AMGN Study Meets Goal, BRLI Hits New High, DPRX On Watch, GMED Opens Wallet

(RTTNews) - Amgen's (AMGN) head-to-head phase 3 study comparing its drug candidate AMG 416 with its approved drug Sensipar (cinacalcet) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving hemodialysis has met the primary endpoint of non-inferiority.

According to the trial results, AMG 416, when compared to Sensipar, achieved a greater than 30 per cent reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels during the Efficacy Assessment Phase (EAP), defined as the period between weeks 20 and 27.

AMGN closed Wednesday's trading at $158.08, up 0.45%.

Antares Pharma Inc.'s (ATRS) ongoing phase III clinical study of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males has met the primary endpoint - with 92.7% of the enrolled patients achieving testosterone levels within the pre-defined range.

Participants in the study will remain on QuickShot Testosterone and will be followed for an additional 40 weeks, and the collection of safety data is ongoing, noted the company.

ATRS closed Wednesday's trading at 6.18% higher at $2.66.

BioMarin Pharmaceutical Inc. (BMRN) delivered another year of strong results - reporting revenue of $751 million for the full year of 2014, up 37% from last year. Looking ahead to 2015, the company expects revenue to range between $840 million and $870 million.

Drisapersen, the drug candidate for the treatment of Duchenne Muscular Dystrophy, which came into BioMarin's fold when it acquired Prosensa recently, is currently under rolling review as part of a New Drug Application with the FDA. The NDA submission is expected to be completed in April 2015 and the Marketing Authorization Application with the European Medicines Agency is expected to be submitted this summer.

The company has a couple of catalysts coming its way including, the data from the first three cohorts of a phase 2 study of BMN 111 for the treatment of achondroplasia expected late in the second quarter of 2015, proof of concept results from a phase 2 switch study of Reveglucosidase alfa (BMN 701) for the treatment of late onset Pompe Disease expected in the fourth quarter of 2015 and complete phase 1/2 results of Cerliponase alfa (BMN 190) for the treatment of late infantile CLN2 disease, a form of Batten disease, expected in the fourth quarter of 2015.

BMRN closed Wednesday's trading 1.39% higher at $107.50.

Bio-Reference Laboratories Inc. (BRLI) has launched "OnkoSight", a novel next-generation sequencing program for cancer testing - for both solid tumors and myeloid disorders.

The company said that the two new sequencing tests will significantly enhance the information that providers can obtain from the tumor itself when treating oncology patients.

BRLI touched a new high of $35.12 on Wednesday, before closing the day's trading at $35.05.

Dipexium Pharmaceuticals Inc.'s (DPRX) two pivotal phase III clinical trials, known as OneStep-1 and OneStep-2, have passed the 25% enrollment milestone, in the aggregate, with each study having enrolled nearly the same number of patients.

The OneStep Phase 3 clinical trials are evaluating Locilex (pexiganan cream 0.8%), a broad-spectrum topical antibiotic peptide for the treatment of patients with mild infections of diabetic foot ulcers.

The company anticipates completion of enrollment and release of top-line data from both trials in the second half of 2015.

DPRX closed Wednesday's trading at $13.30, down 1.99%.

Globus Medical Inc. (GMED) is all set to acquire Branch Medical Group Inc., a third party manufacturer of high precision medical devices, for $52.9 million in cash, subject to certain closing adjustments, on a cash-free, debt-free basis.

The transaction, which is slated to close next month, is expected to be neutral to Globus' 2015 earnings.

GMED closed Wednesday's trading at $25.01, down 1.07%.

Shares of Pernix Therapeutics Holdings Inc. (PTX) were up more than 8% on Wednesday after the company announced a 125% revenue growth for the fourth quarter ended December 31, 2014.

On a non-GAAP basis, adjusted net income for the fourth quarter of 2014 increased to $14.5 million or $0.25 per share from $6.3 million or $0.17 per share, a year ago. The company's net sales were $53.8 million for the fourth quarter of 2014 compared with $23.9 million for the fourth quarter of 2013, attributable primarily to sales of migraine treatment Treximet and increased sales of Silenor, indicated for the treatment of insomnia.

PTX closed Wednesday's trading at $10.34, up 8.27%.