PHARMACY

Impax, Banner to develop two softgel capsule products

BY Allison Cerra

HAYWARD, Calif., and HIGH POINT, N.C. — Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

Impax said it has entered a deal with Banner Pharmacaps in respect to the supply and commercialization of two softgel capsule products.

The products and terms of the agreement were not disclosed.

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Watson faces patent challenge over generic Vigamox

BY Allison Cerra

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon’s Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

On Thursday, Alcon and Alcon Research filed suit against the generic drug maker in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of its patents for Vigamox.

Alcon’s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s abbreviated new drug application until Sept. 1, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

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Regeneron, Bayer commence phase-3 trial for diabetic macular edema treatment

BY Allison Cerra

TARRYTOWN, N.Y. and BERLIN — Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

The drug makers said that it would evaluate the efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular edema, a prevalent cause of vision loss among diabetes patients, after promising results from its previous clinical trial.

The first phase-3 trial, VIVID-DME, being led by Bayer HealthCare, has commenced in Australia and also will be conducted in Europe and Japan. A second study led by Regeneron, VISTA-DME, is expected to begin later in 2011 in the United States, Canada and other countries.

"Clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes," said Kemal Malik, head of global development and member of the Bayer HealthCare executive committee. "We are pleased to start a phase-3 program with VEGF Trap-Eye in DME, which may help to address this significant unmet medical need."

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