ATRC On The GO, BMRN Gets Panel's Nod, CLVS Opens Purse Strings, POZN Surges

(RTTNews) - AtriCure Inc. (ATRC) has been given the go-ahead by FDA to begin enrollment in a clinical study of its AtriClip Left Atrial Appendage Exclusion System. The study will evaluate the use of the AtriClip device to prevent stroke in patients with atrial fibrillation.

The company noted that the study is significant because it is the first of its kind to focus entirely on a group of untreated and undertreated atrial fibrillation patients that may benefit the most from total and permanent exclusion of their left atrial appendage.

ATRC closed Tuesday's trading 1.39% higher at $14.55.

BioMarin Pharmaceutical Inc.'s (BMRN) drug candidate for the treatment of Morquio A syndrome - Vimizim, has been recommended for approval by an FDA panel.

Morquio A syndrome is a rare congenital disorder caused by the absence or malfunctioning of an enzyme involved in an important metabolic pathway, leading to problems with bone development, growth and movement.

The FDA's final decision on Vimizim is scheduled for February 28, 2014.

BMRN closed Tuesday's trading at $66.91, unchanged from the previous day's close. In after-hours, the stock was up 4.77% to $70.10.

Biota Pharmaceuticals Inc. (BOTA) has commenced dosing in two phase I clinical trials of laninamivir octanoate, its long-acting neuraminidase inhibitor being developed for the treatment of influenza.

The top-line results from both the studies are expected in the first half of 2014.

BOTA closed Tuesday's trading at $3.90, up 0.52%.

Clovis Oncology (CLVS) has acquired Ethical Oncology Science S.p.A., a privately-held Italian biopharmaceutical company, for an up-front payment of $200 million. The acquisition enables Clovis to gain rights to Lucitanib, an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor (FGF) receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3).

A broad phase II program is being initiated to explore Lucitanib in multiple indications including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous NSCLC.

CLVS closed Tuesday's trading at $46.76, down 3.27%.

OncoGenex Pharmaceuticals Inc. (OGXI) expects final survival results from a phase III trial evaluating its experimental drug Custirsen in men with metastatic castrate-resistant prostate cancer by mid-2014.

In the trial dubbed, SYNERGY, enrollment was completed in 2012, and the trial is continuing as planned per the recommendation of the Independent Data Monitoring Committee.

OGXI closed Tuesday's trading at $7.31, down 2.27%.

POZEN Inc. (POZN) touched a new 52-week high of $7 on Tuesday before closing 14.58 percent higher at $6.68, following a deal for arthritis drug Vimovo delayed-release tablets.

Vimovo was co-developed by AstraZeneca and POZEN, and the drug received approval in the U.S. and EU in 2010. All along, AstraZeneca has been marketing Vimovo, and has been paying POZEN royalties on net sales of VIMOVO worldwide.

In the deal announced today, Horizon Pharma Inc. (HZNP) has acquired the U.S. rights to Vimovo from AstraZeneca. The rights to commercialize VIMOVO outside of the United States will be retained by AstraZeneca.

POZEN will continue to receive a 10% royalty on net sales of Vimovo sold in the United States, with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided no generic versions of the drug are introduced.