PHARMACY

Santen completes Phase III testing of eye drug

BY Alaric DeArment

NEW YORK Inspire Pharmaceuticals announced Friday a $1.25 million milestone payment from Japan-based company Santen Pharmaceutical for the completion of Phase III testing of the eye drug diquafosol tetrasodium, also known as DE-089. The two companies have a collaborative agreement to develop the drug.

DE-089 is designed to treat such eye-surface diseases as dry eye. Santen expects to file for marketing approval in Japan by June, and also plans to market the drug throughout Asia. Pending approval of DE-089 by regulatory agencies, Santen will market the drug while Inspire will receive royalties on net sales.

New York-based Inspire discovers, develops and commercializes ocular and respiratory drugs. Santen specializes in ocular and anti-rheumatic drugs and had headquarters in Osaka, Japan.

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Scientific Labs shut down by the FDA

BY Drew Buono

WASHINGTON The Food and Drug Administration announced that Scientific Laboratories and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction that bars the company from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Labs is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug and Cosmetic Act. The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements.

The unapproved new drugs manufactured and marketed as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Labs against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations.

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Amgen cancer drug trials show significantly reduced fracture risk

BY Alaric DeArment

THOUSAND OAKS, Calif. Amgen’s cancer drug denosumab cuts fracture risk in cancer patients and women with postmenopausal osteoporosis, tests have shown.

According to early results released by the American Society of Clinical Oncology, the experimental cancer drug reduced fracture risk in 64 percent of the 111 patients tested, most of whom had breast and prostate tumors. Breast and prostate cancer are two types of cancer likely to spread to bones.

Results of Phase III testing of the drug released last month showed increases in bone mineral density among women with postmenopausal osteoporosis. Those tests examined 332 patients over a two-year period in which subjects received injections of denosumab twice a year.

Denosumab is a genetically engineered antibody that inhibits RANK Ligand, a protein that contributes to bone loss.

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