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RPRX To Meet With FDA, ANX Begins QT/QTc Trial, GEVA On Track


Oxygen Biotherapeutics Inc. (OXBT) on Monday entered into a license and supply agreement for its cosmetic product Dermacyte with the Cosmetics Division of Valor SA of Lausanne, Switzerland. The agreement calls for Valor to pay Oxygen Biotherapeutics an annual, non-refundable license fee as well as a royalty on all sales of Dermacyte when a specific agreed upon sales goal is achieved.

Repros Therapeutics Inc. (RPRX) said Monday it has requested an end of phase 2 meeting with the FDA for its vaginal Proellex program for the treatment of uterine fibroids before the end of April 2013.

RPRX closed Monday's trading 3.40% higher at $10.96.

Perrigo Co. (PRGO) on Monday completed the acquisition of Leeds, U.K.-based Rosemont Pharmaceuticals Ltd. for approximately £180 million or $283 million in cash. The deal positions Perrigo to launch multiple specialty and generic prescription liquid formulations into the U.K. and continental European markets, enhancing accessibility and affordability for international consumers.

Perrigo noted that the acquisition is anticipated to be approximately $0.24 accretive to adjusted EPS and neutral to GAAP EPS in its first 12 months post-closing and accretive to ROIC (Return on invested capital) in fiscal year 2015.

ADVENTRX Pharmaceuticals Inc. (ANX) said Monday it has commenced a QT/QTc clinical study of ANX-188, an investigational drug for sickle cell disease. The QT/QTc study determines a drug's effect on QT interval. QT prolongation is a surrogate marker for the risk of developing torsade de pointes (TdP), a rare but potentially catastrophic event in hospital settings. The company expects to announce results from the QT/QTc study in the second quarter of 2013.

The pivotal phase III trial of ANX-188, dubbed EPIC, in sickle cell disease patients is currently underway.

ANX closed Monday's trading at $0.72, down 2.03%.

Synageva BioPharma (GEVA) announced Monday it has initiated a phase III trial of Sebelipase Alfa in children and adults with late onset lysosomal acid lipase deficiency.

The trial, dubbed ARISE, will enroll 50 patients (children and adults) with late onset LAL Deficiency who will be randomized on a one-to-one basis to every other week infusions of Sebelipase Alfa (1 mg/kg), or placebo for the double-blind treatment period of 20 weeks.

GEVA closed Monday's trading 1.24% higher at $48.82.

by RTTNews Staff Writer

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