SUPN In Legal Bout, NSPR Put On Notice, It's Advantage TEVA, KTWO Gets FDA Nod

(RTTNews) - InspireMD Inc. (NSPR) has been issued a notice of delisting by the NYSE MKT LLC for failure to satisfy continued listing standards of the Exchange.

The company reported stockholders' equity of less than $2 million, $4 million, and $6 million respectively, as of September 30, 2014 and had net losses in its five most recent fiscal years ended June 30, 2013.

According to the NYSE MKT, it appears questionable, as to whether InspireMD will be able to continue operations and/or meet its obligations as they mature, given the fact that the company has sustained losses that are substantial in relation to its overall operations.

NSPR closed Wednesday's trading at $0.83, down 4.97%.

K2M Group Holdings Inc. (KTWO) has received FDA clearance to market MESA 2 Deformity Spinal System, its next-generation pedicle screw system designed to address the most complex spinal pathologies.

The company expects total Q4 revenue to range between $48.7 million to $49.3 million, up approximately 15% to 16% year-over-year. The complete fourth quarter and full year 2014 financial results are expected to be reported in February.

K2M Group went public on May 8, 2014, priced at $15 per share.

KTWO closed Wednesday's trading at $19.26, down 0.10%.

Ocular Therapeutix Inc. (OCUL) has initiated a phase 2 clinical trial to evaluate the safety and efficacy of Sustained Release Dexamethasone (OTX-DP), an ophthalmic corticosteroid for the treatment of inflammatory dry eye disease. The study is designed to enrol 40 patients.

A phase III trial of OTX-DP for the treatment of post-operative ocular inflammation and pain is underway, with results expected in the first quarter of 2015.

OCUL closed Wednesday's trading at $25, up 1.54%.

Supernus Pharmaceuticals Inc. (SUPN) has sued generic drug makers TWi Pharmaceuticals Inc. and TWi International LLC for infringement of patents covering its antiepileptic drug Oxtellar XR (Oxcarbazepine Extended-Release Tablets).

TWi Pharmaceuticals and TWi International have filed an Abbreviated New Drug Application seeking approval to sell a generic version of Oxtellar XR.

Approved by the FDA in October 2012, Oxtellar XR was launched by Supernus in the United States in February 2013. The patents covering Oxtellar XR are said to expire on April 13, 2027.

Another company that is looking to launch generic Oxtellar XR is Actavis plc (ACT), and Supernus had filed patent infringement lawsuit against Actavis in August 2013.

Supernus' second marketed product - Trokendi XR - an epilepsy drug is also facing patent challenge. Trokendi XR, which received final approval from FDA in June 2013, was launched in the U.S. in September of that year. Patent protection for Trokendi XR expires no earlier than 2027.

Par Pharmaceutical Inc. is seeking to market a generic version of Trokendi XR, and Supernus sued Par Pharma for infringement of patents earlier this month.

Oxtellar XR and Trokendi XR are the company's two marketed drugs, and together they accounted for $22.45 million in net product sales in Q3, 2014 compared to $1.13 million in net product sales in Q3, 2013.

SUPN closed Wednesday's trading at $8.52, down 5.53%.

This time, it is advantage Teva Pharmaceutical Industries Ltd. (TEVA) in the patent infringement lawsuit concerning its multiple sclerosis drug Copaxone as the Supreme Court has ruled in favour of the Israeli company.

Reversing the Federal Circuit Court's judgment of invalidity of Teva's patent for Copaxone, the Supreme Court has remanded the case back to the Federal Circuit for further review.

A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, and had invalidated another patent (the '808 patent) that is set to expire on September 1, 2015.

The ruling by the Supreme Court now means that entry of generic Copaxone is going to be delayed at least until September 2015.

Momenta and its partner Sandoz, a unit of Novartis AG (NVS), filed an Abbreviated New Drug Application for a generic version of Copaxone in December 2007, including a paragraph IV certification in their filing, which asserts that the patents are invalid, unenforceable, or will not be infringed. Teva filed a suit against Momenta and its partner for patent infringement in August 2008.

Momenta and Sandoz are not the only companies that have sought approval for a generic version of Copaxone. Mylan Inc. (MYL) and Natco Pharma Ltd have also filed an ANDA for generic Copaxone, and Teva has sued these two companies as well for patent infringement.

TEVA closed Wednesday's trading at $58.49, up 0.09%.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has initiated a phase I clinical trial of TKM-HBV, a therapeutic agent designed to reduce hepatitis B surface antigen in patients chronically infected with hepatitis B virus.

TKMR closed Wednesday's trading 2.71% higher at $24.25.