SPRING Makes AMPE Jump, AVNR Buys Peace, FRX Delays NDA Submission

(RTTNews) - Advaxis Inc. (ADXS.OB) has been granted Orphan Drug Designation by FDA for the company's lead drug candidate - ADXS-HPV, for the treatment of human papillomavirus (HPV)-associated anal cancer. A phase 1/2 study being coordinated by Brown University Oncology Group is evaluating the safety and efficacy of ADXS-HPV when combined with standard chemotherapy and radiation treatment in patients with anal cancer.

ADXS.OB closed Wednesday's trading at $3.21, up 4.56%.

Alnylam Pharmaceuticals Inc. (ALNY) plans to file an investigational new drug application for ALN-AT3 for the treatment of hemophilia in the fourth quarter of 2013 and initiate a phase I clinical trial in early 2014.

ALN-AT3 has been granted an Orphan Drug Designation for the treatment of hemophilia B.

ALNY closed Wednesday's trading at $48.76, up 0.41%.

Ampio Pharmaceuticals Inc.'s (AMPE) lead biologic candidate Ampion for the chronic treatment of pain in osteoarthritis of the knee has demonstrated a clinically meaningful reduction in pain in patients in a phase III study, dubbed SPRING, even with a single intra-articular injection of Ampion.

The company noted that detailed 12 week data analysis from the SPRING study will be released following discussions with the FDA and will be presented at upcoming medical conferences.

AMPE rose 15.30% to close Wednesday's trading at $6.18.

Avanir Pharmaceuticals Inc. (AVNR) set a new 52-week high of $5.21 on Wednesday before closing at $5.05 following news of a settlement agreement with Sandoz related to Avanir's marketed drug NUEDEXTA.

Avanir's NUEDEXTA is the first and only FDA-approved treatment for pseudobulbar affect.

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 NUEDEXTA. (As part of an asset purchasing agreement Watson transferred its abbreviated new drug application to Sandoz last November).

Now that Avanir and Sandoz have resolved their litigation, Sandoz has been granted the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances.

The two companies have also agreed to file a stipulation and order of dismissal with the United States District Court for the District of Delaware which will conclude this litigation with respect to Sandoz.

The settlement does not end Avanir's ongoing litigation against the other four ANDA filers.

BIOLASE Inc. (BIOL), a biomedical company, was up more than 29 percent in Wednesday's extended trading to $1.55 after the company dismissed speculation that it is in a liquidity crunch and must raise a large amount of money to continue its operations.

In order to settle the confusion in the marketplace, the company announced that it has decided to reduce total offering on Form S-3 to $5 million from $30 million. BIOLASE clarified that it is entering into its 'high season' from September to December where it generates a large percentage of its revenue and generates cash.

Chelsea Therapeutics International Ltd. (CHTP) has submitted additional information to FDA to resolve certain technical deficiencies in the company's resubmitted NORTHERA NDA.

The company is seeking approval for NORTHERA as a treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure.

The FDA issued a complete response letter for NORTHERA last March and asked the company to submit additional clinical efficacy data.

The company resubmitted the NORTHERA NDA, which included data from an additional study, on July 9, 2013. The resubmitted NORTHERA NDA was accepted by the FDA last month and was assigned a decision date of January 3, 2014.

However on July 29, the FDA notified the company of certain technical deficiencies in the resubmission that will require resolution prior to the resubmission being deemed a complete response. It is in response to this notification that Chelsea submitted additional information on Wednesday.

CHTP closed Wednesday's trading 1.08% higher at $2.82.

DARA BioSciences Inc. (DARA), which has been seeking orphan drug status for its drug candidate KRN5500, said that it has provided additional information regarding the same as requested by FDA on August 8, 2013. KRN5500 is under phase II testing for the treatment of painful, treatment-refractory, chronic chemotherapy-induced peripheral neuropathy.

DARA rose more than 4% in after-hours on Wednesday to $0.63.

Forest Laboratories Inc. (FRX) and Spain-based Almirall SA announced that the planned Q4 2013 submission of a New Drug Application for the combination of aclidinium bromide and formoterol fumarate for the indication of Chronic Obstructive Pulmonary Disease has been delayed to resolve chemistry, manufacturing and control specifications associated with the combination formulation.

FRX closed Wednesday's trading at $43.28, down 0.14%.

Galectin Therapeutics Inc. (GALT) expects top line clinical results from a phase I study of GR-MD-02 in patients with fatty liver disease with advanced fibrosis to be reported sometime late in 2013 or early 2014.

Synthetic Biologics Inc. (SYN) expects topline results from a phase II study of multiple sclerosis candidate, Trimesta, in the first half of 2014. The company expects to initiate a preclinical program for Pertussis (whooping cough) in 3Q, 2013 and IND-enabling study in 4Q, 2013.

SYN closed Wednesday's trading at $1.46, down 2.67%.