PHARMACY

AstraZeneca, Moderna Therapeutics to develop drugs using RNA technology

BY Alaric DeArment

NEW YORK — AstraZeneca will pay $420 million to Moderna Therapeutics in a deal to develop drugs for a variety of diseases using a technology developed by Moderna, AstraZeneca said.

The Anglo-Swedish drug maker said it would partner with Moderna to use the latter’s messenger RNA therapeutics technology to develop treatments for cardiovascular, metabolic and kidney disease, as well as cancer. The technology allows the body to produce therapeutic proteins itself, and the companies said it would open up new treatment options for diseases that can’t be addressed using existing technologies.

AstraZeneca’s payment includes $240 million upfront and $180 in milestone payments. The agreement gives AstraZeneca the option to select up to 40 drug products for clinical development, while Moderna will be entitled to development and commercial milestone payments, as well as royalties.

 

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Genzyme drug shows improvement in MS patients

BY Alaric DeArment

CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.

"These findings are important because they suggest that the benefits of Lemtrada as observed in the phase-3 studies are maintained, even though most patients did not receive further dosing," Multiple Sclerosis Clinic of Central Texas director Edward Fox said, presenting the results at the annual meeting of the American Academy of Neurology in San Diego.

 

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Ga. compounding pharmacy recalls all lots of sterile products

BY Alaric DeArment

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

The agency said the Clinical Specialties Compounding Pharmacy of Augusta, Ga., was recalling all lots of sterile products it had produced and distributed following reports of five patients diagnosed with serious eye infections after using Genentech’s drug Avastin (bevacizumab) that the pharmacy had repackaged into syringes from vials labeled as sterile. The infections, known as endophthalmitis, occur inside the eyeball and can lead to permanent loss of vision; the Centers for Disease Control and Prevention reported the infections to the FDA.

"A compromised sterile product puts patients at risk of serious infections," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "Healthcare professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered."

The products were distributed between Oct. 19, 2012 and Tuesday this week, and the FDA said healthcare providers should stop using all products that the company had produced through sterile compounding and return them.

The recall comes in the wake of a nationwide scandal involving the New England Compounding Center in which hundreds of patients contracted serious fungal meningitis after receiving injections of compounded steroids from the pharmacy, leading to dozens of deaths. An investigation of the NECC found widespread contamination and lack of attention to sanitation. The case has brought increased scrutiny among the public and policymakers to the practice of compounding, particularly sterile compounding.

 

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