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OCLS, INSV Spike, FDA Panel Nod For JNJ, SNSS VALOR On Track, PIP's Day In Court


Oculus Innovative Sciences Inc. (OCLS) rose over 13% to close Thursday's trading at $0.77 following news that its board of directors has unanimously approved a spin-off of its novel biotechnology business, Ruthigen Inc.

The spinoff is expected to be a tax-free stock distribution and Ruthigen is anticipated to become an independent NASDAQ-traded company.

InSite Vision Inc. (INSV.OB) rose 5.97% to close Thursday's trading at $0.35 after the company announced it has completed dosing and evaluation in a phase III clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery. Top-line data from this trial will be available in the first quarter of 2013.

Another phase III study for BromSite will be finalized pending full input from both the U.S. Food and Drug Administration and European regulatory authorities, according to the company.

Johnson & Johnson's (JNJ) subsidiary, Janssen Research & Development, on Thursday said that an FDA panel voted 10-5 recommending approval of Canagliflozin, whose proposed trade name is INVOKANA, to treat type 2 diabetes in adult patients. The FDA's final decision is scheduled for March 31, 2013.

Intellipharmaceutics International Inc. (IPCI) said Thursday that it has closed its previously announced US$1.5 million convertible debenture financing, which will mature January 1, 2015.

The company is focused on developing controlled-release and targeted pharmaceutical products using its proprietary Hypermatrix technology.

IPCI closed Thursday's trading 2.12% higher at $2.41.

Aegerion Pharmaceuticals Inc. (AEGR) intends to offer for sale its common stock in an underwritten public offering. Last December, the FDA approved the company's JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia. The company expects 2013 to be a transformational year as it works to execute on its launch plan of JUXTAPID.

Aegerion continues to anticipate a European Medicines Agency decision on JUXTAPID in mid-2013.

AEGR has traded in a 52-week range of $11.75 to $28.04. The stock closed Thursday's trading at $26.64, down 3.16%. In after-hours, the stock was up 1.73% to $27.10.

Sunesis Pharmaceuticals Inc. (SNSS) announced Thursday that enrollment in its pivotal phase III study, dubbed VALOR, which is evaluating Vosaroxin in combination with Cytarabine in patients with relapsed or refractory acute myeloid leukemia, or AML, has reached 500 patients. The company expects to reach the target enrollment of 675 patients in the study this year. A planned interim safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board is scheduled for June, 2013.

PharmAthene Inc. (PIP) has concluded oral arguments before the Delaware Supreme Court, which represent the final stage before a ruling from the Delaware Supreme Court, in its on-going litigation against SIGA Technologies.

Last May, Delaware Court of Chancery ruled that PharmAthene be awarded 50% of the net profits over a period of ten years from all sales of SIGA's smallpox antiviral therapeutic, Arestvyr and related products, after SIGA receives the first $40 million in net profits, as well as a portion of the attorney's fees and other costs. SIGA had appealed the final judgment of Delaware Court of Chancery.

PIP closed Thursday's trading at $1.13. In after-hours, the stock rose 1.77% to $1.15.

BioTime Inc. (BTX) announced it has submitted a Clinical Investigation Protocol to European regulatory authorities for approval to initiate human clinical of Renevia in Europe.

Renevia is a proprietary formulation that mimics the human extracellular matrix, a web of molecules surrounding cells that is essential to cellular function. The initiation of human clinical studies is expected in Q2 of this year upon approval of the Clinical Investigation Protocol.

BTX closed Thursday's trading 4.55% higher at $4.37.

by RTTNews Staff Writer

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