RMTI Awaits CRUISE-2, AVNR On A High, ENTA Gets More Funds, Watch Out For ZLCS

(RTTNews) - Shares of Avanir Pharmaceuticals Inc. (AVNR) touched a new 52-week high of $5.50 on Tuesday before closing at $5.39, following the settlement of a pending patent litigation with Actavis related to Nuedexta, a drug approved to help manage uncontrollable emotional outbursts.

Avanir had sued Par, Actavis, Wockhardt, Impax and Watson to prevent them from marketing a generic version of NUEDEXTA. The 5 generic drug companies have submitted ANDA filings for Avanir's NUEDEXTA. (As part of an asset purchasing agreement Watson transferred its abbreviated new drug application to Sandoz last November).

Avanir entered into a settlement agreement with Sandoz related to the NUEDEXTA patent suit last month. Now that the patent suit has been settled with yet another company, Avanir has only three more ANDA filers on the defendant side.

Tekmira Pharmaceuticals Corp.'s (TKMR) (TKM.TO) licensee, Spectrum Pharmaceuticals Inc. (SPPI) has launched leukemia drug Marqibo in the United States and has shipped the first commercial orders. The sales of Marqibo represent a recurring revenue stream for Tekmira as the company is entitled to royalty payments based on the drug's commercial sales.

Marqibo is also under 2 phase III trials namely, in patients 60 years old with newly diagnosed acute lymphoblastic leukemia, and in elderly patients with CD20+ aggressive B-cell lymphoma.

TKMR closed Tuesday's trading at $5.39, down 0.74%.

Rockwell Medical (RMTI) is scheduled to announce top-line results from CRUISE-2 - the second phase III efficacy study of its drug candidate Soluble Ferric Pyrophosphate, or SFP, for the prevention and treatment of iron deficiency anemia in end stage renal disease or ESRD patients tomorrow.

The first phase III study for SFP, dubbed CRUISE-1, the results of which were reported in July of this year, met primary and key secondary endpoints of the study.

RMTI closed Tuesday's trading at $5.54, up 0.18%.

Oncothyreon Inc. (ONTY) has initiated an investigator-sponsored phase I trial of ONT-380 in combination with Herceptin in patients with brain metastases from HER2+ breast cancer.

ONT-380, also known as ARRY-380, is being developed by Oncothyreon in collaboration with Array BioPharma Inc. (ARRY).

The phase I trial is designed to enroll up to 50 patients. The primary objectives are to determine the maximum-tolerated dose and recommended phase II dose and schedule of ONT-380 in combination with Herceptin in patients with HER2+ breast cancer and central nervous system metastases.

ONTY closed Tuesday's trading 1.78% higher at $1.72.

Enanta Pharmaceuticals Inc. (ENTA) said it will get an additional funding of $9.2 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), for the preclinical and early clinical development of its new class of bridged bicyclic antibiotics known as Bicyclolides.

ENTA closed Tuesday's trading at $18.74, up 0.86%.

Zalicus Inc. (ZLCS) has completed patient enrollment in two phase II clinical studies of Z160 for chronic neuropathic pain indications including lumbosacral radiculopathy and postherpetic neuralgia. The company expects top-line results of both studies to be reported in the fourth quarter of 2013.

ZLCS closed Tuesday's trading 17.61% higher at $0.83. In after-hours, the stock rose another 6.57% to $0.89.