Eagle Soars, VBLT Crushed Over Drug Failure, Study Fails To Soothe CLTX

(RTTNews) - The U.S. patent rights for AstraZeneca plc's (AZN) asthma drug Pulmicort Respules was rendered invalid by the United States District Court for the District of New Jersey on February 13, 2015, following which Actavis plc (ACT) immediately launched its generic version of the drug.

In consideration of AstraZeneca's request for an injunction pending appeal, the United States Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules. A response for the hearing is due to the Court from Actavis by February 20, 2015.

Under an agreement with AstraZeneca, Teva launched a generic Pulmicort Respules product in the U.S. in November 2008. For the 12 months ended June 30, 2014, total U.S. brand and generic sales of Pulmicort Respules were approximately $1.1 billion.

ACT touched a new high of $288.80 on Tuesday before closing the day's trading at $286.90.

Celsus Therapeutics plc (CLTX) plunged 81% on Tuesday after the company announced that its phase II trial of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis failed to meet the primary endpoint.

The trial enrolled 73 children with mild to moderate atopic dermatitis into a four-week double-blind period, followed by a four-week open label extension for those patients who wished to continue in the trial. According to the trial results, MRX-6 cream did not demonstrate a difference in mean change from baseline to Day 28 in the Investigator's Global Assessment.

CLTX slipped 81.36% on Tuesday to close at $1.15.

Cytori Therapeutics Inc. (CYTX) announced that the first patient has been treated in its phase II trial evaluating the efficacy and safety of autologous adipose derived therapy ECCO-50 for osteoarthritis of the knee.

The trial, dubbed ACT-OA is designed to enrol 90 patients.

CYTX closed Tuesday's trading at $0.47, up 0.94%.

Eagle Pharmaceuticals Inc. (EGRX) has submitted a New Drug Application for Bendamustine Rapid Infusion to the FDA, seeking approval of the product for the treatment of patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.

The company anticipates the regulatory agency's decision in mid-August or mid-December, depending on whether its request for Priority Review is granted.

Eagle Pharma has entered into an exclusive license agreement for the Bendamustine product with Teva Pharmaceutical Industries Ltd. (TEVA). The agreement entitles Eagle to receive an upfront payment of $30 million and up to $90 million in additional milestone payments. In addition, Eagle will receive double digit percentage royalties on future net sales of the product.

EGRX climbed 24.40% on Tuesday to close at $26.25.

Ignyta Inc.'s (RXDX) lead product candidate Entrectinib has been granted orphan drug designation by the FDA for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Entrectinib is currently in two Phase I/II clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial.

Ignyta, which was trading over the counter, commenced trading on the NASDAQ Capital Market on March 14, 2014, priced at $9.15 per share.

RXDX closed Tuesday's trading at $6.90, down 0.14%.

Oncolytics Biotech Inc. (ONC.TO) (ONCY) has been granted Orphan Drug Designation by the FDA for its lead product candidate REOLYSIN, for the treatment of pancreatic cancer.

This is the second indication for which REOLYSIN has received the Orphan Drug Designation - with the first one being for the treatment of ovarian cancer.

The company's current clinical program comprises human trials using REOLYSIN both alone and in combination with chemotherapy, delivered via local and/or intravenous administration in numerous cancer types.

In the indication of metastatic pancreatic cancer, a phase II study of intravenous administration of REOLYSIN in combination with Paclitaxel and Carboplatin is ongoing. In the indication of ovarian cancer, a phase II study of intravenous administration of REOLYSIN in combination with Paclitaxel is underway.

ONCY rose 40.32% on Tuesday to close at $0.72.

pSivida Corp.'s (PSDV) initial nationwide shipments of ILUVIEN for diabetic macular edema are scheduled to begin in the U.S. on February 23, 2015. ILUVIEN, licensed to Alimera Sciences Inc. (ALIM), was approved by the FDA last September.

pSivida is entitled to 20% of net profits on the sales of ILUVIEN on a country-by-country, quarter-by-quarter basis.

ILUVIEN has also received marketing authorization approvals in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom.

PSDV closed Tuesday's trading at $4.39, up 4.77%.

Rosetta Genomics Ltd. (ROSG) surged more than 31% on Tuesday, following the receipt of a Notice of Allowance from the United States Patent and Trademark Office for a patent claiming the use of miR-34a for the treatment of p53-associated cancers.

In addition, the company announced its first allowance from the European Patent Office for a patent claiming the specific composition for miR-451, a miR relating to its Cancer of Unknown Primary (CUP) testing franchise.

ROSG closed Tuesday's trading 31.51% higher at $4.80.

Shares of VBL Therapeutics (VBLT) cratered nearly 66% after the company announced that its phase 2 studies evaluating its drug candidate VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints.

The company does not plan to continue development of VB-201 in the above indications.

In other news, the FDA has given the go-ahead for the company to proceed with a pivotal phase 3 trial of VB-111 in recurrent glioblastoma following removal of the clinical hold previously imposed on the study. VBL plans to initiate this trial in mid-2015 under a special protocol assessment with the FDA.

VBLT slumped 65.49% on Tuesday to close the day's trading at $4.87.