PHARMACY

Elan, Boehringer Ingelheim enter development, manufacturing agreement

BY DSN STAFF

DUBLIN — Irish biotech company Elan and German drug maker Boehringer Ingelheim will collaborate to develop and manufacture antibody-based medicines.

The two companies said BI would perform technical development, clinical manufacturing and regulatory filing support, while Elan would lead discovery, preclinical testing, clinical development and commercialization of the drugs. Financial terms of the deal were not disclosed.

“We are excited to collaborate with Boehringer Ingelheim, a highly regarded and world-class leader in biological technical development and manufacturing,” Elan SVP and head of biologic strategy, planning and operations Johannes Roebers said. “The agreement enables Elan to focus resources on discovery and the clinical progression of our science while leveraging Boehringer Ingelheim’s process development and production capabilities.”

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Mallinckrodt receives FDA approval for generic Duragesic

BY Alaric DeArment

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

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Lucentis improves vision among diabetes patients in trial

BY Allison Cerra

SOUTH SAN FRANCISCO, Calif. — Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

In its phase-3 RISE study, Genentech said diabetic macular edema patients that received monthly Lucentis (ranibizumab injection) achieved an improvement in vision at 24 months, compared with placebo.

The RISE study is one of two late-stage clinical trials that Genentech is conducting on Lucentis. The drug maker said it hopes that with results from the RISE study and the second phase-3 trial, RIDE, Lucentis can be approved for a new indication by the Food and Drug Administration.

DME is a serious complication of diabetes that affects up to 10% of people with the disease and can lead to blurred vision, severe vision loss and blindness, the drug maker said. “DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, Genentech chief medical officer and head of global product development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”

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