Watson faces patent challenge over generic Vigamox
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.
Regeneron, Bayer commence phase-3 trial for diabetic macular edema treatment
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."
NCPA to Texas government: Contain Medicaid costs by utilizing community pharmacists
ALEXANDRIA, Va. — Texas policymakers seeking to contain Medicaid costs should utilize community pharmacists to achieve both savings and optimal health outcomes, the National Community Pharmacists Association suggested on Thursday.
"Local, community pharmacists see firsthand both patients struggling to afford their medications and states grappling with significant budget deficits,” stated NCPA EVP and CEO Douglas Hoey. "Community pharmacists are leading the way to dispense lower-cost generic drugs, where appropriate for the patient, and we can work with state officials to further increase their use. In addition, pharmacists are trusted by their patients and can play a leading role to ensure proper medication use — an area estimated to have savings potential as high as $290 billion annually."
Both NCPA and the National Association of Chain Drug Stores have sent Texas leaders recommendations to help reduce Medicaid costs, while ensuring patients have continued access to their local pharmacists.
There is a concern that the state will opt to reduce dispensing reimbursements and push prescription fills toward mail order. "The truth is that the present dispensing fees paid by Medicaid to Texas pharmacies fail to cover a pharmacy’s cost of dispensing, as determined by a study conducted by the state of Texas and independently verified,” Hoey noted. “Reducing pharmacy dispensing fees would widen that gap and could force pharmacies out of the Medicaid program and reduce patient access to cost-effective treatments. Ensuring adequate dispensing fees is even more important today as Texas proceeds with its plans to reimburse pharmacies at no more than the cost they pay for medications.”