well-known risk factors for type 2 diabetes— including excess weight, high blood sugar, elevated triglycerides, and high blood pressure. In the study, 9 percent of the participants using Lipitor developed type 2 diabetes over five years compared to 6 percent in the placebo group.

Myrexis, formerly known as Myriad Pharmaceutical, is cutting its workforce by 41 percent as part of a reorganization to focus its resources on its current portfolio of clinical and preclinical drug candidates. The reorganization includes an immediate reduction in the company's workforce by 57 employees. The reduction was primarily in the company's internal drug discovery group and related support functions. In addition, Myrexis will close its research services business. The company will retain a critical translational science capability to continue to support the advancement of its two clinical and two preclinical programs. As a result of the reorganization, the company estimates it will generate annual expense reductions of approximately $7.2 million, primarily from savings in employee salaries and benefits and reductions in laboratory supply costs. The company will record one-time severance costs of approximately $3 million, which will be recorded in the third fiscal quarter ending March 31, 2011.

Pfizer’s subsidiary Greenstone said that it is voluntarily recalling versions of its antidepressant Citalopram and the prostate drug Finasteride that are distributed in the United States because of possibly incorrect labels on the bottles placed by a third-party manufacturer. The only lot number lot number involved in the recall is FI0510058-A. Bottles labeled as Citalopram Lot # FI0510058-A may contain Finasteride. The issue is a particular concern because of possible side effects Finasteride can have on women who take or handle the drug, such as causing abnormalities in a developing male fetus. Citalopram is contraindicated in patients taking monoamine oxidase inhibitors or pimozide, It is also contraindicated in patients with a hypersensitivity to Citalopram or any of the inactive ingredients in the tablet. Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.


April 01, 2011
http://www.burrillreport.com/article-omeros_knee_surgery_drug_fails_in_late_stage_trial.html