IDIX Sues GILD, ICPT Shows POISE, Watch Out For BDSI, SCMP Takes A Hit

(RTTNews) - BioDelivery Sciences International Inc. (BDSI) has a couple of events scheduled to happen in 2014. The company's New Drug Application for BUNAVAIL for the maintenance treatment of opioid dependence is under FDA review, with a decision date set for June 7, 2014.

A second phase III pivotal study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in opioid experienced patients is underway, and top-line results from this study are expected in mid-2014. Positive top-line results from a phase III clinical trial of BEMA Buprenorphine in opioid naive patients were reported in January of this year.

The company is also scheduled to begin the first of two phase III studies of Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy, this quarter.

BDSI closed Friday's trading at $8.88, down 1.44%.

Bristol-Myers Squibb Co.'s (BMY) oral anticoagulant Eliquis has received FDA approval in the additional indication of treating prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients who have undergone hip or knee replacement surgery.

ELIQUIS is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Bristol-Myers has a worldwide collaboration with Pfizer to develop and commercialize Eliquis.

BMY closed Friday's trading at $54, down 0.33%.

Idenix Pharmaceuticals Inc. (IDIX) has filed patent infringement lawsuits against Gilead Sciences Inc. (GILD) in France, Germany and the United Kingdom, alleging that Gilead infringes Idenix's recently-granted, co-owned European patent EP 1 523 489 that covers 2'-methyl-2'-fluoro nucleosides for treating the hepatitis C virus.

In these lawsuits, Idenix is seeking remedies with respect to Gilead's marketing and sales of drugs containing sofosbuvir, which Idenix believes infringes its European patent.

IDIX closed Friday's trading at $6.94. GILD was down 3.79% to $75.05.

Intercept Pharmaceuticals Inc. (ICPT) on Sunday announced that its phase III trial of obeticholic acid for the treatment of primary biliary cirrhosis, dubbed POISE, has successfully met the primary endpoint with high statistical significance.

The POISE trial is Intercept's third successful international, placebo controlled trial of obeticholic acid in primary biliary cirrhosis patients conducted over the past seven years.

Early this year, the company announced that its phase II trial of obeticholic acid for the treatment of nonalcoholic steatohepatitis, dubbed FLINT, met the primary endpoint. The news sent the stock soaring more than 320 percent to $305 on Jan.9, 2014.

ICPT closed Friday's trading at $462.26, up 3.19%. In after-hours, the stock fell 15.85% to $389.

Sucampo Pharmaceuticals Inc.'s (SCMP) New Drug Application for the liquid formulation of AMITIZA will not be filed in the second half of 2014 as the company has been asked by FDA to submit additional data for the new formulation.

AMITIZA in capsule formulation is already approved to treat Chronic Idiopathic Constipation in adults and to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic, noncancer pain.

SCMP closed Friday's trading at $8.04, down 1.23%. In after-hours, the stock fell another 9.20% to $7.30.