ACT Gets Its Act Right, AKRX Shrivels, CUPID2 Misses Targets, GWPH On A High

(RTTNews) - Actavis plc's (ACT) phase III study comparing a single 1500 mg dose of DALVANCE with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus, has demonstrated positive results.

The study achieved its primary endpoint of non-inferiority to the two-dose regimen at 48-72 hours after initiation of therapy.

DALVANCE was approved by the FDA in May 2014 as a 2-dose regimen of 1000 mg followed 1 week later by 500 mg to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.

Actavis plans to file a supplemental New Drug Application for Single-Dose DALVANCE in Q3 2015.

ACT closed Friday's trading at $295.41, down 0.99%.

Shares of Akorn Inc. (AKRX) were down more than 13% in after-hours trading on Friday after the company announced that it will restate its previously issued financial statements for the annual period ending December 31, 2014 and the quarterly periods ending June 30, 2014, September 30, 2014 and December 31, 2014 due to errors identified during the first quarter 2015 financial review process.

AKRX closed Friday's trading at $55.24, down 1.22%. In after-hours, the stock shed 13.40% to $47.84.

Celladon Corp.'s (CLDN) phase 2b trial of MYDICAR in advanced heart failure has failed to meet its primary and secondary endpoints.

In the study, dubbed CUPID2, MYDICAR was evaluated against placebo added to a maximal, optimized heart failure regime. The primary endpoint was time to recurrent heart failure related events (defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure) and the secondary efficacy endpoint was time to first terminal event (defined as all-cause death, heart transplant or placement of a mechanical circulatory support device).

In the phase 2a trial of MYDICAR, known as CUPID 1, the drug candidate was found to be safe and well-tolerated, reduced heart failure-related hospitalizations, improved patients' symptoms and quality of life, and improved key markers of cardiac function predictive of survival.

CLDN closed Friday's trading at $13.68, down 1.87%.

Eli Lilly & Co.'s (LLY) cancer drug CYRAMZA has received FDA approval for yet another indication - this time in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. This marks the fourth FDA approval for CYRAMZA in the U.S.

CYRAMZA is already approved for use as a single agent or in combination with Paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with Docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy.

Lilly launched CYRAMZA in the U.S. last June. The drug generated sales of $67.5 million in Q1, 2015.

GW Pharmaceuticals plc (GWPH) has received orphan drug designation for Cannabidiol for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy, or NHIE in short.

NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth.

The company expects to submit an Investigational New Drug Application for intravenous Cannabidiol formulation for this rare pediatric conditions in mid-2015 and to commence a phase I trial in the second half of 2015.

GWPH touched a new high of $122.82 on Friday before closing the day's trading at $121.