DEPO Prevails In Markman Hearing, IDIX, KBIO Get Smacked, ONVO Ahead Of Target

(RTTNews) - Depomed Inc. (DEPO) touched a new 52-week high of $12.88 on Wednesday before closing at $11.91, following a favorable "Markman" claim construction ruling in its ongoing patent infringement case against three filers of Abbreviated New Drug Applications for a generic version of Gralise product.

Depomed markets Gralise, an extended-release formulation of Gabapentin, for the management of postherpetic neuralgia.

Since its launch in October 2011, the product sales of Gralise have increased - $508 thousand in 2011; $17.3 million in 2012 and 24.1 million in the nine months ended Sep.30, 2013.

In a patent interference dispute between Idenix Pharmaceuticals Inc. (IDIX) and Gilead Sciences Inc's (GILD) subsidiary, Gilead Pharmasset LLC., involving certain 2'-methyl-2'-fluoro nucleoside compounds useful in the treatment of hepatitis C virus, the United States Patent and Trademark Office Patent Trial and Appeal Board has ruled in favor of Gilead.

Patent interference proceedings determine which party is entitled to a patent when two or more parties claim patent rights to the same technology.

Idenix said it does not believe that the patent application at issue in the interference is relevant to any of the compounds currently under clinical development, including Samatasvir, which is in two ongoing 12-week phase II all-oral HCV combination studies, or IDX21437, which is in an ongoing phase I/II clinical trial.

IDIX fell 10.45% on Wednesday to close at $7.20. In extended trading, the stock dropped another 5.14% to $6.83.

KaloBios Pharmaceuticals Inc. (KBIO) fell more than 29 percent to $3.29 in extended trading on Wednesday after it announced that a phase II study of KB003, its anti-GM-CSF monoclonal antibody (mAb), in patients with severe asthma failed to meet its primary clinical endpoint of improvement in FEV1 (a measurement of pulmonary function) compared to placebo.

Organovo Holdings Inc. (ONVO) announced it has delivered its 3D Liver tissue to a laboratory outside of the company to a key opinion leader for experimentation, well ahead of its April 2014 target date.

The company expects key opinion leaders to make recommendations on improvements to the tissue before launch and to influence peers through their reporting of their research results at conferences and through peer reviewed publications.

ONVO rose 10.22% to close Wednesday's trading at $9.60. In after-hours, the stock was up another 2.81% to $9.87.

As the first of several new kits in its pipeline for healthcare-associated infections, QIAGEN N.V. (QGEN) has submitted its 510(k) application to FDA seeking clearance for C. difficile test. Along with the C. difficile test, the company has also submitted the automation platform QIAsymphony RGQ MDx to the U.S. regulatory agency.

QIAGEN launched the C. difficile test in Europe after receiving CE-marking last December.

QGEN closed Wednesday's trading at $22.55, down 2.25%.

Trinity Biotech plc.'s (TRIB) high sensitivity Troponin I product - Meritas - which allows doctors to evaluate whether or not patients are having a heart attack within a short time of admission has received European approval.

The company intends to immediately launch Meritas for sale in Europe and other selected markets through its specialist Cardiology Distributor network.

Trinity also plans to immediately commence US clinical trials for the product.

TRIB closed Wednesday's trading 3.20% higher at $25.82.