Labopharm's ( DDSS) mutually exclusive frustration with the Food and Drug Administration was balanced by positive study results from other health companies Friday, flattening stock indices at the end of the holiday-shortened week. Labopharm was down $3.19, or 50.1%, to $3.11 after the drugmaker announced the FDA issued a
second approvable letter saying the company hasn't demonstrated the efficacy of its once-daily formulation of pain-reliever Tramadol. Research firm Leerink Swann downgraded Labopharm from outperform to market perform Friday morning. Labopharm competitor Biovail ( BVF), which makes painkiller Ultram ER, offered news as well. It restated its 2004, 2005 and 2006 financial results in a filing with the Securities and Exchange Commission due to an error it found while preparing first-quarter results for 2007. Among a few other changes in the restatement, the company said it earned $1.32 a share rather than $1.27 in 2006, $1.54 a share instead of $1.48 in 2005 and $1 a share instead of $1.01 a share in 2004. Biovail shares were up $1.20, or 5%, to $25.46. Other companies increased modestly after announcements of study results. Among them was Ista Pharmaceuticals ( ISTA), which said the preliminary analysis of its phase IIb clinical trial of ecabet sodium, for dry eye, are positive. The trial is looking to confirm observations from prior clinical trials on the treatment and was not focusing on statistical significance. However, the company said ecabet sodium did achieve statistical significance in the Ocular Symptom Disease Index assessment.
Ista said there were no reports of serious ocular adverse events compared with placebo, and further analyses of the results are ongoing. It plans to start phase III studies in 2008. After initially climbing, Ista was recently hugging the flatline. Ista is part of the Nasdaq Biotechnology Index, which was up 1.11, or 0.1%, at 836.37. Gentium ( GENT) said the results of an independent study from Royal Marsden Hospital in the U.K. suggest the investigational drug Defibrotide, a preventive treatment for postallogeneic stem-cell-transplant patients, reduces the risk of veno-occlusive disease and hemorrhagic complications. The study was published in the journal Bone Marrow Transplant. The drug has been granted orphan-drug status by the FDA to prevent and treat severe VOD and fast-track designation for the treatment of severe VOD in recipients of stem-cell transplants. It's in a U.S. phase III trial to treat severe VOD and a European phase II/III trial to prevent VOD in pediatric patients. Shares rose 38 cents, or 2.2%, to $17.58. Preclinical data also nudged Novavax ( NVAX) and EntreMed ( ENMD) higher on Friday. Novavax presented preclinical data at the Second International Conference on Avian Influenza in Humans that suggested its pandemic influenza vaccine provided protection against a lethal challenge of live H5N1 viruses. The biopharmaceutical stock rose 21 cents, or 6.9%, to $3.11. At the second Protein Kinases in Drug Discovery Conference in Boston, EntreMed said that its Aurora Kinase Inhibitor induced regression in tumors in preclinical xenograft models of human leukemia. The stock was up 18 cents, or 10%, to $1.97.